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Archive for the ‘Hypopituitarism’ Category

Diagnosis and Management of Pituitary Incidentaloma – Endocrinology Advisor

Pituitary incidentaloma is defined as a previously unsuspected pituitary lesion that is discovered on imaging study performed for an unrelated reason in a patient with no obvious symptoms to suggest pituitary disease.1,2 The incidence of these lesions is between 10% and 20% of the population and the prevalence can approach 1 in 1000 people.3,4

Pituitary adenoma is the most common incidentally found pituitary lesion, but the differential diagnosis of a pituitary lesion identified on imaging also includes Rathke cleft cyst, craniopharyngioma, meningioma, hypophysitis, or metastasis.2,5

Pituitary adenomas can be either functioning or nonfunctioning, the latter being the most common.2 Although functional tumors can be associated with significant symptoms secondary to the hormone excess, cases of nonfunctional pituitary tumors may present with symptoms related to the mass effect on surrounding structures, such as headache, visual defects, and hypopituitarism.6

The natural history of pituitary incidentalomas is not fully understood, but data suggest that most microincidentalomas (lesions <10 mm) have a benign course, whereas macroincidentalomas (10 mm) require more attention as the risk for hormone abnormalities and mass effects is higher.5

In the largest series of pituitary incidentalomas published in 2016,7 including 328 patients diagnosed with these tumors, researchers reported that most incidentalomas were pituitary adenomas (73%) and that approximately one-quarter (27%) of cases were nonpituitary sellar masses. There was no sex difference in the prevalence of these tumors. Most tumors were macroadenomas at presentation, likely because they were detected on imaging of the brain and not that of the sella, which may have missed smaller lesions.7

The most common indication for imaging in the case series was headache, which relates one of the controversial topics regarding the association between headaches and pituitary incidentalomas: considering the fact that headache may be one of the symptoms of pituitary tumors and that in some patients the headache resolves following removal of the tumor, would it be correct to classify these tumors as incidental?

Interestingly, pituitary incidentalomas in children have different patterns than those detected in the adulthood with a high prevalence of physiologic pituitary hypertrophy.8 As most incidentalomas in pediatric patients are not associated with hormonal hypersecretion or hypopiuitarism and structural progression is not common, it is believed that the extensive follow-up assessment recommended for adults might not be necessary for children.8

The Endocrine Society clinical practice guidelines for management of pituitary incidentaloma recommend completing a thorough history and physical examination, as well as laboratory evaluation for pituitary hormone excess or deficiency.1 Magnetic resonance imaging (MRI) should be completed in all cases that were initially diagnosed by computed tomography and visual field assessment is recommended in the presence of a tumor abutting the optic nerves or chiasm on MRI.1

There are different opinions on how to screen for pituitary hormone deficiencies, but as a general rule, the investigation should include measurements of total or free thyroxine, thyrotropin, cortisol, insulinlike growth factor-1 (IGF-1), luteinizing hormone and follicular-stimulating hormone (FSH) in men and postmenopausal women, and total testosterone in men.5 Stimulation tests should be performed for adrenocorticotropic hormone (ACTH) and growth hormone (GH) deficiency when baseline test results are not confirmatory.1,5 The most common deficits are GH deficiency and hypogonadism, followed by central hypothyroidism and secondary adrenal insufficiency.6

Significant hypopituitarism is not commonly seen with microincidentaloms.2 The Endocrine Society clinical practice guidelines strongly favor routine testing for hypopituitarism in macroincidentalomas and larger microincidentalomas measuring 6 to 9 mm, as asymptomatic pituitary hormone deficits are more likely to occur with larger lesions.1

As for hormone hypersecretion, it is recommended to include an assessment for prolactin, GH, and possibly ACTH hypersecretion.1 Although approximately half of pituitary incidentalomas are nonfunctional, prolactin-secreting pituitary tumors are the most common functional type.7 Elevated prolactin can indicate either direct tumor secretion or disconnection of the hypothalamus and normal pituitary gland by a large nonfunctioning pituitary mass.2 Silent somatotroph-secreting tumors are rare, but evaluation for GH excess is recommended by measurement of IGF-1 level, as treatment could reduce long-term morbidity. When clinically suspected, laboratory screening for glucocorticoid excess and Cushing syndrome is suggested.1

The available natural history data on pituitary incidentalomas are mostly derived from small-scale studies with relatively limited follow-up and the risk of developing hormonal dysfunction over longer follow-up is unknown.7 A systematic review and meta-analysis to assess the natural history of nonfunctioning pituitary adenomas revealed that tumor growth was more common in macroadenomas (12.5 per 100 person-years) and solid lesions (5.7 per 100 person-years) compared with the incidence of tumor growth in microadenomas (3.3 per 100 person-years) and cystic lesions (0.05 per 100 person-years).9

The follow-up testing of a pituitary incidentaloma is different for microincidentaloma and macroincidentaloma. For macroincidentaloma, pituitary MRI with clinical and biochemical testing for hypopituitarism should be completed at 6 months after the initial diagnosis and then yearly for several years, with visual field assessment if the tumor enlarges to abut or compress the optic nerves or chiasm. For microincidentaloma, MRI should be performed at 12 months after the initial diagnosis, but there is no need to test for hypopituitarism if there was no change in the clinical and radiographic features.1

Surgical intervention should be recommended for cases of hypersecreting tumors other than prolactinomas, pituitary apoplexy with visual disturbances, lesions abutting or compressing the optic nerves or chiasm on MRI, or in the presence of visual field deficit or other visual abnormalities due to the lesion.1 Surgical resection of nonfunctioning microadenomas is not indicated as tumor growth is rare, with less than 5% growing significantly during long-term follow-up.6

Medical treatment for pituitary incidentaloma may include dopamine agonist therapy for patients with prolactinoma. In some cases of pituitary incidentaloma, somatostatin analogues may be used, but there are limited data on the use of medical therapy for these tumors.1

References

1. Freda PU, Beckers AM, Katznelson L, et al. Pituitary incidentaloma: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2011;96(4):894-904.

2. Bevan JS. Pituitary incidentaloma. Clin Med J R Coll Physicians London. 2013;13(3):296-298.

3. Ezzat S, Asa SL, Couldwell WT, et al. The prevalence of pituitary adenomas: a systematic review. Cancer. 2004;101(3):613-619.

4. Scangas GA, Laws ER. Pituitary incidentalomas. Pituitary. 2014;17(5):486-491.

5. Boguszewski CL, de Castro Musolino NR, Kasuki L. Management of pituitary incidentaloma. Best Pract Res Clin Endocrinol Metab. 2019;33(2):101268.

6. Esposito D, Olsson DS, Ragnarsson O, Buchfelder M, Skoglund T, Johannsson G. Non-functioning pituitary adenomas: indications for pituitary surgery and post-surgical management. Pituitary. 2019;22(4):422-434.

7. Imran SA, Yip C-E, Papneja N, et al. Analysis and natural history of pituitary incidentalomas. Eur J Endocrinol. 2016;175(1):1-9.

8. Souteiro P, Maia R, Santos-Silva R, et al. Pituitary incidentalomas in paediatric age are different from those described in adulthood. Pituitary. 2019;22(2):124-128.

9. Fernndez-Balsells MM, Murad MH, Barwise A, et al. Natural history of nonfunctioning pituitary adenomas and incidentalomas: a systematic review and metaanalysis. J Clin Endocrinol Metab. 2011;96(4):905-912.

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Diagnosis and Management of Pituitary Incidentaloma - Endocrinology Advisor

Male Hypogonadism Market Future Aspect Analysis and Current Trends by 2017 to 2025 – 3rd Watch News

Global Male Hypogonadism Market: Snapshot

Hypogonadism in males refers to a condition in the male body where the testes show a significantly reduced level of functioning than normal. The overall result of male hypogonadism is a reduction in the rate of biosynthesis of male sex hormones. This state is more commonly known as interrupted stage 1 puberty. Hypoandrogenism, or the low androgen or testosterone level in a male can vary in severity from person to person. It is often the cause of partial or complete infertility. There are multiple forms of male hypogonadism and even more ways to classify them. Most endocrinologists commonly classify male hypogonadism on the basis of the level of defectiveness of the male reproductive system.

In many cases, doctors also measure the level of gonadotropins to classify a patient between primary and secondary male hypogonadism. Primary male hypogonadism refers to the cause of the condition being due to defective gonads. There are different types of primary male hypogonadism, including Turner syndrome and Klinefelter syndrome. Secondary male hypogonadism is caused by defects in pituitary or hypothalamic glands. They include Kallmann syndrome and hypopituitarism.

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Global Male Hypogonadism Market: Overview

Male Hypogonadism refers to a clinical condition, wherein the testes fail to produce enough testosterone leading to delayed puberty or incomplete development. The condition is related to impaired development of muscle mass, development of breast tissues, impaired body hair growth, and lack of deepening of the voice.

The male Hypogonadism market can be segmented by therapy, type, drug delivery, and geography.

The report presents an in-depth analysis of the global male hypogonadism market with current trends and future estimates to explain the imminent investment pockets. The quantitative analysis of the market for the forecast period from 2017 to 2025 will enable stakeholders to capitalize on the prevailing growth opportunities.

Global Male Hypogonadism Market: Trends and Opportunities

The top driver of the male hypogonadism market includes rising prevalence of testosterone deficiency among men, increasing infertility rates, and increasing awareness among individuals about hypogonadism treatment due to awareness drives organized by several governments across the world. Moreover, high risk of hypogonadism among the geriatric population with obesity and diabetes, and increasing prevalence of chronic disorders among the geriatrics are further expected to boost the markets growth.

However, factors such as high side effects of testosterone products are challenging the growth of testosterone replacement therapy market. Top players in the market are focused on research and development to introduce newer products with fewer or negligible side effects and improved results. For example, LPCN 1111, a product which is under development from Lipocine Inc., is a newer testosterone prodrug that utilizes Lipral technology for enhanced systemic absorption and for enhanced solubility of testosterone. Nevertheless, technological advancements are anticipated to extend new opportunities to the markets growth.

Global Male Hypogonadism Market: Regional Overview

The global male Hypogonadism market can be analyzed with respect to the regional segments of North America, Asia Pacific, Europe, Latin America, and the Middle East and Africa. North America held the majority share of the global market in the recent past and is expected to retain its dominant position in the near future. This is mainly due to the rise in the number of individuals suffering from primary and secondary conditions of hypogonadism, and rising awareness among individuals about treatment options for the condition. Moreover, the presence of ultra-modern healthcare infrastructure and increasing popularity of technologically advanced products are expected to offer new opportunities for top players in this market. The region is closely followed by Europe.

Asia Pacific is expected to offer lucrative opportunities to this market due to the modernization of the healthcare infrastructure in the emerging economies of India and China and the increasing awareness about the treatment for the condition. In Asia Pacific, the increasing prevalence of hypogonadism and infertility rates along with the rising geriatric population base with diabetes and obesity are propelling the growth of this market. China, Taiwan, and Malaysia are some of the countries that display the highest rate of male hypogonadism.

Major Companies Mentioned in Report

Some of the key players in the male Hypogonadism market include AbbVie Inc., Astrazeneca plc, Eli Lilly and Company Ltd., Merck & Co. Inc., SA, Finox Biotech, Laboratories Genevrier, Teva Pharmaceutical Industries Ltd., Allergan plc, Bayer AG, Endo International plc, IBSA Institut Biochimque, and Ferring.

Key players are focused on product approval for growth considerations and to cater to the changing demand of the industry. The introduction of innovative and technologically advanced products is also the focus of key players to increase their market share and for serving patients in a better manner.

Read Comprehensive Overview of Report @https://www.tmrresearch.com/male-hypogonadism-market

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Male Hypogonadism Market Future Aspect Analysis and Current Trends by 2017 to 2025 - 3rd Watch News

Breakthrough Innovation in Cancer Care From EMD Serono Pipeline to Be Presented at ASCO 2020 – PRNewswire

Not intended for UK-based media

- Results from two studies of BAVENCIOto be featured in ASCO press briefing

- Primary efficacy, biomarker and HRQoL analyses for tepotinib, the first MET inhibitor to have received a regulatory approval for NSCLC with METgene alterations

- Two-year follow-up for first-in-class bifunctional immunotherapy bintrafusp alfatargeting TGF-/PD-L1, in second-line NSCLC

ROCKLAND,Massachusetts, May 13, 2020 /PRNewswire/ --EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada,today announced data for its innovative investigational agents and investigational uses of marketed medicines to be presented at the American Society of Clinical Oncology (ASCO) ASCO20 Virtual Scientific Program, to be held virtually from May 29-31.

This year, ASCO will be highlightingduring its embargoed presscast on Tuesday, May 26 and at the plenary session on Sunday, May 31the Phase III JAVELIN Bladder 100 study (Abstract# LBA1) of BAVENCIO (avelumab) in the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC)*. Additional data will be presented for early- to late-stage molecules discovered and developed in-house that demonstrate the Company's commitment and relentless drive to discover, develop and deliver innovative treatment options in its hope to turn cancer patients into cancer survivors. Research from several investigator-sponsored and collaborative research studies also will be shared. This includes a late-breaking oral presentation of results of the investigator-sponsored, multicenter Phase II TROPHIMMUN study of avelumab for the treatment of chemotherapy-resistant gestational trophoblastic tumors (Cohort A), which also will be featured in the ASCO press program (Abstract# LBA6008).

"Despite the many advances in cancer treatment, we have an urgency to continue to discover and develop innovative treatment options that will have a major impact on the lives of people living with cancer,"said Luciano Rossetti, Global Head of Research & Development for EMD Serono. "Taking on this challenge, we've applied our deep knowledge of cancer biology to highly focused areas to develop the first-in-class oral MET inhibitor, tepotinib, which received the first approval anywhere in the world for the treatment of NSCLC with MET gene alterations, and our first-in-class bifunctional fusion protein immunotherapy, bintrafusp alfa, both of which have promising outcomes featured at this year's ASCO meeting."

For tepotinib, approved in Japan for the treatment of patients withunresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with METexon 14 (METex14)skipping alterationsand the first oral MET inhibitor indicated for the treatment of advanced NSCLC harboring MET gene alterations to receive a regulatory approval, data will be presented from the primary analysis of the VISION study with promising activity in patients with advanced EGFR/ALK wild-type, METex14 skipping NSCLC who were prospectively enrolled using liquid biopsy or tissue biopsy. Results (Abstract #9556) include6-month follow-updata for the primary endpoint of objective response rate (ORR) as determined by independent review committee. Secondary endpoints include ORR as assessed by investigators, duration of response, disease control rate, progression-free survival, molecular responses, and safety data. Additionally, patient-reported outcomes (PROs) of health-related quality of life (HRQoL) for the VISION study will be presented at the meeting (Abstract# 9575). These outcomes are the first time HRQoL have been reported for patients with METex14skipping NSCLC.

For bintrafusp alfa, a novel bifunctional fusion protein targeting TGF- and PD-L1, two-year follow-up data from a global Phase I study in second-line NSCLC will be presented (Abstract# 9558). These data continue to show manageable safety with durable responses and encouraging long-term survival, especially in patients with high PD-L1 expression (80%). The overall safety profile has remained consistent since the interim analysis, with no new safety signals or deaths and one additional treatment-related discontinuation (blood alkaline phosphatase increased). Studies in the bintrafusp alfa lung cancer program include:

The Company's broad portfolio of investigational DNA damage response (DDR) inhibitors represents multiple development paths, including combinations with other agents and modalities. A trial-in-progress poster (Abstract #TPS4117) will review a multicenter Phase Ib/II study evaluating the safety, tolerability, pharmacokinetics and efficacy of the DNA-PK inhibitor peposertib (formerly M3814) in combination with capecitabine and radiotherapy as neoadjuvant treatment in patients with locally advanced rectal cancer.

*BAVENCIO is under clinical investigation for the first-line maintenance treatment of advanced UC. There is no guarantee that BAVENCIO will be approved for first-line maintenance treatment of advanced UC by any health authority worldwide.

Tepotinib is currently under clinical investigation in NSCLC and not yet approved in any markets outside of Japan.

Bintrafusp alfa is currently under clinical investigation and not approved for any use anywhere in the world.

About BAVENCIO (avelumab)

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.10-12 In November 2014, Merck KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications

BAVENCIO (avelumab) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

BAVENCIO Important Safety Information from the US FDA-Approved Label

BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis, and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can cause hepatotoxicity and immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis occurred with BAVENCIO as a single agent in 0.9% of patients, including two (0.1%) patients with Grade 5, and 11 (0.6%) with Grade 3.

BAVENCIO in combination with axitinib can cause hepatotoxicity with higher than expected frequencies of Grade 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used as monotherapy. Withhold BAVENCIO and axitinib for moderate (Grade 2) hepatotoxicity and permanently discontinue the combination for severe or life-threatening (Grade 3 or 4) hepatotoxicity. Administer corticosteroids as needed. In patients treated with BAVENCIO in combination with axitinib, Grades 3 and 4 increased ALT and AST occurred in 9% and 7% of patients, respectively, and immune-mediated hepatitis occurred in 7% of patients, including 4.9% with Grade 3 or 4.

BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis until resolution. Permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon reinitiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% of patients, including seven (0.4%) with Grade 3.

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% of patients, including one (0.1%) with Grade 3.

Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders. Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis, were reported in 6% of patients, including three (0.2%) with Grade 3.

Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer antihyperglycemics or insulin in patients with severe or life-threatening (Grade 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% of patients, including two cases of Grade 3 hyperglycemia.

BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy, if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO as a single agent or in 489 patients who received BAVENCIO in combination with axitinib: myocarditis including fatal cases, pancreatitis including fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barr syndrome, and systemic inflammatory response.

BAVENCIO can cause severe or life-threatening infusion-related reactions. Premedicate patients with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent infusions based upon clinical judgment and presence/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO in combination with axitinib can cause major adverse cardiovascular events (MACE) including severe and fatal events. Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue BAVENCIO and axitinib for Grade 3-4 cardiovascular events. MACEoccurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with axitinib compared to 3.4% treated with sunitinib. These events included death due to cardiac events (1.4%), Grade 3-4 myocardial infarction (2.8%), and Grade 3-4 congestive heart failure (1.8%).

BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine aminotransferase (20%).

The most common adverse reactions (all grades, 20%) in patients with locally advanced or metastatic urothelial carcinoma (UC) were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%), and urinary tract infection (21%).

Selected laboratory abnormalities (Grades 3-4, 3%) in patients with locally advanced or metastatic UC were hyponatremia (16%), increased gamma-glutamyltransferase (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%).

Fatal adverse reactions occurred in 1.8% of patients with advanced renal cell carcinoma (RCC) receiving BAVENCIO in combination with axitinib. These included sudden cardiac death (1.2%), stroke (0.2%), myocarditis (0.2%), and necrotizing pancreatitis (0.2%).

The most common adverse reactions (all grades, 20%) in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were diarrhea (62% vs 48%), fatigue (53% vs 54%), hypertension (50% vs 36%), musculoskeletal pain (40% vs 33%), nausea (34% vs 39%), mucositis (34% vs 35%), palmar-plantar erythrodysesthesia (33% vs 34%), dysphonia (31% vs 3.2%), decreased appetite (26% vs 29%), hypothyroidism (25% vs 14%), rash (25% vs 16%), hepatotoxicity (24% vs 18%), cough (23% vs 19%), dyspnea (23% vs 16%), abdominal pain (22% vs 19%), and headache (21% vs 16%).

Selected laboratory abnormalities (all grades, 20%) worsening from baseline in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were blood triglycerides increased (71% vs 48%), blood creatinine increased (62% vs 68%), blood cholesterol increased (57% vs 22%), alanine aminotransferase increased (ALT) (50% vs 46%), aspartate aminotransferase increased (AST) (47% vs 57%), blood sodium decreased (38% vs 37%), lipase increased (37% vs 25%), blood potassium increased (35% vs 28%), platelet count decreased (27% vs 80%), blood bilirubin increased (21% vs 23%), and hemoglobin decreased (21% vs 65%).

Please see full US Prescribing Information and Medication Guide available at http://www.BAVENCIO.com.

About tepotinib

Tepotinib is an oral MET inhibitor that is designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations, including both METex14 skipping alterations and MET amplifications, or MET protein overexpression. Discovered in-house at Merck KGaA, Darmstadt, Germany, it has been designed to have a highly selective mechanism of action,7 with the potential to improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations.Tepotinibis currently under clinical investigation in NSCLC and not yet approved in any markets outside of Japan.Merck KGaA, Darmstadt, Germany is actively assessing the potential of investigating tepotinib in combination with novel therapies and in other tumor indications. Tepotinib is approved under the brand name TEPMETKO in Japan for the treatment of unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping alterations. The brand name TEPMETKO is not approved for use outside of Japan.

About bintrafusp alfa

Bintrafusp alfa (M7824), discovered in-house at Merck KGaA, Darmstadt, Germany, is a potential first-in-class investigational bifunctional fusion protein designed to simultaneously block two immunosuppressive pathways, TGF- and PD-L1, within the tumor microenvironment. This bifunctional approach is thought to control tumor growth by potentially restoring and enhancing anti-tumor responses.In preclinical studies, bintrafusp alfa has demonstrated antitumor activity both as monotherapy and in combination with chemotherapy. Based on its mechanism of action, bintrafusp alfa offers a potential targeted approach to addressing the underlying pathophysiology of difficult-to-treat cancers.

[emailprotected] is the global clinical trial program investigating the potential co-localized, dual inhibition of TGF- and PD-L1 with bintrafusp alfa (M7824) in multiple tumor types. Current clinical trial information can be found on the [emailprotected] website at http://www.intrapidclinicaltrials.com. To date, more than 850 patients with various types of solid tumors have been treated globally in the bintrafusp alfa [emailprotected] clinical development program.

All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to http://www.emdgroup.com/subscribeto register for your online subscription of this service as our geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

About EMD Serono, Inc.

EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt,Germany in the U.S. andCanada- is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state ofMassachusetts.www.emdserono.com.

About Merck KGaA, Darmstadt, Germany

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany generated sales of 16.2 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

Contacts:

Media: Julissa Viana 781 206 5795

Investor Relations +49 6151 72-3321

SOURCE EMD Serono

See the rest here:
Breakthrough Innovation in Cancer Care From EMD Serono Pipeline to Be Presented at ASCO 2020 - PRNewswire

Breakthrough Innovation in Cancer Care From EMD Serono Pipeline to Be Presented at ASCO 2020 – WFMZ Allentown

Not intended for UK-based media

- Results from two studies of BAVENCIOto be featured in ASCO press briefing

- Primary efficacy, biomarker and HRQoL analyses for tepotinib, the first MET inhibitor to have received a regulatory approval for NSCLC with METgene alterations

- Two-year follow-up for first-in-class bifunctional immunotherapy bintrafusp alfatargeting TGF-/PD-L1, in second-line NSCLC

ROCKLAND,Massachusetts, May 13, 2020 /PRNewswire/ --EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada,today announced data for its innovative investigational agents and investigational uses of marketed medicines to be presented at the American Society of Clinical Oncology (ASCO) ASCO20 Virtual Scientific Program, to be held virtually from May 29-31.

This year, ASCO will be highlightingduring its embargoed presscast on Tuesday, May 26 and at the plenary session on Sunday, May 31the Phase III JAVELIN Bladder 100 study (Abstract# LBA1) of BAVENCIO (avelumab) in the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC)*. Additional data will be presented for early- to late-stage molecules discovered and developed in-house that demonstrate the Company's commitment and relentless drive to discover, develop and deliver innovative treatment options in its hope to turn cancer patients into cancer survivors. Research from several investigator-sponsored and collaborative research studies also will be shared. This includes a late-breaking oral presentation of results of the investigator-sponsored, multicenter Phase II TROPHIMMUN study of avelumab for the treatment of chemotherapy-resistant gestational trophoblastic tumors (Cohort A), which also will be featured in the ASCO press program (Abstract# LBA6008).

"Despite the many advances in cancer treatment, we have an urgency to continue to discover and develop innovative treatment options that will have a major impact on the lives of people living with cancer,"said Luciano Rossetti, Global Head of Research & Development for EMD Serono. "Taking on this challenge, we've applied our deep knowledge of cancer biology to highly focused areas to develop the first-in-class oral MET inhibitor, tepotinib, which received the first approval anywhere in the world for the treatment of NSCLC with MET gene alterations, and our first-in-class bifunctional fusion protein immunotherapy, bintrafusp alfa, both of which have promising outcomes featured at this year's ASCO meeting."

For tepotinib, approved in Japan for the treatment of patients withunresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with METexon 14 (METex14)skipping alterationsand the first oral MET inhibitor indicated for the treatment of advanced NSCLC harboring MET gene alterations to receive a regulatory approval, data will be presented from the primary analysis of the VISION study with promising activity in patients with advanced EGFR/ALK wild-type, METex14 skipping NSCLC who were prospectively enrolled using liquid biopsy or tissue biopsy. Results (Abstract #9556) include6-month follow-updata for the primary endpoint of objective response rate (ORR) as determined by independent review committee. Secondary endpoints include ORR as assessed by investigators, duration of response, disease control rate, progression-free survival, molecular responses, and safety data. Additionally, patient-reported outcomes (PROs) of health-related quality of life (HRQoL) for the VISION study will be presented at the meeting (Abstract# 9575). These outcomes are the first time HRQoL have been reported for patients with METex14skipping NSCLC.

For bintrafusp alfa, a novel bifunctional fusion protein targeting TGF- and PD-L1, two-year follow-up data from a global Phase I study in second-line NSCLC will be presented (Abstract# 9558). These data continue to show manageable safety with durable responses and encouraging long-term survival, especially in patients with high PD-L1 expression (80%). The overall safety profile has remained consistent since the interim analysis, with no new safety signals or deaths and one additional treatment-related discontinuation (blood alkaline phosphatase increased). Studies in the bintrafusp alfa lung cancer program include:

The Company's broad portfolio of investigational DNA damage response (DDR) inhibitors represents multiple development paths, including combinations with other agents and modalities. A trial-in-progress poster (Abstract #TPS4117) will review a multicenter Phase Ib/II study evaluating the safety, tolerability, pharmacokinetics and efficacy of the DNA-PK inhibitor peposertib (formerly M3814) in combination with capecitabine and radiotherapy as neoadjuvant treatment in patients with locally advanced rectal cancer.

*BAVENCIO is under clinical investigation for the first-line maintenance treatment of advanced UC. There is no guarantee that BAVENCIO will be approved for first-line maintenance treatment of advanced UC by any health authority worldwide.

Tepotinib is currently under clinical investigation in NSCLC and not yet approved in any markets outside of Japan.

Bintrafusp alfa is currently under clinical investigation and not approved for any use anywhere in the world.

About BAVENCIO (avelumab)

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.10-12 In November 2014, Merck KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications

BAVENCIO (avelumab) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

BAVENCIO Important Safety Information from the US FDA-Approved Label

BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis, and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can cause hepatotoxicity and immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis occurred with BAVENCIO as a single agent in 0.9% of patients, including two (0.1%) patients with Grade 5, and 11 (0.6%) with Grade 3.

BAVENCIO in combination with axitinib can cause hepatotoxicity with higher than expected frequencies of Grade 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used as monotherapy. Withhold BAVENCIO and axitinib for moderate (Grade 2) hepatotoxicity and permanently discontinue the combination for severe or life-threatening (Grade 3 or 4) hepatotoxicity. Administer corticosteroids as needed. In patients treated with BAVENCIO in combination with axitinib, Grades 3 and 4 increased ALT and AST occurred in 9% and 7% of patients, respectively, and immune-mediated hepatitis occurred in 7% of patients, including 4.9% with Grade 3 or 4.

BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis until resolution. Permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon reinitiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% of patients, including seven (0.4%) with Grade 3.

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% of patients, including one (0.1%) with Grade 3.

Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders. Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis, were reported in 6% of patients, including three (0.2%) with Grade 3.

Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer antihyperglycemics or insulin in patients with severe or life-threatening (Grade 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% of patients, including two cases of Grade 3 hyperglycemia.

BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy, if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO as a single agent or in 489 patients who received BAVENCIO in combination with axitinib: myocarditis including fatal cases, pancreatitis including fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barr syndrome, and systemic inflammatory response.

BAVENCIO can cause severe or life-threatening infusion-related reactions. Premedicate patients with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent infusions based upon clinical judgment and presence/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO in combination with axitinib can cause major adverse cardiovascular events (MACE) including severe and fatal events. Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue BAVENCIO and axitinib for Grade 3-4 cardiovascular events. MACEoccurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with axitinib compared to 3.4% treated with sunitinib. These events included death due to cardiac events (1.4%), Grade 3-4 myocardial infarction (2.8%), and Grade 3-4 congestive heart failure (1.8%).

BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine aminotransferase (20%).

The most common adverse reactions (all grades, 20%) in patients with locally advanced or metastatic urothelial carcinoma (UC) were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%), and urinary tract infection (21%).

Selected laboratory abnormalities (Grades 3-4, 3%) in patients with locally advanced or metastatic UC were hyponatremia (16%), increased gamma-glutamyltransferase (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%).

Fatal adverse reactions occurred in 1.8% of patients with advanced renal cell carcinoma (RCC) receiving BAVENCIO in combination with axitinib. These included sudden cardiac death (1.2%), stroke (0.2%), myocarditis (0.2%), and necrotizing pancreatitis (0.2%).

The most common adverse reactions (all grades, 20%) in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were diarrhea (62% vs 48%), fatigue (53% vs 54%), hypertension (50% vs 36%), musculoskeletal pain (40% vs 33%), nausea (34% vs 39%), mucositis (34% vs 35%), palmar-plantar erythrodysesthesia (33% vs 34%), dysphonia (31% vs 3.2%), decreased appetite (26% vs 29%), hypothyroidism (25% vs 14%), rash (25% vs 16%), hepatotoxicity (24% vs 18%), cough (23% vs 19%), dyspnea (23% vs 16%), abdominal pain (22% vs 19%), and headache (21% vs 16%).

Selected laboratory abnormalities (all grades, 20%) worsening from baseline in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were blood triglycerides increased (71% vs 48%), blood creatinine increased (62% vs 68%), blood cholesterol increased (57% vs 22%), alanine aminotransferase increased (ALT) (50% vs 46%), aspartate aminotransferase increased (AST) (47% vs 57%), blood sodium decreased (38% vs 37%), lipase increased (37% vs 25%), blood potassium increased (35% vs 28%), platelet count decreased (27% vs 80%), blood bilirubin increased (21% vs 23%), and hemoglobin decreased (21% vs 65%).

Please see full US Prescribing Information and Medication Guide available at http://www.BAVENCIO.com.

About tepotinib

Tepotinib is an oral MET inhibitor that is designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations, including both METex14 skipping alterations and MET amplifications, or MET protein overexpression. Discovered in-house at Merck KGaA, Darmstadt, Germany, it has been designed to have a highly selective mechanism of action,7 with the potential to improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations.Tepotinibis currently under clinical investigation in NSCLC and not yet approved in any markets outside of Japan.Merck KGaA, Darmstadt, Germany is actively assessing the potential of investigating tepotinib in combination with novel therapies and in other tumor indications. Tepotinib is approved under the brand name TEPMETKO in Japan for the treatment of unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping alterations. The brand name TEPMETKO is not approved for use outside of Japan.

About bintrafusp alfa

Bintrafusp alfa (M7824), discovered in-house at Merck KGaA, Darmstadt, Germany, is a potential first-in-class investigational bifunctional fusion protein designed to simultaneously block two immunosuppressive pathways, TGF- and PD-L1, within the tumor microenvironment. This bifunctional approach is thought to control tumor growth by potentially restoring and enhancing anti-tumor responses.In preclinical studies, bintrafusp alfa has demonstrated antitumor activity both as monotherapy and in combination with chemotherapy. Based on its mechanism of action, bintrafusp alfa offers a potential targeted approach to addressing the underlying pathophysiology of difficult-to-treat cancers.

INTR@PID is the global clinical trial program investigating the potential co-localized, dual inhibition of TGF- and PD-L1 with bintrafusp alfa (M7824) in multiple tumor types. Current clinical trial information can be found on the INTR@PID website at http://www.intrapidclinicaltrials.com. To date, more than 850 patients with various types of solid tumors have been treated globally in the bintrafusp alfa INTR@PID clinical development program.

All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to http://www.emdgroup.com/subscribeto register for your online subscription of this service as our geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

About EMD Serono, Inc.

EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt,Germany in the U.S. andCanada- is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state ofMassachusetts.www.emdserono.com.

About Merck KGaA, Darmstadt, Germany

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany generated sales of 16.2 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

Contacts:

Media:Julissa Viana781 206 5795

Investor Relations+49 6151 72-3321

Originally posted here:
Breakthrough Innovation in Cancer Care From EMD Serono Pipeline to Be Presented at ASCO 2020 - WFMZ Allentown

Hypopituitarism | Endocrine Society

What is hypopituitarism?

Hypopituitarism (also called pituitary insufficiency) is a rare condition in which your pituitary gland doesn't make enough of certain hormones. Your body can't work properly when important glands, such as your thyroid glandand adrenal gland, don't get the hormones they need from your pituitary gland. Hypopituitarism can develop very slowly, over several months or even over several years.

Hypopituitarism can be caused by:

Sometimes, the cause is unknown.

Symptoms can include one or more of the following:

Your doctor will check your hormone levels with blood tests. You may have other tests, such as an MRI of your pituitary gland, to help find the cause of your hypopituitarism.

Treatment usually includes taking the hormones you're missing, sometimes for life. Your doctor also will teach you how to take extra cortisone (a hormone) when you are sick or under stress. If a tumor is causing your hypopituitarism, you might need surgery to remove it and/or possibly radiation treatment. If needed, you can take medicine for infertility.

You will need to get regular check-ups. It's wise to wear medical identification, such as a bracelet or pendant, which provides information about your condition in case of an emergency.

You can expect a normal life span, as long as you regularly take the medications recommended by your doctor.

Editor(s): Craig Alter, M.D., Anne Klibanski, M.D., Janet Schlechte, M.D.

Last Updated: November 2017

More:
Hypopituitarism | Endocrine Society

Certain Types of Steroids Could Increase the Risk of Coronavirus – Myhealthyclick

A new study, published online last week in the Journal ofClinical Endocrinology & Metabolism, has found that certain steroids usedfor the treatment of inflammatory conditions such as allergies, asthma, andarthritis could increase the risk of COVID-19, the disease caused by the novelcoronavirus.

Certain types of steroids, such as glucocorticoids, suppressthe immune system, making people vulnerable to catch the virus.

Researchers explained that people who take glucocorticoidsmay also have severe illnesses if they are infected by the new coronavirusbecause the drugs suppress the bodys steroid response to the infection.

The journals editor-in-chief Dr. Paul Stewart of theUniversity of Leeds, England, and deputy editors Dr. Ursula Kaiser of Brighamand Womens Hospital in Boston and Dr. Raghavendra Mirmira of the University ofChicago conducted the study.

The researchers said, People with primary adrenalinsufficiency (Addisons disease) and secondary adrenal insufficiency occurringin hypopituitarism should also take extra precautions.

Patients should increase their oral glucocorticoid dose bytwice if they experience symptoms such as fever and persistent dry cough. Theyshould continue doing so until the fever subsides. If their condition worsens,they will require injectable glucocorticoids.

The authors wrote, People with diabetes who contractCOVID-19 also appear to be at risk of more severe illness than those withoutdiabetes.

Studies from Wuhan, China, the epicenter of the coronavirusoutbreak, found that COVID-19 patients with hypertension and diabetes were atincreased risk of severe illness and death.

Dr. Stewart and his team wrote, In our professional lives,we have not witnessed a health care crisis of this magnitude and severity.

They also noted that scientists have learned how the novelcoronavirus enters the cells and how it spreads from person to person.

Some researchers have even found how the virus interactswith the endocrine system. The authors wrote, Endocrine-related targets are at theforefront of discovery science as we collectively tackle this pandemic.

Continued here:
Certain Types of Steroids Could Increase the Risk of Coronavirus - Myhealthyclick

EMD Serono and Pfizer Receive US FDA Breakthrough Therapy Designation and Submit Application for BAVENCIO for First-Line Maintenance Treatment of…

Not intended for UK-based media

ROCKLAND, Mass. and NEW YORK, April 9, 2020 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced completion of the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for BAVENCIO (avelumab)* for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). The FDA granted Breakthrough Therapy Designation to BAVENCIO for this indication, and the sBLA is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program.

The application is based on positive results from an interim analysis of the Phase III JAVELIN Bladder 100 trial, which met its primary endpoint of overall survival (OS). In this study, BAVENCIO plus best supportive care (BSC) as first-line maintenance therapy significantly extended the survival of patients with previously untreated locally advanced or metastatic UC whose disease did not progress on induction chemotherapy, compared with BSC only. A statistically significant improvement was demonstrated in both co-primary populations: all randomized patients and patients with PD-L1positive tumors. The safety profile for BAVENCIO in the trial was consistent with that in the JAVELIN monotherapy clinical development program. Detailed results from the JAVELIN Bladder 100 study will be presented at an upcoming medical congress.

"BAVENCIO is the first immunotherapy to demonstrate a statistically significant improvement in overall survival in a Phase III clinical trial in the first-line setting for patients with locally advanced or metastatic urothelial carcinoma," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. "Participation in the Real-Time Oncology Review program, coupled with the Breakthrough Therapy Designation, reflect the potential impact of BAVENCIO in this patient setting and provide the opportunity to work towards bringing this treatment option to patients as quickly as possible."

The RTOR program is intended to create a more efficient review process to bring safe and effective treatments to patients earlier, including drugs that are likely to demonstrate substantial improvements over currently available therapy. It allows the FDA to review clinical trial data from certain applications before the complete application is formally submitted. Review under the program does not guarantee or influence the approvability of the application.1

Breakthrough Therapy Designation is a program created by the FDA to accelerate the development and review of medicines intended to treat serious or life-threatening diseases where the new treatment may be a substantial improvement over available therapy. In order to receive Breakthrough Therapy Designation, preliminary clinical evidence must indicate that the drug may demonstrate a significant improvement over available therapy on a clinically significant endpoint.2

"Given the poor prognosis for patients with advanced urothelial carcinoma, there is an urgent need for additional treatment options that improve overall survival," said Luciano Rossetti, Head of Global R&D for EMD Serono. "Our data highlight the potential for a first-line maintenance treatment approach with BAVENCIO to advance the current standard of care for previously untreated patients, and we are working with urgency toward our goal of bringing this regimen to patients."

"For the past 30 years, chemotherapy has been the first-line standard of care for patients with advanced urothelial carcinoma. While this is an effective short-term option for many patients, most will ultimately experience disease progression, underscoring a need for additional treatment options," said Petros Grivas, M.D., Ph.D., one of the principal investigators in the JAVELIN Bladder 100 trial. "Based on the positive overall survival results from JAVELIN Bladder 100, I believe avelumab has the potential to be practice-changing."

In 2017, the FDA approved BAVENCIO for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response and duration of response. JAVELIN Bladder 100 is the confirmatory study for the conversion to full approval.

*BAVENCIO is under clinical investigation for the first-line maintenance treatment of advanced UC. There is no guarantee that BAVENCIO will be approved for first-line maintenance treatment of advanced UC by any health authority worldwide.

About JAVELIN Bladder 100JAVELIN Bladder 100 (NCT02603432) is a Phase III, multicenter, multinational, randomized, open-label, parallel-arm study investigating first-line maintenance treatment with BAVENCIO plus BSC versus BSC alone in patients with locally advanced or metastatic UC. A total of 700 patients whose disease had not progressed after platinum-based induction chemotherapy as per RECIST v1.1 were randomized to receive either BAVENCIO plus BSC or BSC alone. The study achieved its primary endpoint of OS in each of the co-primary populations of all randomized patients and patients with PD-L1-positive tumors. Secondary endpoints include progression-free survival, anti-tumor activity, safety, pharmacokinetics, immunogenicity, predictive biomarkers and patient-reported outcomes in the co-primary populations. The safety profile for BAVENCIO in the trial was consistent with that in the JAVELIN monotherapy clinical development program.

About Urothelial Carcinoma Bladder cancer is the tenth most common cancer worldwide.3 In 2018, there were over half a million new cases of bladder cancer diagnosed, with around 200,000 deaths from the disease globally.3 UC accounts for about 90% of all bladder cancers.4 This subtype becomes harder to treat as it advances, spreading through the layers of the bladder wall.5 For patients with metastatic UC, the five-year relative survival rate is 5%.6 Combination chemotherapy is currently the first-line standard of care for patients with advanced disease, and while a majority of patients experience high initial response rates, most patients will ultimately experience disease progression within nine months after initiation of treatment.7,8 Given the poor prognosis for patients with advanced bladder cancer whose disease progresses after first-line chemotherapy, there is an urgent need for additional treatment options that improve overall survival.9

About BAVENCIO (avelumab)BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.10-12 In November 2014, Merck KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications BAVENCIO (avelumab) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

BAVENCIO Important Safety Information from the US FDA-Approved LabelBAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis, and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can cause hepatotoxicity and immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis occurred with BAVENCIO as a single agent in 0.9% of patients, including two (0.1%) patients with Grade 5, and 11 (0.6%) with Grade 3.

BAVENCIO in combination with axitinib can cause hepatotoxicity with higher than expected frequencies of Grade 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used as monotherapy. Withhold BAVENCIO and axitinib for moderate (Grade 2) hepatotoxicity and permanently discontinue the combination for severe or life-threatening (Grade 3 or 4) hepatotoxicity. Administer corticosteroids as needed. In patients treated with BAVENCIO in combination with axitinib, Grades 3 and 4 increased ALT and AST occurred in 9% and 7% of patients, respectively, and immune-mediated hepatitis occurred in 7% of patients, including 4.9% with Grade 3 or 4.

BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis until resolution. Permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon reinitiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% of patients, including seven (0.4%) with Grade 3.

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% of patients, including one (0.1%) with Grade 3.

Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders. Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis, were reported in 6% of patients, including three (0.2%) with Grade 3.

Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer antihyperglycemics or insulin in patients with severe or life-threatening (Grade 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% of patients, including two cases of Grade 3 hyperglycemia.

BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy, if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO as a single agent or in 489 patients who received BAVENCIO in combination with axitinib: myocarditis including fatal cases, pancreatitis including fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barr syndrome, and systemic inflammatory response.

BAVENCIO can cause severe or life-threatening infusion-related reactions. Premedicate patients with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent infusions based upon clinical judgment and presence/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO in combination with axitinib can cause major adverse cardiovascular events (MACE) including severe and fatal events. Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue BAVENCIO and axitinib for Grade 3-4 cardiovascular events. MACE occurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with axitinib compared to 3.4% treated with sunitinib. These events included death due to cardiac events (1.4%), Grade 3-4 myocardial infarction (2.8%), and Grade 3-4 congestive heart failure (1.8%).

BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine aminotransferase (20%).

The most common adverse reactions (all grades, 20%) in patients with locally advanced or metastatic urothelial carcinoma (UC) were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%), and urinary tract infection (21%).

Selected laboratory abnormalities (Grades 3-4, 3%) in patients with locally advanced or metastatic UC were hyponatremia (16%), increased gamma-glutamyltransferase (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%).

Fatal adverse reactions occurred in 1.8% of patients with advanced renal cell carcinoma (RCC) receiving BAVENCIO in combination with axitinib. These included sudden cardiac death (1.2%), stroke (0.2%), myocarditis (0.2%), and necrotizing pancreatitis (0.2%).

The most common adverse reactions (all grades, 20%) in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were diarrhea (62% vs 48%), fatigue (53% vs 54%), hypertension (50% vs 36%), musculoskeletal pain (40% vs 33%), nausea (34% vs 39%), mucositis (34% vs 35%), palmar-plantar erythrodysesthesia (33% vs 34%), dysphonia (31% vs 3.2%), decreased appetite (26% vs 29%), hypothyroidism (25% vs 14%), rash (25% vs 16%), hepatotoxicity (24% vs 18%), cough (23% vs 19%), dyspnea (23% vs 16%), abdominal pain (22% vs 19%), and headache (21% vs 16%).

Selected laboratory abnormalities (all grades, 20%) worsening from baseline in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were blood triglycerides increased (71% vs 48%), blood creatinine increased (62% vs 68%), blood cholesterol increased (57% vs 22%), alanine aminotransferase increased (ALT) (50% vs 46%), aspartate aminotransferase increased (AST) (47% vs 57%), blood sodium decreased (38% vs 37%), lipase increased (37% vs 25%), blood potassium increased (35% vs 28%), platelet count decreased (27% vs 80%), blood bilirubin increased (21% vs 23%), and hemoglobin decreased (21% vs 65%).

Please see full US Prescribing Information and Medication Guide available at http://www.BAVENCIO.com.

About Merck KGaA, Darmstadt, Germany-Pfizer AllianceImmuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany and Pfizer. The global strategic alliance between Merck KGaA, Darmstadt, Germany and Pfizer enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of BAVENCIO, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance is jointly developing and commercializing BAVENCIO. The alliance is focused on developing high-priority international clinical programs to investigate BAVENCIO as a monotherapy as well as combination regimens, and is striving to find new ways to treat cancer.

All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to http://www.emdgroup.com/subscribe to register again for your online subscription of this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

About EMD Serono, Inc.EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada - is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. http://www.emdserono.com.

About Merck KGaA, Darmstadt, GermanyMerck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany, generated sales of 16.2 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

Pfizer Inc.: Breakthroughs that change patients' livesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.pfizer.com. In addition, to learn more, please visit us on http://www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure NoticeThe information contained in this release is as of April 9, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about BAVENCIO (avelumab), including a potential indication for first-line maintenance therapy for BAVENCIO for the treatment of patients with locally advanced or metastatic urothelial carcinoma, the alliance between Merck KGaA, Darmstadt, Germany, and Pfizer involving BAVENCIO and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BAVENCIO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications may be filed for BAVENCIO for first-line maintenance therapy for locally advanced or metastatic urothelial carcinoma in any jurisdictions outside the U.S. or in any jurisdictions for any other potential indications for BAVENCIO or combination therapies; whether and when regulatory authorities in any jurisdictions where any applications are pending or may be submitted for BAVENCIO or combination therapies, including BAVENCIO for locally advanced or metastatic urothelial carcinoma may approve any such applications, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy, and, if approved, whether they will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of BAVENCIO, including BAVENCIO for locally advanced or metastatic urothelial carcinoma; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

References

Your Contacts

EMD Serono Inc.

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Noelle Piscitelli

+1 781 427 4351

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+49 6151 72-3321

Pfizer Inc., New York, USA

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+1 212 733 6213

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+1 212 733 8160

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Company Codes: NYSE:PFE

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EMD Serono and Pfizer Receive US FDA Breakthrough Therapy Designation and Submit Application for BAVENCIO for First-Line Maintenance Treatment of...

Corticosteroids With COVID-19 in Asthma, Allergies, and Arthritis Patients – MedicineNet

APRIL 07, 2020 --Endocrinologists have underlined the importance that physicians consider "a stress dose" of glucocorticoids in the event of severe COVID-19 infection in endocrine, and other, patients on long-term steroids.

People taking corticosteroids on a routine basis for a variety of underlying inflammatory conditions, such as asthma, allergies, and arthritis, are at elevated risk of being infected with, and adversely affected by, COVID-19.

This also applies to a rarer group of patients with adrenal insufficiency and uncontrolled Cushing syndrome, as well as secondary adrenal insufficiency occurring in hypopituitarism, who also rely on glucocorticoids for day-to-day living.

As such, it is vitally important to recognize that "Injectable supplemental glucocorticoid therapy in this setting can reverse the risk of potentially fatal adrenal failure and should be considered in every case," Stewart and colleagues emphasize in a newly published editorial in JCEM.

They note this advice must be considered alongside World Health Organization (WHO) guidance against prescribing therapeutic glucocorticoids to treat complications of COVID-19, based on prior experience in patients with acute respiratory distress syndrome, as well as those affected by severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).

The key difference here is not to use pharmacologic doses of glucocorticoids as treatment for COVID-19 (where they have no effect), but rather to prevent death from adrenal failure by using "stress" doses of replacement glucocorticoid, Stewart explained to Medscape Medical News.

"The intent here is to ensure that no patient with a history of prior exposure to chronic glucocorticoid therapy (> 3 months) by whatever route should die without consideration for parenteral glucocorticoid therapy," the editorialists write.

He advises using physiological stress doses of hydrocortisone (50-100 mg intravenously tid).

Specific Advice for Adrenal Insufficiency: Follow Sick Day Rules

A separate statement by the American Association of Clinical Endocrinologists (AACE) also emphasizes that it is particularly important for patients with adrenal insufficiency to follow advice from the Centers for Disease Control and Prevention (CDC) or similar guidance on preventing COVID-19 infection, including social distancing and frequent hand washing.

Such patients should continue to take medications as prescribed and ensure they have appropriate supplies of oral and injectable steroids, ideally for 90 days, AACE advises.

And if there is a shortage of hydrocortisone, the statement advises patients ask a pharmacist or physician about replacement hydrocortisone with different doses that might be available.

Stewart agrees that patients with adrenal insufficiency need to be hypervigilant, but says that "if they do become ill, for the most part they are well counseled to respond appropriately to intercurrent infections."

Nevertheless, it is "invaluable to reiterate 'sick day rules'" for suspected COVID-19 infection.

"Any patient who develops a dry continuous cough and fever should immediately double their daily oral glucocorticoid dose and continue on this regimen until the fever has subsided."

If a patient still deteriorates on this regimen, develops diarrhea or vomiting, or is unable to take oral glucocorticoids for other reasons, they should contact their physicians or seek urgent medical care to receive parenteral treatment with a glucocorticoid.

References

2020 WebMD, LLC. All Rights Reserved.

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Corticosteroids With COVID-19 in Asthma, Allergies, and Arthritis Patients - MedicineNet

How the Sunflowers Children’s Action Group has brought joy to poorly youngsters in lockdown – Grimsby Live

Children with life-limiting illnesses have been receiving parcels of joy to help put smiles on their faces during the coronavirus lockdown, thanks to the Sunflowers Children's Action Group.

Joanne Wright set up the charity in July last year after spotting a gap in the provision of support across the northern Lincolnshire area for children with life limiting illnesses or life threatening conditions.

The handful of unpaid volunteers who work with Joanne, simply wanted to make a difference in the community and the gift parcels have been the charity's way of putting a smile on a child's face during the ockdown.

Joanne said: "Even before the national lockdown, many parents were advised to keep their children at home because of their childrens vulnerability owing to medical problems.

"I was talking to one parent and so wanted to do a little something to show we cared and would help to give a poorly child a surprise.

"We realised that it would be some time before we could do a group event, so the closest thing we could get to that was to do this."

Items in the parcels include sweets and chocolate left over from a Santa's sweet stall - all individually wrapped, still in date and properly stored - along with bags of mini eggs Deebees had previously donated and previously received toys and books.

Each parcel is carefully tailored to the age of the recipient, which currently ranges from three to 16.

Sunflowers has sent out around 60 of these cheery parcels and Joanne said the feedback she has received had been wonderful.

She said: "The children have been thrilled, judging by the reactions that have been posted on our Facebook page.

"I think it really means something to the parents too, that people out there are thinking of them.

"What we have to remember is that although isolation and the current situation brings us all problems. These are families who are largely isolated, struggling and battling to try and keep their children healthy every day of their lives."

Among those to benefit from the initiative is nine-year-old Ethan Meadows, from Keadby, near Scunthorpe.

He has a range of conditions including septo optic dysplasia,diabetes insipidus, pan hypopituitarism and microphaly. He is gastrostomy-fed, registered blind, is non-mobile and non verbal.

His mum Tina said: "Ethan is blind so we opened the box for him, he was really happy with it. It was a lovely thing to send.

"It's nice to know you've got that support - everything is up in the air.

"It's trying to keep the kids entertained as we are out of routine."

Six year old Nathaniel Hodges from Market Rasen, who has Type I diabetes, gave a huge thumbs up to his parcel.

His mum Caroline Hodges said: "He was absolutely over the moon. We didn't tell him, it was a surprise when it came.

"It made his day because we are stuck inside. He liked the car, he wants to build it and said, 'I love it, I can't believe it!'

"They are like angels, they're so thoughtful. We're not in a normal routine so it's tough on him.

"It just brings a bit of sunshine into his day - they're an amazing group.

"We tell him how proud we are but for someone to send something through the post, it's really special. We are very grateful."

Ava Eastwood-Morgan, 4, from Grimsby has AVSD (Atrioventricular Septal Defect) and leaking heart valves, which she had successful open heart surgery for in January 2017.

The people of northern Lincolnshire have been warming hearts with their selfless gestures.

They say challenging times often bring out the best in people and thats what were seeing here inGrimsby,CleethorpesandScunthorpe.

We want to celebrate anybody and everybody who is helping others through the coronavirus outbreak and have set up a special area dedicated to them on our website.

This includes but is not limited to our heroes in the NHS, policing teams, supermarket workers, delivery drivers and cleaners.

Not to forget our wonderful community members who have been helping others out in any way they can! Its a huge thank you to you ALL.

So, click here to view our live blog and if you have something you want to share email paige.freshwater@reachplc.com

However her last heart check up revealed the valve leakage had worsened.

Mum Lottie Eastwood said: "Ava's reaction was absolutely priceless, she was so, so delighted!

"Her face lit up, she was all excitable, giggly and absolutely smitten with her gifts. She received books, teddys, sweeties, a doll and a magnetic drawing board.

" I think the gift parcel idea is brilliant. Families that are going through tough times, or children that have been through lengthy procedures or are awaiting to receive treatment deserve to feel special.

"To know that somebody is thinking about them, taking time out of their day to make sure children receive gift packages is so uplifting.

"One simple act of kindness goes a very long way and I think its important that we all look after each other through the hard times, so a big thank you to all the lovely volunteers at Sunflowers Childrens Action Group for your time and generosity."

For more top stories, breaking news and sport see GrimsbyLive

Email the reporter who wrote this story

Follow GrimsbyLive on Facebook - Like our Facebook page to get the latest news in your feed and join in the lively discussions in the comments.

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To help Joanne and her team continue their work throughout the year and beyond the pandemic, donations can be made via http://www.justgiving.com/sunflowers-cag

Joanne added: "I think with the current situation we cant set anything in stone, so we are just trying to support our families in our own little way in the meantime."

To get in touch with the registered charity, email hello@sunflowers.org.uk or phone 07597 988809. Alternatively, see http://www.sunflowers.charity or follow @sunflowerslocal on Twitter or Facebook.

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How the Sunflowers Children's Action Group has brought joy to poorly youngsters in lockdown - Grimsby Live

Patients on Steroids With COVID-19 Might Need Rescue Steroids – Medscape

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

Endocrinologists have underlinedthe importance that physicians consider "a stress dose" of glucocorticoids in the event of severe COVID-19 infection in endocrine, and other, patients on long-term steroids.

People taking corticosteroids on a routine basis for a variety of underlying inflammatory conditions, such as asthma, allergies, and arthritis, are at elevated risk of being infected with, and adversely affectedby, COVID-19.

This also applies to a rarer group of patients with adrenal insufficiency and uncontrolled Cushingsyndrome, as well as secondary adrenal insufficiency occurring in hypopituitarism, who also rely on glucocorticoids for day-to-day living.

In the event of COVID-19, all of these individuals may be unable to mount a normal stress response, and "in the case of adrenal suppression...such patients may run into severe difficulties, particularly if on intensive care units," warns Paul Stewart, MD, University of Leeds, UK, and editor-in-chief of the Journal of Clinical Endocrinology & Metabolism (JCEM).

As such, it is vitally important to recognize that "Injectable supplemental glucocorticoid therapy in this setting can reverse the risk of potentially fatal adrenal failure and should be considered in every case," Stewart and colleagues emphasize in a newly published editorial in JCEM.

They note this advice must be considered alongside World Health Organization (WHO) guidance against prescribing therapeutic glucocorticoids to treat complications of COVID-19, based on prior experience in patients with acute respiratory distress syndrome, as well as those affected by severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).

The key difference here is not to use pharmacologic doses of glucocorticoids as treatment for COVID-19 (where they have no effect), but rather to prevent death from adrenal failure by using "stress" doses of replacement glucocorticoid, Stewart explained to Medscape Medical News.

"No patient with a history of prior exposure to chronic glucocorticoid therapy (> 3 months)...should die without consideration" for a stress dose of replacement glucocorticoid therapy.

"The intent here is to ensure that no patient with a history of prior exposure to chronic glucocorticoid therapy (> 3 months) by whatever route should die without consideration for parenteral glucocorticoid therapy," the editorialists write.

He advises using physiological stress doses of hydrocortisone (50-100 mg intravenously tid).

A separate statement by the American Association of Clinical Endocrinologists (AACE) also emphasizes that it is particularly important for patients with adrenal insufficiency to follow advice from the Centers for Disease Control and Prevention (CDC) or similar guidance on preventing COVID-19 infection, including social distancing and frequent hand washing.

Such patients should continue to take medications as prescribed and ensure they have appropriate supplies of oral and injectable steroids, ideally for 90 days, AACE advises.

And if there is a shortage of hydrocortisone, the statement advises patients ask a pharmacist or physician about replacement hydrocortisone with different doses that might be available.

Stewart agrees that patients with adrenal insufficiency need to be hypervigilant, but says that "if they do become ill, for the most part they are well counseled to respond appropriately to intercurrent infections."

Nevertheless, it is "invaluable to reiterate 'sick day rules'" for suspected COVID-19 infection.

"Any patient who develops a dry continuous cough and fever should immediately double their daily oral glucocorticoid dose and continue on this regimen until the fever has subsided."

If a patient still deteriorates on this regimen, develops diarrhea or vomiting, or is unable to take oral glucocorticoids for other reasons, they should contact their physicians or seek urgent medical care to receive parenteral treatment with a glucocorticoid.

J Clin Endocrinol Metab. Published online March 31, 2020. Position statement

For more diabetes and endocrinology news, follow us on Twitter and Facebook.

Continued here:
Patients on Steroids With COVID-19 Might Need Rescue Steroids - Medscape

Patients taking steroids with COVID-19 may need rescue steroids. – NewsDio

What your doctor is reading on Medscape.com:

April 3, 2020 Endocrinologists have underscored the importance of physicians considering a "stress dose" of glucocorticoids for severe COVID-19 infection in endocrine and other long-term steroid patients.People who routinely take corticosteroids for a variety of underlying inflammatory conditions, such as asthma, allergies, and arthritis, are at high risk of becoming infected with COVID-19 and being negatively affected.This also applies to a rarer group of patients with adrenal insufficiency and uncontrolled Cushing's syndrome, as well as the secondary adrenal insufficiency that occurs in hypopituitarism, who also depend on glucocorticoids for everyday life.

In the case of COVID-19, all these individuals may be unable to generate a normal response to stress and "in the case of adrenal suppression such patients may have serious difficulties, particularly if they are in intensive care units", warns Paul Stewart, MD, University of Leeds, UK, and editor-in-chief of the Journal of Clinical Endocrinology & Metabolism (JCEM).As such, it is vitally important to recognize that "injectable supplemental glucocorticoid therapy in this setting can reverse the risk of life-threatening adrenal insufficiency and should be considered in all cases," Stewart and colleagues emphasize in a recently published editorial in JCEM.They point out that this advice should be considered together with the guidance of the World Health Organization (WHO) against the prescription of therapeutic glucocorticoids to treat complications of COVID-19, based on previous experience in patients with acute respiratory distress syndrome, as well as those affected by severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).The key difference here is not using pharmacological doses of glucocorticoids as treatment for COVID-19 (where they have no effect), but rather preventing death from adrenal insufficiency by using replacement glucocorticoid stress doses, Stewart explained to Medscape Medical News."The intention here is to ensure that no patient with a history of prior exposure to chronic glucocorticoid therapy (> 3 months) by any route dies without taking parenteral glucocorticoid therapy into account," the editorialists write.He advises using physiological stress doses of hydrocortisone (50-100 mg intravenously).. (tagsToTranslate) steroids (t) Coronavirus (t) 2019 New coronavirus (t) 2019-nCoV (t) Wuhan coronavirus (t) Human coronavirus HKU1 (t) Human coronavirus OC43 (t) HCoV-OC43 (t) Human coronavirus 229E ( t) HCoV-229E (t) glucocorticosteroids (t) adrenal insufficiency (t) adrenal disease (t) crush

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Patients taking steroids with COVID-19 may need rescue steroids. - NewsDio

EMD Serono and Pfizer Provide Update on Phase III JAVELIN Head and Neck 100 Study – P&T Community

ROCKLAND, Mass. and NEW YORK, March 13, 2020 /PRNewswire/ --EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE)today announced an update from the Phase III JAVELIN Head and Neck 100 study evaluating avelumab in addition to chemoradiotherapy (CRT) versus standard-of-care CRT in patients with untreated locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).The alliance has accepted the recommendation of the independent Data Monitoring Committee (DMC) to terminate the JAVELIN Head and Neck 100 trial, as the study is unlikely to show a statistically significant improvement in the primary endpoint of progression-free survival (PFS) based on a preplanned interim analysis. A detailed analysis of the Phase III JAVELIN Head and Neck 100 study is being conducted and study findings will be shared with the scientific community.

There has been limited innovation for patients with locally advanced SCCHN over the past 10 years.1 Despite aggressive standard-of-care treatment with high-dose chemotherapy combined with radiotherapy, LA SCCHN will ultimately recur in a large proportion of patients.2 In recognition of the unmet need for additional treatment options that can prevent recurrence or metastatic disease,3 the alliance initiated the JAVELIN Head and Neck 100 trial, which is the first Phase III study to report topline results for an immune checkpoint inhibitor in combination with CRT in LA SCCHN.

About JAVELIN Head and Neck 100 JAVELIN Headand Neck 100 (NCT02952586) is a Phase III, randomized, double-blind, placebo-controlled, parallel-arm study investigating treatment with avelumab plus standard-of-care CRT followed by avelumab maintenance versus CRT alone in patients with previously untreated LA SCCHN. A total of 697 patients who had not received prior therapy for locally advanced SCCHN and were eligible for CRT with curative intent were randomly assigned to receive avelumab plus CRT or CRT alone. The primary endpoint was PFS per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary endpoints included overall survival (OS), time to locoregional failure, time to distant metastatic failure, overall response, duration of response and pathologic complete response.

About Head and Neck CancerHead and neck cancer is the sixth most common cancer worldwide.4 In 2016, there were nearly 150,000 newly diagnosed cases in the United States, Japan and Europe.4Approximately 60% of people are diagnosed with head and neck cancer when their disease has already progressed to the locally advanced stage (Stage III-IVB).5 At this stage, the cancer has spread from its site of origin to local lymph nodes, but not another part of the body.6 Standard of care for these patients includes high-dose chemotherapy combined with radiotherapy.7

About BAVENCIO (avelumab)BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.8-10 In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications BAVENCIO (avelumab) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

BAVENCIO Important Safety Information from the US FDA-Approved LabelBAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis, and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can cause hepatotoxicity and immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis occurred with BAVENCIO as a single agent in 0.9% of patients, including two (0.1%) patients with Grade 5, and 11 (0.6%) with Grade 3.

BAVENCIO in combination with axitinib can cause hepatotoxicity with higher than expected frequencies of Grade 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used as monotherapy. Withhold BAVENCIO and axitinib for moderate (Grade 2) hepatotoxicity and permanently discontinue the combination for severe or life-threatening (Grade 3 or 4) hepatotoxicity. Administer corticosteroids as needed. In patients treated with BAVENCIO in combination with axitinib, Grades3 and 4 increased ALT and AST occurred in 9% and 7% of patients, respectively, and immune-mediated hepatitis occurred in 7% of patients, including 4.9% with Grade3 or 4.

BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis until resolution. Permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon reinitiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% of patients, including seven (0.4%) with Grade 3.

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% of patients, including one (0.1%) with Grade 3.

Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders. Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis, were reported in 6% of patients, including three (0.2%) with Grade 3.

Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer antihyperglycemics or insulin in patients with severe or life-threatening (Grade 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% of patients, including two cases of Grade 3 hyperglycemia.

BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy, if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO as a single agent or in 489 patients who received BAVENCIO in combination with axitinib: myocarditis including fatal cases, pancreatitis including fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barr syndrome, and systemic inflammatory response.

BAVENCIO can cause severe or life-threatening infusion-related reactions. Premedicate patients with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent infusions based upon clinical judgment and presence/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO in combination with axitinib can cause major adverse cardiovascular events (MACE) including severe and fatal events. Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue BAVENCIO and axitinib for Grade 3-4 cardiovascular events. MACEoccurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with axitinib compared to 3.4% treated with sunitinib. These events included death due to cardiac events (1.4%), Grade 3-4 myocardial infarction (2.8%), and Grade 3-4 congestive heart failure (1.8%).

BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine aminotransferase (20%).

The most common adverse reactions (all grades, 20%) in patients with locally advanced or metastatic urothelial carcinoma (UC) were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%), and urinary tract infection (21%).

Selected laboratory abnormalities (Grades 3-4, 3%) in patients with locally advanced or metastatic UC were hyponatremia (16%), increased gamma-glutamyltransferase (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%).

Fatal adverse reactions occurred in 1.8% of patients with advanced renal cell carcinoma (RCC) receiving BAVENCIO in combination with axitinib. These included sudden cardiac death (1.2%), stroke (0.2%), myocarditis (0.2%), and necrotizing pancreatitis (0.2%).

The most common adverse reactions (all grades, 20%) in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were diarrhea (62% vs 48%), fatigue (53% vs 54%), hypertension (50% vs 36%), musculoskeletal pain (40% vs 33%), nausea (34% vs 39%), mucositis (34% vs 35%), palmar-plantar erythrodysesthesia (33% vs 34%), dysphonia (31% vs 3.2%), decreased appetite (26% vs 29%), hypothyroidism (25% vs 14%), rash (25% vs 16%), hepatotoxicity (24% vs 18%), cough (23% vs 19%), dyspnea (23% vs 16%), abdominal pain (22% vs 19%), and headache (21% vs 16%).

Selected laboratory abnormalities (all grades, 20%) worsening from baseline in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were blood triglycerides increased (71% vs 48%), blood creatinine increased (62% vs 68%), blood cholesterol increased (57% vs 22%), alanine aminotransferase increased (ALT) (50% vs 46%), aspartate aminotransferase increased (AST) (47% vs 57%), blood sodium decreased (38% vs 37%), lipase increased (37% vs 25%), blood potassium increased (35% vs 28%), platelet count decreased (27% vs 80%), blood bilirubin increased (21% vs 23%), and hemoglobin decreased (21% vs 65%).

Please see full US Prescribing Information and Medication Guide available at http://www.BAVENCIO.com.

About Merck KGaA, Darmstadt, Germany-Pfizer AllianceImmuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany and Pfizer. The global strategic alliance between Merck KGaA, Darmstadt, Germany and Pfizer enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of BAVENCIO, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance is jointly developing and commercializing BAVENCIO. The alliance is focused on developing high-priority international clinical programs to investigate BAVENCIO as a monotherapy as well as combination regimens, and is striving to find new ways to treat cancer.

All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to http://www.emdgroup.com/subscribe to register again for your online subscription of this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

About EMD Serono, Inc.EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt,Germany, in the U.S. andCanada- is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state ofMassachusetts.www.emdserono.com.

About Merck KGaA, Darmstadt, GermanyMerck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany, generated sales of 16.2 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

Pfizer Inc.: Breakthroughs that change patients' livesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.pfizer.com.In addition, to learn more, please visit us on http://www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure NoticeThe information contained in this release is as of March 13, 2020. Pfizer assumes no obligation to update forward-looking statementscontained in this release as the result of new information or future events or developments.

This release contains forward-looking information about BAVENCIO (avelumab), the alliance between Merck KGaA, Darmstadt, Germany,and Pfizer involving BAVENCIO and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BAVENCIO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and whenany drug applications may be filed in any jurisdictions for any potential indications for BAVENCIO or combination therapies; whether and when regulatory authorities in any jurisdictions where any applications are pending or may be submitted for BAVENCIO or combination therapies may approve any such applications, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy, and, if approved, whether they will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of BAVENCIO; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

References

Your Contacts

EMD Serono Inc.

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Noelle Piscitelli

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Pfizer Inc., New York, USA

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Jessica Smith

+1 212 733 6213

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+1 212 733 8160

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SOURCE EMD Serono

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EMD Serono and Pfizer Provide Update on Phase III JAVELIN Head and Neck 100 Study - P&T Community

Is dwarf boy Quaden Bayles 18-year-old or just 9? Internet is divided and debate continues – International Business Times, Singapore Edition

A kind gesture towards the victims in china

If anyone is familiar with the 2009 thriller Orphan, they know that it was just a story. But people are rushing to correlate dwarfism depicted in the movie with several other cases of dwarfism in real life.

The movie Orphan follows a 33-year-old woman with hypopituitarism who disguises herself as a young child so that she is adopted by a family. The adoption is followed by several events that point out that she is a woman and the family was in trouble. The current case of a young boy with dwarfism is trending on Twitter with people rushing to prove that he is, in fact, an 18-year-old posing as a 9-year-old.

The internet can be a beautiful place where people are supportive and understanding, but sometimes the support goes to the wrong person and everyone feels scammed. This has made people question everything that is being posted on the internet. Unfortunately, this has also led to people having mixed thoughts about the Quaden Bayles, the young boy from Australia who is allegedly going through bullying in his school because of dwarfism.

A heartbreaking video showed Quaden crying and saying that he wants to kill himself because of the bullying. So the internet did its job and made it go viral, and now the internet sea has split.

Quaden recently received a GoFundMe page donation to go to Disney land after several Hollywood and other stars came forward supporting the young boy and asking him not to worry. Brad Williams, the comedian set up a GoFundMe page for the young boy to bring him to the US for a vacation.

But several believe that this is a scam set up by the Bayles to make money. People went into Quaden's Instagram handle. According to the Twitterati, it showed Quade celebrating his 18th birthday and had pictures of him wearing expensive clothes.

People are continuously arguing on various platforms that Bayles is lying about his age. According to the investigative work done by several people on the internet, they believe that the videos posted by Quaden on his Instagram handle looked like those of an adult. The Instagram account @quadosss that had the videos has since disappeared from the internet.

Quade Bayles is said to have been born with achondroplasia dwarfism. He was diagnosed with it just days after he was born. Quade's mother Yarraka is his supporting pillar. Under her son's name, the mother has worked towards creating awareness about dwarfism.

There have been three videos where the boy was in front of the camera before this incident. One was associated with his first case of bullying and unwanted attention. Yarraka posted a video in 2015 when a group of girls started pointing towards the boy and following them around while they were out shopping. The video was trending in Australia which led to Yarraka and Quade coming in front of the screen during a Studio 10 interview.

There is another video from 2015 which sets the records straight. It is a feature where Yarraka explains what Quade's condition is when he was around 4-years old in an SBS program called Living Black.

Apart from this, there is another evidence that says that he is actually 9-years-old. According to the family, the child was posing with a friend who turned 18 on his Instagram picture. Two years ago his mother posted a picture that showed them celebrating Quaden's 8th birthday.

Several of the pictures and videos have since been removed because of the extreme levels of negative attention that the family is receiving.

Similar to Quaden there is someone else who has gone through extreme trauma and that is Natalia Grace. The young girl was abandoned by her family who adopted her at a very young age. She was the Ukranian orphan who was called rude names by the internet including comparing her with Esther from the Orphan.

Natalia is said to be a teenager and her adoptive family said that she is actually in her 30s. Her adoptive parents Kristine Barnett, 46, and her ex-husband Michael Barnett, 43, were charged with neglect of a dependent, to which they pleaded not guilty.

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Is dwarf boy Quaden Bayles 18-year-old or just 9? Internet is divided and debate continues - International Business Times, Singapore Edition

‘Orphan’ Prequel to Tell the Origins of ‘Esther’ – Bloody Disgusting

One of the more underrated horror-thrillers is Warner Bros./Dark Castles 2009 Orphan, directed by Jaume Collet-Serra and starring a young Isabelle Fuhrman as Esther, an adopted9-year-old girl who is not nearly as innocent as she claims to be.

As its revealed, Esther is actually a 33-year-old woman named Leena Klammer. She has hypopituitarism, a rare hormonal disorder that stunted her physical growth and caused proportional dwarfism, and has spent most of her life posing as a little girl. (Wiki)

In an interesting turn, Sierra/Affinity is launching sales at the EFM in Berlin on Esther, a prequel to Orphan that will be directed by William Brent Bell (The Devil Inside, The Boy, Brahms: The Boy II), reports Deadline.

In it, Lena Klammer orchestrates a brilliant escape from a Russian psychiatric facility and travels to America by impersonating the missing daughter of a wealthy family. But Lenas new life as Esther comes with an unexpected wrinkle and pits her against a mother who will protect her family at any cost.

Orphans big selling point was the shocking twist that changed the way you viewed the intense and immensely uncomfortable events of the film. It will be interesting to see if the prequel can conjure up the same kind of suspense with the audience already being in on the Esthers secret. Its unclear if Fuhrman will return, although its extremely unlikely.

The prequel, expected to start in the third quarter, is written by David Coggeshall.

Dark Castle Entertainments Alex Mace, Hal Sadoff and Ethan Erwin will produce with James Tomlinson. David Leslie Johnson will serve as an executive producer and Jen Gorton and Josie Liang will oversee for eOne.

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'Orphan' Prequel to Tell the Origins of 'Esther' - Bloody Disgusting

Acromegaly Treatment Industry 2020 Global Market Size, Demand, Growth Prospects, Key Insights, Top Companies and Forecast till 2025 – Instant Tech…

The global Acromegaly Treatment market is driven by the growing prevalence of the genetic disease, changing lifestyle. Also, factors such as rising incidence of hormonal diseases, such as hypopituitarism and endocrine diseases, and high demand for the advanced treatment is expected to increase the demand for Acromegaly treatment market.

Factors, such as unavailability of precise treatment and high cost of the surgery can restrain the market growth.

Some of the key players operating in this market include Pfizer Inc., Chiasma Inc., Novartis AG, Ipsen Biopharmaceuticals Inc., Wockhardt Ltd., Troikaa Pharmaceuticals Limited, GlaxoSmithKline plc, Aegis Therapeutics LLC, Crinetics Pharmaceuticals Inc, Daewoong Pharmaceutical Co Ltd, Peptron Inc, among others.

You can get a sample copy of this report @ https://www.orianresearch.com/request-sample/804039

Increasing government support, favorable government insurance policies and schemes for the patients and rapid developments in technology will offer lucrative opportunities.

Based on Application, the Acromegaly Treatment market is segmented into Hospitals, Clinics, and others.

Based on Disease Types, the Acromegaly Treatment market is segmented into Ectopic Acromegaly, Pseudo Acromegaly.

Regionally, North America was the largest revenue generator in the Acromegaly Treatment market in 2017, because of high investments in research and development activities to investigate the applications of Acromegaly Treatment market.

Key Benefits of the Report:

* Global, Regional, Country, Application, and Disease Types Market Size and Forecast from 2014-2025

* Detailed market dynamics, industry outlook with market specific PESTLE, Value Chain, Supply Chain, and SWOT Analysis to better understand the market and build strategies

* Identification of key companies that can influence this market on a global and regional scale

* Expert interviews and their insights on market shift, current and future outlook and factors impacting vendors short term and long term strategies

* Detailed insights on emerging regions, Application& Disease Types, and competitive landscape with qualitative and quantitative information and facts.

Global Acromegaly Treatment Industry 2020 Market Research Report is spread across 121 pages and provides exclusive vital statistics, data, information, trends and competitive landscape details in this niche sector.

Inquire more or share questions if any before the purchase on this report @ https://www.orianresearch.com/enquiry-before-buying/804039

Target Audience:

* Acromegaly Treatment providers

* Traders, Importer and Exporter

* Raw material suppliers and distributors

* Research and consulting firms

* Government and research organizations

* Associations and industry bodies.

Research Methodology

The Market is derived through extensive use of secondary, primary, in-house research followed by expert validation and third party perspective like analyst report of investment banks. The secondary research forms the base of our study where we conducted extensive data mining, referring to verified data sources such as government and regulatory published materials, technical journals, trade magazines, and paid data sources.

For forecasting, regional demand & supply factor, investment, Market dynamics including technical scenario, consumer behavior, and end use industry trends and dynamics , capacity Production, spending were taken into consideration.

We have assigned weights to these parameters and quantified their Market impacts using the weighted average analysis to derive the expected Market growth rate.

The Market estimates and forecasts have been verified through exhaustive primary research with the Key Industry Participants (KIPs) which typically include:

* Original Manufacturer,

* Application Supplier,

* Distributors,

* Government Body & Associations, and

* Research Institute.

Order a Copy of Global Acromegaly Treatment Market Report @ https://www.orianresearch.com/checkout/804039

Table Of Content

1 Executive Summary

2 Methodology And Market Scope

3 Acromegaly Treatment Market Industry Outlook

4 Acromegaly Treatment Market Type Outlook

5 Acromegaly Treatment Market Application Outlook

6 Acromegaly Treatment Market Regional Outlook

7 Competitive Landscape

End Of The Report

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Acromegaly Treatment Industry 2020 Global Market Size, Demand, Growth Prospects, Key Insights, Top Companies and Forecast till 2025 - Instant Tech...

The motive within the serve of this man’s suffering became once hiding in undeniable look – Invest Records

Lopez spoke back that he had now not too prolonged ago returned from California the place he had gone thru a painful, costly process to repair a seemingly spinal fluid leak. It became once, he told Smith, the most up-to-date chapter in his seven-One year quest to diagnose the illness that had made his lifestyles a effort.

Lopez had consulted extra than one consultants at one of the crucial nations Most critical hospitals, leading to assessments and scans too reasonably heaps of to rely. His stepfather and accomplices father, each and every physicians, were baffled. One gastroenterologist even suggested to Lopez that his accomplice, a nurse, may very smartly be poisoning him.

His gallbladder had been eliminated, an pointless operation that caused eternal problems. And the well-known of three spinal procedures had left him feeling extra unhappy than ever.

Smith requested about a questions, then equipped to review Lopezs medical records. The lawyer within the open refused, then relented after Smith pressed him.

It became once, he says, one of many appropriate decisions he ever made.

Smiths eagle-eyed examination noticed a severe clue that had been now not illustrious for years, culminating in a prognosis that the 15 physicians who treated Lopez apparently by no scheme regarded as.

At first I didnt imagine Davids plot, recalled Lopez, now 44. I had been burned reasonably heaps of times.

In December 2010, Lopez became once visiting an airplane hangar with his employer, who owned a Cessna. Whereas strolling all the scheme in which thru the plane Lopez, blinded by the glare of the late afternoon sun, smacked forehead first exhausting into the low-slung fly.

I fell to the ground, but didnt black out, he remembered. Lopez got to his feet and insisted he became once swish. I became once extra embarrassed than the leisure.

Per week later, he began feeling hung over. Getting back from his each day five-mile bustle, Lopez started trembling and felt so fashioned he needed to lie on the rest room ground. His accomplice brought him a glass of orange juice. Inside minutes, he looked to possess recovered.

But about a weeks later on Lopez with out warning grew to turn out to be dizzy and extraordinarily nauseated while ingesting a beer. He stopped ingesting alcohol, but the hung-over feeling continued, accompanied by a headache, shakiness, vomiting and diarrhea.

His well-known care doctor at the time, Lopez said, became once dismissive, telling him he became once anxious and working too exhausting. It became once a proof he would hear from other medical doctors.

Within the center of the next six months, Lopez consulted an ear, nostril and throat specialist in Albuquerque, who ruled out labyrinthitis, an infection of the internal ear that causes vertigo and nausea. An ENT skilled in Los Angeles suggested he may need power fatigue syndrome.

At the advice of his internist stepfather, Lopez underwent a mind MRI. A neurologist told Lopez he had an acoustic neuroma, a benign mind tumor, then with out word changed her solutions and said the scan confirmed nothing.

Visits to gastroenterologists led nowhere. One Fresh Mexico specialist, for reasons that stay inexplicable, suggested that Lopezs accomplice may very smartly be deliberately poisoning him, but did now not represent toxicology assessments.

Lopez remembers feeling flabbergasted by the speculation. His accomplice, Lorena, had been unfailingly supportive in each and every doable scheme.

His stepfather, whom Lopez referred to as my medical rock, became once aghast.

That is absurd, Lopez remembers him saying. I willt imagine these folk.

In 2014, a third gastroenterologist instantaneous elimination of Lopezs gallbladder, citing his 45-pound weight reduction, coupled with the outcomes of a scan that looked to existing biliary dyskinesia, a disorder wherein bile drainage is impaired. The operation became once a failure and left him feeling sicker.

A fourth gastroenterologist identified postcholecystectomy syndrome, a complication of gallbladder surgical operation that causes severe nausea and diarrhea. She referred him to a prominent out-of-train medical center for a comprehensive GI work-up.

Lopez spent per week there in 2015. Doctors werent certain what became once terrifying, but told him he surprisingly sensitive to certain meals. Lopez illustrious that even when he craved salt, he grew to turn out to be violently in unhappy health after eating salty meals comparable to popcorn. Doctors prescribed a diet now and again instantaneous for touchy bowel syndrome apart from to a drug to late digestion; neither helped.

In 2016, Lopez determined to cessation seeing medical doctors for a while. He had exhausted each and every choice he may per chance deem. Too in unhappy health to motivate his kidss faculty events or eat dinner with his family most nights, he mechanically came home from work and fell into bed.

Now and then, I concept I became once going to possess to cessation my practice, he recalled. Shedding my work would possess been the ideally suited nail within the coffin.

In July 2017, a seemingly promising contemporary explanation emerged after Lopez and his accomplice traveled to a well-known instructing health center in California.

Several assessments, including a spinal MRI, confirmed a seemingly power leak of cerebrospinal fluid from the dura, the outer membrane that surrounds the mind and spinal twine. Consultants told Lopez they believed the leaks were the outcomes of his 2010 collision with the Cessna, but couldnt pinpoint their enviornment. They instantaneous a series of epidural blood patches, wherein a little quantity of blood is injected into the epidural home within the spine to plug the leak.

Days after the October process, Lopez said he vividly remembers convalescing in a resort room lying flat on my serve and my accomplice feeding me cereal. He became once told to temporarily enhance his consumption of caffeine and salt to amplify the production of spinal fluid. For weeks later on he became once violently in unhappy health.

I got very unhappy, Lopez recalled. Within the center of an emotional conversation with his accomplice, he confided that while he by no scheme felt suicidal, he wasnt certain how he may per chance continue living in his present condition.

The meeting with Smith befell about a weeks later.

As he paged thru Lopezs records, Smith became once struck by the absence of a positional headache, nervousness that improves when lying flat. It is seemingly one of many most in vogue symptoms of a spinal fluid leak. And when he looked at the MRI, the neurologist did now not watch a leak.

Lopez told Smith, as he had the medical doctors he had seen, that his symptoms started after he hit his head. He said he became once swish until then, Smith said. To me it looked logical to open up there.

Lopez mentioned that he had now not too prolonged ago told his internist that he became once getting up six or extra times each and every night to urinate. Smith suspected the plot off may per chance now not be his prostate, the most in vogue foundation of this kind of challenge, but reasonably dehydration that may consequence from an electrolyte challenge.

Reviewing his lab assessments, Smith noticed a a little bit but again and again elevated sodium rely within the years after the accident but now not sooner than. He calculated Lopezs serum osmolality, which measures the focus of sodium ions and other substances within the blood. The essentially unprejudiced appropriate test is now and again ordered to envision for an electrolyte imbalance, but had by no scheme been ordered. Smiths calculations confirmed that it, too, became once elevated.

Smith suspected that the blow to Lopezs head may need damaged his pituitary, the pea-sized gland at the infamous of the mind, which serves as the bodys metabolic abet watch over center. A stressful mind atomize can plot off hypopituitarism, a condition wherein a hormone deficiency impairs customary characteristic. One in all the hormones launched by the pituitary is antidiuretic hormone (ADH), which regulates fluid balance.

The neurologist theorized that Lopezs damaged pituitary had caused central diabetes insipidus, a rare disorder wherein the kidneys prefer away too grand fluid. (The condition is unrelated to the far extra customary diabetes mellitus, which entails blood sugar.)

Lopez became once within the open skeptical.

I undergo in solutions feeling roughly irritated when David said I didnt possess a CSF leak and shouldnt get one other patch, he recalled. I had already pursued reasonably heaps of slow ends.

But Lopez became once desperate. I undergo in solutions thinking, I dont even care if I get better, I correct desire an solution.

Smith urged Lopez to query his well-known care doctor to represent osmolality and urine assessments. Lopez said his contemporary internist balked, telling him, You dont possess diabetes insipidus, its so rare. After Lopez insisted, the internist ordered the assessments, adopted by a second round. All were habitual, but the doctor remained unconvinced.

Lopez pushed for a referral to an endocrinologist. He, too, became once skeptical, but ordered extra assessments that yielded the identical consequence, alongside with a scan that ruled out a pituitary tumor.

Now there may very smartly be absolute self assurance. Smiths meticulous prognosis had ended in the prognosis of diabetes insipidus that essentially had been hiding in undeniable look.

Lopez began taking a manufacture of vasopressin, the artificial hormone hell need for the remainder of his lifestyles. Slowly but frequently, he began to augment. His slow night urination stopped once he started taking the medication.

Ive 80 to 90 percent better, Lopez said now not too prolonged ago. He fastidiously monitors his salt intake to cessation sodium overload, must steer clear of becoming overheated he now not runs and cant devour alcohol or caffeine, which may per chance be too dehydrating. He additionally takes costly drugs to tackle the penalties of his pointless gallbladder surgical operation.

Lopez is attempting to invent up for the years he lost with his kids, who are now 5, 12 and 14. He deeply regrets that his stepfather, who he said became once consumed by attempting to serve him, did now not dwell to glimpse the end result. He died in 2015.

Lopez thinks his work as a malpractice lawyer essentially plot me serve. There were too many cooks within the kitchen, he said. I deem the indisputable reality that I had so many connections, it place me on the terrifying direction.

I additionally deem that but for me doing this work, I would by no scheme possess met the actual person that identified it, he added. He said he worries about others who are suffering and shortage beef up or sources. I represent folk love that one and all of the time, he added.

Smith, who has been in practice for 18 years, has a clear level of view.

I felt there became once reasonably heaps of tunnel vision, he said, adding that he believes time constraints may per chance possess played a job. There are reasonably heaps of practices that bustle love an assembly line.

Within the neurologists peep, the most evident error may per chance possess been the failure to prefer a entire and careful historical previous the cornerstone of the diagnostic process and to hear fastidiously to what Lopez became once reporting.

Smith said he stays bowled over by the resistance that Lopez, a medically knowledgeable affected person, encountered when he pursued a seemingly prognosis of diabetes insipidus.

Some smug physicians are offended by an out of doors doctors advice, Smith said. It wounds egos.

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The motive within the serve of this man's suffering became once hiding in undeniable look - Invest Records

Male Hypogonadism Market Analytical Overview and Growth Opportunities by 2025 – Fusion Science Academy

Global Male Hypogonadism Market: Snapshot

Hypogonadism in males refers to a condition in the male body where the testes show a significantly reduced level of functioning than normal. The overall result of male hypogonadism is a reduction in the rate of biosynthesis of male sex hormones. This state is more commonly known as interrupted stage 1 puberty. Hypoandrogenism, or the low androgen or testosterone level in a male can vary in severity from person to person. It is often the cause of partial or complete infertility. There are multiple forms of male hypogonadism and even more ways to classify them. Most endocrinologists commonly classify male hypogonadism on the basis of the level of defectiveness of the male reproductive system.

In many cases, doctors also measure the level of gonadotropins to classify a patient between primary and secondary male hypogonadism. Primary male hypogonadism refers to the cause of the condition being due to defective gonads. There are different types of primary male hypogonadism, including Turner syndrome and Klinefelter syndrome. Secondary male hypogonadism is caused by defects in pituitary or hypothalamic glands. They include Kallmann syndrome and hypopituitarism.

Get Sample Copy of the Report @https://www.tmrresearch.com/sample/sample?flag=B&rep_id=1127

Global Male Hypogonadism Market: Overview

Male Hypogonadism refers to a clinical condition, wherein the testes fail to produce enough testosterone leading to delayed puberty or incomplete development. The condition is related to impaired development of muscle mass, development of breast tissues, impaired body hair growth, and lack of deepening of the voice.

The male Hypogonadism market can be segmented by therapy, type, drug delivery, and geography.

The report presents an in-depth analysis of the global male hypogonadism market with current trends and future estimates to explain the imminent investment pockets. The quantitative analysis of the market for the forecast period from 2017 to 2025 will enable stakeholders to capitalize on the prevailing growth opportunities.

Global Male Hypogonadism Market: Trends and Opportunities

The top driver of the male hypogonadism market includes rising prevalence of testosterone deficiency among men, increasing infertility rates, and increasing awareness among individuals about hypogonadism treatment due to awareness drives organized by several governments across the world. Moreover, high risk of hypogonadism among the geriatric population with obesity and diabetes, and increasing prevalence of chronic disorders among the geriatrics are further expected to boost the markets growth.

However, factors such as high side effects of testosterone products are challenging the growth of testosterone replacement therapy market. Top players in the market are focused on research and development to introduce newer products with fewer or negligible side effects and improved results. For example, LPCN 1111, a product which is under development from Lipocine Inc., is a newer testosterone prodrug that utilizes Lipral technology for enhanced systemic absorption and for enhanced solubility of testosterone. Nevertheless, technological advancements are anticipated to extend new opportunities to the markets growth.

Global Male Hypogonadism Market: Regional Overview

The global male Hypogonadism market can be analyzed with respect to the regional segments of North America, Asia Pacific, Europe, Latin America, and the Middle East and Africa. North America held the majority share of the global market in the recent past and is expected to retain its dominant position in the near future. This is mainly due to the rise in the number of individuals suffering from primary and secondary conditions of hypogonadism, and rising awareness among individuals about treatment options for the condition. Moreover, the presence of ultra-modern healthcare infrastructure and increasing popularity of technologically advanced products are expected to offer new opportunities for top players in this market. The region is closely followed by Europe.

Asia Pacific is expected to offer lucrative opportunities to this market due to the modernization of the healthcare infrastructure in the emerging economies of India and China and the increasing awareness about the treatment for the condition. In Asia Pacific, the increasing prevalence of hypogonadism and infertility rates along with the rising geriatric population base with diabetes and obesity are propelling the growth of this market. China, Taiwan, and Malaysia are some of the countries that display the highest rate of male hypogonadism.

Major Companies Mentioned in Report

Some of the key players in the male Hypogonadism market include AbbVie Inc., Astrazeneca plc, Eli Lilly and Company Ltd., Merck & Co. Inc., SA, Finox Biotech, Laboratories Genevrier, Teva Pharmaceutical Industries Ltd., Allergan plc, Bayer AG, Endo International plc, IBSA Institut Biochimque, and Ferring.

Key players are focused on product approval for growth considerations and to cater to the changing demand of the industry. The introduction of innovative and technologically advanced products is also the focus of key players to increase their market share and for serving patients in a better manner.

Read Comprehensive Overview of Report @https://www.tmrresearch.com/male-hypogonadism-market

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Original post:
Male Hypogonadism Market Analytical Overview and Growth Opportunities by 2025 - Fusion Science Academy

Rare Skeleton Points to Compassion, Care, and Tragedy in Prehistoric China – Gizmodo

The 5,000-year-old skeleton, designated M53, with physical dysplasia. Image: S. E. Halcrow et al., 2019

The discovery of a 5,000-year-old skeleton of a young adult who had serious physical limitations suggests a form of social support existed in Neolithic China, but only to a point, as this individual may have met an untimely death.

The skeleton was found at the Guanjia site in Chinas Henan Province, and it dates back to the late Neolithic Yangshao cultural period (33002900 BCE). A recent analysis of this skeleton has revealed an array of physical and possibly cognitive health issues that would have required others to take care of this individual, according to new research published in the International Journal of Paleopathology.

Designated M53, this person had normal body proportions but was far shorter than typical, with a slender build. The researchers, a collaborative team from Queens College in New York, the University of Otago in New Zealand, and other institutions, were unable to determine the individuals sex, but the person died after reaching adulthood. M53 was buried according to normal Yangshao customs, but their hands were positioned behind their back, for reasons that arent clear. Analysis of the skeleton also revealed neck fractures, which likely contributed to M53's deathinjuries that were possibly inflicted intentionally.

Importantly, M53 had bones that were very thin and hollow, similar to severe osteoporosis, and they likely had very weak muscles, as evidenced by specific skeletal muscle markings. Taken together, this suggests M53 had physical dysplasia, leading to a kind of dwarfism, an underdeveloped body, and a feebleness. This individual wouldve been very physically limited and possibly even paralyzed. Whats more, if M53 was affected by severe hormonal problemswhich appears to be the casethey may have also experienced cognitive delays and mood disorders, according to the new research.

Ekaterina Pechenkina, a co-author of the study and an anthropologist at Queens College, said these anomalous traits may have been caused by a reduced function of the pituitary gland, a critical gland that regulates our growth and general well-being, she explained in an email to Gizmodo. Among other things, it produces the growth hormone. Indeed, her teams analysis of the skull revealed depressions in a bony structure that hosts the pituitary glanda sign that a tumor had caused the gland to stop working properly.

Pechenkina said all these skeletal manifestations suggest hypopituitarism as a diagnosis, a rare condition in which the pituitary gland cant produce sufficient hormones, leading to a host of problems, including muscle weakness. Consequently, this rare find is offering new insights into the cultural norms of the period and how individuals with noticeable physical differences or disabilities were treated.

We know that M53 was a tiny individual with very slender, fragile bones and underdeveloped muscles, who despite their limited physical abilities survived into adulthood, said Pechenkina.

Survival in this 5,000-year-old northern Chinese farming community wouldve required considerable physical strength, Pechenkina explained. Chopping wood to build fires during the cold winters wouldve been an essential skill, she said. To acquire food, people needed to turn soil, plant seeds, water crops, and so on.

I think that a slender and a fragile individual, such as M53, needed lots of support and help from their family members, said Pechenkina. It is unlikely that they were ostracized by their community, she said, as there was no evidence of abuse or signs of old fractures. And because M53 was buried in a (reasonably) typical way, they were regarded as one of their own, she said.

The exact model of care, in the words of the researchers, is unknown, but Sian Halcrow, a co-author of the study and a researcher at the University of Otago, said it very likely existed in some form.

Thats because the dysplasia likely had some associated health effects from an early age, and that would have meant M53 would have had extra care needs, said Halcrow in a press release. But they lived into adulthood so its likely they were the recipient of care from other members in their family or wider society.

That said, Pechenkina and her colleagues believe M53 likely died from the aforementioned neck fracture.

Their neck vertebrae appear to be fractured around the time of death, which makes it likely that eventually they were killed by their group members, either because they became to be seen as a burden or because their health deteriorated or, perhaps, because their caretakers became too old or died, said Pechenkina. For me, an interesting question is whether our M53 individual was recognized as different from an early childhood or only after a certain age when their short stature and fragility became apparent, she said, adding that, I suspect that up until a certain age they were likely cared for as a child.

The troublesome circumstances of M53s death notwithstanding, their survival into adulthood would have required lots of time, patience, and resourcesand also a certain degree of compassion and acceptance. Yes, the Neolithic was tough, but it was clearly far from barbaric.

No doubt, this discovery shows one way in which Neolithic culture was socially advanced, but we shouldnt be too surprised (evidence from earlier this year revealed that Neolithic European babies drank animal milk from sippy cups, as just one example). Evidence of social support goes back even further in timeas far back as the Neanderthals and other archaic humans, who cared for severely physically disabled members of their communities. Prosocial behaviors such as these, it might be argued, contributed greatly to the success of our species.

Originally posted here:
Rare Skeleton Points to Compassion, Care, and Tragedy in Prehistoric China - Gizmodo

Acromegaly Treatment Industry 2019 Global Market Size, Demand, Growth Prospects, Key Insights, Top Companies and Forecast till 2025 – Market Research…

The global Acromegaly Treatment market is driven by the growing prevalence of the genetic disease, changing lifestyle. Also, factors such as rising incidence of hormonal diseases, such as hypopituitarism and endocrine diseases, and high demand for the advanced treatment is expected to increase the demand for Acromegaly treatment market.

Factors, such as unavailability of precise treatment and high cost of the surgery can restrain the market growth.

Some of the key players operating in this market include Pfizer Inc., Chiasma Inc., Novartis AG, Ipsen Biopharmaceuticals Inc., Wockhardt Ltd., Troikaa Pharmaceuticals Limited, GlaxoSmithKline plc, Aegis Therapeutics LLC, Crinetics Pharmaceuticals Inc, Daewoong Pharmaceutical Co Ltd, Peptron Inc, among others.

You can get a sample copy of this report @https://www.orianresearch.com/request-sample/804039

Increasing government support, favorable government insurance policies and schemes for the patients and rapid developments in technology will offer lucrative opportunities.

Based on Application, the Acromegaly Treatment market is segmented into Hospitals, Clinics, and others.

Based on Disease Types, the Acromegaly Treatment market is segmented into Ectopic Acromegaly, Pseudo Acromegaly.

Regionally, North America was the largest revenue generator in the Acromegaly Treatment market in 2017, because of high investments in research and development activities to investigate the applications of Acromegaly Treatment market.

Key Benefits of the Report:

* Global, Regional, Country, Application, and Disease Types Market Size and Forecast from 2014-2025

* Detailed market dynamics, industry outlook with market specific PESTLE, Value Chain, Supply Chain, and SWOT Analysis to better understand the market and build strategies

* Identification of key companies that can influence this market on a global and regional scale

* Expert interviews and their insights on market shift, current and future outlook and factors impacting vendors short term and long term strategies

* Detailed insights on emerging regions, Application& Disease Types, and competitive landscape with qualitative and quantitative information and facts.

Global Acromegaly Treatment Industry 2019 Market Research Report is spread across 121 pages and provides exclusive vital statistics, data, information, trends and competitive landscape details in this niche sector.

Inquire more or share questions if any before the purchase on this report @https://www.orianresearch.com/enquiry-before-buying/804039

Target Audience:

* Acromegaly Treatment providers

* Traders, Importer and Exporter

* Raw material suppliers and distributors

* Research and consulting firms

* Government and research organizations

* Associations and industry bodies.

Research Methodology

The Market is derived through extensive use of secondary, primary, in-house research followed by expert validation and third party perspective like analyst report of investment banks. The secondary research forms the base of our study where we conducted extensive data mining, referring to verified data sources such as government and regulatory published materials, technical journals, trade magazines, and paid data sources.

For forecasting, regional demand & supply factor, investment, Market dynamics including technical scenario, consumer behavior, and end use industry trends and dynamics , capacity Production, spending were taken into consideration.

We have assigned weights to these parameters and quantified their Market impacts using the weighted average analysis to derive the expected Market growth rate.

The Market estimates and forecasts have been verified through exhaustive primary research with the Key Industry Participants (KIPs) which typically include:

* Original Manufacturer,

* Application Supplier,

* Distributors,

* Government Body & Associations, and

* Research Institute.

Order a Copy of Global Acromegaly Treatment Market Report @https://www.orianresearch.com/checkout/804039

Table Of Content

1 Executive Summary

2 Methodology And Market Scope

3 Acromegaly Treatment Market Industry Outlook

4 Acromegaly Treatment Market Type Outlook

5 Acromegaly Treatment Market Application Outlook

6 Acromegaly Treatment Market Regional Outlook

7 Competitive Landscape

End Of The Report

Disclaimer

Customization Service of the Report:Orian Research provides customization of reports as per your need. This report can be personalized to meet your requirements. Get in touch with our sales team, who will guarantee you to get a report that suits your necessities.

About Us:

Orian Research is one of the most comprehensive collections of market intelligence reports on the World Wide Web. Our reports repository boasts of over 500000+ industry and country research reports from over 100 top publishers. We continuously update our repository so as to provide our clients easy access to the worlds most complete and current database of expert insights on global industries, companies, and products. We also specialize in custom research in situations where our syndicate research offerings do not meet the specific requirements of our esteemed clients.

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Acromegaly Treatment Industry 2019 Global Market Size, Demand, Growth Prospects, Key Insights, Top Companies and Forecast till 2025 - Market Research...

5,000-Year-Old Human Found with ‘Extremely Rare’ Form of Dwarfism – Livescience.com

Archaeologists made an "extremely rare" find in China when they found a human skeleton with an uncommon form of dwarfism, according to a recent news report.

The skeleton was originally recovered from a burial site near the Yellow River in east-central China, along with other remains of people who had lived between 3300 and 2900 B.C., Forbes reported. All the skeletons were found with their hands placed on top of their bodies, except for one, whose hands were tucked behind its back. The bones of this skeleton appeared short and weak compared to the other skeletal remains; on closer inspection, the archaeologists diagnosed the young adult with skeletal dysplasia, also known as dwarfism.

A wide range of conditions fall under the umbrella term "skeletal dysplasia," but in general, these conditions tend to disrupt bone development, causing individuals to grow to shorter-than-average stature, the authors noted in a report published Dec. 13 in the International Journal of Paleopathology. Skeletal dysplasia is fairly rare in modern humans, occurring in about 3.22 out of every 10,000 births, but the condition crops up even less often in the archaeological record to date, fewer than 40 cases have been discovered. Of these, most cases represent a relatively common form of dwarfism called achondroplasia, which causes the limbs to grow disproportionately shorter than the head and trunk.

Related: Photos: A 400-Year-Old War Grave Revealed

But archaeologists at the burial site soon realized that they had stumbled upon an even rarer find. While the limbs of the skeleton appeared short, the bones of the head and trunk also seemed small. Judging by the skeleton's teeth, the team determined that the remains belonged to a young adult, but the skeleton's full-grown limb bones remained unfused. The authors diagnosed the Neolithic skeleton with a condition known as "proportionate dwarfism," rarely seen in either archaeological or living human populations.

The team theorized that the skeleton's short stature stemmed from "pediatric onset hypopituitarism and hypothyroidism," meaning that the individual likely developed either an underactive thyroid gland or pituitary gland early in life. Both glands direct the function of hormones throughout the body, and without their guidance, body tissues and organs may fail to grow as they should. The condition can stunt bone growth, cognitive development and heart and lung function; the individual uncovered in China likely required "support from other community members" to survive, the authors noted.

Unlike achondroplasia, which typically arises from a genetic mutation, thyroid and pituitary dysfunction is thought to be linked to a lack of essential nutrients, such as iodine. Rates of hypothyroidism remain higher in China than in the U.S., partly due to the fact that many Chinese people still consume iodine-deficient diets, according to Forbes.

Related: Photos: Looking for Extinct Humans in Ancient Cave Mud

Although the short-statured skeleton was buried differently than the ones nearby in the tomb, the archaeologists aren't sure if or how the individual may have been treated in life. Confucian texts from the 4th century B.C. suggest that people with physical differences would not have been ostracized in Neolithic China. ("If virtue is pre-eminent, the body will be forgotten," the philosopher Zhuangzi once wrote.) But this sentiment clashes with historical accounts from the 2nd century B.C., which imply that those with dwarfism "were seen as outsiders," the authors noted.

"I think it is important for us to recognize that disability and difference can be found in the past, but these did not necessarily have negative connotations socially or culturally," co-author Sin Halcrow, an archaeologist at the University of Otago, told Forbes. "The ancient historical texts show that they may, in fact, have been revered in some situations."

Originally published on Live Science.

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5,000-Year-Old Human Found with 'Extremely Rare' Form of Dwarfism - Livescience.com

How Hypopituitarism is Treated | Learn More About …

Hormone deficiency is treated by replacing the deficient hormones. The goals of treatment are to improve symptoms (see Table 2) and to replace the deficient hormone or hormones at a level that is as close to physiologically correct (mother nature) as possible. However, one rule of hormone replacement is that no one dose will suit every patient. Thus, when hormone replacement therapy is prescribed, the patient will need to be seen regularly after starting treatment to assess the effect. It often takes time and repeated dose changes to find the optimal dose for each patient. Typically, once the optimal dose is determined, the dose remains adequate for long-term treatment unless other medications are added or the patients condition changes in a way that alters the blood levels (e.g., introduction of GH therapy may require an increase in cortisol replacement, whereas pregnancy may require an increase in the dose of thyroid hormone).

Cortisol: On average, cortisol replacement therapy consists of giving approximately 15 mg of cortisol daily in divided doses. Approximately 2/3 of the dose is given in the morning and 1/3 in the late afternoon or evening. Excess cortisol can cause side effects (see the section on risks below), so it is best to use cortisol replacement in doses that are adequate but not too high.

Some endocrinologists prescribe prednisone instead of cortisol, and the dose of prednisone can be given once or twice a day. Patients with cortisol deficiency must always remember that during periods of stress their bodies may not be able to produce the increased level of cortisol needed. Therefore, patients should always carry a medical or steroid alert card or wear a medical alert bracelet or necklace to inform physicians that they are taking chronic steroid therapy. If patients have multiple pituitary hormone deficiencies, cortisol should always be the first hormone replaced as medications like thyroid hormone or GH can increase the bodys need for cortisol.

Thyroid hormone:Levothyroxine given daily is the therapy for thyroid hormone deficiency.

Sex-related hormones:Women: Premenopausal women who have no menstrual cycles as a result of pituitary disease (secondary hypogonadism) should receive replacement therapy with estrogen and progesterone. Estrogen can be given orally, by patch or by gel. Progesterone equivalent is only required in woman who have an intact uterus. Women who have undergone a hysterectomy can be treated with estrogen alone.

Men: In testosterone-deficient men, testosterone is given by patch, gel or injection either daily (patch or gel) or every 2-4 weeks by intramuscular injection.

GH therapy:GH prescribing practices vary depending upon local customs, national guidelines and insurance coverage. It is important to do tests to prove that patients are indeed GH deficient. Human GH is administered by daily injection. Most pituitary endocrinologists start at relatively low doses to avoid side effects and increase as needed.

DI therapy:Desmopressin is usually given in tablet or spray form (nasal tube or nasal spray). Hospitalized patients may be given desmopressin by injection.

See more here:
How Hypopituitarism is Treated | Learn More About ...

Acromegaly Treatment Industry 2019 Global Market Size, Demand, Growth Prospects, Key Insights, Top Companies and Forecast till 2025 – VaporBlash

The global Acromegaly Treatment market is driven by the growing prevalence of the genetic disease, changing lifestyle. Also, factors such as rising incidence of hormonal diseases, such as hypopituitarism and endocrine diseases, and high demand for the advanced treatment is expected to increase the demand for Acromegaly treatment market.

Factors, such as unavailability of precise treatment and high cost of the surgery can restrain the market growth.

You can get a sample copy of this report @https://www.orianresearch.com/request-sample/804039

Some of the key players operating in this market include Pfizer Inc., Chiasma Inc., Novartis AG, Ipsen Biopharmaceuticals Inc., Wockhardt Ltd., Troikaa Pharmaceuticals Limited, GlaxoSmithKline plc, Aegis Therapeutics LLC, Crinetics Pharmaceuticals Inc, Daewoong Pharmaceutical Co Ltd, Peptron Inc, among others.

Increasing government support, favorable government insurance policies and schemes for the patients and rapid developments in technology will offer lucrative opportunities.

Based on Application, the Acromegaly Treatment market is segmented into Hospitals, Clinics, and others.

Based on Disease Types, the Acromegaly Treatment market is segmented into Ectopic Acromegaly, Pseudo Acromegaly.

Regionally, North America was the largest revenue generator in the Acromegaly Treatment market in 2017, because of high investments in research and development activities to investigate the applications of Acromegaly Treatment market.

Key Benefits of the Report:

* Global, Regional, Country, Application, and Disease Types Market Size and Forecast from 2014-2025

* Detailed market dynamics, industry outlook with market specific PESTLE, Value Chain, Supply Chain, and SWOT Analysis to better understand the market and build strategies

* Identification of key companies that can influence this market on a global and regional scale

* Expert interviews and their insights on market shift, current and future outlook and factors impacting vendors short term and long term strategies

* Detailed insights on emerging regions, Application& Disease Types, and competitive landscape with qualitative and quantitative information and facts.

Global Acromegaly Treatment Industry 2019 Market Research Report is spread across 121 pages and provides exclusive vital statistics, data, information, trends and competitive landscape details in this niche sector.

Inquire more or share questions if any before the purchase on this report @https://www.orianresearch.com/enquiry-before-buying/804039

Target Audience:

* Acromegaly Treatment providers

* Traders, Importer and Exporter

* Raw material suppliers and distributors

* Research and consulting firms

* Government and research organizations

* Associations and industry bodies.

Research Methodology

The Market is derived through extensive use of secondary, primary, in-house research followed by expert validation and third party perspective like analyst report of investment banks. The secondary research forms the base of our study where we conducted extensive data mining, referring to verified data sources such as government and regulatory published materials, technical journals, trade magazines, and paid data sources.

For forecasting, regional demand & supply factor, investment, Market dynamics including technical scenario, consumer behavior, and end use industry trends and dynamics , capacity Production, spending were taken into consideration.

We have assigned weights to these parameters and quantified their Market impacts using the weighted average analysis to derive the expected Market growth rate.

The Market estimates and forecasts have been verified through exhaustive primary research with the Key Industry Participants (KIPs) which typically include:

* Original Manufacturer,

* Application Supplier,

* Distributors,

* Government Body & Associations, and

* Research Institute.

Order a Copy of Global Acromegaly Treatment Market Report @https://www.orianresearch.com/checkout/804039

Table Of Content

1 Executive Summary

2 Methodology And Market Scope

3 Acromegaly Treatment Market Industry Outlook

4 Acromegaly Treatment Market Type Outlook

5 Acromegaly Treatment Market Application Outlook

6 Acromegaly Treatment Market Regional Outlook

7 Competitive Landscape

End Of The Report

Disclaimer

Customization Service of the Report:Orian Research provides customization of reports as per your need. This report can be personalized to meet your requirements. Get in touch with our sales team, who will guarantee you to get a report that suits your necessities.

About Us:

Orian Research is one of the most comprehensive collections of market intelligence reports on the World Wide Web. Our reports repository boasts of over 500000+ industry and country research reports from over 100 top publishers. We continuously update our repository so as to provide our clients easy access to the worlds most complete and current database of expert insights on global industries, companies, and products. We also specialize in custom research in situations where our syndicate research offerings do not meet the specific requirements of our esteemed clients.

Originally posted here:
Acromegaly Treatment Industry 2019 Global Market Size, Demand, Growth Prospects, Key Insights, Top Companies and Forecast till 2025 - VaporBlash

Alopecia Market Outlook and Opportunities in Grooming Regions with Forecast to 2027 | CAPILLUS, Sun Pharmaceutical Industries, Cipla, Merck and Co,…

Alopecia is a medical term, which is generally used for hair loss. It is a common autoimmune disorder that often results in unpredictable hair loss, which can lead to complete loss of hair on the scalp or, in uttermost cases, the entire body. This extreme condition can affect anyone irrespective of gender and age. Medications such as Minoxidil or Rogaine are the topical agents that are used for the treatment of disease. Other treatments of alopecia include medications that are sometimes used for other autoimmune disorders.

The alopecia market is anticipated to grow in the forecast, owing to the increasing prevalence of alopecia areata and Rise in incidence of chronic disorders such as, cancer, polycystic ovary syndrome (PCOS), hyperthyroidism, hypothyroidism, acute stress disorder, hypopituitarism, lupus. However, the rising awareness among people about hair loss is likely to add novel opportunities in the forecast period.

Top Companies Covered in this Report:1. CAPILLUS, 2. Sun Pharmaceutical Industries Ltd., 3. Cipla Inc., 4. Merck and Co., Inc., 5. Transitions Hair, 6. Follica, Inc., 7. Johnson and Johnson Services, Inc., 8. Concert Pharmaceuticals, 9. HCell Inc., 10. GlaxoSmithKline plc.

Get sample copy of Alopecia Market at: https://www.premiummarketinsights.com/sample/TIP00020711

The Global Alopecia Market Analysis to 2027 is a specialized and in-depth study of the healthcare IT industry with a special focus on the global market trend analysis. The report aims to provide an overview of Alopecia market with detailed market segmentation by service type, age group, and geography. The global Alopecia market is expected to witness high growth during the forecast period. The report provides key statistics on the market status of the leading Alopecia market players and offers key trends and opportunities in the market.

The global alopecia market is segmented on the basis of disease type, drug type, route of administration and distribution channel. Based on disease type, the market is classified as, alopecia areata, androgenic alopecia, alopecia totalis, ciatricial alopecia and traction alopecia. Based on the drug type, the market is segmented into minoxidil, finasteride and other drug types. On the basis of route of administration, the market is categorized as oral, topical and injectable. Based on the distribution channel, the market is segmented as hospitals, retail pharmacies and online pharmacies.

The report analyzes factors affecting Alopecia market from both demand and supply side and further evaluates market dynamics effecting the market during the forecast period i.e., drivers, restraints, opportunities, and future trend. The report also provides exhaustive PEST analysis for all five regions namely; North America, Europe, APAC, MEA and South & Central America after evaluating political, economic, social and technological factors effecting the Alopecia market in these regions.

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Fundamentals of Table of Content:

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered1.4 Market Analysis by Type1.5 Market by Application1.6 Study Objectives1.7 Years Considered

2 Global Growth Trends2.1 Alopecia Market Size2.2 Alopecia Growth Trends by Regions2.3 Industry Trends

3 Market Share by Key Players3.1 Alopecia Market Size by Manufacturers3.2 Alopecia Key Players Head office and Area Served3.3 Key Players Alopecia Product/Solution/Service3.4 Date of Enter into Alopecia Market3.5 Mergers & Acquisitions, Expansion Plans

4 Breakdown Data by Product4.1 Global Alopecia Sales by Product4.2 Global Alopecia Revenue by Product4.3 Alopecia Price by Product

5 Breakdown Data by End User5.1 Overview5.2 Global Alopecia Breakdown Data by End User

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Originally posted here:
Alopecia Market Outlook and Opportunities in Grooming Regions with Forecast to 2027 | CAPILLUS, Sun Pharmaceutical Industries, Cipla, Merck and Co,...

Look inside the old Natwest in Prescot after its total transformation – Liverpool Echo

A former Natwest Bank in Prescot has undergone an unrecognisable transformation - and will now offer a vital service to the community.

Six years ago, mum-of-four Debbie O'Brien, from Huyton, struggled to find a day centre where her daughter Jodie could socialise and her complex needs would be met.

Jodie, 25, has multiple health needs, including cerebral palsy, severe learning developmental delay, encephalitis, Lennox Gastuat syndrome, short-term memory loss, cirrhosis, kyphosis, osteoporosis, hypopituitarism, edema and a rare disease called panhypopituitarism.

Fearful her daughter was becoming isolated, Debbie decided to set up her own club for adults and their families in Kirkby .

Through Al's Club, Debbie met fellow-mum Andrea Evans, originally from Halewood , who attended with her son Callam James Jones, 29.

Callam, who has autism, has defied the odds through his life, having a double heart bypass, kidney failure and now being 5 years in remission.

Forming a close bond and wanting to make a change, the pair teamed up to offer a bespoke service for adults aged 18 and over with disabilities and complex medical needs.

Transforming the former Natwest Bank on Eccleston Street in Prescot , Al's Activity Respite Centre (Arc) officially launched in the town this week - and the response has been overwhelming.

Director Andrea Evans, 51, said: "My son Callam, he's the one who inspires me more than anyone else in the world.

"I'm so glad that we've done this.

"It hasn't been easy because I've juggled my own job, but I knew what the end goal would be and it's going to be an absolute honour working alongside Debbie.

"Years ago adults with disabilities were told that they had to fit into society.

"We're here to re-educate society and our guys are going to be told they no longer need to try and fit in.

"They are the community, they are society and there is no reason on this earth why they shouldn't be valued and accepted."

Al's Arc offers everything from an aromatherapy room and sensory room to a mini gym, a variety of activity sessions and more.

The space is also available for other community groups to use in the evenings, as well as having subletting offices upstairs.

Founder Debbie O'Brien, 47, said: "I do know and I do believe that the two of us together are going to transform adult services for the better.

"We want our members out in the community doing what we do, they're just going to have some guidance and support.

"Everyone has given up their time to help us with this project.

"We've had a team of different tradesman in and the transformation to us has been huge."

Al's Arc received dozens of donations and support from neighbours, local businesses and Knowsley Council - as well as help from family-friend Graham in completing the buildings transformation.

The pair said they also received emotional support from others in the community, including Social Growth Officer Jacqui Meadows and Eileen from Breast Mates, a local support group who will also be utilising the space.

Andrea said: "This is a dream come true. This is our children's future and their children's future and this is all about saying disability belongs.

"We're not in competition with any other disability service. We are going to be enabling every single day and if we can enable any other services to promote themselves and be more successful then that's what we'll do."

John Maddox, operations manager at Structec N.W. Limited said: "Much of the work that we do in Knowsley is centred around adaptations to the homes of people with disabilities, so we were delighted when Debbie invited us to get involved and provide some help to get this wonderful facility off the ground.

"The passion of those at the heart of this much needed community project is truly inspirational and will make Al's Arc a huge success."

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Cllr Sean Donnelly, Cabinet Member for Health and Social Care, said: Im delighted that Als Arc has opened its doors in Prescot, providing much-needed services here in the borough.

"The services they are offering will really benefit young adults in Knowsley, helping them to develop their skills, confidence and independent living.

"This is a great example of Knowsley Better Together in action seeing people and organisations coming together for the benefit of Knowsley and its residents. I wish them well and look forward to visiting.

For more information email: thearcprescot@gmail.com

Read the original here:
Look inside the old Natwest in Prescot after its total transformation - Liverpool Echo

PRACTICALLY ACTIVE: Love your liver and it will love you back – Arkansas Democrat-Gazette

The cruise director is the ship's liver because almost everything you can think of filters through them at some point.

Actor Willie Aames

October is Liver Awareness Month, the month chosen by the American Liver Foundation to raise public awareness of the importance of liver health.

As a diabetic, I see the importance, even though I'm not really sure what the old workhorse does.

Diabetes Education Online, the website of the Diabetes Teaching Center at the University of California, San Francisco states that the liver acts as the body's glucose (or fuel) reservoir and helps keep circulating blood sugar levels and other body fuels steady and constant. It stores and manufactures glucose, depending on the body's need.

The need to store or release glucose is primarily signaled by the hormones insulin and glucagon.

During a meal, the liver will store sugar or glucose as glycogen for a later time when your body needs it. When you are not eating, especially overnight or between meals, the body has to make its own sugar. The liver supplies sugar or glucose by turning glycogen into glucose in a process called glycogenolysis.

The liver can also manufacture the needed glucose by harvesting amino acids, waste products and fat byproducts. That process is gluconeogensis.

The liver also makes another fuel, ketones, when sugar is in short supply. When glycogen storage is running low, the body starts to conserve sugar supplies for organs that always require sugar. They include the brain, red blood cells and parts of the kidney. That process is called ketogenesis.

Ketones are burned as fuel by muscles and other body organs, and the sugar is saved for the organs that need it.

When you have diabetes, these bodily processes can be thrown off balance. Everything affects everything.

More and more these days I see the term fatty liver disease, but there is also nonalcoholic fatty liver disease. According to the website of the Mayo Clinic (mayoclinic.org), NAFLD is an umbrella term for a range of liver conditions affecting people who drink little to no alcohol. The main characteristic is too much fat stored in liver cells.

They say it is increasingly common around the world, especially in Western nations. In the United States, it is the most common form of chronic liver disease, affecting about one-quarter of the population.

Some people with nonalcoholic fatty liver disease can develop nonalcoholic steatohepatitis, an aggressive form of fatty liver disease marked by liver inflammation. It can progress to advanced scarring (cirrhosis) and liver failure. The damage is similar to the damage caused by heavy alcohol use.

There are usually no real signs or symptoms, but when any do appear, they can include fatigue, and pain or discomfort in the upper right abdomen.

Possible signs of this steatohepatitis include abdominal swelling, enlarged blood vessels just beneath the skin's surface, an enlarged spleen, red palms and yellowing of the skin and eyes.

There seems to be limited understanding of why some people accumulate fat in the liver and others do not. And there is also limited understanding of why some fatty livers develop inflammation that progresses to cirrhosis. But both conditions are linked to the following:

Overweight or obesity.

Insulin resistance, in which cells don't take up sugar in response to the hormone insulin.

High blood sugar (hyperglycemia), indicating prediabetes or Type 2 diabetes.

High levels of fats, particularly trigylcerides, in the blood.

A wide range of diseases and conditions can increase the risk too. They include high cholesterol, polycystic ovary syndrome, sleep apnea, underactive thyroid (hypothyroidism) and underactive pituitary gland (hypopituitarism).

Those at risk include older people, Type 2 diabetics and people with body fat concentrated in the abdomen.

The condition is a bit scary. Have a frank talk with your doctor if any of this seems familiar to you.

Email me at:

rboggs@arkansasonline.com

Style on 10/07/2019

Originally posted here:
PRACTICALLY ACTIVE: Love your liver and it will love you back - Arkansas Democrat-Gazette

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