Archive for December, 2019

Stem Cell Therapy Market: Snapshot

Of late, there has been an increasing awareness regarding the therapeutic potential of stem cells for management of diseases which is boosting the growth of the stem cell therapy market. The development of advanced genome based cell analysis techniques, identification of new stem cell lines, increasing investments in research and development as well as infrastructure development for the processing and banking of stem cell are encouraging the growth of the global stem cell therapy market.

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One of the key factors boosting the growth of this market is the limitations of traditional organ transplantation such as the risk of infection, rejection, and immunosuppression risk. Another drawback of conventional organ transplantation is that doctors have to depend on organ donors completely. All these issues can be eliminated, by the application of stem cell therapy. Another factor which is helping the growth in this market is the growing pipeline and development of drugs for emerging applications. Increased research studies aiming to widen the scope of stem cell will also fuel the growth of the market. Scientists are constantly engaged in trying to find out novel methods for creating human stem cells in response to the growing demand for stem cell production to be used for disease management.

It is estimated that the dermatology application will contribute significantly the growth of the global stem cell therapy market. This is because stem cell therapy can help decrease the after effects of general treatments for burns such as infections, scars, and adhesion. The increasing number of patients suffering from diabetes and growing cases of trauma surgery will fuel the adoption of stem cell therapy in the dermatology segment.

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

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Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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This post was originally published on Market Research Sheets

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Stem Cell Therapy Market Consumer Outlook 2025 | MEDIPOST Co., Ltd., Osiris Therapeutics, Inc. - Market Research Sheets

By Gerald Tan December 23, 2019 Tatler Focus

The centre offers the latest scalp innovations that address all your hair thinning woes by getting to the root cause

While you are pampering your skin with the most luxurious creams and lotions, dont forget to show your crowning glory some tender loving care, too. Beautiful tresses require plenty of effort and dedication to upkeep, but when you are faced with unfortunate scalp ailments or hair-loss issues, however, maintaining its volume and healthy shine can seem like anuphill task.

Enter hair loss and scalp care centre Papilla Haircare, which might have the solution for all your hair woes.

From state-of-the-art equipment to medicallybacked technologies, here are five things to know about the brand:

Thankfully, advances in science and technology can help alleviate many hairrelated problems. Papilla Haircare has the latest innovative solutions. Located at Ngee Ann City, it is a one-stop hub that utilises the latest medicallybacked technologies. The centre collaborates with doctors and scientists to concoct serums rich in stem cells in its own Korean laboratory to ensure the highest safety standards.

(Related: 7 Natural Beauty Products Your Skin Will Love You For)

Boasting sleek black and gold accents, Papilla Haircares contemporary interiors are a reflection of its cutting-edge services. Its clinically proven programmes are the result of extensive scientific research, meticulously developed by a group of Korean dermatologists and hair transplant surgeons. Thanks to their efficacies, these remedies have also been adopted for post-procedure use at top hair transplant centres in South Korea.

(Related: 5 Foods To Eat For Healthy Hair And Nails)

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5 Things to Know About Hair loss and Scalp Care Centre Papilla Haircare - Singapore Tatler

Technavio has been monitoring the global allogeneic stem cells market and the market is poised to grow by USD 1.24 billion during 2020-2024 at a CAGR of over 12% during the forecast period. Request Free Sample Pages

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Technavio has announced its latest market research report titled global allogeneic stem cells market 2020-2024. (Graphic: Business Wire)

Read the 131-page research report with TOC on "Allogeneic Stem Cells Market Analysis Report by geography (Asia, Europe, North America, and ROW), by application (regenerative therapy and drug discovery and development), and segment forecasts, 2020-2024".

https://www.technavio.com/report/allogeneic-stem-cells-market-industry-analysis

The new product approvals and special drug designations are anticipated to boost the growth of the market. Based on the application, the allogeneic stem cells market has been segmented into regenerative therapy and drug discovery and development. Manufacturers are increasingly emphasizing innovations and improvisation in the development of regenerative therapies. Many of the regenerative therapeutic candidates have obtained approval for clinical trials in the US, Europe, and APAC due to the efficacy of allogeneic stem cell therapeutics. This is encouraging market players to launch new product lines to stimulate the overall product demand for stem or regenerative therapy using allogeneic stem cell therapeutics and provide better options for their customers. Thus, new product approvals are expected to drive market growth during the forecast period.

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Major Five Allogeneic Stem Cells Market Companies:

Biosolution Co. Ltd.

Biosolution Co. Ltd. is headquartered in South Korea (Republic of Korea) and operates the business under its Unified business segment. The company offers an allogeneic keratinocyte spread medication, Keraheal-Allo, that promotes skin regeneration.

Cynata Therapeutics Ltd.

Cynata Therapeutics Ltd. is engaged in the discovery, development, licensing, manufacturing, marketing, distribution, and sales of innovative therapeutics for the treatment of various diseases. The company provides a mesenchymal stem cell product, Cymerus, which is used to treat graft-versus-host disease.

JCR Pharmaceuticals Co. Ltd.

JCR Pharmaceuticals Co. Ltd. is headquartered in Japan and operates under two business segments, namely Pharmaceuticals, and Medical Devices and Laboratory Equipment. The company offers a regenerative medical product, TEMCELL HS Injection, which uses human mesenchymal stem cells for the treatment of acute graft-versus-host disease.

Lineage Cell Therapeutics Inc.

Lineage Cell Therapeutics Inc. is headquartered in the US and offers products through its Unified business segment. The company provides OpRegen, which is currently being tested in a Phase I/IIa clinical trial. This product is intended for the treatment of dry AMD.

MEDIPOST Co. Ltd.

MEDIPOST Co. Ltd. is headquartered in South Korea (Republic of Korea) and offers products through its Unified business segment. The company provides an allogeneic umbilical cord blood-derived mesenchymal stem cell drug, CARTISTEM, which is used for the treatment of knee cartilage defects.

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Allogeneic Stem Cells Application Outlook (Revenue, USD Million, 2020-2024)

Allogeneic Stem Cells Regional Outlook (Revenue, USD Million, 2020-2024)

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Related Reports on Health Care include:

Cancer Stem Cell Therapeutics Market Global Cancer Stem Cell Therapeutics Market by type (allogeneic stem cell transplant and autologous stem cell transplant) and geography (Asia, Europe, North America, and ROW).

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Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions.

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Global Allogeneic Stem Cells Market 2020-2024 | Evolving Opportunities with Biosolution Co. Ltd. and Cynata Therapeutics Ltd. | Technavio - Yahoo...

Turning back time when it comes to our skin, doesnt necessarily have to mean cosmetic procedures and in-depth dermatologist appointments. No matter how old you are, using the right anti-ageing creams regularly can make a visible difference in our skin elasticity, plumpness and reduction of fine lines.

And if you dont think anti-wrinkle creams are for you just yet? You might want to think againthe earlier you start taking care of your skin, the better. This can mean anything from drinking enough water, eating the right foods and especially staying out of the sun, but luckily for us in this day and age, we also have a plethora of products to choose from to help us out along the way.

Whether youre an anti-ageing skincare pro or considering starting to use products for the first time, it can be a totally overwhelming experience trying to find the best cream for you. Thats why weve done the hard work and rounded up the 10 best ever anti-ageing creams that weve not only tried and tested but heard the experts raving about countless times. And the best thing? You wont have to spend a months wages on them.

Before we start, however, lets simplify things with a few key tips and important things to know. When shopping around for legit anti-ageing creams there are some essential ingredients to look out for. Retinol (or vitamin A) speeds up cell turnover, boosts collagen production and is the ultimate anti-ageing ingredient. It can be harsh on the skin to start with, though, so only use every few days to begin with and always use SPF with it, as it can make your skin more sensitive to rays.

Antioxidants like vitamins C and E help fight free radicalsmolecules that can do damage to your skin cells. Peptides help repair skin damage. Glycolic acid is an AHA that increases cell turnover to reveal smoother skin. Ceramides and other hydrators like hyaluronic acid and shea butter all lock in moisture and form a protective layer for your skin. And of course, SPF, which is the number one preventative anti-ageing ingredient.

Any one of these ingredients will aid anti-ageing, but the more you can find in one product, the better. Its also important to know your skin. If you know it has an oily nature, dont overdo it with rich creams, stick to lighter lotions, but if you struggle with drier skin, its the moisture-rich products to pick.

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Elemis Pro-Collagen Marine Cream 50ml (87)

This lightweight, award-winning cream is a great all-rounder. Its gentle so it will suit most complexions but its also highly effective in smoothing, firming and hydrating fine and deeper wrinkles. Somewhere in between a gel and a creamy texture, this goes on so smoothly and wont leave skin greasy.

Olay Regenerist 3 Point Firming Anti-Ageing Cream Fragrance Free with Hyaluronic Acid, 50 ml (19)

You cant really argue with the price of this hero product, and youre more than likely to see it every time you read about the best anti-wrinkle creams. This has had rave reviews since its launch. The winning combination of hyaluronic acid, amino-peptides and niacinamide (vitamin B3) is great for moisturising, plumping and refreshing surface cells all helping to smooth fine lines.

SkinCeuticals A.G.E. Interrupter 48ml (160)

Okay, this cream is on the more expensive side, but you do get a lot of bang for your buck. SkinCeuticals is one of the best anti-ageing brands on the market and this cream in particular works wonders. A.G.E. stands for Advanced Glycation End-Products, which is a big part of the natural ageing process. This cream fights it by boosting collagen levels and slowing down the loss of elasticity in the skin. It also reduces the thinning of the skin and generally improves the skins texture.

Dr Dennis Gross Skincare Ferulic and Retinol Anti-Ageing Moisturizer (72)

As we mentioned, retinol is the absolute gold-standard in anti-ageing skincare. Thiscreams magic is based around its renewing and brightening power, paired with intensely moisturising properties that help strengthen the skins natural barrier allowing it to feel less irritated by the strength of the retinol. Add in the antioxidant-rich ferulic acid and the brands own complex to brighten and reduce dark spots and you have a cream that brightens, tightens and ultimately makes skin look younger.

Sunday Riley C.E.O. Vitamin C Rich Hydration Cream (50ml ) (60)

Were big fans of this cult Sunday Riley cream. Vitamin C is a highly effective ingredient in any anti-aging day cream. The antioxidant will fight signs of aging such as damage from free radicals and reduce fine lines. This cream also calms redness, providing natural beta hydroxy acid to brighten appearance all day.

Ole Henriksen Goodnight Glow Retin-ALT Sleeping Creme 50ml (46)

As powerful and effective as retinol is, it can be a difficult product to use on sensitive skin, no matter how slowly you try and build it up into your daily routine. Bakuchiol is a plant-based alternative that has the same results but is less intense on the skin and so perfect for those on the more sensitive side. Similar to retinol the ingredient helps to boost skin-cell turnover revealing glowy new layers beneath. This cream also nourishes with edelweiss stem cell and is gentle enough for use every night.

Neutrogena Rapid Wrinkle Repair Night Moisturiser (26)

Another great overall cream but with the added bonus of higher than average daily SPF. Neutrogenas dermatologist-approved product is not only great value, but its also highly effective. Still including retinol in its ingredients but in a slightly milder form, it will help bring new cells to the forefront as well as encouraging collagen growth. Start using this every few days to begin with and build up to daily use to avoid any irritation.

RoC Retinol Correxion Deep Wrinkle Daily Moisturiser SPF 30 (21)

This best-selling and reasonably pricednight cream also works with retinol to prevent signs of ageing. Added hydration ease any irritation but dont worryits also oil-free and non-comedogenic, meaning it wont clog pores and cause breakouts.

Caudalie Resveratrol Face Lifting Soft Cream, 50ml (42)

This lightweight cream is great for protecting skin early on from signs of ageing.Resveratrol fights free radicals as well as stopping their formation, increasing and maintaining visible firmness in the skin. With added peptides, nourishing oils, elastin and hyaluronic acid, this is a truly multitasking cream with innovative technology meaning it works its way into the skin throughout the day.

Charlotte Tilbury Magic Skin Cream (49)

Before makeup artist royalty Charlotte Tilbury released her own line, she used to mix this very concoction of collagen-boosting creams herself for use on all her celebrity clients including Kate Moss, Nicole Kidman and Jennifer Lopez. Luckily for you and me, she bottled this great everyday cream, with hyaluronic acid, vitamins E and C, rosehip and camelia oil and aloe vera, leaving us all with plump and glowy skin.

Next: We asked six women with incredible skin for the products they swear by.

This article originally appeared on Who What Wear

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Trust UsThese Are the Best Anti-Ageing Creams in the Business - Yahoo Style

BEIJING, China and CAMBRIDGE, Mass., Dec. 22, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) for REVLIMID (lenalidomide), in combination with rituximab, for the treatment of patients with relapsed or refractory indolent lymphoma (follicular lymphoma or marginal zone lymphoma). REVLIMID was first approved in China in 2013 for the treatment of multiple myeloma in combination with dexamethasone, in adult patients who have received at least one prior therapy, and the label for the combination was expanded in 2018 to include adult patients with newly-diagnosed multiple myeloma (NDMM) who are not eligible for transplant. It is currently marketed in China by BeiGene under an exclusive license from Celgene Logistics Sarl, a Bristol-Myers Squibb company.

This milestone for REVLIMID marks another step in the expansion of our hematology franchise into non-Hodgkins lymphoma (NHL) in China, where significant unmet medical needs remain. Together with the pending approvals of tislelizumab for Hodgkins lymphoma and zanubrutinib for mantle cell lymphoma and chronic lymphocytic leukemia as well as Revlimid for multiple myeloma, Vidaza for myelodysplastic syndromes and acute myeloid leukemia and additional products from the collaboration we have announced with Amgen, we are working to build a market-leading presence in the treatment of hematological cancers in China, said Dr. Xiaobin Wu, General Manager of China and President of BeiGene. We are excited about this opportunity and look forward to working closely with Bristol-Myers Squibb and the NMPA to bring this chemotherapy-free treatment option to patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma in China as soon as possible.

The sNDA is supported by a clinical, non-clinical, and chemistry, manufacturing and control (CMC) data package, including the results from the pivotal Phase 3 AUGMENT study (NCT01938001) sponsored and conducted by Bristol-Myers Squibb. AUGMENT is a randomized, double-blind, multicenter trial in which a total of 358 patients with relapsed or refractory follicular or marginal zone lymphoma were randomized 1:1 to receive REVLIMID and rituximab (R2) or rituximab and placebo. With a median follow-up of 28.3 months (range: 0.1 to 51.3 months), R2 demonstrated clinically meaningful and statistically significant improvement in progression-free survival (PFS), evaluated by an independent review committee (IRC), relative to the control arm with a 54% reduction in the risk of progression or death (hazard ratio [HR] = 0.46; 95% confidence interval [CI]: 0.34, 0.62; p < 0.0001). The median PFS was 39.4 months for the R2 arm and 14.1 months for the control arm with an improvement by more than 2 years. Overall response rate (ORR), a secondary endpoint, was 78% in the R2 arm vs. 53% in the control arm, as assessed by the IRC. Duration of response (DoR) was significantly improved for R2 vs. control with median DoR of 37 vs. 22 months, respectively (P =0.0015; HR: 0.53; 95% CI, 0.36-0.79). The most frequent adverse event (AE) in the R2 arm was neutropenia (58%), vs. 22% in the control arm. Additional commonly observed AEs in more than 20% of patients included diarrhea (31% in the R2 arm vs. 23% in the control arm), constipation (26% vs. 14%), cough (23% vs. 17%), and fatigue (22% vs. 18%). Adverse events that were reported at a higher rate (>10%) in the R2 arm were neutropenia, constipation, leukopenia, anemia, thrombocytopenia and tumor flare.

About follicular lymphoma (FL) and marginal zone lymphoma (MZL)

FL and MZL are two major types of indolent lymphomas;1 FL is the most common subtype, constituting approximately 20% to 25% of all NHL,2 followed by MZL (approximately 5% to 17% of all NHLs).3 NHL incidence in China is 88,090 according to the World Health Organizations Globocan 2018 database.4 Given the incurable nature of relapsed or refractory FL/MZL, the efficacy and safety limitations of current treatment options, and the fact that patients are typically older and with comorbidities, a high unmet medical need exists for the development of novel treatment options with new differentiated mechanisms of action and a more tolerable safety profile that can improve the quality of response and PFS in the setting of previously treated FL/MZL.

About REVLIMID

In China, REVLIMID was approved in combination with dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma (MM) who are not eligible for transplant in 2018. It received approval in China in 2013 for the treatment of multiple myeloma in combination with dexamethasone in adult patients who have received at least one prior therapy.

REVLIMID is approved in Europe and the United States as monotherapy, indicated for the maintenance treatment of adult patients with newly diagnosed MM who have undergone autologous stem cell transplantation. REVLIMIDas combination therapy is approved inEurope, inthe United States, inJapanand in around 25 other countries for the treatment of adult patients with previously untreated MM who are not eligible for transplant. REVLIMID is also approved in combination with dexamethasone for the treatment of patients with MM who have received at least one prior therapy in nearly 70 countries, encompassingEurope, theAmericas, theMiddle-EastandAsia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy inAustralia and New Zealand.

REVLIMIDis also approved inthe United States,Canada,Switzerland,Australia,New Zealandand several Latin American countries, as well asMalaysiaandIsrael, for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and inEuropefor the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

In addition, REVLIMIDis approved inEuropefor the treatment of patients with mantle cell lymphoma (MCL) and inthe United Statesfor the treatment of patients with MCL whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. InSwitzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

U.S. Indications for REVLIMID

REVLIMID (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of adult patients with multiple myeloma (MM).

REVLIMID is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).

REVLIMID is indicated for the treatment of adult patients with transfusion-dependent anemia due to low-or intermediate-1risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

REVLIMID is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

REVLIMID in combination with a rituximab product is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).

REVLIMID in combination with a rituximab product is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

REVLIMID is only available through a restricted distribution program, REVLIMID REMS.

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS program.

Information about the REVLIMID REMS program is available at http://www.celgeneriskmanagement.com or by calling the manufacturers toll-free number 1-888-423-5436.

Hematologic Toxicity (Neutropenia and Thrombocytopenia)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.

Venous and Arterial Thromboembolism

REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patients underlying risks.

CONTRAINDICATIONS

Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus.

Severe Hypersensitivity Reactions: REVLIMID is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide.

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: See Boxed WARNINGS.

REVLIMID REMS Program: See Boxed WARNINGS. Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements.

Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. Patients may require a dose interruption and/or dose reduction. MM: Monitor complete blood counts (CBC) in patients taking REVLIMID + dexamethasone or REVLIMID as maintenance therapy, every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MDS: Monitor CBC in patients on therapy for del 5q MDS, weekly for the first 8 weeks of therapy and at least monthly thereafter. See Boxed WARNINGS for further information. MCL: Monitor CBC in patients taking REVLIMID for MCL weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. FL/MZL: Monitor CBC in patients taking REVLIMID for FL or MZL weekly for the first 3 weeks of Cycle 1 (28 days), every 2 weeks during Cycles 2-4, and then monthly thereafter.

Venous and Arterial Thromboembolism: See Boxed WARNINGS. Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on the patients underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision.

Increased Mortality in Patients With CLL: In a clinical trial in the first-line treatment of patients with CLL, single-agent REVLIMID therapy increased the risk of death as compared to single-agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials.

Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID and in patients with FL or MZL receiving REVLIMID + rituximab therapy, an increase of hematologic plus solid tumor SPM, notably AML, have been observed. In patients with MM, MDS was also observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment.

Increased Mortality With Pembrolizumab: In clinical trials in patients with MM, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with MM with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID + dexamethasone. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered.

Severe Cutaneous Reactions: Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. Consider REVLIMID interruption or discontinuation for Grade 2-3 skin rash. Permanently discontinue REVLIMID for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN, or DRESS.

Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with REVLIMID. The patients at risk of TLS are those with high tumor burden prior to treatment. Closely monitor patients at risk and take appropriate preventive approaches.

Tumor Flare Reaction (TFR): TFR has occurred during investigational use of REVLIMID for CLL and lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL, FL, or MZL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physicians discretion.

Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection.

Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before starting REVLIMID treatment and during therapy.

Early Mortality in Patients With MCL: In another MCL study, there was an increase in early deaths (within 20 weeks); 12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk factors for early deaths include high tumor burden, MIPI score at diagnosis, and high WBC at baseline (10 x 109/L).

Hypersensitivity: Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to REVLIMID has been reported. Permanently discontinue REVLIMID for angioedema and anaphylaxis.

ADVERSE REACTIONS

Multiple Myeloma

Myelodysplastic Syndromes

Mantle Cell Lymphoma

Follicular Lymphoma/Marginal Zone Lymphoma

DRUG INTERACTIONS

Periodically monitor digoxin plasma levels due to increased Cmax and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin-stimulating agents or estrogen-containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dexamethasone and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin.

USE IN SPECIFIC POPULATIONS

Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.

Please see the rituximab full Prescribing Information for Important Safety Information at http://www.rituxan.com.

About BeiGene

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 3,000 employees in the United States, China, Australia, and Europe; BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. In the United States, BeiGene markets and distributes BRUKINSA (zanubrutinib) and in China, the Company markets ABRAXANE (paclitaxel for injection [albumin bound]), REVLIMID (lenalidomide), and VIDAZA (azacitidine) under a license from Celgene Logistics Sarl, a Bristol-Myers Squibb company.5

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGenes plans and expectations for further development and commercialization of REVLIMID in China and the potential implications for patients. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGenes limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled Risk Factors in BeiGenes most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

______________________1 Bello C, Zhang L, Naghashpour M. Follicular lymphoma: current management and future directions. Cancer Control. 2012;19:187-95.

2 Sousou T, Friedberg J. Rituximab in indolent lymphomas. Semin Hematol. 2010; 47(2):133-42.

3 Zinzani, P. L. (2012). The many faces of marginal zone lymphoma. Hematology, 2012(1), 426432.

4 https://gco.iarc.fr/

5 ABRAXANEis registered trademark ofAbraxis Bioscience LLC, aBristol-Myers Squibb company; REVLIMIDand VIDAZAare registered trademarks ofCelgene Corporation, aBristol-Myers Squibbcompany.

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BeiGene Announces Acceptance of a Supplemental New Drug Application in China for REVLIMID in Relapsed or Refractory Indolent Lymphoma - GlobeNewswire

It was the year before my son Lysander was born, in 2004, that we saw our firstpolarbears, magnificent nomads of imponderable grace roaming the tundra like predatory ghosts in Manitoba, Canada.Polarbearsembody vastness and unspeakable endurance in their very gait. Theirs is an almost phantomic presence. They began to haunt us as an unmatched monarch whose freedom and poise and ability to survive for months without food should humble our species.

It was only recently, returning from Svalbard in the Norwegian Arctic, that we learned from Ole Jorgen Liodden, photographer and population expert, that thepolarbearswere not just being seriously threatened by melting ice but also by the continued onslaught of trophy hunters who have impaired the population for decades. In Nunavut in 2003 hunters killed 373bears, while in 2005 almost 500 were killed. The estimates ofpolarbearsin the 19 subpopulations ranging from Alaska to Russia are anywhere from 20,000 to 25,000, as is estimated byPolarBearsInternational. But as Danish biologist Morten Jorgensen claims in his cautionaryPolarBearson the Edge, this division is arbitrary. The population may be smaller.

Polarbearsare divided into units to better manage their harvesting as if they were a mere commodity.Andrew Derocher, professor of biology at the University of Alberta, wrote that he has little faith in Canadianpolarbearmanagement anymore. We have populations with no estimate for almost 20 years.When it comes topolarbears, the main threat remains climate change. Harvest, however, has impacts and some of them are obvious (eg. direct mortality) but some are more subtle (eg. number of males available for breeding.)"

In Canada, hunting for trophies has taken on insidious proportions for years. As Liodden explains,"Adult males with the best furs and trophy characteristics have been targeted for years and this is definitely affecting local populations.The large males with the fittest genes are removed from the overall population that would have benefited from the strength and experience of these males whilebearsthat are less likely to survive are left to fend for themselves impairing the mating success of the species.Trophy hunting is forcing 'reverse evolution' or evolutionarydegeneration by increasing less desirable genetic characteristics in a population.

The conservation of one of the most majestic species on Earth has been reduced to quota management. If this way of conservingpolarbearscontinues, the harvesting, the actual murder ofpolarbearsas a cash crop, will come to a climax and one day, with the added challenge of climate change, they will quite simply be no more.

I had the occasion to meet Erling Madsen, an Inuit elder awarded byPolarBearsInternational for being asteward ofpolarbearsin his village, Ittooqoormitt in Eastern Greenland. He is the guardian of his people, and with flare guns and occasionally rifles has the job of making sure children are safe frompolarbearsand daily makes sure there are no straybearscoming into the village looking for food. His village is allowed a quota of 35polarbearsa year by the Greenland government, and while Erling explained that in the old days one had to go further afield to findbears, today many more come closer to town because of climate change.

I wondered if this quota did not seem too high, especially since the overall population is decreasing worldwide. Madsen insisted that hunters respected thebears. I asked how he would feel if his people lost thepolarbearforever. He paused as if I had asked something taboo, and with a sigh answered, We would lose our souls.

Not very long ago the Inuit honored thepolarbearand hunted them for survival. As John Houston, who was born on Baffin Island and who learned Inuktikuk as a child, explains, the Inuit hope we who are polluting and melting the very ground of the Arctic will grow up and become mature adults, stop fighting amongst ourselves and acknowledge the truth of the ancient prophecy that the earth and sky can be changed by people. Stop burning thepolarbear. They are Very Important Persons and worthy of our utmost respect. Look into their souls and you will be changed.

Canada, with its vast resources, can make up for any revenue native communities miss out on if they stoppedhuntingpolarbear. As Jorgensen exclaims, the precautionary principle should be heeded. We need to "consider honestly the summative pressure onpolarbearsof all human activities. Stop claiming thatpolarbearconservation is effective today. Speak out against overexploitation and commercial abuse."Canada as a country should take responsibility for its most iconic mammal while it still can. In 10 years time, with the ice dissolving beneath their feet, its might well be too late.

In the old days, certainly before the mid-20th century, thepolarbearwas honored. Kutsikitsoq, an elder, once said, After all, thepolarbearis the one closest to us!

Thepolarbearwas closely identified with man, so much so, that according to another Inuit elder, Inurterssuaq, when one had killed abear, one was to observe a period of mourning as for humans three days for a male, five for a female. Today, trophy hunters, and members of safari clubs, pay Inuit hunters to bag apolarbear, one of the least appropriate species on earth for such killing as they have a low birthrate and high cub death rate.

As opposed to the old days, when an Inuit hunter would face down apolarbearwith a spear and put his very life on the line, today skidoos and high-powered rifles out run their prey.

Commercial exploitation becomes the focus of the relationship, and it invariably becomes a question of taking the harvest to the limit. In 2013, an 11-footpolarbearskin was being sold for $20,500 in Canadian money. In 2014, pelts cost up to $40,000 in U.S. money.One recently was sold to a Chinese client for close to $80,000 U.S. A mountedbearcan earn as much as $100,000 in U.S. money. Skyrocketing prices are fueling greed worldwide, greed that if left unchecked, could eventually lead to extermination. Canada has more than enough resources to make up the loss of revenue for native peoples, they whose world was turnedupside down by the Canadian government not so very long ago. The same trophy hunters are looking for jaguar parts in the Amazon, lions in Africa and tigers in Asia and countless other irreplaceable species around the world. As Jorgensen underscores, Phasing out the unnecessary hunt of a threatened species would send a strong signal of true stewardship of the environment, and it would constitute a strong starting point for building a solid identity in a meaningful future.

Lysander floated on a zodiac near the Svalbard shoreline just a few weeks before his 14th birthday. He had come to the same place when he was a child ten years ago. Spellbound by the ice, he reveled in the presence of a giant of being, the great icebear, a creature he had once molded into a clay figurine incarnating all the marvel and joy of childhood. There was a sense of returning to a place that had helped forge the human imagination during the Pleistocene, the roof of the world whose supreme sentinel was holding on to the last vestiges of its world.

Apolarbearmeandered among the fragmented ice, like a seemingly lost nomad searching for redemption on a scattered planet.

Time is running out for many species on Earth. The bloodlust that runs in our veins serves not our survival but our eventual defeat. As the eloquent writer and explorer of mans place in the universe Loren Eiseley warned, The need is not really for more brains, the need is now for a gentler, a more tolerant people than those who won for us against the ice, the tiger, thebear. The hand that hefted the axe, out of some blind allegiance to the past fondles the machine gun as lovingly. It is a habit man will have to break to survive, but the roots go very deep.

Legislative action worldwide andespecially in Canada should be implemented immediately so that shooting ofpolarbearsis considered a crime. The trade inpolarbearbody parts should be banned. Such trade should shame the foundation of our kind. Trophy hunting needs to be eliminated forever so that the monarch of the north continues to be one of the ultimate sentinels of life on Earth. Its future is slipping through its paws as we rummage through numbers and statistics. Let humanity have a change of heart for a being we will mourn like few others, if that clay figurine our son molded when he was 6 becomes the only thing left to remind us of what was. As for future of the ice on which thepolarbeardepends so very dearly, I leave the last words to Lysander, now 14, who astutely said, The melting ice is the hourglass that measures the remainder of our time on this Earth.

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Can we stop killing polar bears while they still roam the top of the world? - The Hill

Olaf is almost two months old. (Submitted by Diane Barber)

Contact: Vanessa Beeson

STARKVILLE, Miss.A Mississippi State University partnership with the Fort Worth Zoo has hatched the first of more than 30 metamorphosed toadlets produced through in vitro fertilization.

A Puerto Rican crested toad named Olaf, hatched at the Fort Worth Zoo this year, is what one might call a work of art. ART, or assisted reproductive technologies, developed by scientists in the universitys Mississippi Agricultural and Forestry Experiment Station and the Forest and Wildlife Research Center, helps amphibians like the Puerto Rican crested toad, considered a threatened species by the U.S. Fish and Wildlife Service.

The technologies include hormone therapies, sperm cryopreservation and in vitro fertilization. MSU also is home to the countrys only National Amphibian Genome Bank, a repository of cryopreserved sperm from approximately 10 of the worlds most threatened and endangered amphibian species.

Carrie Vance, assistant research professor in the Department of Biochemistry, Molecular Biology, Entomology and Plant Pathology who co-leads the project, said Olaf is an example of how ART helps increase the genetic diversity and sustainability of populations of threatened amphibians.

Olaf represents the first time we used cryopreserved sperm from a wild Puerto Rican crested toad as a new genetic line to be combined with an egg from a captive female, said Vance, who also is a MAFES scientist at MSU. Whats more is that both of Olafs parents have since died of natural causes so Olaf is truly the last of this particular genetic line.

Vance pointed out that while cryopreserving sperm from wild males, researchers have been able to use hormone therapies to assist breeding. As opposed to other methods, this technique enables researchers to collect sperm without killing the animal, which Vance believes will result in a wider adoption of the practice.

Previously to introduce genetics from wild individuals into a captive population, the animals were brought into captivity, then paired, and often would never breed anyway. If the collection of sperm from testes macerates was needed, it would require the animal be euthanized, Vance said. This new method means we can collect the sperm and release the specimen back into the wild.

Vance said ART is one facet of a larger species survival plan, which includes steps such as habitat restoration, disease control and establishing an assurance colony in captivity.

ART helps when amphibians have difficulty breeding in captivity. Typically, amphibian breeding is cued by environmental factors such as day length, rainfall and temperature, which are things that can be difficult to control in a 10-gallon aquarium. When they dont breed, the genetic lines are lost, and a zoos entire assurance colony can collapse.

Vance said it comes down to overriding the environmental cues and synchronizing the timing of the actual breeding, noting that while it takes males only hours to generate sperm, it can take weeks for females to produce eggs.

The hormone therapy overrides the environmental factors to trigger the production of reproductive hormones, which cause sperm and egg release. Sperm cryopreservation holds the sperm in perpetuity until the eggs are ready for synchronization.

Vance has partnered with Andy Kouba, professor and head of the Department of Wildlife, Fisheries and Aquaculture in MSUs College of Forest Resources and scientist in the Forest and Wildlife Research Center, for more than 20 years developing innovative reproductive technologies for threatened and endangered species.

The researchers also have applied ART to the Mississippi gopher frog, considered one of the most endangered in the U.S. Their pioneering work resulted in thousands of Mississippi gopher frogs being produced by zoos around the country and reintroduced into their native habitat.

Many of the techniques we use on species like the Puerto Rican crested toad were developed using the Mississippi gopher frog, Kouba said. The Mississippi gopher frog was the first endangered species ever produced from frozen sperm. The offspring are still alive and have subsequently produced a second generation of offspring, considered another first of its kind.

Kouba said seeing the applied conservation in action and being able to reintroduce animals back into the wild is what excites him most about the work.

Globally, it is estimated that 30-40 percent of amphibians are threatened with extinction. In the U.S. that number is closer to 50 percent, Kouba said. Our assisted reproductive technologies have led to millions of tadpoles from threatened and endangered species being released into the wild across many species.

Kouba added that amphibians serve as indicator species for the health of their surrounding ecosystems.

They are the canary in the coal mine, Kouba said. Anything happening in the environment soaks through their permeable skin. Also, they have two life stages, an early aquatic stage and a terrestrial stage, which lets scientists know what is happening in two different environments. As an indicator species, it is important to understand why amphibian populations are disappearing and to try and help the populations recover.

In addition to the Puerto Rican crested toad and the Mississippi gopher frog, other species the team focuses on include the Boreal toad, Houston toad, Chiricahua leopard frog and various species of salamanders. Graduate students on the project include doctoral student Allison Julien of Scotts Valley, California; masters student Isabella Burger of Prattville, Alabama; and Kristen Counsell, a spring 2018 masters graduate of Cedar Falls, Iowa. Masters student Amanda Gillis of Fallston, Maryland, and research associate Emmet Guy of Oxford contribute to the labs salamander research.

Support for the Olaf project includes funding from Disneys Conservation Endowment Fund and the Association of Zoos and Aquariums. Longtime funding partner, the Institute of Museums and Library Services, supported the early development of this work and currently sponsors the labs salamander research. Morris Animal Foundation also has provided previous financial support.

For more on the Mississippi Agricultural and Forestry Experiment Station, visit http://www.mafes.msstate.edu. For more on the Forest and Wildlife Research Center, visit http://www.fwrc.msstate.edu.

MSU is Mississippis leading university, available online at http://www.msstate.edu.

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One-of-a-kind toad born through MSU pioneering technology that's saving threatened species - Mississippi State Newsroom

By BONNIE J. GORDON

Los Alamos Daily Post

Los Alamos National Laboratory Director Thom Mason presented a talk Thursday evening about leveraging the nations scientific base against national security threats.

Mason was the guest speaker at a meeting of the Los Alamos Committee on Arms Control and International Security meeting at the United Church of Los Alamos.

The Lab is in the business of applying science and technology to constantly changing geopolitical realities, Mason said.

He explained that with the fall of the Soviet Union and the 9/11 attack that occurred in 2001, the focus of nuclear deterrence changed from attacks by nation-states to terrorism by extremist groups.

Hopes were high that Russia and China were moving toward peacefully joining the world community, he said. With the Russian invasion of Ukraine in 2018 and new Chinese leadership that departed from the previous peaceful rise strategy, things have changed dramatically, he said.

Although Ukraine is not in NATO, the Baltic States are, and they feel threatened by Russia, Mason said. The reality is if Russia wanted to move into the Baltic States, the things that prevent it are NATO and the nuclear deterrent.

China also has rattled its saber in its region, he said.

The nuclear deterrent affects the actions of others, Mason said. You dont have to use it for it to be effective.

The deterrent also affects the security decisions of allies like Japan and South Korea who depend on us, rather than developing their own nuclear weapons, Mason said.

They have the capacity to become nuclear powers if they are not convinced we have their backs, he said.

Current nuclear powers have followed the New START (Strategic Arms Reduction Treaty) in committing to reduce nuclear arms. Nuclear testing ended in 1992 when the first START treaty (Strategic Arms Reduction Treaty) was entered into by the U.S. and the USSR. Current nuclear powers have followed the START guidelines to end testing, although not compelled by it, Mason said.

The only way wanna-be nuclear powers get there is through testing, he said. Thats why it shines a bright light every time the earth shakes in North Korea.

Riding the tiger of maintaining the nuclear arsenal without tests, through the use of scientific tools is a big part of LANLs mission, Mason said. Most of the weapons were relatively new when testing ended, having mostly been built in the 1980s, but now its 40 years down the road.

The whole key to deterrence is to make sure the weapons will work, and enemies must have confidence they will work, Mason said.

LANL has a number of life extension programs, including replacing aging components and changes to improve safety and security as well as address environmental concerts, he said.

Particle accelerators at Los Alamos Neutron Science Center (LANSCE) are used to film and understand materials at extremes. The DNNSC free electron laser that Mason hopes will be built at LANL, brings an exquisite ability to understanding how microstructure of material affects its mechanical properties, he said.

Computational tools provide another way forward in both stockpile stewardship as well as other modeling jobs such as tracking climate change, Mason said.

Computational tools can go where experiments cant, he said.

Another task is the development of sensors to be used in treaty verification, Mason said.

LANLs mission is to create what Mason calls a deterrence of knowledge or the demonstrated capacity of the nation to respond to emergency threats.

Potential enemies must be convinced that, No matter what you come up with, well be smart enough to counter it, Mason said.

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LANL Director Thom Mason Speaks To LACACIS On Leveraging Science Against National Security Threats - Los Alamos Daily Post

OTTAWA Call it the case of the missing icebreaker.

The fate of the Canadian Coast Guards next heavy icebreaker has been wrapped in mystery since the federal government quietly removed the $1.3-billion project from Vancouver shipyard Seaspans order book in May.

But plans to build the icebreaker, which was first promised by Stephen Harpers Conservative government more than a decade ago, have not been cancelled, says Coast Guard Commissioner Mario Pelletier.

Rather, Pelletier said the icebreaker has been sent back to the drawing board as the Coast Guard looks to update the original design to account for changes in technology and the governments requirements.

Its still in the plan, Pelletier told The Canadian Press this week. Actually, were updating our design. It was a really good design. Because its been a number of years, were just updating the design and well see how that unfolds and were going to queue it somewhere.

Exactly when and where the CCGS John G. Diefenbaker, as the icebreaker is to be named, will be built and how much it will ultimately cost remains up in the air.

We're just updating the design and we'll see how that unfolds and we're going to queue it somewhere

But Pelletier expressed confidence the icebreaker it is expected to replace, the CCGS Louis S. St-Laurent in service since 1969 will be able to operate through to the late 2020s thanks to various upgrades. That includes a recent $7.1-million life extension by Quebecs Chantier Davie shipyard.

The Diefenbaker was originally supposed to replace the St-Laurent in 2017.

Before we decided to invest in vessel life extension, we did an extensive survey and they were amazed at the amount of steel left on the ship, said Pelletier, who previously served on the Louis S. St-Laurent when it was still running on steam power.

So yes, the ship is old. (But it has) a lot of steel left so that makes it safe and the propulsion-control system and everything else have been upgraded. They were upgraded in the 90s, were upgraded four or five years ago again. So shes been extremely reliable.

Seaspan was tapped in 2011 to build Diefenbaker as part of a larger order that also included four science vessels for the Coast Guard and two navy supply ships, but it was removed from the Vancouver shipyards order book and replaced with 16 smaller multipurpose vessels in May.

Davie has been jumping at the chance to have the Diefenbaker built at its shipyard outside Quebec City.

The federal government announced Thursday that Davie was the only shipyard to qualify for addition into Canadas multibillion-dollar shipbuilding strategy, through which Ottawa is already building new naval warships, Arctic patrol vessels and Coast Guard science ships.

While that sets the company up to win potentially billions of dollars of federal work building six medium icebreakers for the Coast Guard, it has been lobbying hard for the heavier Diefenbaker as well.

The government has said Ontario-based Heddle Shipyards, which had raised concerns from the start that the selection process was rigged in Davies favour, did not qualify for inclusion in the strategy. The company has said it is looking at its options.

Pelletier said no decision has been made on where the Diefenbaker will be built, adding: The way things are starting up, we are going to start the (multipurpose vessels) and the (six) icebreakers before. When we look at all options for the polar, well see where it can go.

The industry both down south and up north are putting a lot of pressure for us to renew our program icebreakers

The Coast Guard commissioner applauded the governments addition of a third shipyard focused exclusively on building icebreakers as good news for his service given the age of its current fleet, with many ships having already exceeded their expected lifespans.

That has resulted in more unplanned breakdowns, leading to ferry-service disruptions, difficulties resupplying northern and coastal communities and complaints from industry about negative impacts on maritime trade.

The industry both down south and up north are putting a lot of pressure for us to renew our program icebreakers, Pelletier said, referring to the main icebreaker fleet.

The Coast Guard did obtain three second-hand icebreakers for more than $800 million from Davie. The company is still in the process of converting two of them for the Coast Guards use to help fill the gap, but those are considered a temporary measure.

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Back to the drawing board for missing heavy icebreaker: Coast Guard - National Post

The low-carbohydrate, high-fat ketogenic diet has become hugely popular over the last few years. For many people, the keto diet including variations such as keto cycling or the less restrictive lazy keto has become the go-to eating plan for weight loss and fighting disease.

Two years ago, I interviewed cancer specialist Dr. Patrick Hwu of MD Anderson in Houston about his research into what he calls the fat-burning metabolism diet, or fat-burning diet. Hwu, a tumor immunologist, has been following the ketogenic diet himself for six years, long before it was trending on social media.

As a leading cancer doctor, he has many patients asking him for the ideal diet while they go through treatment and he often suggests keto.

Hwu emphasizes that more research is needed to determine the ideal diet for cancer patients, but as he has seen in himself, the keto diet has been shown to improve biomarkers associated with heart health.

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Keto is a diet that was developed decades ago and originally used for patients with severe epilepsy, some of whom were on the diet for life with no evidence of harm. It consists of low carb, high fat and only moderate protein intake, as opposed to the Atkins diet. Keto isnt as meat-heavy as commonly believed. Hwu relies on certain go to foods like full-fat regular cream cheese, sour cream and avocados as staples. He also consumes a lot of green vegetables and cauliflower.

Since starting the keto diet, Hwu has dropped 25 pounds and has maintained the weight loss. His blood pressure, triglycerides and sugar levels have all decreased, which are healthy signs. His biomarkers, including lipid profile and blood pressure have been excellent, he said.

There have been a number of studies that show the connection between obesity and certain cancers. Hwu feels that keto makes sense because his patients are not hungry on it, it manages their weight and blood sugar levels and keeps insulin and IGF-1 levels low two proteins that have been shown to drive some cancers.

I feel that fat intake has been overly emphasized as a negative factor and that a high intake of carbs and the subsequent spikes in insulin and IGF-1 (an insulin-like hormone in the blood) that they cause are more harmful to health overall, Hwu said.

Hwus colleague, Dr. Jennifer McQuade, an assistant professor and physician scientist in Melanoma Medical Oncology at MD Anderson says they are currently conducting both human and animal studies of the effects of diet, including the ketogenic diet, on cancer. In addition, they are testing a plant-based high-fiber diet aimed at the gut microbiome, which has been shown to impact response to immunotherapy, a type of cancer treatment that utilizes the patients own immune system to fight the disease. They expect results from the studies early next year.

Recent work from the laboratory of Lew Cantley at Cornell has shown that the ketogenic diet can improve cancer control in mice treated with a type of targeted therapy that can cause elevated levels of insulin.

The MD Anderson researchers will test the ketogenic diet in cancer survivors to see if it lowers insulin and IGF-1, they will then move on to combining with targeted therapy.

The keto diet research will be prepared in an MD Anderson kitchen and provided to the patients in a controlled setting.

Meanwhile, Hwu would like to see a greater variety of keto-friendly offerings in grocery stores because the key to sticking with keto is having enough substitutes, so you never feel deprived.

You can bake almost anything with almond flour," said Hwu, "and stevia, erythritol and monk fruit are all safe sweeteners.

Kristin Kirkpatrick

Kristin Kirkpatrick is the lead dietitian at Cleveland Clinic Wellness & Preventive Medicine in Cleveland, Ohio. She is a best-selling author and an award winning dietitian.

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Is the keto diet healthy? Cancer researchers study effects of keto - TODAY

Another busy year for clinical research has come and gone. What are the most important findings from 2019? Here is our overview of some of the most noteworthy studies of the year.

"Medicine is of all the Arts the most noble," wrote the Ancient Greek physician Hippocrates whom historians call the "father of medicine" over 2,000 years ago.

Advances in therapeutic practices have been helping people cure and manage illness since before the time of Hippocrates, and, today, researchers continue to look for ways of eradicating diseases and improving our well-being and quality of life.

Each year, specialists in all areas of medical research conduct new studies and clinical trials that bring us a better understanding of what keeps us happy and in good health, and what factors have the opposite effect.

And, while each year, experts manage to overcome many obstacles, challenges old and new keep the medical research field buzzing with initiatives.

Reflecting on how research has evolved over the past decade, the editors of the reputable journal PLOS Medicine in a recent editorial emphasize "ongoing struggles" with infectious diseases, as well as growing tensions between two approaches in medical research. These approaches are the effort of finding treatments that are consistently effective in large populations versus the notion of "precision medicine," which favors therapy that we closely tailor to an individual's very personal needs.

But how has clinical research fared in 2019? In this special feature, we look at some of the most prominent areas of study from this year and give you an overview of the most noteworthy findings.

The medication we take as long as we follow our doctors' advice is meant to help us fight off disease and improve our physical or mental well-being. But can these usually trusty allies sometimes turn into foes?

Most drugs can sometimes cause side effects, but more and more studies are now suggesting a link between common medication and a higher risk of developing different conditions.

In March this year, for instance, experts affiliated with the European Resuscitation Council whose goal is to find the best ways to prevent and respond to cardiac arrest found that a conventional drug doctors use to treat hypertension and angina may actually increase a person's risk of cardiac arrest.

By analyzing the data of more than 60,000 people, the researchers saw that a drug called nifedipine, which doctors often prescribe for cardiovascular problems, appeared to increase the risk of "sudden cardiac arrest."

Project leader Dr. Hanno Tan notes that, so far, healthcare practitioners have considered nifedipine to be perfectly safe. The current findings, however, suggest that doctors may want to consider offering people an alternative.

Another study, appearing in JAMA Internal Medicine in June, found that anticholinergic drugs which work by regulating muscle contraction and relaxation may increase a person's risk of developing dementia.

People may have to take anticholinergics if some of their muscles are not working correctly, usually as part of health issues, such as bladder or gastrointestinal conditions, and Parkinson's disease.

The research that specialists from the University of Nottingham in the United Kingdom led looked at the data of 58,769 people with and 225,574 people without dementia.

It revealed that older individuals at least 55 years old who were frequent users of anticholinergics were almost 50% more likely to develop dementia than peers who had never used anticholinergics.

But, while common drugs that doctors have prescribed for years may come with hidden dangers, they are, at least, subject to trials and drug review initiatives. The same is not true for many other so-called health products that are readily available to consumers.

Such findings says the study's lead researcher, Prof. Carol Coupland, "highlight the importance of carrying out regular medication reviews."

In 2019, we have celebrated 50 years since someone first successfully sent a message using a system that would eventually become the internet. We have come a long way, and now, we have almost everything within reach of a "click and collect" order.

This, unfortunately, includes "therapeutics" that specialists may never have assessed, and which can end up putting people's health and lives in danger.

In August, the Food and Drug Administration (FDA) issued a warning against an allegedly therapeutic product that was available online, and which appeared to be very popular.

The product variously sold under the names Master Mineral Solution, Miracle Mineral Supplement, Chlorine Dioxide Protocol, or Water Purification Solution was supposed to be a kind of panacea, treating almost anything and everything, from cancer and HIV to the flu.

Yet the FDA had never given the product an official assessment, and when the federal agency looked into it, they saw that the "therapeutic" a liquid solution contained no less than 28% sodium chlorite, an industrial bleach.

"[I]ngesting these products is the same as drinking bleach," which can easily be life threatening, warned the FDA's Acting Commissioner Dr. Ned Sharpless, who urged people to avoid them at all costs.

Many studies this year have also been concerned with cardiovascular health, revisiting long held notions and holding them up to further scrutiny.

For instance, a study in the New England Journal of Medicine in July which involved around 1.3 million people suggested that, when it comes to predicting the state of a person's heart health, both blood pressure numbers are equally important.

When a doctor measures blood pressure, they assess two different values. One is systolic blood pressure, which refers to the pressure the contracting heart puts on the arteries when it pumps blood to the rest of the body. The other is diastolic blood pressure, which refers to the pressure between heartbeats.

So far, doctors have primarily taken only elevated systolic blood pressure into account as a risk factor for cardiovascular disease.

However, the new study concluded that elevated systolic and diastolic blood pressure are both indicators of cardiovascular problems.

Its authors emphasize that the large amount of data they had access to painted a "convincing" picture in this respect.

"This research brings a large amount of data to bear on a basic question, and it gives such a clear answer."

Lead researcher Dr. Alexander Flint

At the same time, a slightly earlier study, appearing in the European Heart Journal in March, emphasizes that having high blood pressure may not mean the same thing for everyone, and while doctors may associate it with adverse outcomes in some, this does not hold for all populations.

The study's first author, Dr. Antonio Douros, argues that "[w]e should move away from the blanket approach of applying the recommendations of professional associations to all groups of patients."

Dr. Douros and team analyzed the data of 1,628 participants with a mean age of 81 years. The researchers found that older individuals with lower systolic blood pressures actually faced a 40% higher risk of death than peers with elevated blood pressure values.

"[A]ntihypertensive [blood pressure lowering] treatment should be adjusted based on the needs of the individual," the study's first author advises.

When it comes to protecting heart health, 2019 studies have shown that diet likely plays an important role. Thus, research in the Journal of the American Heart Association in August showed that people who adhered to plant-based diets had a 32% lower risk of death that researchers associate with cardiovascular disease than those who did not.

People who ate plant-based foods also had a 25% lower risk of all-cause mortality, according to this study.

And another study from April in the journal Nutrients warned that people who follow a ketogenic diet, which is high in fats and low in carbohydrates, and who decide to take a "day off" from this commitment every now and again, may experience blood vessel damage.

Ketogenic or keto diets work by triggering ketosis, a process in which the body starts burning fat instead of sugar (glucose) for energy. But "cheat days" mean that, for a brief interval, the body switches back to relying on glucose.

"[W]e found [...] biomarkers in the blood, suggesting that vessel walls were being damaged by the sudden spike in glucose," notes first author Cody Durrer.

In 2019, the topic of how our food choices influence our health has remained popular among researchers and readers alike.

According to Google Trends, some of the top searches in the United States this year included intermittent fasting diets, the Noom diet, and the 1,200 calorie diet.

And this year's studies have certainly reflected the widespread interest in the link between dietary choices and well-being.

One intriguing study in Nature Metabolism in May pointed out that protein shakes, which are popular among individuals who want to build muscle mass, may be a threat to health.

Fitness protein powders, the study authors explain, contain mostly whey proteins, which have high levels of the essential amino acids leucine, valine, and isoleucine.

The research in mice suggested that a high intake of these amino acids led to overly low levels of serotonin in the brain. This is a key hormone that plays a central role in mood regulation, but which science also implicates in various metabolic processes.

In mice, the heightened levels of leucine, valine, and isoleucine, which caused excessively low serotonin, led to obesity and a shorter life span.

So, if too much of certain types of protein can have such detrimental effects on health, what about fiber? Dietary fiber present in fruit, vegetables, and legumes is important in helping the body take up sugars little by little.

But how much fiber should we consume? This is the question that a study commissioned by the World Health Organization (WHO) and appearing in The Lancet in January sought to lay to rest.

The research took into account the findings of 185 observational studies and 58 clinical trials, covering almost 40 years.

It concluded that to lower their death risk, as well as the incidence of coronary heart disease, stroke, type 2 diabetes, and colon cancer, a person should ideally consume 2529 grams of fiber per day.

"Fiber-rich whole foods that require chewing and retain much of their structure in the gut increase satiety and help weight control and can favorably influence lipid and glucose levels," explains one of the authors, Prof. Jim Mann.

On the other hand, several studies from this year draw attention to just how detrimental foods that are not 100% natural can be. A small trial, whose results came out in Cell Metabolism in May, showed that processed food leads to abrupt weight gain but not for the reasons we may think.

The study authors said they were surprised that when they asked participants to eat either an ultraprocessed food diet or a nonprocessed food diet whose caloric contents the researchers matched perfectly the people who ate processed foods rapidly gained more weight than the ones who ate the nonprocessed foods.

The researchers blame this on the speed with which individuals end up eating processed foods, in particular. "There may be something about the textural or sensory properties of the food that made [participants] eat more quickly," says study author Kevin Hall, Ph.D.

"If you're eating very quickly, perhaps you're not giving your gastrointestinal tract enough time to signal to your brain that you're full. When this happens, you might easily overeat," he hypothesizes.

And more research in mice from Scientific Reports in January found that emulsifiers, which are a common additive present in many products from mayonnaise to butter, could affect gut bacteria, leading to systemic inflammation.

What is more, the impact on the gut could even influence processes that occur in the brain, increasing anxiety levels. "[W]e [now] know that inflammation triggers local immune cells to produce signaling molecules that can affect tissues in other places, including the brain," explains co-lead researcher Prof. Geert de Vries.

While some of the studies that made the headlines in 2019 were conclusive, many encourage further research to confirm their findings or further investigate the underlying mechanisms.

Stepping into the next decade, this much is clear: The wheels of medical research will keep on turning for better health across the globe.

Originally posted here:
2019 in medical research: What were the top findings? - Medical News Today

Shares of Horizon Therapeutics (NASDAQ:HZNP) closedmore than 4% higher on Monday after an U.S. Food and Drug Administration advisory committee votedin support of the company's treatment for thyroid eye disease, and the stock extended gains by more than 2% over the next two trading sessions.The FDA's Dermatologic and Ophthalmic Drugs Advisory Committee concluded that potential benefits of teprotumumab outweighed possible treatment risks.

IMAGE SOURCE: GETTY IMAGES.

But a long-term rally may be limited, at least for now. The FDA has until March 8 to issue its decision on the treatment, leaving investors plenty of time to speculate, wonder, and buy or sell shares. Of course, the committee's vote for teprotumumab is a strong positive indicator, and the FDA does take such a recommendation into consideration. That said, the vote doesn't guarantee the drug's approval.

At the moment, there are more reasons to be positive about Horizon than negative. Any sign of possible approval is good news, and what's particularly interesting here is the fact that if the FDA gives the green light, teprotumumab will become the firstFDA-approved treatment for thyroid eye disease.

In its latest earnings call, the company said it estimated15,000 to 20,000 patients per year are eligible for its treatment and said initial physician feedback supports those figures. As for how that translates into sales, Horizon forecastspeak annual net sales of more than $750 million. Analysts predict peak sales could reach $500 million to $1.5 billion.

Thyroid eye disease is an autoimmune disease resulting in eye bulging, double vision, and even blindness, and often affects those who suffer from Graves' disease.In Graves' disease, the body's immune system attacks the thyroid, causing it to make more thyroid hormone than needed, while in thyroid eye disease, the body's immune system attacks tissue surrounding the eye. Teprotumumab acts by inhibiting a key receptor involved in the development of thyroid eye disease. The global Graves' disease market totaled $306.3 million last year, according to a Research and Markets report, and about 25% of people suffering from that disease can also develop thyroid eye disease, datafrom Persistence Market Research showed.

Even without teprotumumab on the market, Horizon's general financial picture is bright, with the company postingpositive earnings surprises for the past four quarters. Third-quartersales rose 3%, and Horizon increased its full-year 2019 adjusted EBITDA guidance to the range of $465 million to $475 million from the earlier forecast range of $460 million to $475 million. The company also took steps to improve its capital structure, issuing senior notes and, through proceeds and cash on hand, repaying $625 million of outstanding debt.

Now the question is: What's in store for the stock in the next few weeks? Let's have a look at the stock's performance this year. Horizon has climbedabout 61% since the start of 2019, and now, trading at close to $35, its shares are approaching the average analyst price target of $38.10. By that measure, investors can expect an upside of more than 8%. The stock clearly has further to go if indeed the FDA approves teprotumumab, but considering the stock's gains so far this year and the fact that the FDA hasn't yet issued a decision, volatility may be ahead.

That doesn't mean it's too late for investorsto bet on the Horizon story. In fact, any volatility that drives the shares down may make for the perfect buying opportunity. The FDA's March deadline to issue a decision on teprotumumab will be the next catalyst for the stock and should determine clear direction one way or the other.

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Horizon Therapeutics Rally May Be Short-Lived As Investors Wait For Key Date In March - Motley Fool

Quality of Life Maintained With Abemaciclib Plus Trastuzumab With or Without Fulvestrant in Patients with HR-Positive, HER2-Negative Breast Cancer

The results were published as a poster session during the San Antonio Breast Cancer Symposium in San Antonio, TX. In the randomized, 3-arm, phase 2 study monarcHER study for HR-positive, HER2-positive ABC, abemaciclib in combination with trastuzumab and fulvestrant significantly improved investigator-assessed progression-free survival versus trastuzumab plus chemotherapy.

In the study, 237 postmenopausal (surgical, natural, or chemical ovarian suppression) women with ABC prior to HER2-positive directed therapies in the advanced setting were randomized 1:1:1 to 150 mg abemaciclib + trastuzumab (intravenous infusion every 21 days) with 500 mg fulvestrant or without fulvestrant vs trastuzumab plus physicians choice of chemotherapy. Patient-reported outcomes were measured at baseline and at every cycle using the modified Brief Pain inventory-short form and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30.

Abemacilib is an oral selective inhibitor of cyclin-dependent kinases 4 and 6 approved for HR-positive, HER2-negative metastatic breast cancer.

Patient-reported outcome compliance rates were 90% through cycle 15. The range for median duration of each treatment component of each group was 7.5-10.0 cycles. No statistically significantly differences or clinically meaningful changes from baseline differences were observed between treatment groups for global health score, function scales, or for symptoms of fatigue, dyspnea, appetite loss, or financial difficulties. Worsening adverse events (AEs), including nausea/vomiting and diarrhea, showed statistically significant improvements with the fulvestrant plus trastuzumab group versus chemotherapy.

Overall, quality of life was maintained for patient-reported pain, global health, functioning, and most symptoms when abemaciclib was added to fulvestrant plus trastuzumab compared with physicians choice of chemotherapy in patients with HR-positive, HER2-positive ABC. Furthermore, gastrointestinal-related adverse events were transient and consistent with the manageable, reversible AE profile.

REFERENCEHealth-related quality of life (HRQoL) in monarcHER: Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in HR+, HER2+ advanced breast cancer. Accessed December 2, 2019. https://plan.core-apps.com/sabcs2019/abstract/a25f48e96f590da9de0d7c903eddc944.

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Quality of Life Maintained With Abemaciclib Plus Trastuzumab With or Without Fulvestrant in Patients with HR-Positive, HER2-Negative Breast Cancer -...

Winter's official arrival this weekend is not welcomed by those of us who experience cold more severely than others.

I'm unfortunate to be one of the so-called cold-natured who feel chilled when everyone is getting along just fine; we are often ridiculed and heartily despised by warmer brethren for our tiresome complaints.

This isn't limited to winter. I'm cold for most of the summer because of aggressive air-conditioning, which requires me to schlep around sweaters and fleeces to restaurants, movie theaters, shopping venues, early morning outings with my dogs, and my newspaper office, where I persuaded our kindly and accommodating building manager to disconnect the fan that was blowing chilled air on me (I was long ago banned from messing with the thermostat outside my door, which also controls the temperature in a nearby conference room usually filled with warm-natured colleagues).

Wearing summery sleeveless dresses to work is out of the question. Soft flannel throws are easily found draped on furniture around my house year-round.

Right now, in December, the temperature in the newsroom is set on 70 degrees. I'm wearing a V-neck sweater over which is draped a thick gray mohair cardigan (the sort of ugly pilling garment that no one would ever wear when out in public). I'm clutching a HotHands single use air-activated heat pack, which keeps my fingers warm but makes it difficult to type. (It's also hard to type when one's index finger is numb.)

This is apparently all my fault.

According to the The Conversation, an online community of more than 93,200 academics and researchers from 3,044 institutions, most of us who are healthy but claim to feel excessively cold "have only ourselves to blame. We have habituated ourselves to feeling comfortably warm. In the developed world we rarely expose ourselves to cold, letting expensive clothing protect us from outdoor cold and letting power companies warm our living and working spaces." (My raggy office sweater, purchased at a recycled clothing store, was definitely not expensive, but I get the point.)

Noting that we allow power companies to do the work that our metabolism is supposed to do, "We'd probably all be much better off if we spent more time being cold," concludes The Conversation.

Easy for the website to say; I grew up in northern Ohio, where the type of depression known as seasonal affective disorder is alive and well. Winter is deeper, colder, darker, longer and snowier on the edge of Lake Erie than it is in central Arkansas, so presumably I would have arrived here physically and psychologically able to cope with far less frosty conditions.

While I was delighted my first year here by the ability to sit poolside in a bikini at the end of March (we didn't fear skin cancer then like we do now), I didn't find such adaptations to exist, let alone do me any good.

WebMD comes to the defense of cold-natured sufferers in an online submission titled Why Am I Cold? Possible causes include anemia (not enough red blood cells to carry oxygen throughout he body), hypothyroidism (the body doesn't make enough thyroid hormone, which controls metabolism; a sluggish metabolism can result in feeling chilled), blood vessel problems such as Raynaud's disease (spasms of narrowing arteries to the fingers and toes), diabetes (can cause kidney damage resulting in diabetic nephropathy, a symptom of which is feeling cold all the time), and anorexia.

Like most medical sites, WebMD recommends you check with your doctor. I like my family physician just fine, but figure I'm better off by investing in a puffy down jacket (reversible from navy blue to screaming yellow), quilted pull-on fleece-lined boots (on sale for $18--probably because they're purple--that are supposed to be waterproof, but they're not), furry ear muffs, and my most successful investment: ultra-thick fleece-lined mittens.

Such clothing--jackets from Carhartt, Lands' End and North Face, tights and sweats from Under Armour, dense woolen socks from Bass Pro, flannel-lined jeans from L.L. Bean, snow boots from REI--takes up a lot of closet space. But since I have no need for wispy summer dresses and loosely woven cropped-sleeved shirts, there's always room for something warm.

Karen Martin is senior editor of Perspective.

kmartin@arkansasonline.com

Editorial on 12/22/2019

Print Headline: Take pity on those who suffer from the cold

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Take pity on those who suffer from the cold - NWAOnline

It was a decade that began with the electrifying results of a clinical trial for a revolutionary new cancer therapy and ended with a Nobel Prize in Medicine for very different cancer-related research. In between those dramatic bookends, the 2010s were packed with progress, with discoveries leading to the FDAs 2017 approval of the first CAR T-cell therapy. Additional approvals would follow.

The 2010s started with clinical trial results centered on the use of checkpoint inhibitors, drugs that unleash a powerful immune system attack on cancer cells. The results founded on decades of research by scientists like Dana-Farbers Gordon Freeman, PhD helped usher in a new era of cancer immunotherapy.

Checkpoint blockersare transformational, Laurie H. Glimcher, MD, president and CEO of Dana-Farber and a prominent immunologist, said back in 2017, but they are only the tip of a proverbial immunotherapy iceberg.

On the other side of the last 10 years in cancer research was the Nobel Prize in Medicine, shared by Dana-Farbers William G. Kaelin, Jr., MD, for discoveries into the mechanism that enables cells to sense and adapt to changes in oxygen abundance research that has already led to exciting new treatments for cardiovascular disease and cancer.

As cancer research pioneer and Dana-Farber founder Sidney Farber, MD, said back in 1965, I have never accepted the incurability of cancer. And I have remained hopeful, not because of wishful thinking thats not progress but because of the factual evidence of progress. There is no such thing as a hopeless case.

Aside from these prominent discoveries, what were the most significant advances in cancer research and treatment? Heres what scientists and clinicians from around Dana-Farber said.

William Hahn, MD, PhD, Chief Research Strategy Officer

The sequencing of human cancer genomes over the past decade has demystified the genetics of cancer. We now have a blueprint of cancer genes in every type of cancer and information about the frequency and type of mutations that occur. This has revealed new genes and pathways important for cancer development and in some cases has already led to new approved cancer therapies.

In addition, geneticallysequencing tumor tissue samples guides the therapeutic agents selected for asubset of cancer patients. This tailored approach, termed precision medicine,selects patients most likely to respond and spares those that are unlikely torespond from untoward side effects. Recent discoveries that its possible tosequence DNA in the blood to detect cancers provide hope that this approach canbe used to identify cancers earlier and follow the response to therapy.

Through the study of rare cancers, we have identified mutations in genes that regulate the epigenome, the cells machinery for activating and deactivating genes. These studies have revealed that these same pathways are dysregulated in many common cancers and play key roles in cancer pathogenesis and resistance to therapy.

Sapna Syngal, MD, MPH, Director of Research, Center for Cancer Genetics and Prevention

The realization that upto 10% of many solid tumors have an inherited genetic basis provides us with agreat opportunity for precision prevention and early interception.

Scott Armstrong, MD, PhD, President, Dana-Farber/Boston Childrens Cancer and Blood Disorders Center

Were now able to identify several premalignant states that significantly increase peoples risk of developing certain hematologic cancers. Individuals with clonal hematopoiesis of indeterminate potential (CHIP), for example, have certain genetic mutations in their blood-forming stem cells that are associated with leukemia.

People with CHIP dont have symptoms of disease, but their risk of developing a blood cancer such as leukemia is 10 times higher than average and their risk of cardiovascular disease is elevated as well. Being able to identify high-risk individuals means we can begin to think about early-intervention strategies to prevent these cancers from developing an active area of research.

Ursula Matulonis, MD, Chief, Division of Gynecologic Oncology

The introduction of drugs known as PARP inhibitors has had a major impact on the treatment of ovarian cancer, and now they are showing effectiveness against other cancers including breast and pancreatic. PARP inhibitors work by blocking one of the key routes by which cells repair damaged DNA and are especially effective in cancers with existing DNA-repair deficiencies such as those harboring BRCA mutations.

Also, better understanding of the genomics of gynecologic cancers the set of genetic mutations within the cancer cells is transforming the way we approach treatment and prevention. Its now widely recognized that women with ovarian cancer, regardless of age, histology type, or the stage at which their cancer is diagnosed, should undergo genetic testing. A percentage of them will have a predisposing mutation in one of the BRCA genes. Women with newly diagnosed endometrial cancer should have their cancer tested for mismatch repair deficiencies, which interfere with the proper copying of DNA during cell division.

The presence of these genetic features not only influences the treatment patients receive, but, because they can be inherited, often enable us to identify family members who are also at risk and can benefit from more intensive monitoring or preventive treatment.

Richard Stone, MD, Program Director in Adult Leukemia

Morethan 10 drugs have been approved for acute leukemia in the past three years,whereas there had been very few new agents in the previous 25 years.

DNA sequencing of patients leukemia cells to identify mutations is being used to help guide treatment decisions.

Eric Winer, MD, Senior Vice President for Medical Affairs and Faculty Development; Chief, Division of Breast Oncology

In the treatment of breast cancer, we now know for a certainty that one size does not fit all. This allows us to personalize therapy to a much greater extent than ever before. In some patients, this means we can treat them with less-intensive therapy and still obtain excellent results. Others may require more extensive therapy or benefit from a different therapeutic approach. For all patients, this means better, more effective care, fewer side effects, and, for many, a longer life.

Kimberly Stegmaier, MD, Vice Chair of Pediatric Oncology Research

There have been multiple approvals of new targeted drugs in adult acute myeloid leukemia (AML) in the past two years, as well as TRK inhibitor approval for adult and pediatric patients with TRK fusion-positive cancers.

Bruce Johnson, MD, Chief Clinical Research Officer

Addingthe kinase inhibitor midostaurin to standard chemotherapy significantlyprolonged overall and event-free survival in patients with acute myeloidleukemia whose cancer cells have a FLT3 mutation.

Enzalutamide,an androgen receptor inhibitor, was associated with significantly longer progression-freeand overall survival than standard care in men with metastatic,hormone-sensitive prostate cancer receiving testosterone suppression.

Dana-Farberscientists reported on the feasibility, safety, and immunogenicity of apersonalized cancer vaccine that caused immune T cells to recognizecancer-related neoantigens on tumor cells. These results have promptedfurther development of a neoantigen vaccine approach.

Nadine Jackson McCleary, MD, MPH, Gastrointestinal Oncologist

Weve made strides in ensuring that evidence from cancer research studies actually makes its way into clinical practice. For too long, research findings often seemed to remain in academia without being translated to clinical medicine.

Professional and patient advocacy organizations have undertaken a variety of steps to not only implement these advances in the clinical setting but also to make sure theyre sustainable. For example, organizations such as the American Society of Clinical Oncology (ASCO) and cooperative research groups regularly inform the broader public about research results and work at the state and federal level on behalf of patients. The development of implementation science is having a sizable impact on clinical practice.

Were also making progress in improving equity in cancer care delivery. Where equity issues have traditionally involved issues such as race, gender, and socioeconomic status, were broadening the focus to include considerations of gender identity, patient location (where patients receive treatment may affect their outcome), and treatment of the very youngest and oldest patients. These efforts will help ensure that advances in cancer medicine reach all populations.

Toni Choueiri, MD, Director of the Lank Center for Genitourinary Oncology

An important ongoing approach is liquid biopsies obtaining tumor-related DNA in the blood as a means of early cancer detection. Liquid biopsies also have the potential to detect minimal residual disease in the body following surgery to predict the risk of relapse.

Rameen Beroukhim, MD, PhD, Physician-Scientist in Neuro-Oncology

This decade is the first in which targeting collateral vulnerabilities in cancer cells has become an important strategy. Most efforts at treating cancer focus treatment on the genetic changes within cells that cause them to become cancer. But along the way, many genes that have nothing to do with cancer are also affected, and scientists have found that targeting these genes on which the cancer cells depend can be an effective way of attacking cancer. Immunotherapy, for example, detects cancer cells based on this collateral damage.

I predict that targeting collateral vulnerabilities will become increasingly important in future decades. Another recent strategy is based on the emerging technology of protein degradation, which removes cancer-related proteins from cells rather than simply binding to these proteins to inhibit their activity.

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The Most Significant Cancer Research Advances of the 2010s - Dana-Farber Cancer Institute

December 17, 2019 Cover

Let the Laughlin resorts serve your family a special meal this Christmas.

How anyone can confuse The Vogues, a white male singing group from the 1960s, with En Vogue, the R&B girl group of the 1990s makes you wonder what people are thinking or drinking.But that happened to Troy Elich, (son of the late Stan Elich, an early member of the Vogues), who has been a member and manager of the group since the passing of his father.

What if the nostalgia of holiday television specials and films were blended with vintage Vegas Rat Pack-type shows to create a whole new kind of musical magic?A swinging show filled with these elements like classic hits and Christmas favorites might just set the tone for creating a new holiday tradition the whole family can enjoy together.

Dress up in cowboy duds and learn to navigate the Wild West frontier with a trip to Stagecoach Trails Guest Ranch in Yucca, Arizona.Dudes from across the world come to the ranch for a one-of-a-kind experience stepping back to the simpler times to learn the cowboy lifestyle wrangling horses, trail rides at dawn, campfires and three home-cooked meals a day.Stagecoach Trails has been around since 1999, but switched hands in 2014 when JP and Tricia McCormick bought the ranch.

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Buy viagra professional - Viagra vs viagra professional - What is the difference between viagra professional and viagra super active - Laughlin...

December 20, 2019 (LifeSiteNews) The Teacher was right: What has been will be again, what has been done will be done again; there is nothing new under the sun. This observation by King Solomon rings true -- and loudly in 2019 America. Arguably the most intense and divisive year in the abortion wars, 2019 reminds us all of the dangers of forgetting our history, which one political party seems committed to repeat.

Kicking off 2019 with New Yorks Reproductive Health Act, New York Democrats renewed their resolve to repeat the judicial tyranny of their partys history by treating some human beings as an inferior class of non-persons. This 2019 Act is disturbingly reminiscent of the 1857 Dred Scott vs. Sandford ruling, which denied personhood to African American Dred Scott. Seven Democrats on the Supreme Court ruled that Dred Scott, while temporarily residing in American territory that declared African American men free persons, was not truly a person after returning to Missouri with his slave-owner, a Captain John Emerson. The court declared that Scott was the property of Emersons wife (Emerson having already passed), and as a non-citizen with no rights of personhood, Scott could be treated as any other form of property owned by Emersons wife, Eliza Sandford. Summarizing the case, Chief Justice Roger [racist] Taney, wrote: "A black man has no rights a white man is bound to respect."

What has been will be again.

In January of 2019, New Yorks Reproductive Health Act, declared that while unborn human beings may have certain personhood rights in other territories of America, New Yorks unborn children have no rights of personhood and can be treated as property through the moment of birth. Denying the personhood of the unborn in the most extreme way, New York legislators even declared that murderers of pregnant women will only be charged with one count of homicide. Channeling the historical discrimination of his party, New York Governor, Andrew Cuomo sent the same message as Taney did so long ago: An unborn human has no rights a born human is bound to respect. Since then, Illinois, Rhode Island, and Vermont have passed similar, radical legislation.

Shortly after the New York Reproductive Health Act passed, Virginia Governor Ralph Northam went on WTOP radio to publicly defend Virginia DelegateKathy Tran's bill that would legalize abortion to point of birth. Likely realizing that there is no meaningful difference between a full-term baby about to be born and that same baby just after birth, Northam went a step further by saying that mothers and physicians should be able to have conversations about whether born babies should be left to die or not. In response to Northams clinically cool demeanor describing infanticide, Nebraska Senator Ben Sasse brought the Born-Alive Abortion Survivors Protection Act (BAASPA) for a vote in the Senate. The bill would have done three simple things:

Each of these requirements is very important, because while the 2002Born-Alive Infants Protection Act (which gained unanimous consent from Republican and Democrat senators) specifies that babies who survive abortions and are born are to be recognized as human beings with human rights, the bill did not define what types of care, if any, are to be rendered. Nor did it specify what punishments would be levied against physicians who failed to act to save the life of an abortion-survivor.

Tragically and predictably, Senate Democrats took their cue from racist Democrats in the early 20th century who routinely filibustered every Republican effort to enact an antilynching law. Ideological consistency can be a dangerous thing. According to the reasoning of Democrats of that day, if blacks were truly not persons, then lynching them theyd claim would be no more morally problematic than killing an animal, as many racists described African Americans.

Today we see the same ideology leading to the dehumanization and slaughter of the unborn. Both African Americans and unborn human persons have died on the altar of an evil ideology.

And so, what has been done will be done again. In February of 2019, the United States Senate voted in majority favor (53-44) of the BAASPA. However, the bill didnt gain the 60 votes necessary to overcome the filibuster initiated by Democrat senators. Additionally, only 3 Democrat Senators crossed the aisle to vote for protecting newborns from abortionists. And all of the Democratic Senators running for President voted against the BAASPA!

It seems filibustering bills that would prevent discrimination and violence against actual innocent human persons (while simultaneously denying that theyre persons) is a Democratic party trademark. As of December 2019, Senate Democrats have blocked a vote on the BAASPA over 80 times. By refusing to pass the BAASPA, Senate Democrats are enabling abortionists to kill born-alive infants that they failed to kill in the womb. But this pales in comparison to Senate Democrats support of abortion-on-demand, which takes the lives of nearly one-million babies every year in America.

When abortion is treated as sacrosanct, politics becomes liturgy: a spiritual practice engaged in for the purpose of praising and protecting that which is sacred. Therefore, anyone who questions the Lefts political liturgy is an apostate and must be purged and exchanged for those sufficiently woke to the escalating political threat posed by those pro-lifers.

In order to protect their liturgical purity, Planned Parenthood fired their new president, Dr. Leana Wen in July 2019. Buzzfeed News, who broke the story, reported that there were internal concerns over her [Wens] management style and a perceived shift away from the groups political work (emphasis own).

A source familiar with the matter said that her removal was accelerated by the intensifying battle over abortion rights, saying that she was not the right leader in this climate. Wen herself confirmed all this in her Twitter statement saying, I believe that the best way to protect abortion care is to be clear that it is not a political issue but a health care one (emphasis own).

Denying abortions political centrality to the leftist liturgy is tantamount to a Catholic priest denying the centrality of the eucharist to Catholic liturgy. Such an action would oust you from the Catholic Church. And Wen was quickly ousted. A movement based on the belief that human value is found in your wanted-ness, its unsurprising that Planned Parenthood, the political war hawk of the pro-choice movement, will quickly abort its own, whose apostasy renders them unwanted. Wen was quickly replaced by Alexis McGill Johnson, a lifelong political activist, and more of the Cecile Richards mold than Wen ever was.

This is noteworthy because Planned Parenthood is publicly dropping its healthcare organizational faade and fully embracing its identity as a political machine. Ironically, removing this healthcare mask will likely further damage their reputation and cause more Americans to distance themselves from the organization. Americans are not interested in supporting a political hackery of a machine focused on enshrining abortion rights through the day of birth. According to a 2019 Gallup Poll, only 25% of Americans believe abortion should be legal under any circumstances (the de facto position of Planned Parenthood). In fact, a 2007 Gallup Poll found that 72% of Americans think late-term abortions should be illegal, a procedure euphemistically described by the abortion juggernaut as reproductive health care.

Not to be outdone by East Coast radicals in New York, California Governor, Gavin Newsom moved to establish himself in the abortion hall of fame books by signing SB24, a move that makes pro-abortion, former Governor, Jerry Brown look pro-life. In fact, Brown vetoed the bill in 2018. Introduced under the guise of combatting abortion access problems, this bill will force California 4-year state universities (Cal State and UC) to provide the RU-486 abortion pill to students through university health centers.

According to the bills sponsor, Connie Leyva, Students shouldnt have to travel off campus or miss class or work responsibilities in order to receive care that can easily be provided at a student health center. Ignoring for the moment that slaughtering unborn children is not care, Leyva blatantly ignores the fact that former Governor Jerry Brown rightly pointed out that the average distance to abortion providers in campus communities varies from five to seven miles, not an unreasonable distance.Despite easily accessible resources such as this Youtube video, many pro-choice advocates dont know or care how the abortion pill kills a baby. An RU-486 chemical abortion is offered through 10 weeks gestation. A pregnant woman first takes Mifepristone, which blocks the hormone progesterone, without which the lining of the uterus breaks down, cutting off blood and nourishment to the baby, who is starved to death. One or two days later, she takes misoprostol, forcing her uterus to have contractions, in order to dispel her dead baby in the toilet. Not only does the abortion pill kill a human being, but it also poses threats to the health and life of the women taking it. While the combatting abortion access problem is clearly a guise for Newsom and the bills defenders, it is a guise they must maintain, because the reality is too ghoulish for even the most ardent pro-choice advocates.

According to the FDA, risk & effects include: Abdominal pain, nausea, vomiting, diarrhea, headache, heavy bleeding, even maternal death. They further report that 24 women have died taking RU-486, average bleeding lasts 9-16 days and 8% of women will endure bleeding more than 30 days. It gets worse. According to a 2000 Oxford University Press study, the average failure rate of a medication abortion is eight percent. Live Action News points out that an eight percent failure rate means that about one in every 12 chemical abortion attempts will be unsuccessful, which means women will need to be subjected to a surgical abortion, which, of course, alsohas its own risks. Left undiagnosed and untreated, the eight percent of women whose babies were not properly dispelled will be walking around with a dead baby in their uterus, thus susceptible to sepsis and death. As such, the FDA has requirements for prescribers of the abortion pill, including that providers must also be able to provide any necessary surgical intervention and must be able to ensure that women have access to medical facilities for emergency care. Because university health centers are not equipped with surgical abortion instruments or staff qualified or licensed to perform surgical abortions, Newsom will endanger the health and lives of young women who show up to their health centers bleeding and in immense pain, only to be turned away or pointed toward Planned Parenthood. All this under the mantle of healthcare.

Naturally, neither Newsom, Leyva or any of the other bills supporters, addressed these concerns. Ignoring reality and its consequences in favor of ideology is nothing new for the abortion juggernaut. In fact, in June of 2018, Cecile Richards, then President of Planned Parenthood, wrote an LA Times opinion editorial in which she claimed that non-invasive medication abortion is safe by all measures safer than Tylenol and Viagra, even. Heres a perfect example of the linguistic gymnastics that are required by abortion advocates who call a medication safe when its success is gauged on whether its target was murdered.

The first legislation of its kind, SB24 will turn 4-year California state universities into abortion clinics, a far cry from the purpose for which the academy was designed. In a failed sleight of hand, the abortion industry and their cronies have shown their hand and it clearly has nothing to do with real choice. Failing to provide any type of funding for nurseries or daycares on college campuses and fully willing to endanger the actual health and lives of college-aged women in their pursuit of expanding abortion, it is clear that the only choice Newsom is interested in pushing is abortion. Most concerning of all, however, is Californias reputation as a political bellwether in the abortion wars. The moral decay that starts in the Golden State rarely stays in state.

An unprecedented and tragic year for unborn babies and human equality, 2019 serves as a lesson that there can be no bi-partisan or national unity when one political party publicly commits itself to the slaughter of unborn children through the day of birth, even refusing to condemn infanticide and ensure better protections for infants who survive abortions. However, this is not the first time our two-party system has been divided over who is a person.

There is nothing new under the sun.

Woefully ignorant to reality, todays Democratic Party seems to have forgotten that the last time they fought against human equality it led to a war that they lost. This is because, invited or not, reality has an annoying tendency of reasserting itself in our lives. It was self-evidently true that African-Americans were human persons with the same human dignity as everyone else. It is similarly self-evidently true that unborn human beings conceived by human parents are little persons who also share the same dignity. We can either respond to that self-evident reality by aligning our beliefs, lives, and policies correctly, or we can stick our head in the ground and insist that 2 + 2 = 5. But in the end, reality will win out.

Either historically describing the Democratic party during slavery, or prophesying the nature of that same party today, George Orwell, speaking through his character Winston said:

In the end the Party would announce that two and two made five, and you would have to believe it. It was inevitable that they should make that claim sooner or later: the logic of their position demanded it. Not merely the validity of experience, but the very existence of external reality, was tacitly denied by their philosophy. The heresy of heresies was common sense.

In other words, when you base your entire ideology on fantasy, your ideas, foolish though they may be, will merely be a reflection of your ideology. When your worldview leads you to label common sense observations, such as blacks and babies are persons, as heresy, you know youre on the wrong road. And as C.S. Lewis aptly pointed out, the true progressive is the one who, realizing he is on the wrong road, makes an about-turn and walks back to the right road.

Will the abortion juggernaut and its strategic arm, the Democratic party, learn from the mistakes of history and prove their progressiveness by walking back to the right road? I desperately hope and pray so. But Im not holding my breath.

Trump: Boon to pro-life movement

And the pro-life movement hasnt been holding its breath. While 2019 saw a significant rise in pro-abortion radicalism and legislation, this rise correlates directly to the threat posed by what has become the most pro-life administration in American history. After eight years of the most pro-abortion president our country has ever seen, the Trump administration gave a weary pro-life movement the political encouragement necessary to catapult them back onto the offensive.

In his first year alone, President Trump proved to be more pro-life than either Reagan or Bush, appointing pro-life judges, permitting states to defund Planned Parenthood of Title X funds, stopping the overseas funding of abortion, cutting Planned Parenthoods tax funding by $60 million, and creating a new office of conscience protections at HHS, among many more. Encouraged to know that this administration was on their side, pro-life legislators across the country, all began implementing pro-life laws, with the intent of presenting a credible challenge to Roe v. Wade.

It was this rising threat that led New York Governor Cuomo to pass the Reproductive Health Act. Clearly on the defensive, Cuomo rationalized his support of the bill, saying Kavanaugh is going to reverse Roe v. Wade. I have no doubt. Gorsuch is going to reverse Roe v. Wade. I have no doubt. The abortion industry and their political pawns are scared. This should greatly encourage the pro-life movement. And it has.

Americans United for Life released their Fall 2019 State Legislative Sessions Report. They report that so far in 2019, 58 life-affirming laws passed and were signed into law across 22 states, representing a more than 25% increase from 2018. Laws ranging from informed consent, parental involvement, heartbeat, abortion-survivor protections, and down-syndrome protections; these laws are saving lives.

Dr. Michael New of the Charlotte Lozier Institute has researched the effect of state anti-abortion laws and found a direct correlation between the number of pro-life laws and a decrease in the number of abortions. This spike in pro-life legislation has led Planned Parenthood to stick their head further in the ground, launching a campaign titled Bans Off My Body, repeating the decades old trope that the unique human life you pay a physician to intentionally dismember is actually just part of your body.

The pro-life movement heads into election year with massive victories and substantial momentum. Contrastively, the abortion juggernaut is limping into 2020 and their political cronies will soon face an electorate that is growing increasingly uncomfortable with the idea of abortion through point of birth. One of the abortion juggernauts political backers will become the nominee and face the President in debate, who in 2016 correctly defined abortion as rip[ping] the baby out of the womb. That moral clarity on abortion will destroy any euphemistic attempts by the Democratic nominee to appeal to the voters with a reproductive health care pitch.

163 years after the Dred Scott decision, the Democratic party is still the enemy of human equality. They are still dehumanizing a certain class of human beings by defining personhood according to randomly and arbitrarily selected criteria. As Scott Klusendorf rightly points out, We used to discriminate on the basis of skin color and gender (and still do at times), but now with elective abortion, we discriminate on the basis of size, level of development, location, and degree of dependency. Weve simply swapped one form of bigotry for another.

The consequences of that bigotry are the 62 million babies who have been slaughtered in the last 47 years. And now, as in 1857, the Republican party is the only political party staying the madness and attempting to enshrine rights of personhood to every human being. Until the Democratic party and the pro-choice movement choose to bring something new under the sun, what has been will be again: The Democratic party will again be remembered as the party of discrimination and have to account for instituting and protecting the greatest genocide in human history.

Seth Gruber is the West Coast Director for Life Training Institute. He is also the host of "UnAborted with Seth Gruber. Visit his website here.

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Abortion is the greatest genocide in human history, and Democrats are its greatest champion - Lifesite

3D illustration of cells releasing exosomes

Scientists have developed a new gene-therapy technique by transforming human cells into mass producers of tiny nano-sized particles full of genetic material that has the potential to reverse disease processes.

Though the research was intended as a proof of concept, the experimental therapy slowed tumor growth and prolonged survival in mice with gliomas, which constitute about 80 percent of malignant brain tumors in humans.

The technique takes advantage of exosomes, fluid-filled sacs that cells release as a way to communicate with other cells.

While exosomes are gaining ground as biologically friendly carriers of therapeutic materials because there are a lot of them and they dont prompt an immune response the trick with gene therapy is finding a way to fit those comparatively large genetic instructions inside their tiny bodies on a scale that will have a therapeutic effect.

This new method relies on patented technology that prompts donated human cells such as adult stem cells to spit out millions of exosomes that, after being collected and purified, function as nanocarriers containing a drug. When they are injected into the bloodstream, they know exactly where in the body to find their target even if its in the brain.

Think of them like Christmas gifts: The gift is inside a wrapped container that is postage paid and ready to go, said senior study author L. James Lee, professor emeritus of chemical and biomolecular engineering at The Ohio State University.

And they are gifts that keep on giving, Lee noted: This is a Mother Nature-induced therapeutic nanoparticle.

The study is published in the journal Nature Biomedical Engineering.

In 2017, Lee and colleagues made waves with news of a regenerative medicine discovery called tissue nanotransfection (TNT). The technique uses a nanotechnology-based chip to deliver biological cargo directly into skin, an action that converts adult cells into any cell type of interest for treatment within a patients own body.

By looking further into the mechanism behind TNTs success, scientists in Lees lab discovered that exosomes were the secret to delivering regenerative goods to tissue far below the skins surface.

The technology was adapted in this study into a technique first author Zhaogang Yang, a former Ohio State postdoctoral researcher now at the University of Texas Southwestern Medical Center, termed cellular nanoporation.

The scientists placed about 1 million donated cells (such as mesenchymal cells collected from human fat) on a nano-engineered silicon wafer and used an electrical stimulus to inject synthetic DNA into the donor cells. As a result of this DNA force-feeding, as Lee described it, the cells need to eject unwanted material as part of DNA transcribed messenger RNA and repair holes that have been poked in their membranes.

They kill two birds with one stone: They fix the leakage to the cell membrane and dump the garbage out, Lee said. The garbage bag they throw out is the exosome. Whats expelled from the cell is our drug.

The electrical stimulation had a bonus effect of a thousand-fold increase of therapeutic genes in a large number of exosomes released by the cells, a sign that the technology is scalable to produce enough nanoparticles for use in humans.

Essential to any gene therapy, of course, is knowing what genes need to be delivered to fix a medical problem. For this work, the researchers chose to test the results on glioma brain tumors by delivering a gene called PTEN, a cancer-suppressor gene. Mutations of PTEN that turn off that suppression role can allow cancer cells to grow unchecked.

For Lee, founder of Ohio States Center for Affordable Nanoengineering of Polymeric Biomedical Devices, producing the gene is the easy part. The synthetic DNA force-fed to donor cells is copied into a new molecule consisting of messenger RNA, which contains the instructions needed to produce a specific protein. Each exosome bubble containing messenger RNA is transformed into a nanoparticle ready for transport, with no blood-brain barrier to worry about.

The advantage of this is there is no toxicity, nothing to provoke an immune response, said Lee, also a member of Ohio States Comprehensive Cancer Center. Exosomes go almost everywhere in the body, including passing the blood-brain barrier. Most drugs cant go to the brain.

We dont want the exosomes to go to the wrong place. Theyre programmed not only to kill cancer cells, but to know where to go to find the cancer cells. You dont want to kill the good guys.

The testing in mice showed the labeled exosomes were far more likely to travel to the brain tumors and slow their growth compared to substances used as controls.

Because of exosomes safe access to the brain, Lee said, this drug-delivery system has promise for future applications in neurological diseases such as Alzheimers and Parkinsons disease.

Hopefully, one day this can be used for medical needs, Lee said. Weve provided the method. If somebody knows what kind of gene combination can cure a certain disease but they need a therapy, here it is.

See more here:
A New Gene Therapy Strategy, Courtesy of Mother Nature - Global Health News Wire

Many women will tell you that the idea that menopause can wreak havoc on their sleep isn't news to them. Indeed, a study in Sleep published in April 2017 reported that sleep disturbances become very common during menopause, with an estimated 40 percent to 60 percent of menopausal women reporting poor sleep quality and about 25 percent meeting criteria for an insomnia disorder.

RELATED: 10 Ways to Beat Menopausal Belly Fat

What is news comes from a study published in the journal Menopause in December 2019 titled Effects of Menopause on Sleep Quality and Sleep Disorders: Canadian Longitudinal Study on Aging. Many studies have looked at the effect of aging on sleep, but very few have delved deeper into the issue by looking at menopause status and by looking at exactly what kind of sleep problems are associated with menopause. In the Canadian Longitudinal Study on Aging, researchers studied 6,100 Canadian women between ages 45 and 60, dividing participants into two groups: pre/perimenopausal and post-menopausal. They also tried to figure out what sleep disruptions are caused by menopause and what is caused purely by aging.

RELATED:Perimenopause and Menopause: Whats the Difference?

We under-address sleep issues in midlife women in general. This study brings much-needed attention to multiple issues concerning sleep disturbances. Poor sleep is associated with poor health [cardiovascular disease, diabetes, depression, and anxiety] so its not something to just blow off, saysStephanie Faubion, MD,the medical director of theNorth American Menopause Society and the director of the Mayo Clinic Center for Womens Health.

The research team discovered that post-menopausal women required more time (over 30 minutes) to get to sleep and were more apt to develop sleep-onset insomnia disorder (trouble falling but not staying asleep) and possible obstructive sleep apnea (OSA) than women who had not reached menopause.

The different menopause stages did not differ on the percentages of difficulty with staying asleep, excessive sleepiness, restless leg syndromeand rapid eye movement (REM) sleep behavior disorder.

We have confirmed that the sleep disruption is related to menopause, and not age, and that the problem lies mostly in falling asleep, not staying asleep. Something may change in the biology of the brain that makes these women lose the drive to sleep, says a coauthor of the study, Ron Postuma, MD, a professor in the department of neurology at McGill University in Montreal.

RELATED: 12 Women Over Age 60 Who Inspire Wellness and Living Your Best Life

Does the sleep trouble relate to hormones? So far, the connections between sleep and menopause are associative, but not causal. We don't yet know the mechanism driving it. It is difficult to study because when you're having menopause, you're also getting older; how do you disentangle the menopause from aging? says Dr. Postuma.

Treatments for various sleep issues are generally the same, no matter what is causing it, says Dr. Faubion. If you want to get some better z's at night, here are some ideas from the National Sleep Foundation:

RELATED: The Wild History of Womens Hormone Therapy

If you just cannot fall asleep at night, dont immediately start seeking out over-the-counter or prescription medications. Postuma points out that the first-line treatment for insomnia is cognitive behavioral therapy, which teaches you how to change your sleep habits and reframe any negative thoughts on the subject, with specific techniques for falling asleep. If there is no sleep clinician in your area, you can find online resources to guide you through the process.

RELATED: Light Therapy May Give Women Quick Relief From Midlife Sleep Trouble, Research Shows

If you suspect you may be dealing with something more complicated, such as obstructive sleep apnea, restless leg syndrome, or REM sleep behavior disorder, see a sleep clinician. You can find one in your area at the American Academy of Sleep Medicine.

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Sleep Apnea and Other Sleep Disorders Linked to Menopause, Not Age - Everyday Health

Men with metastatic castration-sensitive prostate cancer will now have a fourth treatment option to consider.

BY Kristie L. Kahl

With this new FDA approval, men with metastatic hormone-sensitive prostate cancer now have another treatment option that can delay prostate cell growth in metastases both hidden and seen on scans, and disease progression, Dr. Jonathan Simons, CEO of the Prostate Cancer Foundation (PCF), said in a statement issued to CURE. Enzalutamide now joins (Zytiga [abiraterone]), (Erleada [apalutamide]) and docetaxel chemotherapy as options to be added at the time of initiating androgen deprivation therapy in men.

Metastatic Castration-Sensitive Prostate Cancer

Men with metastatic castration-sensitive disease means that their prostate cancer has spread to areas in the body that are outside of the prostate, however, these men are also responsive to testosterone suppression therapy.

Androgen receptor inhibitors stop testosterone from working so that it cannot bind to the chemical structures in cancer cells that allow the hormone to enter the cells. Depending on their health and the extent of their disease, men have previously been treated with one of the following:

ARCHES Trial

The FDA made its decision to approve Xtandi based on results from the international, double-blind, phase 3 ARCHES clinical trial designed to compare the agent versus placebo in 1,150 patients with histologically verified metastatic castration-sensitive prostate cancer.

Patients were enrolled across North America, Europe, and the Asia-Pacific region.

The primary endpoint of the study was radiographic progression-free survival (the length of time during and after the treatment that cancer does not progress or worsen), which was not reached in the Xtandi plus ADT group, compared with 19.45 months with placebo and ADT. This reduced the risk for radiographic progression by 61% in patients who received Xtandi.

Moreover, Xtandi was associated with a reduction in the risk of time to progression of prostate-specific antigen, also known as PSA (a protein made by the prostate gland, whose high levels can be a sign of prostate cancer), by 81% and the time to initiation of a new antineoplastic therapy by 72%, compared with placebo.

In the trial, the most common side effects reported more frequently in patients treated with Xtandi plus ADT, compared with placebo and ADT, included hot flashes (27% vs. 22%, respectively), asthenic conditions (24% vs. 20%), hypertension (8% vs. 5.6%), fractures (6.5% vs. 4.2%) and musculoskeletal pain (6.3% vs. 4%).

Prostate Cancer Foundation

Of note, PCF funded the initial discovery of Xtandi at UCLA by chemist Michael Jung, who worked with prostate cancer physician-scientist Dr. Charles Sawyers, MD, who is now at Memorial Sloan Kettering Cancer Center in New York.

The Prostate Cancer Foundation is proud to have funded the initial discovery of enzalutamide at UCLA, as well as the early translational research into the clinic that led to the development of this entire large class of more potent androgen receptor-targeting drugs, Simons said. This class of new precision anti-androgen receptor drugs has extended the lives of thousands of patients already.

Read CUREs original coverage of the FDAs approval of Xtandi.

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What You Need to Know About the FDA's Approval of Xtandi in Prostate Cancer - Curetoday.com

You may associate essential oils with aromatherapy products and fancy day spas. But did you know certain varieties of these fairly inexpensive oils may have legit benefits when it comes to relieving anxiety and stress?

According to Yufang Lin, MD, an integrative medicine specialist at the Cleveland Clinics Center for Integrative Medicine, essential oils work through inhalation or through topical application and have mind-body benefits. For inhalation, essential oils can be easily used as a room spray or via diffuser. A few drops on a pendant worn close to skin also allows for a slow release over time.

Topically, essential oils can be added to a carrier oil and used as perfume, massage oil, cream, or salves. Last but not least, adding an essential oil to your bath is a wonderful way to relax at the end of a busy day, says Dr. Lin.

The quickest way to change ones mood is through smell, thus essential oil is an excellent way to reduce anxiety and support relaxation, says Dr. Lin. However, it takes a lot of herbs to make a small amount of essential oil, which makes it a strong medicine that should be used judiciously.

While research on essential oils for mental health benefits is still expanding, there is some info to suggest that certain oils may work for things like stress relief, better sleep, and more. The thing is, though, even if one study shows that a particular scent is great for, say, reducing anxious feelings, it may not work for every single person. If you don't enjoy a scent, you probably won't feel much better after sniffing it, for instance.

The essential oils below have been shown to reduce anxiety in human studies, says Dr. Lin. Other scents are also commonly used to reduce anxiety and support relaxation, but research beyond animal studies is needed to know if they have real benefits for people.

The essential oils ahead have been shown to help people feel calmer and more relaxed, says Dr. Lin. One potential caveat is that most people have scent memory. So, for instance, if a person has a negative memory associated with a particular scent, they may not feel relaxed when they smell that scent, she explains.

Its important to keep potential side effects in mind, as they can be mild to severe. For one thing, certain essential oils (citrus in particular) can cause photosensitivitymeaning you can get a sunburn more easily after using orange essential oil on the skin, says Dr. Lin. (This is why it's a common recommendation to dilute oils before applying them topically, just to be extra cautious.)

Additionally, some essential oils are safe in small amounts but can dangerous in higher doses. Tea tree and eucalyptus essential oils are commonly used for their antimicrobial benefits, but in excess, can cause nerve and liver damage, says Dr. Lin. Some essential oils are toxic in general and should not be usedarnica, parsley, rue, and tansy are a few that fall into this category.

Finally, do not ingest essential oil without supervision from a trained herbalist, and be extra cautious using essential oils around young children, the elderly, pregnant women, and small pets because they are most at risk for toxicity and side effects, she says.

The bottom line: Research on using essential oils to ease anxiety or for stress reduction is growing, but remains limited. But if you're a healthy adult and are using essential oils safely and at the guidance of your doctor, there is little harm in testing some oils out to see which ones help you feel mentally better.

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Majestic Pure Lavender Oil

$21.50

According to a 2012 study, lavender essential oil has been shown to help treat symptoms of anxiety and depression. This might be due to how it impacts the limbic system of the brain, which controls your emotions.

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Bergamot Essential Oil

Bergamot oil, which comes from bergamot oranges and thus has an energizing citrusy scent, has been shown to improve mood and reduce symptoms of anxiety, according to 2015 research.

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Now Essential Orange Oil

$8.37

If youre pregnant and hoping for a Zen birth experience, a 2015 study suggested that orange essential oil may help to lower feelings of anxiety during labor.

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Plant Therapy Peppermint Organic Essential Oil

$7.95

The menthol content in peppermint oil has been shown to help relieve tension and discomfort, which can in turn help you feel more calm and relaxed.

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Frankincense Essential Oil

$8.99

Frankincense comes from the resin of the Boswellia tree. Within 2008 research, massaging a blend of this oil in combination with bergamot and lavender oils helped to relieve anxiety, depression, and pain in terminal cancer patients.

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Pure Gold Myrrh Essential Oil

Similar to lavender, myrrh essential oil (which has a woodsy scent) may help you to feel relaxed and less stressed in general.

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Majestic Pure Rose Oil

$24.50

Rose essential oil, which has similar effects to those of orange oil, has been shown to reduce anxiety during labor in pregnant women when used in a foot bath, according to 2014 research.

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Plant Therapy Marjoram Sweet Essential Oil

$9.95

Although more research is needed, sweet marjoram (also known as oregano) is believed to help relieve headaches and anxiety, as well as promote calmness.

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Eucalyptus Essential Oil

$5.79

Similar to peppermint oil, eucalyptus oil contains menthol, which has a cooling effect that may help to relieve aches and tension, which can in turn promote relaxation and reduce feelings of anxiety.

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Handcraft TeaTree Essential Oil

$14.95

Although there isnt substantial research on it, tea tree oil is believed to reduce stress and even boost immunity and ward off sickness.

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Roman Chamomile Essential Oil

Chamomile isnt just a relaxing tea that can help you sleep. The oil can also have the same calming effect if added to an aromatherapy diffuser or hot bath.

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Jasmine Essential Oil Aromatherapy

$8.22

You may already love jasmine for its uplifting floral scent, but 2013 research showed that it can also promote feelings of well-being as well as reduce sleepiness and symptoms of anxiety.

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Valerian Essential Oil

If you tend to have trouble falling asleep, valerian oil can help you feel more relaxed and calm your nerves at bedtime.

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Patchouli Essential Oil

$7.49

Although there isnt sufficient research available, patchouli oil is believed to promote calmness and relaxation if youre suffering from anxiety, depression, or stress in general. It can be added to a warm bath or diffuser in combination with lavender oil.

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NOW Foods 100% Pure Clary Sage Essential Oil

According to 2015 research, clary sage can relieve tension and help to maintain optimal levels of the stress hormone cortisol in women. This is beneficial because high cortisol levels have been shown to increase the occurrence of anxiety and depression.

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Pure Gold Holy Basil Essential Oil

Rest assured: This isnt the same basil you put in your pasta sauce. Holy basil (also known as tulsi) has a minty scent and, according to 2014 research, it may help to alleviate mental stress.

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Best Ylang Ylang Essential Oil

$13.01

If youve ever gotten a professional massage, youre likely familiar with ylang ylang and the fact that it promotes relaxation. Additionally, per 2013 research, ylang ylang can help to reduce symptoms of anxiety and promote better sleep.

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Geranium Essential Oil

Similar to rose and orange essential oils, geranium oil has been shown to reduce anxiety for pregnant women in labor, in addition to decreasing blood pressure, according to a 2015 study.

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Cliganic Organic Rosemary Essential Oil

$9.95

Another one that isnt just for cooking, rosemary essential oil has been shown to reduce cortisol (stress hormone) levels, which can then, in turn, relieve anxiety, according to 2007 research.

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Art Naturals Lemongrass Essential Oil

$11.95

While research on lemongrass oil is fairly limited, a 2015 study showed that it can possibly provide a rapid response when used by people who experience anxiety and tension.

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The 20 Best Essential Oils For Anxiety And Stress, Per Research - Women's Health

The Fulton County Health Department has scheduled the following health clinics and services. Please call the number listed with each service for an appointment or more information.

CANTON The Fulton County Health Department has scheduled the following health clinics and services. Please call the number listed with each service for an appointment or more information.

All offices of the Fulton County Health Department will be closed Tuesday, Dec. 24 and Wednesday, Dec. 25 in observance of the Christmas holiday.

Maternal child health: Health screenings, WIC nutrition education and supplemental food coupons for women, infants and children. To make an appointment or for more information call 647-1134 (ext. 254). For Astoria clinic appointments call 329-2922.

Canton - Clinic - Monday, Dec. 23 - 8-4 - Appt needed

Canton - Clinic - Thursday, Dec. 26 - 8-4 - Appt needed

Adult Health Immunizations: Various vaccines are available. There is a fee for immunization administration. Medicaid cards are accepted. To make an appointment or for more information call 647-1134 (ext. 254).

Canton - Immunizations - Wednesday, Dec. 18 - 8-4 Appt needed

Other times available by special arrangement at Canton, Cuba and Astoria.

Blood Lead Screening: Blood lead screenings are available for children ages one to six years. A fee is based on income. To make an appointment or for more information call 647-1134 (ext. 254). For Astoria appointments call 329-2922.

Family Planning: Confidential family planning services are available by appointment at the Canton office for families and males of child-bearing age. Services provided include physical exams, pap smears, sexually transmitted disease testing, contraceptive methods, pregnancy testing, education and counseling. Services are available to individuals of all income levels. Fees are based on a sliding fee scale with services provided at no charge to many clients. Medicaid and many insurances are accepted. After hours appointments are available. To make an appointment or for more information call the 647-1134 (ext. 244). *Program funding includes a grant from the US DHHS Title X.

Pregnancy testing: Confidential urine pregnancy testing is available at the Canton and Astoria offices. This service is available to females of all income levels. A nominal fee is charged. No appointment is needed. A first morning urine specimen should be collected for optimal testing and brought to the health department. Services are provided on a walk-in basis on the following days each week:

Canton: Every Wednesday & Thursday, 8-3:30 (for more information call 647-1134 ext. 244)

Astoria: Every Wednesday, 9-2:30 (for more information call 329-2922)

Womens Health: A womens clinic for pap tests, clinical breast examinations and vaginal examinations is available by appointment. There is a nominal fee for this service. Medicaid cards are accepted. Financial assistance is available for a mammogram. Cardiovascular screenings may be available to age and income eligible women. To make an appointment or for more information call 647-1134 (ext. 244).

Mammograms: Age and income eligible women may receive mammograms at no charge. Speakers are available to provide information to clubs and organizations. For more information or to apply for financial assistance, call 647-1134 (ext. 254).

Mens Health: Prostate specific antigen (PSA) blood tests are available for men for a fee. To make an appointment or for more information call 647-1134 (ext. 224).

Canton - Clinic - Monday, Dec. 23 - 8-12 - Appt needed

Sexually Transmitted Disease (STD) Clinic: Confidential STD and HIV testing services are available by appointment to males and females at the Canton office. Services include physical exams to identify STDs, a variety of STD testing, HIV testing, education, counseling, medications and condoms. There is a nominal fee for services. Services are available to individuals of all income levels. Medicaid cards are accepted. To make an appointment or for more information call 746-1134 (ext. 224).

HIV Testing and Counseling: Confidential HIV testing and counseling services are available by appointment through the sexually transmitted disease (STD) clinic at the Canton office. To make an appointment or for more information call 647-1134 (ext. 224).

Tuberculosis (TB) Testing: TB skin tests are available at no charge by appointment. To make an appointment or for more information call 647-1134 (ext. 254).

Blood Pressure Screenings: The Fulton County Health Department provides blood pressure screenings at no charge on a walk-in basis during the following times:

Canton - Screening - Monday, Dec. 23 - 8-4 - Walk in/Room 108

Cuba - Screening - Monday, Dec. 23 - 8-12 - Walk in

Health Watch Wellness Program: The Health Watch Program provides low cost lab services. Through this program adults can obtain venous blood draws for a variety of blood tests. Blood tests offered without a doctors order Comprehensive Metabolic Panel (CMP), Complete Blood Count (CBC), Lipid Panel, Prostate Specific Antigen (PSA) test, Hepatitis C test, and Thyroid Stimulating Hormone (TSH). A wide variety of blood tests are also available with a doctors order. There is a charge at the time of service. To make an appointment or for more information call 647-1134 (ext. 254).

Canton - Clinic - Monday, Dec. 23 - 8-12 - Appt needed

Dental Services: The Dental Center offers a variety of basic dental services to children and adults. An appointment is needed. Medicaid and Kid Care cards are accepted. To make an appointment or for more information call 647-1134 (ext. 292).

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Health Department announces services for the week of Dec 23 - Geneseo Republic

Neveah Taouk, 4

At last, when Mary was seven and Neveah three, new developments in whole-genome sequencing enabled specialists to identify the disorder. The diagnosis gave the Taouks information but not hope. They knew what the problem was, but there was no treatment and no cure.

Desperate, Charlie contacted specialists around the world. I must have spoken to at least fifty people scientists, doctors, professors, he says. Most of them had never heard of the condition.

His search eventually led to Dr Wendy Gold, a specialist in rare genetic disorders in children, based at the University of Sydney and the Childrens Hospital at Westmead. We arranged to talk, says Charlie. To be honest, I wasnt expecting much. But then she said, Have you heard of gene therapy?

Gene therapy is a new and rapidly evolving field of research. One of the therapys forms involves adding new genes to a patients cells to replace missing or malfunctioning genes. The new genes are typically delivered to the appropriate cells in the body using a benign virus as a carrier. Gene therapy is already being used to treat diseases including spinal muscular atrophy. It could also be a promising treatment for Parkinsons disease. Dr Gold believed there was a chance it could help the Taouk girls.

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The gene therapy research that could save a family of four - News - The University of Sydney

A new method allows researchers to develop adeno-associated virus (AVV) commonly used as the vehicle for gene therapies that accurately target and deliver genes to specific cells in the body.

This new technology may be suitable to target dopaminergic neurons that are damaged in Parkinsons disease.

We believe that the new synthetic [lab-made] virus we succeeded in creating would be very well suited for gene therapy for Parkinsons disease, for example, and we have high hopes that these virus vectors will be able to be put into clinical use, Tomas Bjrklund, PhD,Lund University, Sweden, said in a press release.

Bjrklund is lead author of the studyA systematic capsid evolution approach performed in vivo for the design of AAV vectors with tailored properties and tropism, which was published in the journal Proceedings of the National Academy of Sciences.

The adeno-associated virus (AAV)is a common, naturally-occurring virus, which has been shown to work as an effective gene therapy delivery vehicle for genetic diseases, such asspinal muscular atrophy. In gene therapy, scientists deliver a working version of a faulty gene using a harmless AAV that was modified and inactivated in the lab. This way the virus functions only as a delivery vehicle and does not have the capacity to damage tissues and cause disease.

While AAVs have a natural ability to penetrate any cell of the body and infect as many cells as possible, their usefulness as a potential therapy requires the capacity to specifically deliver a working gene to a particular cell type, such as dopamine producing-nerve cells. Those are the ones hose responsible for releasing the neurotransmitter dopamine and that are gradually lost during Parkinsons disease.

A team of Swedish researchers have developed a new method called barcoded rational AAV vector evolution, or BRAVE that combines powerful computational analysis with the latest gene and sequencing technology to produce AAVs that can specifically target neurons.

To make AAVs neuron specific, the team selected 131 proteins known to specifically interact with synapses (the junctions between two nerve cells that allow them to communicate).

They then divided the proteins into small sequences, called peptides, and created a large library where each peptide could be identified by a specific pool of genetic barcodes (a short sequence of DNA that is unique and easily identified).

The peptide is then displayed on the surface of the AAV capsid, allowing researchers to test the simultaneous delivery of many cell-specific AAVs in a single experiment.

The team then injected these AAVs into the forebrain of adult rats and observed that around 13% of the peptides successfully homed to the brain. Moreover, 4% of the peptides were transported effectively through axons (long neuronal projections that conduct electrical impulses) toward the nerve cells body.

Researchers then selected 23 of these unique AAV capsids and injected them into rats striatum, a brain region involved in voluntary movement control and affected in Parkinsons disease. Twenty-one of the new AAV capsids had an improved transport capacity within nerve cells than in standard AAVs.

One particular capsid, called MNM008, showed a high affinity for rat dopaminergic neurons. Researchers then tested whether this viral vector also could target human dopaminergic neurons.

The team transplanted neurons generated from human embryonic stem cells into rats striatum. Six months later, they injected either MNM008 or a control AAV capsid and found that MNM008 was able to target these specific cells and be transported into dopaminergic neuronal cell bodies through axons.

Thanks to this technology, we can study millions of new virus variants in cell culture and animal models simultaneously. From this, we can subsequently create a computer simulation that constructs the most suitable virus shell for the chosen application in this case, the dopamine-producing nerve cells for the treatment of Parkinsons disease, Bjrklund said.

Overall, researchers believe the BRAVE method opens up the design and development of synthetic AAV vectors expressing capsid structures with unique properties and broad potential for clinical applications and brain connectivity studies.

The team has established a collaboration with a biotech company, Dyno Therapeutics, to use the BRAVE method in the design of new AAVs.

Together with researchers at Harvard University, we have established a new biotechnology company in Boston, Dyno Therapeutics, to further develop the virus engineering technology, using artificial intelligence, for future treatments, Bjrklund said.

Patricia holds a Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She has also served as a PhD student research assistant at the Department of Microbiology & Immunology, Columbia University, New York.

Total Posts: 208

Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.

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New Gene Therapy Method May Open BRAVE New World in Parkinson's - Parkinson's News Today

In January 2019, then-FDA commissioner Scott Gottlieb ushered in the new year with a bold prediction: The agency, he said, would be approving between 10 and 20 gene and cell therapies per year by 2025. At the time, there were a whopping 800 such therapies in the biopharma pipeline and the FDA was aiming to hire 50 new clinical reviewers to handle the development of the products.

That momentum will no doubt start to pick up in 2020, as several companies in late-stage development of their gene and cell therapies achieve key milestones or FDA approval. Among the companies expected to make major strides in gene and cell therapies next year are Biomarin, with valoctocogene roxaparvovec to treat hemophilia A, Sarepta and its gene therapy for Duchenne muscular dystrophy, plus multiple players developing CAR-T treatments for cancer, including Bristol-Myers Squibb and Gilead.

But with such explosive growth comes challenges. Gene and cell therapies require enormous up-front investing in complex manufacturing processes, as well asinnovative approaches to securing insurance coverage for products that come with eye-popping price tagssuch as Novartis $2 million gene therapy Zolgensma to treat spinal muscular atrophy. Those are just a few of the obstacles that will be front-and-center in 2020 as more gene and cell therapies make their way towardthe finish line.

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Pharma companies will face challenges figuring out how to incorporate gene and cell therapies into their overall business, said Michael Choy, partner and managing director at Boston Consulting Group, in an interview with FiercePharma. They dont fit well into the normal paradigms of budgeting and decision-making. They require a different pace of evolution and specialized expertise. For now, companies are shoe-horning gene therapies into their current model, but over the long-term there will have to be changes.

That will become increasingly clear in 2020 as both Big Pharma and small up-and-comers move towardthe clinic with their gene and cell therapies. John Zaia, M.D., director of the Center for Gene Therapy at City of Hope, predicts there will be at least three gene and cell therapy FDA approvals in 2020. He also expects to see momentum among companies seeking to improve on the technology to address unmet needs in medicine.

For example, Zaia believes off-the-shelf CAR-T cancer treatments will show promise in early studiesand will be met with enthusiasm in the cancer community, he told FiercePharma in an email. The first generation of FDA-approved CAR-T treatments, Novartis Kymriah and Gileads Yescarta, take several weeks to make because they require removing T cells from patients and engineering them to recognize and attack the patients'cancers. Several companies are advancing off-the-shelf CAR-T treatments, including Precision BioSciences, which has been building out a manufacturing plant equipped to make 10,000 doses per year.

RELATED: Biotech building facility to make genome-edited, off-the-shelf CAR-T therapies

Gene therapies for inherited diseases will make strides in 2020, too, Zaia predicts. City of Hope is one of the participants in a phase 1 study of CSL Behrings gene therapy to treat adults with sickle cell disease. CSL will be racing against several companies working on the disease, including Bluebird Bio, which is testing its beta thalassemia gene therapy Zynteglo in sickle cell. There is a big push from many research centers to cure sickle cell diseaseand early results with the use of gene therapy look very promising, Zaia said. Years of research is finally coming to realization.

With such robust R&D underway in gene and cell therapies, its no surprise several players are stepping up their investments in manufacturing. In October, Sanofi said it would retrofit a vaccine plant in France so it couldbe used for gene therapy manufacturing. Pfizer shelled out $19 million for a North Carolina facility that will serve as its manufacturing hub for gene therapies. Even Harvard University is getting into the game, working with a consortium of contract manufacturers to build a $50 million facility dedicated to making cell therapies and viral vectors for gene therapies.

But how will the healthcare system pay for all of these complex therapies? Its a question that will continue to dog the industry, BCGs Choy said. Theres a lot of interest in outcomes-based payments and payments over time, but the issue is theyre very difficult to implementbecause the infrastructure to track outcomes over time doesnt really exist, he said.

Still, payers and pharma companies are hinting at their willingness to put that infrastructure in place. Pfizer, which is developing DMD and hemophilia gene therapies, said recently its brainstorming with payers on innovative strategies for reimbursement. Novartis and Spark have already pioneered payment strategies that deviate from the standard pay-everything-up-front system. Novartis has some pay-for-performance contracts in place for the $475,000 Kymriah. And in September, Cigna agreed to cover Novartis Zolgensma and Sparks Luxturna on a per-month, per-member schedule.

RELATED: Novartis, Spark gene therapies win a boost with soup-to-nuts Cigna coverage

Despite the many challenges in cell and gene therapy, some players are showing theres likely to be a robust market for these innovative treatments. In its first quarter on the market, Zolgensma brought in $160 million in salesfar surpassing analysts expectations.

The promise of huge returns on gene and cell therapies will likely drive acquisitions in 2020, Choy predicted. These treatments are so transformative for patients, and as the clinical proof of effectiveness continues to grow, youre going to see a lot more deal-making in this area, he said.

Buyers will likely show a willingness to invest in early-stage gene and cell therapies, especially if they come with technology platforms that allow for the development of many follow-up products, Choy added. For these types of therapies, the lifecycles will be much shorter than they are for traditional pharmaceuticals, particularly for rare diseases, he said. If you administer a one-time therapy, that revenue peaks quite quickly and then drops off. So to have a sustainable revenue from a gene therapy business, you need to replace that, which requires managing a pipeline.

Judging from recent events in the burgeoning gene and cell therapy industry, the news flow in 2020 will be generated not just by the industrys largest players, but also by its upstarts. In December, Ferring Pharmaceuticals spinout FerGene turned heads with data showing that its gene therapy to treat non-muscle invasive bladder cancer eliminated tumors in more than half of participants in a phase 3 trial. And Gileads Kite Pharma just applied for FDA approval for its mantle cell lymphoma CAR-T, KTE-X19, based on a 93% overall response rate in a phase 2 trial.

There were 75 gene therapy clinical trials initiated in 2018, nearly doubling the trial starts of 2016momentum thats likely to continue next year, BCG said in a recent report. The scientific foundation is in place, BCG analysts concluded, but there is still much to do to deliver the full benefit of gene therapy to patients."

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Pharma's gene and cell therapy ambitions will kick into high gear in 2020despite some major hurdles - FiercePharma