Archive for the ‘Hypogonadism’ Category

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According to Persistence Market Researchs new report, globalmale hypogonadism marketis slated to exhibit a steady expansion throughout the forecast period (2017-2026). Revenues from the global market for male hypogonadism are estimated to exceed US$ 3,300 Mn by 2026-end.

Governments Taking Initiatives to Spread Awareness about Male Hypogonadism Therapeutics

Lack of sex hormones, usually referred to as male hypogonadism has resulted into many health risks that include osteoporosis, heart disease, and cardiovascular diseases on the back of thinning of bones. Global male hypogonadism market comprises several patented brands that currently have high market penetration. Proliferation in geriatric population in tandem with rising incidences related to rheumatoid arthritis and obesity have been primary factors affecting prevalence of male hypogonadism globally.

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Mounting incidences of testosterone deficiency in male population is a key factor that prevalence of male hypogonadism has surged worldwide. Several governments around the world have been taking initiatives to spread the awareness on hypogonadism treatment procedures, for example testosterone replacement therapy (TST), in order to relieve the painful burden on patients and their families.

As low testosterone levels are increasingly associated with exacerbation of chronic conditions, it further results into disorders apropos to hypothalamic-pituitary-gonadal axis. Advent of TST has however enabled reduction in cases of male hypogonadism considerably. With growing awareness related to its treatment among patients, the market is likely to gain an uptick during the forecast period.

Rising availability of the selective androgen receptor modulators (SARMs) has further sustained the market expansion. The development and high availability of SARMs has led toward the provision of improved treatment procedure to patients having androgen deficiencies, thereby influencing the market growth.

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North America will continue to Dominate Global Male Hypogonadism Market

North America will continue to dominate the global male hypogonadism market, with more than one-third revenue share during the forecast period. In addition, revenues from the male hypogonadism market in North America will exhibit the fastest expansion through 2026, as compared to those from all the other regional segments comprised in the report. Europe and Asia-Pacific excluding Japan (APEJ) are also expected to remain lucrative for the male hypogonadism market. The market in APEJ will ride on a slightly higher CAGR than that in Europe through 2026.

Topical gels are expected to remain the most lucrative among drugs available for treatment of male hypogonadism globally, with sales projected to register the fastest expansion through 2026. Injectables will also remain a major revenue contributor to the market. Sales of injectable and transdermal patches are poised to reflect an equal CAGR through 2026.

Testosterone Replacement Therapy to Remain Preferred among Patients

Based on therapy, testosterone replacement therapy is expected to remain preferred among patients with male hypogonadism worldwide. Roughly 66% revenue share of the market is expected to be held by revenues from testosterone replacement therapy by 2026-end. Revenues from gonadotropin replacement therapy will remain slightly more than half revenues gained from testosterone replacement therapy throughout the forecast period.

Klinefelters syndrome is expected to remain the most prevalent disease type observed in the male hypogonadism market, and revenues from treatment of this disease will exceed US$ 1,800 Mn by 2026-end. Kallmann Syndrome and Pituitary Adenomas among disease types will also account for major revenue shares of the market by 2026-end.

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The Global Androgen Replacement Therapy Market report provides a holistic evaluation of the market for the forecast period (20192025). The report comprises various segments as well as an analysis of the trends and factors that are playing a substantial role in the market. These factors; the market dynamics involve the drivers, restraints, opportunities and challenges through which the impact of these factors in the market are outlined. The drivers and restraints are intrinsic factors whereas opportunities and challenges are extrinsic factors of the market. The Global Androgen Replacement Therapy Market study provides an outlook on the development of the market in terms of revenue throughout the prognosis period.

In order to present an executive-level model of the market and its future perspectives, the Androgen Replacement Therapy Market report presents a clear segmentation based on different parameters. The factors that affect these segments are also discussed in detail in the report.

Androgen replacement therapy (ART), often referred to as testosterone replacement therapy (TRT), is a form of hormone therapy, in which androgens, often testosterone, are replaced. ART is often prescribed to counter the effects of male hypogonadism. It typically involves the administration of testosterone through injections, skin creams, patches, gels, or subcutaneous pellets. Testosterone replacement therapy is a promising technology for improving symptoms of hypogonadism and to raise the testosterone level. Furthermore, benefits related to application of testosterone replacement therapy include an increase in muscle tissue, overall surge in energy, and significant decrease in depression symptoms.

Major Players included in this report are as follows AbbVie, Inc., Allergan Plc, Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin International Plc, Mylan N.V., Novartis International AG, Pfizer, Inc., Clarus Therapeutics, Ferring Holding SA, Perrigo Company Plc, Acerus Pharmaceuticals Corporation, Upsher-Smith Laboratories, LLC, Dr. Reddys Laboratories, Bausch Health Companies Inc., Sun Pharmaceutical Industries Ltd., and Par Pharmaceutical.

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Androgen Replacement Therapy Market: Regional analysis includes:

The study will also feature the key companies operating in the industry, their product/business portfolio, market share, financial status, regional share, segment revenue, SWOT analysis, key strategies including mergers & acquisitions, product developments, joint ventures & partnerships an expansions among others, and their latest news as well. The study will also provide a list of emerging players in the Androgen Replacement Therapy Market.

Androgen Replacement Therapy Market scope

A basic summary of the competitive landscape A detailed breakdown of the regional expanse A short overview of the segmentation

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Some of the Major Highlights of TOC covers:

Androgen Replacement Therapy Regional Market Analysis

Androgen Replacement Therapy Production by Regions Global Androgen Replacement Therapy Production by Regions Global Androgen Replacement Therapy Revenue by Regions Androgen Replacement Therapy Consumption by Regions

Androgen Replacement Therapy Segment Market Analysis (by Type)

Global Androgen Replacement Therapy Production by Type Global Androgen Replacement Therapy Revenue by Type Androgen Replacement Therapy Price by Type

Androgen Replacement Therapy Segment Market Analysis (by Application)

Global Androgen Replacement Therapy Consumption by Application Global Androgen Replacement Therapy Consumption Market Share by Application (2014-2019)

Androgen Replacement Therapy Major Manufacturers Analysis

Androgen Replacement Therapy Production Sites and Area Served Product Introduction, Application and Specification Androgen Replacement Therapy Production, Revenue, Ex-factory Price and Gross Margin (2014-2019)Main Business and Markets Served

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Androgen Replacement Therapy Market to Witness Robust Expansion throughout the Forecast Period 2017-2026 | AbbVie, Inc., Allergan Plc, Bayer AG, Endo...

Pune, India, Jan. 19, 2021 (GLOBE NEWSWIRE) -- The global COVID-19 diagnostics market size is projected to reach USD 11.40 billion by 2027, exhibiting a CAGR of 7.9% during the forecast period. Uncontrolled spread of the coronavirus worldwide will be the major factor propelling the growth of this market, shares Fortune Business Insights in its report. According to Johns Hopkins University, global COVID-19 infections reached 100,000 in just 60 days, growing to 200,000 in the next 12-14 days, and the recent addition of 100,000 cases has taken only 3 days. The calculation of the spread of this disease is based on the estimation of the reproduction number or R Naught (Ro).

The UK Research and Innovation organization states that if the Ro goes above 1, exponential growth will be witnessed. As per a study published in the Journal of Clinical Medicine based on the virus transmission rate in Wuhan, the Ro was computed to be between 2.49 and 2.63. Such rapid transmission of the virus has surged the demand for coronavirus diagnostics tools and kits, which is boosting the growth of this market.

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Concerted Efforts towards Developing COVID Detection Tests to Accelerate Growth

With the COVID-19 pandemic showing no signs of abatement, medical and regulatory bodies are collaborating to encourage innovation and speed up research in developing coronavirus detection tools. For instance, in April 2020, the National Institutes of Health in the US announced the launch of Rapid Acceleration of Diagnostics (RADx) initiative with a funding of USD 1.5 billion to commercialize and widen the accessibility of COVID-19 testing.

Similarly, in June 2020, the US Food and Drug Administration (FDA) joined the COVID-19 Diagnostics Evidence Accelerator created by the Friends of Cancer Research and Reagan-Udall Foundation with the aim to evaluate the performance of PCR and antibody tests for COVID. Together, these and similar initiatives are expected to augment the COVID-19 diagnostics market growth throughout 2020.

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High Number of COVID-19 Cases to Give North America Leading Market Position

The United States is one of the worst-hit countries in the world by the coronavirus pandemic, with the number of cases as of June 2020 standing at 2.68 million and 129,000 deaths. In response, the US government is injecting more funds into medical research facilities to accelerate development of COVID-19 diagnostics and widen the testing net in the country. The regions market size in 2019 stood at USD 2.17 billion.

In Europe, the virus is spreading at a furious pace, with the UK, Italy, Spain, France, and Germany having the highest number of cases. Quick adoption of advanced detection tools in the region will enable it to expand its footprint in the COVID-19 diagnostics market share in the immediate future. Heavy investments by governments in Asia Pacific in the healthcare sector are expected to favor market growth in the region.

Regulatory Support to Novel Diagnostic Solutions to Encourage Innovation

The coronavirus is tightening its hold on the world and pharmaceuticals and governments are in a race against time to develop and launch quick and accurate diagnostic tests for this deadly virus. As a result, bodies such as the FDA are providing the necessary support to companies by removing unnecessary regulatory barriers, which is encouraging other players to innovate.

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Industry Developments:

List of Key Players Covered in this Market Report:

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Market Segmentations:

By Product

Instruments

Reagents & Kits

By Technology

Polymerase Chain Reaction (PCR)

Enzyme-linked Immunosorbent Assay (ELISA)

Point-of-care (POC)

Others

By Sample Type

Oropharyngeal & Nasopharyngeal Swabs

Blood

Urine

Others

By End User

Hospital & Clinics

Laboratories & Diagnostics Centers

Research Institutes

By Geography

North America (U.S. and Canada)

Europe (U.K., Germany, France, Italy, Spain, Scandinavia, and Rest of Europe)

Asia-Pacific (Japan, China, India, Australia, Southeast Asia, and Rest of Asia Pacific)

Latin America (Brazil, Mexico, and Rest of Latin America)

The Middle East & Africa (South Africa, GCC, and Rest of the Middle East & Africa)

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KYZATREX has generated strong results in both safety and efficacy studies for KYZATREX for treatment of primary and secondary hypogonadism in men. Due to the robust results, especially regarding safety, Marius has requested a Priority Review that, if granted, would result in an anticipated six-month review period.

Submission of our first NDA is an important milestone, which is the culmination of over a decade of meticulous research and dedication and is just the beginning for Marius, as our pipeline will continue to advance research and development in this important therapeutic area that has a multitude of effects on our health system, said Himanshu H. Shah, Founder and Executive Chairman of Marius.

The NDA submission is based on efficacy and safety data from its pivotal study (NCT04467697) in which KYZATREX generated the most comprehensive ABPM data in its class. KYZATREX was well tolerated by participants, with greater than 96% of those subjects completing 90 days of treatment achieving average testosterone levels in the normal range in the pivotal Phase 3 study. The most common treatment-related treatment-emergent adverse event (TEAE) in the pooled Phase 3 studies was hypertension, while there were no serious TEAEs across the Phase 3 trials deemed related to the study drug.

We are extremely proud to have generated compelling efficacy and safety data in our Phase 3 trials, commented Dr. Om Dhingra, Co-Founder and CEO of Marius. We look forward to continuing to work collaboratively with the FDA on the review of our application, and if approved, KYZATREX has the potential to become the standard of care (SOC) for the treatment of primary and secondary hypogonadism globally.

Marius also intends to file a marketing authorization application (MAA) with the European Medicines Agency in the first half of 2022. For more information about Marius Pharmaceuticals and KYZATREX, visit mariuspharma.com.

About Testosterone & Hypogonadism

Hypogonadism, often referred to as testosterone deficiency, is a condition that occurs when the body does not produce adequate levels of testosterone. In addition to testosterones widely accepted role in sexual and reproductive function, it also has important roles in numerous other metabolic and inflammatory processes. In the U.S. there are at least six million symptomatic men suffering from hypogonadism, and over 100 million men globally. The resulting medical costs associated with men with untreated hypogonadism and related comorbidities are more than $25 billion in the U.S. alone.

Hypogonadism is also the most common cause of secondary osteoporosis in men. Beyond these diseases, hypogonadism is a common comorbidity in a broader set of conditions from Type-2 diabetes to Non-Alcoholic Steatohepatitis (NASH).

About KYZATREX

KYZATREX if approved, will represent a novel oral testosterone replacement therapy option for adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

The ReTUNE study was a multi-center, 12-month study across the U.S. that studied the safety and efficacy of KYZATREX in hypogonadal subjects (total testosterone 281 ng/dL). Efficacy was determined by number of subjects in the normal, eugonadal range after 90 days of treatment, including dose titrations, while safety was monitored for a further 9 months while on a steady dose. In addition to testosterone parameters, the study collected Patient Reported Outcomes (PROs), which showed statistically significant results both from baseline and against its comparator. A pivotal six-month Phase 3 study was conducted, in which subjects were monitored using ABPM, now considered the standard BP assessment by the FDA and clinical experts. An improved dose regimen was also used in the pivotal six-month Phase 3 study. The results of the Phase 3 studies will be published in leading medical journals and presented at national conferences during 2021.

The FDA has conditionally accepted KYZATREX as the trade name for this investigational drug. The safety and efficacy have not been fully evaluated by any regulatory authority.

About Marius Pharmaceuticals

Marius is a specialty pharmaceutical company focusing on treating conditions that are primarily associated with hypogonadism, commonly referred to as testosterone deficiency. The companys mission is to improve the functional lives of patients and reduce the risks of the downstream effects of endocrine imbalance by ensuring appropriate level of testosterone. For more information, please visit http://www.mariuspharma.com .

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Marius Pharmaceuticals Submits New Drug Application to US FDA for Next-Generation Oral Testosterone Replacement Therapy in Male Patients With...

Testosterone Replacement Therapy Market research report delivers a comprehensive study on production capacity, consumption, import and export for all major regions across the world. Report provides is a professional inclusive study on the current state for the market. Analysis and discussion of important industry like market trends, size, share, growth estimates are mentioned in the report.

The testosterone replacement therapy is used to improve sexual performance, accomplishing higher energy levels and building muscles. Testosterone replacement therapy has many benefits such as improved sexual desire, better blood sugar regulation, lowers bad cholesterol levels, decreased risk of diabetes, increased muscle mass and strength, improved brain function and cognitive ability, decreased body fat, improved ability to handle stress, increased confidence and a more positive mood, improved sleep and increased energy levels throughout the day. Testosterone replacement therapy has many side effects such as acne and oily skin, increased risk of heart attack, lower sperm count, which results in infertility, larger breasts, increased risk of blood clots and shrinkage of the testicles.

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Top impacting factors: Market Scenario Analysis, Trends, Drivers and Impact Analysis

Testosterone replacement therapy includes substitution of testosterone hormone in male patients when they experience the ill effects of hypogonadism and lower testosterone level. The TRT drugs are accessible in six diverse forms that are gels, infusions, inserts, buccal glues and orals, which is influencing the market growth. Settled medicinal services and high use and interest for cutting edge TRT items are causing the growth. Increase in the awareness among people about testosterone replacement therapy is the factor to drive market. The high risks of infections like cardiovascular sickness and prostate disease related with testosterone substitution treatment will limit market development, which will restrain the growth.

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Testosterone Replacement Therapy Market (2020 2027) Explosive Factors of Revenue by Key Manufacturer, Share, Future Trends, COVID-19 Market Scenario,...

Anabolic steroids additionally called androgenic steroids are derivatives of testosterone, significant for advancing and keeping up muscle development and creating auxiliary male sex qualities, for example, an extending voice and facial hair. They are anabolic and increment protein inside cells, particularly in skeletal muscles, Anabolic steroids utilized restoratively in ailments to animate muscle increment, set off male adolescence and treat constant squandering conditions, comprising of malignancy and AIDS.

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Increment in geriatric populace drives the androgens and anabolic steroids commercial center, as more men are susceptible to hypogonadism. Also, ascend in weight issues in men propels the overall androgens and anabolic steroids market. The growing negative health status specifically within the developing countries is projected to fuel the growth of the marketplace during the forecast period. Besides, rise in government ventures for higher human services is attributed to the growth of the overall androgens and anabolic steroids market. Increment in occurrence of hypogonadism among men is anticipated to enlarge the worldwide androgens and anabolic steroids market all through the forecast span. Rise in impotence among men due to weight problems and tiredness is expected to enhance demand for androgens and anabolic steroids during forecast duration.

Anabolic Steroids Market can be segmented on basis of compound derivatives, mode of administration, applications, Distribution channels and geography.

On basis of synthetic derivatives, Anabolic steroids market is segmented as:

On basis of Modes of administration, Anabolic steroids is segmented as:

On basis of Applications, anabolic steroids is segmented as:

On basis of Distribution channels, anabolic steroids market is segmented as:

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Anabolic steroids include di-hydro-testosterone, testosterone, and other marketers. Anabolic steroids stimulate the improvement of male sex organs and male sexual characters including growth of beard and deepening of voice. Various varieties of tissues grow due to stimulation of anabolic steroids, specifically muscle and bone. Rise in red blood cells production is due to anabolic results. Androgens and anabolic steroids are used for the remedy of breast cancer in ladies, impotence, hypogonadism in men, and alternative therapy delayed puberty in adolescent boys. Anabolic steroids are also used for the treatment of numerous conditions with hormonal imbalance, weight loss, osteoporosis, and anemia. Anabolic steroids market can be segmented based on synthetic derivatives, mode of administration, application, end-user, and region. In terms of mode of administration, the market can be categorized into oral, injection, topical, skin patches and inhaler. Based on application type, anabolic steroids market can be divided into Anabolic, Androgenic and others. Based on distribution channels anabolic steroids market can be classified into hospital pharmacies, retail pharmacies and online pharmacies. The hospital pharmacies segment dominated the market owing to elevated availability of medications and hospitals being the first point of contact for treatment.

Anabolic steroids market in North America held the biggest marketplace share due to expanded prevalence of breast cancer in women. According to many researches, breast cancers is one of the main cause of death in U.S. Europe held the second largest share in anabolic steroids market because of accelerated occurrence of hypogonadism in men and delayed puberty in adolescent boys. The Anabolic steroids market in Asia Pacific is expected to grow at a fast pace during the forecast period attributable to multiplied government initiatives to get rid of breast cancer. Anabolic steroids market in Middle East & Africa is predicted to be driven via improved occurrence of impotence, hypogonadism in men, and behind schedule puberty in adolescent boys. The market in Latin America is projected to witness robust increase at some point of the forecast length due to accelerated government tasks within the fitness care sector.

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Valeant, Endo Pharmaceuticals Solutions Inc., Germiphene Corporation, Taro Pharmaceuticals, Inc., Antares Pharma, Inc, Actavis Pharma, Inc, Sandoz, Pfizer, Unimed Pharmaceuticals, Upsher-Smith

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The Anabolic Steroids Market to sharpen in the next decade - The Monitor

This article was originally published here

Glob Reprod Health. 2020 Spring;5(1):e36. doi: 10.1097/grh.0000000000000036.

ABSTRACT

BACKGROUND: Multiple Sclerosis (MS) is an immune-mediated inflammatory disease characterized by demyelination of the CNS that affects women in their child-bearing years. There has been no absolute data to suggest infertility in this population; however, women with MS may exhibit decreased fertility due to various etiologies. Furthermore, their transition into menopause presents unique aspects in patient care.

METHODS: We report a case of a 38 year-old female with a diagnosis of MS with subsequent secondary amenorrhea and primary infertility. Multidisciplinary work-up with was consistent with hypothalamic hypogonadism secondary to MS affecting the pituitary stalk. She was treated for infertility in our clinic as well as management of her menopausal symptoms.

RESULTS: The patient conceived triplets after 2 cycles of ovarian stimulation with injectable gonadotropins and intrauterine insemination. She underwent fetal reduction to twins. After completion of childbearing, she was treated for menopausal symptoms with various hormonal therapies and ultimately remained on oral conjugated estrogens with no symptoms.

CONCLUSION: To our knowledge, this is the first report of infertility caused by suspected MS involvement of the pituitary stalk. In this patient population, infertility treatment can be successful with gonadotropins and alleviation of menopausal symptoms can be achieved with hormone replacement.

PMID:33354640 | PMC:PMC7751803 | DOI:10.1097/grh.0000000000000036

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Brief Report Treatment of infertility and menopause in a patient with multiple sclerosis affecting the pituitary stalk: a case report - DocWire News

The Male Hypogonadism Therapy market report provides a detailed analysis of the emerging trends, opportunities, and as well as the challenges in the market. This extensive report sheds light on the latest developments, market drivers, and competitive analysis to help the new entrants and emerging players to make crucial decisions.

Besides this, the market research report presents insights on consumer behavior, regulatory policies, and supply & demand scenario to provide a holistic view of the market. The primitive aim of the report is to represent the critical data and figures of the market concisely and layout top winning strategies to aid industry players to leverage their market position.

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The dedicated research team has included Porters Five Point Force analysis to tailor the Global Male Hypogonadism Therapy Market. They have conducted interviews with industry experts to provide accurate predictions and better insights in a detailed manner. The research report covers the latest advancements that have overhauled the market dynamics while examined the threats which has impacted the overall market.

Key Answers Captured in the Study are

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Important Features that are under offering & key highlights of the report:

Detailed overview of Male Hypogonadism Therapy

Changing market dynamics of the industry

In-depth market segmentation by Type, Application, etc.

Historical, current, and projected market size in terms of volume and value

Recent industry trends and developments

Competitive landscape of Male Hypogonadism Therapy

Strategies of key players and product offerings

Potential and niche segments/regions exhibiting promising growth

A neutral perspective towards Male Hypogonadism Therapy performance

Market players information to sustain and enhance their footprint

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Research Objectives

To analyze and forecast the Worldwide Male Hypogonadism Therapy, in terms of value and volume.

Which segment has the potential to gain the highest market share?

To help decision-makers from a new offer perspective and benchmark existing marketing strategy.

Correlate cost structure historical data with key business segments.

Analyze marketing contribution and customer acquisition by up-selling and cross-selling.

Identifying Influencing factors keeping Worldwide Male Hypogonadism Therapy Intense, factored with periodic analysis of CR4 & CR8 concentration ratio & HHI Index.

Important Features that are under offering & key highlights of the report:

1) Does the study cover COVID-19 Impact Analysis and its effect on Growth %?

Yes, the overall industry has seen quite a big impact due to slowdown and shutdown in the production line & supply chain. The study covers a separate qualitative chapter on COVID-19 Impact analysis. Additionally, it also provides before and after the scenario of COVID-19 on sales growth & market size estimation to better analyze the exact scenario of the industry.

2) How companies are selected or profiled in the report?

List of some players that are profiled in the report include:

Eli LillyPfizerAbbVieNovo NordiskMerck KGaAMylanBayerTevaNovartisAbbottRocheEndo InternationalIpsenANI PharmaceuticalsTherapeuticsMDMale Hypogonadism Therap

Usually, we follow NAICS Industry standards and validate company profile with product mapping to filter relevant Industry players, furthermore the list is sorted to come up with a sample size of at least 50 to 100 companies having greater topline value to get their segment revenue for market estimation.

** List of companies mentioned may vary in the final report subject to Name Change / Merger etc.

3) Can we add or profiled a new company as per our needs?

Yes, we can add or profile a new company as per client need in the report, provided it is available in our coverage list as mentioned in answer to Question 1 and after feasibility run, final confirmation will be provided by the research team checking the constraints related to the difficulty of survey.

4) Can we narrow the available business segments?

Yes, depending upon the data availability and feasibility check by our Research Analyst, a further breakdown in business segments by end-use application or product type can be provided (If applicable) by Revenue Size or Volume*.

Male Hypogonadism Therapy market segmentation

The Study is segmented by following Product Type:

ParenteralTransdermalOralOthersMale Hypogonadism Therap

Major applications/end-users industry are as follows:

HospitalsDrugstoresOthers

5) Can a specific country of interest be added? What all regional segmentation covered?

Yes, Country-level splits can be modified in the study as per objectives. Currently, the research report gives special attention and focus on the following regions:

North America [United States, Canada, Mexico], Asia-Pacific [China, India, Japan, South Korea, Australia, Indonesia, Malaysia, Philippines, Thailand, Vietnam], Europe [Germany, France, UK, Italy, Russia, Rest of Europe], South America [Brazil, Argentina, Rest of South America], Middle East & Africa [GCC Countries, Turkey, Egypt, South Africa, Rest of the Middle East & Africa]

** One country of specific interest can be included at no added cost. For inclusion of more regional segment quotes will vary.

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Our reports are more than just research reports to us. They are tools that enable us to maintain long-term relationships with our clients whom we honor and cherish. Our clients business growth is integral for not only them but also us. This is what differentiates us from other market research companies.

At IGI, we provide our expertise and guideline for success. Our team of efficient and experienced researchers and consultants provide progressive market intelligence reports that are accurate, authentic, and in-depth. This empowers the clients to make well-informed decisions.

Moreover, we offer market intelligence studies, ensuring relevant and fact-based research across a range of industries including chemicals and materials, energy, automobile, healthcare, consumer goods, and technology. Our deep understanding of many business environments across industries such as those mentioned above allows us to deliver tailor-made reports.

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Male Hypogonadism Therapy Market Detailed Analysis Of Current Industry Figures With Forecasts Growth By 2026 - Cheshire Media

Dataintelo, one of the worlds leading market research firms has rolled out a new report on Male Hypogonadism market. The report is integrated with crucial insights on the market which will support the clients to make the right business decisions. This research will help both existing and new aspirants for Global Male Hypogonadism Market to figure out and study market needs, market size, and competition. The report provides information about the supply and demand situation, the competitive scenario, and the challenges for market growth, market opportunities, and the threats faced by key players.

The report also includes the impact of the ongoing global crisis i.e. COVID-19 on the Male Hypogonadism market and what the future holds for it. The pandemic of Coronavirus (COVID-19) has landed a major blow to every aspect of life globally. This has lead to various changes in market conditions. The swiftly transforming market scenario and initial and future assessment of the impact are covered in the report.

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The report is fabricated by tracking the market performance since 2015 and is one of the most detailed reports. It also covers data varying according to region and country. The insights in the report are easy to understand and include pictorial representations. These insights are also applicable in real-time scenarios. Components such as market drivers, restraints, challenges, and opportunities for Male Hypogonadism are explained in detail. Since the research team is tracking the data for the market from 2015, therefore any additional data requirement can be easily fulfilled.

The scope of the report has a wide spectrum extending from market scenarios to comparative pricing between major players, cost, and profit of the specified market regions. The numerical data is supported by statistical tools such as SWOT analysis, BCG matrix, SCOT analysis, and PESTLE analysis. The statistics are depicted in a graphical format for a clear picture of facts and figures.

The generated report is strongly based on primary research, interviews with top executives, news sources, and information insiders. Secondary research techniques are utilized for better understanding and clarity for data analysis.

The Male Hypogonadism Market is divided into the following segments to have a better understanding:

By Application:

Kallmann SyndromeKlinefelters SyndromePituitary DisordersOthers

By Type:

Testosterone Replacement TherapyGonadotropin-Releasing Hormones Therapy

By Geographical Regions:

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The Male Hypogonadism Market industry Analysis and Forecast 20192026 help clients with customized and syndicated reports holding key importance for professionals requiring data and market analytics. The report also calls for market-driven results providing feasibility studies for client requirements. Dataintelo promises qualified and verifiable aspects of market data operating in the real-time scenario. The analytical studies are carried out ensuring client requirements with a thorough understanding of market capacities in the real-time scenario.

Some of the prominent companies that are covered in this report:

Key players, major collaborations, merger & acquisitions along with trending innovation and business policies are reviewed in the report. Following is the list of key players:

Astrazeneca Plc.Merck& Co. Inc.Laboratories GenevrierAllergan Plc.Endo International Plc.Ferring

*Note: Additional companies can be included on request

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Dataintelo provides attractive discounts that fit your needs. Customization of the reports as per your requirement is also offered. Get in touch with our sales team, who will guarantee you a report that suits your needs.

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Male Hypogonadism Market is Expected to Thrive at Impressive CAGR by 2026 & Top Key Players are Astrazeneca Plc., Merck& Co. Inc.,...

Long-term androgen-deprivation therapy (ADT) is the standard of care in combination with radiotherapy (RT) in high-risk prostate cancer (PC), despite substantial toxicity from the resulting hypogonadism. We hypothesized that a combination of more potent but shorter-term androgen inhibition in men with intermediate or high-risk localized PC would synergize with definitive RT to provide short-term testosterone recovery and improve disease control.

This prospective phase 2 single arm trial enrolled men with low volume unfavorable intermediate or high-risk localized PC. Treatment included 6 months of ADT concurrent with abiraterone acetate plus prednisone once daily (AAP) and RT to prostate and seminal vesicles. The primary endpoint was the proportion of men with an undetectable PSA at 12-months; secondary objectives included biochemical progression-free survival (PFS), testosterone recovery, toxicity, and sexual/ hormonal quality-of-life.

We enrolled 37 men between January 2014 and August 2016, 45% of whom were high-risk .All patients had T1-2 disease and PSAs <20 ng/ml. Median follow-up is 37 months (95% CI: 35.7, 39.1).Treatment noted 32% grade 3 toxicities related to AAP, predominantly hypertension, with no >G4 toxicities. The rate of undetectable PSA at 12-months was 55% (95% CI 36-72%). With 46 months median follow-up, two of 37 patients developed PSA progression (36-month PFS 96%; 95% CI: 76%, 99%), and 81% of patients recovered testosterone with median time to recovery 9.2 months. Hormonal/sexual function declined at six months with subsequent improvement by 24 months.

The combination of RT and 6 months of ADT and AAP demonstrated acceptable toxicity and a high rate of testosterone recovery with restoration of QOL and excellent disease control in men with low volume intermediate or high-risk localized prostate cancer. Prospective comparative studies are justified.

International journal of radiation oncology, biology, physics. 2020 Nov 28 [Epub ahead of print]

Bridget F Koontz, Karen E Hoffman, Susan Halabi, Patrick Healy, Monika Anand, Daniel J George, Michael R Harrison, Tian Zhang, William R Berry, Paul G Corn, W Robert Lee, Andrew J Armstrong

Duke Cancer Institute Center for Prostate and Urologic Cancers Durham NC USA; Department of Radiation Oncology, Duke University, Durham NC USA. Electronic address: ., Department of Radiation Oncology, The University of Texas, MD Anderson Cancer Center, Houston TX USA., Duke Cancer Institute Center for Prostate and Urologic Cancers Durham NC USA; Department of Biostatistics and Bioinformatics, Duke University, Durham NC USA., Duke Cancer Institute Center for Prostate and Urologic Cancers Durham NC USA., Duke Cancer Institute Center for Prostate and Urologic Cancers Durham NC USA; Department of Medicine, Division of Medical Oncology, Duke University, Durham NC USA; Department of Surgery, Division of Urology, Duke University, Durham NC USA., Duke Cancer Institute Center for Prostate and Urologic Cancers Durham NC USA; Department of Medicine, Division of Medical Oncology, Duke University, Durham NC USA., Duke Cancer Institute Center for Prostate and Urologic Cancers Durham NC USA; Department of Radiation Oncology, Duke University, Durham NC USA., Duke Cancer Institute Center for Prostate and Urologic Cancers Durham NC USA; Department of Medicine, Division of Medical Oncology, Duke University, Durham NC USA; Department of Surgery, Division of Urology, Duke University, Durham NC USA; Department of Pharmacology and Cancer Biology, Duke University, Durham NC USA.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/33259932

Read more here:
Combination of Radiotherapy and Short-Term Androgen Blockade with Abiraterone Acetate plus Prednisone for M... - UroToday

What is Prader-Willi Syndrome?

Prader-Willi syndrome is a rare genetic disorder caused by a defect of genes in the proximal arm of chromosome-15 which leads to life-threatening childhood obesity. It is associated with obesity, hypogonadism, intellectual deficits, small stature along with small hands, and feet.

A child with PraderWilli Syndrome

The first case of Prader-Willi syndrome was first described in a mentally impaired adolescent girl in 1887 by Langdon Down and was later described in medical literature in 1956 by Swiss doctors Andrea Prader, Alexis Labhart, and Heinrich Willi.

Presence of characteristic facial features like almond-shaped eyes, narrow bifrontal diameter, and the nasal bridge thin upper lip and downturned mouth. These features are noticed soon after birth.

Prader-Willi syndrome has been described worldwide and is a genetic disorder occurring in approximately 1 in every 15,000 live birth. It affects males and females equally, all races and ethnicities are equally susceptible.It is highly unlikely for parents to have more than one child with Prader-Willi syndrome.

PWS is caused due to abnormality in the expression of genes on Chromosome 15 specifically on the long arm of chromosome 15. This abnormality can be attributed to the following :

The defects seen in Prader-Willi syndrome is mostly attributed to hypothalamic disorder, which may explain some typical features of the syndrome like delayed growth and hyperphagia as the hypothalamus is the center for hormone production, growth, and hunger regulation.

Various studies have implied the role of Ghrelin in satiety defect and have found Ghrelin to be about 4-5 folds higher in people with PWS. (Ghrelin is a hormone produced by enteroendocrine cells and is also known as the Hunger Hormone)

Three sets of diagnostic criteria have been established for the diagnosis of Prader-Willi Syndrome. These are major, minor, and supportive.

These criteria though they dont have points, aid in the diagnosis of the disease.

Based on the guidelines established by Holmes et.al the diagnosis of Prader-Willi syndrome is highly likely in children younger than 3 years if they score 5 points with 3 of those coming from the major criteria.

In the case of children older than 3 years with Prader Willi syndrome is highly likely if they score 8 points with 4 from major criteria.

Magnetic Resource Imaging (MRI) of the head to assess hypopituitarism. The individuals with Prader-Willi syndrome are at risk of pathological fractures, however high degrees of pain tolerance in these patients make it necessary to diagnose fractures to prevent stiffness and malunion of fractures. DEXA Scan: To detect complications of osteoporosis. Scoliosis Film of the vertebra.

To reach the diagnosis of PWS we need to differentiate it from other diseases which may be causing similar features:

These conditions can be differentiated from PWS with the help of the DNA Methylation technique.

Apart from these, other genetic conditions are causing short stature and obesity which need to be ruled out:

There is no permanent cure for Prader-Willi syndrome currently, and the treatment of the syndrome requires a multidisciplinary approach from geneticists, endocrinologists, nutritionists, pulmonologists, neurologists to prevent complications from PWS.

The treatment is generally directed towards symptomatic relief and problem management.

The treatment plan needs to be continuously reassessed as the child grows older as it needs changes.

Early diagnosis and treatment of PWS can go a long way in improving their quality of life and help them reach their full potential.

Children with PWS require proper care apart from specific symptomatic treatments. Most children can benefit from the following:

Infants with PWS have low muscle tone consequentially they are unable to breastfeed properly. A pediatrician can help by recommending special feeding methods and prescribing high-calorie diets. Use of a Nasogastric tube may be required.

A proper diet low on calories but providing necessary nutrition is key in managing the weight of PWS in children. Supplemental vitamins and minerals are required for balanced growth. Proper diet complemented with increased physical activity help in weight management. The child should exercise for at least 60 minutes. The exercise routine should be broken down into multiple 5- 10 minute sessions in children having decreased energy levels.

As the desire for appetite in children with PWS is high, parents need to keep strict vigilance on their eating habits, there should be proper meal times, food should be kept out of their view and no extra feeding should be done.

Human growth hormone (HGH) treatment. An endocrinologist can help decide if the baby will benefit from HGH injections. In children with Prader-Willi syndrome, it helps in facilitating growth, decreasing body fat content, increasing muscle size, and muscle tone.

Sex hormone treatment. Children with PWS have a very low sex hormone level, requiring hormone replacement therapy (Testosterone for males; estrogen and progesterone for females). HRT begins as the child approaches puberty. Apart from raising hormonal levels, it helps also in preventing bone thinning. Orchidopexy may be required for Cryptorchidism (Undescended testis).

Treating sleep disturbances related to PWS can improve daytime sleepiness and behavioral issues in children.

Strict parenting is required to keep the behavior in check, especially concerning food, to prevent over-eating; a proper diet plan needs to be formulated. Calmness is required while dealing with children showing temper tantrums- the situation should be deflated as soon as possible by engaging the child in another topic. Medication may be required in some cases.

A psychologist or a psychiatric consultation may be required to address obsessive-compulsive disorders, skin picking, or mood disorders in children with PWS. The childs nails should be trimmed so that they do not develop cellulitis or other skin infections as a result of constant skin picking; any cases of skin infection should be treated immediately using antibiotics.

Most people with Prader-Willi syndrome will need specialized care and supervision throughout their lives for continuous consultation with the doctor is required to transition medical care to adulthood.

In cases of severe skin and pinching and psychoses, Anti-depressant or anti-psychotics can be helpful. SSRIs are the antidepressants of choice. These drugs however come with associated risks, so they are generally avoided below the age of 18. Cognitive-behavioral therapy may be required in some cases. It is a talking therapy that helps to change the way the patient thinks and behaves to modify unhealthy behavioral patterns.

Patients with Prader-Willi syndrome are at risk of developing the following complications:

People with PWS, who receive early treatment usually have a normal lifespan and can function in a group home setting, perform vocational work.

People with PWS, having normal IQ can expect to accomplish many of the things their peers do. However, each person requires lifelong support from the people involved to lead an independent life.

Complications due to morbid obesity and psychological issues can affect the quality of life and sometimes shorten life expectancy in patients with PWS.

Scientists worldwide have been working on finding a permanent cure and improving the quality of life by reducing complications for PWS by carrying out various researches worldwide.

Livoletide is being monitored as a drug to reduce ghrelin and consequently hyperphagia and obesity.

A randomized, double-blind placebo-controlled study conducted in 2019 in 47 adults who took 3-4 mg of Livoletide once a day for two weeks, reported a significant decrease in food-related behaviors as compared to people who were given a placebo.

https://www.nhs.uk/conditions/prader-willi-syndrome/

Read more from the original source:
Prader-Willi Syndrome Facts: Causes, Diagnosis, Treatments and Prognosis - Gilmore Health News

Male hypogonadism usually is treated with testosterone replacement to return testosterone levels to normal. Testosterone can help counter the signs and symptoms of male Hypogonadism, such as decreased sexual desire, decreased energy, decreased facial and body hair, and loss of muscle mass and bone density.

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Top Key Players:

Merck & Co. Inc., Laboratories Genevrier, Allergan Plc., Astrazeneca Plc., Endo International Plc., Ferring, AbbVie Inc., Eli Lilly and Company Ltd., Finox Biotech, Teva Pharmaceutical Industries Ltd., Bayer AG, and IBSA Institut Biochimque.

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At the end, of the Global Male Hypogonadism HRT Treatment Market Professional Survey Report 2020 includes:- Methodology, Analyst Introduction and Statistics Supply. At long last, the examination contains Male Hypogonadism HRT Treatment SWOT investigation, venture partialness examination, speculation incorporate innovative work propensity examination.

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Male Hypogonadism HRT Treatment Market 2020-28 booming segments, latest trends and analysis with Merck & Co, Allergan, Endo International,...

Eduardo Rodriguez and the Boston Red Sox agreed to a one-year, $8.3-million contract for 2021, according to multiple reports on Tuesday.

The $8.3 million salary is the same the left-handed starter earned in 2020. The Red Sox beat Rodriguez at a salary arbitration hearing before the 2020 season when they filed at $8.3 million and Rodriguez filed for $8.675 million. The two sides avoided salary arbitration this offseason.

Rodriguez who is eligible for free agency after the 2021 season didnt pitch in 2020 because of myocarditis (inflammation of the heart), an after-effect of COVID-19. Rodriguez tested positive for COVID-19 before flying to Boston for summer training camp in early July. Tests in Boston revealed myocarditis. Rodriguez said he experienced every symptom of COVID.

I feel like I was 100 years old, Rodriguez said in July. My body was tired all the time. Throwing up. Headaches. Like I said, all the symptoms.

Rodriguez began throwing again in November after a lengthy recovery. He was Bostons top starter in 2019 and finished sixth in the American League Cy Young voting, going 19-6 with a 3.81 ERA and 1.33 WHIP in 34 starts.

The deadline for MLB teams to tender 2021 contracts to their pre-arbitration and arbitration-eligible players is Wednesday at 8 p.m. Boston has five other arbitration-eligible players Rafael Devers, Matt Barnes, Ryan Brasier, Kevin Plawecki and Austin Brice on its 40-man roster.

INDIANS-MARLINS: Cleveland sold side-arm reliever Adam Cimber to the Marlins for $100,000, and Miami designated right-hander Jos Urea for assignment.

Urea, the Marlins Opening Day starter in 2018 and 2019, spent six seasons with the Marlins and had been with them longer than any other active player. He went 0-3 with a 5.40 ERA in five starts last season, when he had a $3.75 million salary and earned $1,388,889 in prorated pay. He had been projected for a salary of about $4 million for 2021.

Cimber went 0-1 with a 3.97 ERA in 14 games this past season for Cleveland, which acquired the right-hander in 2018 from the San Diego Padres in the deal that brought All-Star closer Brad Hand to the Indians. The 30-year-old Cimber went 6-7 with a 4.30 ERA in 110 appearances with the Indians over 2 1/2 seasons. He was 6-3 in 2019, when he pitched in 68 games.

INDIANS: Rookie reliever Cam Hill underwent surgery on his right wrist after being involved in a car accident in Tulsa, Oklahoma.

Hill shared details of the incident on his Instagram account, saying he was very blessed to only bang up my wrist. Surgery went really well, most importantly the others involved in the accident were all okay.

Hill also posted a photo of him recovering in his hospital bed with his right arm heavily bandaged. He gave a thumbs up with his left hand.

Cleveland said Dr. Brian Chalkin, a hand specialist, operated Monday night on the right-handers lunate bone, located in the mid-carpal joint. The team said surgery went as expected and that it does not have any details yet on Hills rehab or when he might be able to pitch.

Hill made his major league debut with the Indians on July 26 and got his first save two days later against the Chicago White Sox. The 26-year-old went 2-0 with a 4.91 ERA in 18 games with Cleveland.

He made one postseason appearance, allowing three runs in Game 1 of the wild-card series against the New York Yankees.

HALL OF FAME Manager Tom Lasorda has been moved out of intensive care, although he remains hospitalized in Southern California.

Los Angeles Dodgers spokesman Steve Brener said that the teams 93-year-old former manager is doing rehab at the hospital in Orange County. Lasorda has been hospitalized since Nov. 8, although the team didnt make it public until a week later.

Lasorda attended the teams Game 6 victory over the Tampa Bay Rays on Oct. 27 in Texas that clinched the Dodgers first World Series title since 1988.

Lasorda had a record of 1,599-1,439 while managing the Dodgers from 1976-96, guiding them to World Series championships in 1981 and 88. The franchise won four National League pennants and eight division titles under Lasorda. He had a heart attack in June 1996 and retired from managing the Dodgers the following month.

ATHLETICS: Right-hander Burch Smith agreed to a $705,000, one-year contract a day before Wednesdays deadline for teams to offer deals to unsigned players on their rosters.

Smith went 2-0 with a 2.25 ERA and a save in six outings spanning 12 innings for Oakland but was lost for the season in mid-August because of a strained forearm on his pitching side. The As missed his presence in the bullpen as they won the AL West and the wild-card round against the Chicago White Sox before losing to the rival Astros in the AL Division Series.

Also Tuesday, catcher Francisco Pena received a minor league contract. He would earn $600,000 while in the majors if added to the 40-man roster.

METS: New York reached its first agreement with a free agent since Steven Cohen bought the team, a deal with 31-year-old right-hander Trevor May, a person familiar with the negotiations told The Associated Press.

May had a 3.86 ERA in 24 relief appearances for the Minnesota Twins last season, striking out 38 and walking seven in 23 1/3 innings while allowing 20 hits with a career-high fastball velocity averaging 96.66 mph. He earned $816,667 in prorated pay from a salary of $2,205,000.

May had spent all six big league seasons with the Twins, going 23-21 with a 4.44 ERA in 26 starts and 189 relief appearances.

He made 16 starts in 2015, going 8-9 with a 4.00 ERA over 48 appearances. May had Tommy John surgery on March 22, 2017, and returned to the major leagues on July 31, 2018.

May figures to join a bullpen that includes Edwin Diaz, Dellin Betances, Jeurys Familia, Brad Brach and Jacob Barnes.

New Yorks front office is being run by Sandy Alderson, who returned to the Mets as team president on the day that Cohen completed his $2.42 billion purchase from the Wilpon and Katz families.

DRUG TESTS: Major League Baseballs number of drug tests dropped sharply during the novel coronavirus pandemic.

There were 3,733 urine samples and 412 blood samples for human growth hormone testing collected during the year ending with the World Series, independent program administrator Thomas M. Martin said in his annual report. That was down from 9,332 urine samples and 2,287 blood samples in the year ending with the 2019 World Series.

The lower testing numbers were a result of the COVID-19 pandemic as well as the extended closure of the WADA-accredited anti-doping laboratory in Montreal, Martin wrote.

Spring training was interrupted in mid-March and the start of the regular season was delayed from late March until late July. Each teams schedule was cut from 162 games to 60.

There were 10 positive tests for performance-enhancing substances: two for Stanozolol (New York Mets second baseman Robinson Cano and free agent pitcher Victor Alcantara), five for Boldenone (Houston pitcher Francis Martes, Pittsburgh utilityman Pablo Reyes, Arizona infielder Domingo Leyba, Cleveland pitcher Emmanuel Clase and Pittsburgh pitcher Edgar Santana) and three for Dehydrochlormethyltestosterone (DHCMT) (Colorado pitcher Justin Lawrence, Washington catcher Tres Barrera and Houston pitcher Kent Emanuel).

Ninety-one therapeutic use exemptions were granted, 90 for Attention Deficit Hyperactivity Disorder and one for Hypersomnia. That was down from 94 for the previous year, which included 90 for ADHD and one each for Hypersomnia, Hypogonadism and kidney disease.

Exemptions for hyperactivity disorder had ranged from 105-119 annually from 2008-16, prompting some to criticize their issuance as too lenient.

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MLB notebook: Red Sox, Rodriguez agree to one-year, $8.3 million deal to avoid arbitration - pressherald.com

The report offers a complete research study of the global Testosterone undecanoate Market that includes accurate forecasts and analysis at global, regional, and country levels. It provides a comprehensive view of the global Testosterone undecanoate Market and detailed value chain analysis to help players to closely understand important changes in business activities observed across the industry. It also offers a deep segmental analysis of the global Testosterone undecanoate market where key product and application segments are shed light upon. Readers are provided with actual market figures related to the size of the global Testosterone undecanoate market in terms of value and volume for the forecast period 2020-2027.

The following Companies as the Key Players in the Global Testosterone undecanoate Market Research Report are Bayer AG, Endo Pharmaceuticals, Merck Sharp & Dohme, Taro Pharmaceutical, Cipla, Zhejiang Xianju Pharmaceutical, Zhejiang Medicine Co..

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Asia Pacific and Europe are projected to be Testosterone undecanoate markets during the forecast period. This is primarily due to the presence of prominent industry in China, Germany, Japan, and India.

Market Overview of Global Testosterone undecanoate

On the basis of product, this report displays the production, revenue, price, market share and growth rate of each type, primarily split into Injection, Oral.

On the basis of the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate for each application, including Primary hypogonadism, Hypogonadotropic hypogonadism, Late-onset hypogonadism.

Geographically, The Testosterone undecanoate market report studies the top producers and consumers, focuses on product capacity, production, value, consumption, market share and growth opportunity in these key regions, covering: North America, Europe, China, Japan and others.

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Furthermore, Global Testosterone undecanoate Market following points are involved along with a detailed study of each point:

Major Players: The report provides company profiling for a decent number of leading players of the global Testosterone undecanoate market. It brings to light their current and future market growth taking into consideration their price, gross margin, revenue, production, areas served, production sites, and other factors.

Testosterone undecanoate Market Dynamics: The report shares important information on influence factors, market drivers, challenges, opportunities, and market trends as part of market dynamics.

Global Testosterone undecanoate Market Forecast: Readers are provided with production and revenue forecasts for the global Testosterone undecanoate market, production and consumption forecasts for regional markets, production, revenue, and price forecasts for the global Testosterone undecanoate market by type, and consumption forecast for the global Testosterone undecanoate market by application.

Regional Market Analysis: It could be divided into two different sections: one for regional production analysis and the other for regional consumption analysis. Here, the analysts share gross margin, price, revenue, production, CAGR, and other factors that indicate the growth of all regional markets studied in the report.

Testosterone undecanoate Market Competition: In this section, the report provides information on Competitive situations and trends including merger and acquisition and expansion, market shares of the top three or five players, and market concentration rate. Readers could also be provided with production, revenue, and average price shares by manufacturers.

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Major Highlights of Testosterone undecanoate Market in Covid-19 pandemic covered in report:

Market Competition by key manufacturers in the industry. Discussed Sourcing strategies, industrial chain information and downstream buyers data. Distributors and traders marketing strategy analysis focusing on region wise needs in covid-19 pandemic. Vendors who are providing a wide range of product lines and intensifying the competitive scenario in covid-19 crisis. Also highlights of the key growth sectors of Testosterone undecanoate market and how they will perform in coming years.

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** The market is evaluated based on the weighted average selling price (WASP) and includes the taxes applicable to the manufacturer. All currency conversions used in the creation of this report were calculated using a certain annual average rate of 2020 currency conversion.

Crucial points encompassed in the report:

Customization Available

With the given market data, Researchers offer customization according to the companys specific needs. The following customization options are available for the report:

Regional and country-level analysis of the Testosterone undecanoate market, by end-use.

Detailed analysis and profiles of additional market players.

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Impact of Covid-19 on Testosterone undecanoate Market is slated to grow rapidly in the forthcoming years with Key Players Bayer AG, Endo...

Sometimes people think of estrogen as a female hormone. However, all human bodies require estrogen to function correctly.

Estrogen is a hormone that naturally occurs in a persons body. Levels of estrogen that are too high or too low can cause a person to have health problems.

This article will discuss the role of estrogen in the male body, symptoms of high or low estrogen levels, and how people can treat irregular levels.

Estrogen is a sex hormone found in both males and females, although females have higher estrogen levels than males do.

The ovaries, testes, fat cells, and adrenal glands produce estrogen. It is important for female puberty and controlling the menstrual cycle. Estrogen is also important for the male reproductive system.

There are three types of estrogen:

Testosterone can be converted into estradiol using the enzyme aromatase. Estradiol is used by the male body for:

Estrogen also has other functions in the human body. It can help control cholesterol levels and maintain bone and heart health. It also affects mood, skin, and other tissues of the body.

The amount of estrogen a male should have will depend on their age and health history. According to the Endocrine Society, an adult male should have an estradiol level of 1040 picograms per milliliter (pg/mL) and an estrone level of 1050 pg/ml.

A person who is concerned about their levels of estrogen should speak to their doctor.

Although the male body needs estrogen to function correctly, too much estrogen can cause health problems.

Increased levels of estrogen can cause symptoms such as infertility, erectile dysfunction, and depression.

A person who is concerned about their estrogen levels should contact their doctor.

Low levels of estrogen in the male body can produce symptoms such as:

Researchers found that males with cardiovascular disease had lower levels of testosterone and estrogen.

Hypogonadism, a condition that can cause a decrease in sex hormones, can be a cause of low estrogen in males.

Further research is needed to confirm the symptoms that low estrogen can have on the male body.

Learn more about low estrogen here.

High levels of estrogen can cause a variety of problems in the male body. Symptoms of high estrogen levels in males include:

Increases in estrogen in males can also be an indicator of the following conditions:

Research into the effect of estrogen on migraines indicates that males with higher estrogen levels may be at higher risk of having migraines. However, researchers note that further study is required to confirm these findings.

A 2019 study into the link between high estrogen levels and diffuse cutaneous systemic sclerosis, an autoimmune disease, in males over 50 found that participants with significantly high estrogen levels had higher risk of cardiac involvement or death.

Aromatase excess syndrome and alcohol use disorder may be causes of increased estrogen in males.

Learn more about high estrogen here.

Reducing alcohol intake may cause a drop in estrogen levels.

There have also been studies suggesting that certain types of food may reduce estrogen levels. However, there is no definitive research to confirm the estrogen-lowering effects these foods have.

A male who wants to lower their estrogen levels should speak to their doctor. Certain medications are available that can help lower estrogen. They include selective estrogen receptor modulators and aromatase inhibitors.

A male who is experiencing symptoms of low estrogen should speak to their doctor about treatment options.

Hormone replacement therapy can help treat low estrogen levels in males caused by hypogonadism. A doctor may administer testosterone using a patch, an injection, a gel, or a product absorbed by the gums.

A person who experiences any symptoms of low or high estrogen levels should speak to their doctor.

The doctor may perform tests, such as blood test or urine sample test, in order to determine a persons estrogen levels. The doctor may then discuss what treatment options will suit the person best.

Levels of estrogen that are too high or too low can cause problems in males.

Low or high levels of estrogen can be indicators of underlying health problems.

A person who experiences symptoms of high or low estrogen levels should speak to their doctor.

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Estrogen in men: Symptoms of high and low levels, and more - Medical News Today

ENGLEWOOD, CO / ACCESSWIRE / November 11, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced today that management will present a corporate overview at the Jefferies 2020 Virtual London Healthcare Conference on Wednesday, November 18 at 1:45pm ET / 6:45pm GMT.

A webcast of the presentation will be available at the following link: https://wsw.com/webcast/jeff141/aytu/1873875

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist®, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex® Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal® ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid antibody test and rapid antigen tests. These assays are used in the rapid, qualitative diagnostic assessment of the 2019 Novel Coronavirus. Additionally, Aytu recently licensed worldwide rights to develop the Healight technology platform. Healight is an investigational medical device being studied as a prospective treatment for COVID-19 and other respiratory infections.

Aytu also operates a consumer health subsidiary, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human® marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the regulatory and commercial risks associated with introducing the COVID-19 rapid tests, the accuracy of the COVID-19 rapid tests as compared to other COVID-19 tests, market acceptance of the tests, the ability to obtain FDA approval or authorization for the tests, our ability to obtain sufficient tests to meet consumer demand, if any, the manufacturers' ability to scale up manufacturing to meet customer demand, if any, reputation risks if the tests are not as effective as anticipated, and that the current regulatory environment continues to permit the sale of the tests. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Media and Investors:

James Carbonara Hayden IR (646) 755-7412 james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/615765/Aytu-BioScience-to-Present-at-the-Jefferies-2020-Virtual-London-Healthcare-Conference-Wednesday-November-18-at-145pm-ET

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Aytu BioScience to Present at the Jefferies 2020 Virtual London Healthcare Conference Wednesday, November 18 at 1:45pm ET - Stockhouse

Global Testosterone Replacement Therapy Market Report, History and Forecast 2015-2024, Breakdown Data by Manufacturers, Key Regions, Types and Application is a highly comprehensive research document released by 360 Research Reports that provides a reliable source of the global Testosterone Replacement Therapy market study. Major players, competitive intelligence, market dynamics and geographic opportunities are discussed in detail in the report. Independent sections cover each of the major regions, as well as the trends for Testosterone Replacement Therapy market products within those regions. The report includes market estimations and trends through the forecast period and analyses market dynamics across the major geographies. The report also discusses recent developments and product portfolios of the key players.

COVID-19 can affect the global economy in three main ways: by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on firms and financial markets.

Final Report will add the analysis of the impact of COVID-19 on this industry.

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Short Description About Testosterone Replacement Therapy Market:

Testosterone replacement therapy (TRT) is a class of hormone replacement therapy in which androgens, often testosterone, are replaced. Testosterone replacement therapy (TRT) is an FDA-approved medical treatment for men of any age who have low testosterone, a hormone necessary for male sexual development.

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The research covers the current Testosterone Replacement Therapy market size of the market and its growth rates based on 5-year records with company outline ofKey players/manufacturers:

Scope of the Testosterone Replacement Therapy Market Report:This report focuses on the Testosterone Replacement Therapy in global market, especially in North America, Europe and Asia-Pacific, South America, Middle East and Africa. This report categorizes the market based on manufacturers, regions, type and application.Testosterone deficiency, also referred to as hypogonadism, is a common problem among men aged between 40 and 79 years, with some studies stating that nearly 30% of all men worldwide are affected by hypogonadism. As the incidence of testosterone deficiency increases, it is expected that the demand for TRT will also show a simultaneous increase.The global average price of testosterone replacement therapy is in the decreasing trend, from 45.4 USD/Unit in 2012 to 34.9 USD/Unit in 2016. With the situation of global economy, prices will be in decreasing trend in the following five years.The classification of testosterone replacement therapy includes gels, injections, patches and other types, and the proportion of gels in 2016 is about 72%.Testosterone replacement therapy is widely sold in hospitals, clinics and other field. The most proportion of testosterone replacement therapy is sold in clinics, and the consumption proportion is about 43%.North America region is the largest supplier of testosterone replacement therapy, with a production market share nearly 86% in 2016. Europe is the second largest supplier of Testosterone Replacement Therapy, enjoying production market share nearly 9.9% in 2016.North America is the largest consumption place, with a consumption market share nearly 83% in 2016. Following North America, Europe is the second largest consumption place with the consumption market share of 12%. Market competition is intense. AbbVie, Endo International, Eli Lilly, Pfizer, Actavis (Allergan)Bayer, etc. are the leaders of the industry. The top five players together held about 80% of the market in the same year and they hold key technologies and patents, with high-end customers; have been formed in the monopoly position in the industry. The worldwide market for Testosterone Replacement Therapy is expected to grow at a CAGR of roughly -4.2% over the next five years, will reach 1410 million US$ in 2023, from 1820 million US$ in 2020, According to a New Research study.

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Report further studies the market development status and future Testosterone Replacement Therapy Market trend across the world. Also, it splits Testosterone Replacement Therapy market Segmentation by Type and by Applications to fully and deeply research and reveal market profile and prospects.

Major Classifications are as follows:

Major Applications are as follows:

Geographically,this report is segmented into severalkey regions, with sales, revenue, market share and growth Rate of Testosterone Replacement Therapy in these regions, from 2014 to 2024, covering

This Testosterone Replacement Therapy Market Research/Analysis Report Contains Answers to your following Questions

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Major Points from Table of Contents:

Market Overview1.1 Testosterone Replacement Therapy Introduction1.2 Market Analysis by Type1.3 Market Analysis by Applications1.4 Market Dynamics1.4.1 Market Opportunities1.4.2 Market Risk1.4.3 Market Driving Force

2.Manufacturers Profiles

2.4.1 Business Overview2.4.2 Testosterone Replacement Therapy Type and Applications2.4.2.1 Product A2.4.2.2 Product B

3.Global Testosterone Replacement Therapy Sales, Revenue, Market Share and Competition By Manufacturer (2019-2020)

3.1 Global Testosterone Replacement Therapy Sales and Market Share by Manufacturer (2019-2020)3.2 Global Testosterone Replacement Therapy Revenue and Market Share by Manufacturer (2019-2020)3.3 Market Concentration Rates3.3.1 Top 3 Testosterone Replacement Therapy Manufacturer Market Share in 20203.3.2 Top 6 Testosterone Replacement Therapy Manufacturer Market Share in 20203.4 Market Competition Trend

4.Global Testosterone Replacement Therapy Market Analysis by Regions

4.1 Global Testosterone Replacement Therapy Sales, Revenue and Market Share by Regions4.1.1 Global Testosterone Replacement Therapy Sales and Market Share by Regions (2014-2019)4.1.2 Global Testosterone Replacement Therapy Revenue and Market Share by Regions (2014-2019)4.2 North America Testosterone Replacement Therapy Sales and Growth Rate (2014-2019)4.3 Europe Testosterone Replacement Therapy Sales and Growth Rate (2014-2019)4.4 Asia-Pacific Testosterone Replacement Therapy Sales and Growth Rate (2014-2019)4.6 South America Testosterone Replacement Therapy Sales and Growth Rate (2014-2019)4.6 Middle East and Africa Testosterone Replacement Therapy Sales and Growth Rate (2014-2019)

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5.Testosterone Replacement Therapy Market Forecast (2020-2024)5.1 Global Testosterone Replacement Therapy Sales, Revenue and Growth Rate (2020-2024)5.2 Testosterone Replacement Therapy Market Forecast by Regions (2020-2024)5.3 Testosterone Replacement Therapy Market Forecast by Type (2020-2024)5.3.1 Global Testosterone Replacement Therapy Sales Forecast by Type (2020-2024)5.3.2 Global Testosterone Replacement Therapy Market Share Forecast by Type (2020-2024)5.4 Testosterone Replacement Therapy Market Forecast by Application (2020-2024)5.4.1 Global Testosterone Replacement Therapy Sales Forecast by Application (2020-2024)5.4.2 Global Testosterone Replacement Therapy Market Share Forecast by Application (2020-2024)

6.Sales Channel, Distributors, Traders and Dealers6.1 Sales Channel6.1.1 Direct Marketing6.1.2 Indirect Marketing6.1.3 Marketing Channel Future Trend6.2 Distributors, Traders and Dealers

7.Research Findings and Conclusion

8.Appendix8.1 Methodology8.2 Data Source

Continued..

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Global Testosterone Replacement Therapy Market 2020 : Industry Analysis by Top Countries Data Definition, Size, Share, Segmentation and Forecast data...

Male Hypogonadism Therapy Market Size And Forecast

A comprehensive overview of the Male Hypogonadism Therapy Market is recently added by Market Research Intellect to its humongous database. Furthermore, the Male Hypogonadism Therapy Market report has been aggregated by collecting informative data of various dynamics such as market drivers, restraints, and opportunities. Furthermore, this innovative report makes use of SWOT, PESTLE, and Porters Five Forces analyses to get a closer outlook on the Male Hypogonadism Therapy Market. Furthermore, the Male Hypogonadism Therapy Market report offers a detailed analysis of the latest industry developments and trending factors in the market that are influencing the market growth. Furthermore, this statistical market research repository examines and estimates the Male Hypogonadism Therapy Market at the global and regional levels. The study covers the impact of various drivers and manacles on the Male Hypogonadism Therapy Market growth opportunities over the forecast period.

Impact of Covid-19 :

During the first quarter of 2020, different global economies were badly impacted by a viral outbreak of COVID-19. This viral outbreak of the Covid-19 was later recognized as a global pandemic by the World Health Organization (WHO). COVID-19 spread in different global countries, affecting a large number of people in a short timeframe. The outburst of COVID-19 adversely hit different global economies in the world. The stringent regulations imposed by several governments, including complete lockdown and quarantine methodologies to fight against COVID-19, resulted in a massive impact on various business sectors. We at Market Research Intellect offer an informative report on the Male Hypogonadism Therapy Market which helps in making strategic decisions over the forecast period.

Competitive Landscape:

The degree of competition among leading global companies has been elaborated by examining various leading key players operating across the global regions An expert team of research analysts sheds light on various attributes such as -global market competition, market share, latest industry developments, innovative product launches, partnerships, mergers or acquisitions by leading companies in the Male Hypogonadism Therapy Market. The leading manufacturers have been analyzed by using research methodologies for getting insight views on global competition.

Following key players have been profiled with the help of proven research methodologies:

The Male Hypogonadism Therapy Market has been examined into different global market segments such as type, applications and global geographies. Each and every global market segment has been studied to get informative insights into various global regions.

Male Hypogonadism Therapy Market Segmentation:

Male Hypogonadism Therapy Market Segment by Type:

Male Hypogonadism Therapy Market Segment by Application:

Male Hypogonadism Therapy Market Segment by Global Presence:

North America Latin America Middle East Asia-Pacific Africa Europe

The report has been aggregated by using a couple of research methodologies such as primary and secondary research techniques. It helps in collecting informative pieces of professional information for deriving effective insights into the market. This informative report helps in making well informed and strategic decisions throughout the forecast period.

Key questions answered through this analytical market research report include:

What are the latest trends, new patterns and technological advancements in the Male Hypogonadism Therapy Market? Which factors are influencing the Male Hypogonadism Therapy Market over the forecast period? What are the global challenges, threats and risks in the Male Hypogonadism Therapy Market? Which factors are propelling and restraining the Male Hypogonadism Therapy Market? What are the demanding global regions of the Male Hypogonadism Therapy Market? What will be the global market size over the coming future? What are the different effective business strategies followed by global companies?

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Male Hypogonadism Therapy Market Forecast to 2027: Top Companies, Trends & Growth Factors and Trend Forecast to 2027 - TechnoWeekly

Market Report Summary

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Read Full Press Release Below

According to Persistence Market Researchs new report, globalmale hypogonadism marketis slated to exhibit a steady expansion throughout the forecast period (2017-2026). Revenues from the global market for male hypogonadism are estimated to exceed US$ 3,300 Mn by 2026-end.

Governments Taking Initiatives to Spread Awareness about Male Hypogonadism Therapeutics

Lack of sex hormones, usually referred to as male hypogonadism has resulted into many health risks that include osteoporosis, heart disease, and cardiovascular diseases on the back of thinning of bones. Global male hypogonadism market comprises several patented brands that currently have high market penetration. Proliferation in geriatric population in tandem with rising incidences related to rheumatoid arthritis and obesity have been primary factors affecting prevalence of male hypogonadism globally.

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Company Profiles

Get To Know Methodology of Report @ https://www.persistencemarketresearch.com/methodology/22303

Mounting incidences of testosterone deficiency in male population is a key factor that prevalence of male hypogonadism has surged worldwide. Several governments around the world have been taking initiatives to spread the awareness on hypogonadism treatment procedures, for example testosterone replacement therapy (TST), in order to relieve the painful burden on patients and their families.

As low testosterone levels are increasingly associated with exacerbation of chronic conditions, it further results into disorders apropos to hypothalamic-pituitary-gonadal axis. Advent of TST has however enabled reduction in cases of male hypogonadism considerably. With growing awareness related to its treatment among patients, the market is likely to gain an uptick during the forecast period.

Rising availability of the selective androgen receptor modulators (SARMs) has further sustained the market expansion. The development and high availability of SARMs has led toward the provision of improved treatment procedure to patients having androgen deficiencies, thereby influencing the market growth.

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North America will continue to Dominate Global Male Hypogonadism Market

North America will continue to dominate the global male hypogonadism market, with more than one-third revenue share during the forecast period. In addition, revenues from the male hypogonadism market in North America will exhibit the fastest expansion through 2026, as compared to those from all the other regional segments comprised in the report. Europe and Asia-Pacific excluding Japan (APEJ) are also expected to remain lucrative for the male hypogonadism market. The market in APEJ will ride on a slightly higher CAGR than that in Europe through 2026.

Topical gels are expected to remain the most lucrative among drugs available for treatment of male hypogonadism globally, with sales projected to register the fastest expansion through 2026. Injectables will also remain a major revenue contributor to the market. Sales of injectable and transdermal patches are poised to reflect an equal CAGR through 2026.

Testosterone Replacement Therapy to Remain Preferred among Patients

Based on therapy, testosterone replacement therapy is expected to remain preferred among patients with male hypogonadism worldwide. Roughly 66% revenue share of the market is expected to be held by revenues from testosterone replacement therapy by 2026-end. Revenues from gonadotropin replacement therapy will remain slightly more than half revenues gained from testosterone replacement therapy throughout the forecast period.

Klinefelters syndrome is expected to remain the most prevalent disease type observed in the male hypogonadism market, and revenues from treatment of this disease will exceed US$ 1,800 Mn by 2026-end. Kallmann Syndrome and Pituitary Adenomas among disease types will also account for major revenue shares of the market by 2026-end.

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Persistence Market Research (PMR) is a third-platform research firm. Our research model is a unique collaboration of data analytics and market research methodology to help businesses achieve optimal performance.

To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.

Our client success stories feature a range of clients from Fortune 500 companies to fast-growing startups. PMRs collaborative environment is committed to building industry-specific solutions by transforming data from multiple streams into a strategic asset.

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The Male Hypogonadism Market To Slither Amidst Covid-19, To Pick Up Pace Post-Covid-19, Reach US$ 3300 Mn - The Think Curiouser

Global hypogonadism drug marketis rising gradually with a substantial CAGR in the forecast period of 2019-2026. Growing number hypogonadism population and robust product pipeline are the key drivers for market growth.

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Few of the major competitors currently working in the global hypogonadism drug market areAbbVie Inc., ALLERGAN, AstraZeneca, Bayer AG., Eli Lilly and Company, Clarus Therapeutics, Endo Pharmaceuticals Inc, Merck & Co., Inc., Ferring B.V., Richter Gedeon Vegyeszeti Gyar Nyrt, IBSA Institut Biochimque SA, Laboratoires Genevrier., Teva Pharmaceutical Industries Ltd, Lipocine Inc., Antares Pharma, Pfizer Inc., Aytu BioScience, Inc., Diurnal, HYUNDAIPHARM. Co Ltd., Perrigo Company plc, Bio-Techne and many others.

Report Scope

Market Drivers

Increase in prevalence rate of hypogonadism worldwide acts as a driver for the marketIncrease in the rate of research and development initiatives is driving the marketRising awareness about hypogonadism therapy and technological advancement is driving the market growthOngoing clinical trials is being carried out by many pharmaceuticals companies which acts as a driver for the market

Market Restraints

Effective treatment is either unavailable or unaffordablePatent expiry of major drugs and introduction of generic drugs of branded version is expected to restrain the growth if the marketInadequate knowledge about hypogonadism in some developing countries

TOC of Hypogonadism drug Market Report Contains:

Get Full Table Of content @https://www.databridgemarketresearch.com/toc/?dbmr=global-hypogonadism-drug-market

Segmentation: Global Hypogonadism Drug Market

By Type

Hypergonadotropic HypogonadismHypogonadotropic Hypogonadism

By Therapy Type

Testosterone Replacement TherapySteroid Replacement Therapy

By Treatment

MedicationHormone therapySurgery

By Mechanism of Action Type

Steroidal androgensTestosteroneMethyltestosteroneGonadotropinsChorionic GonadotropinFollicle Stimulating Hormone

By Route of administration

OralInjectableTopical

By End Users

HospitalsHomecareSpecialty ClinicsOthers

By Geography

North AmericaSouth AmericaEuropeAsia-PacificMiddle East & Africa

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Global Hypogonadism Drug Market Business Share, Industry Size and Future Investment Opportunities by 2026||ALLERGAN, AstraZeneca, Bayer AG., Eli Lilly...

Live Conference Call and Webcast at 4:30 PM ET

ENGLEWOOD, CO / ACCESSWIRE / November 5, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced today that the Company will present its operational results for the fiscal first quarter ended September 30, 2020 on November 12, 2020, at 4:30 p.m. ET. The Company will review accomplishments from the quarter and provide an overview of its business and growth strategy.

Conference Call Information

888-506-0062 (toll-free) Participant Entry Code - 318202973-528-0011 (international) Participant Entry Code - 318202

The webcast will be accessible live and archived at the following link https://www.webcaster4.com/Webcast/Page/2142/38489 and on Aytu BioScience's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.

A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) or 919-882-2331 (international) and using the replay access code 38489.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) Cefaclor, a second-generation cephalosporin antibiotic suspension; (ii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iii) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid antibody test. This assay is used in the rapid, qualitative diagnostic assessment of the 2019 Novel Coronavirus. Additionally, Aytu recently licensed worldwide rights to develop the Healight technology platform. Healight is an investigational medical device being studied as a prospective treatment for COVID-19 and other respiratory infections.

Aytu also operates a consumer health subsidiary, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the regulatory and commercial risks associated with introducing the COVID-19 rapid tests, the accuracy of the COVID-19 rapid tests as compared to other COVID-19 tests, market acceptance of the tests, the ability to obtain FDA approval or authorization for the tests, our ability to obtain sufficient tests to meet consumer demand, if any, the manufacturers' ability to scale up manufacturing to meet customer demand, if any, reputation risks if the tests are not as effective as anticipated, and that the current regulatory environment continues to permit the sale of the tests. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/614510/Aytu-BioScience-to-Report-First-Quarter-Fiscal-2021-Results-and-Provide-Business-Update-on-Thursday-November-12-2020

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Aytu BioScience to Report First Quarter Fiscal 2021 Results and Provide Business Update on Thursday, November 12, 2020 - Press Release - Digital...

The globalHormone Replacement Therapymarket research report offers all the vital data in the domain. The latest report assists new bees as well as established market participants to analyze and predict the Hormone Replacement Therapy market at the regional as well as global level. It covers the volume [k MT] as well as revenues [USD Million] of the global Hormone Replacement Therapy market for the estimated period. Numerous key players Pfizer, Abbott Laboratories, Novo Nordisk, Mylan Laboratories, Eli Lilly, Novartis, Roche, Bayer Healthcare, Merck Serono, Genentech are dominating the global Hormone Replacement Therapy market. These players hold the majority of share of the global Hormone Replacement Therapy market.

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Key points of the global Hormone Replacement Therapy market

Theoretical analysis of the global Hormone Replacement Therapy market stimulators, products, and other vital facets Recent, historical, and future trends in terms of revenue and market dynamics are reported Pin-point analysis of the competitive market dynamics and investment structure is predicted to grow Future market trends, latest innovations, and various business strategies are reported Market dynamics include growth influencers, opportunities, threats, challenges, and other crucial facets

The global Hormone Replacement Therapy market research report offers users with an all-inclusive package of market analysis that includes current market size, expansion rate, and value chain analysis. The global Hormone Replacement Therapy market is segmented on a regional basis Europe, North America, Latin America, Asia Pacific, and Middle East & Africa as well. To offer a comprehensive view and competitive outlook of the global Hormone Replacement Therapy market, our review team employs numerous methodological procedures, for instance, Porters five forces analysis.

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This research report includes the analysis of various Hormone Replacement Therapy market segments {Human Growth Hormone Therapies, Estrogen, Testosterone, Thyroid Hormones}; {Menopause, Male Hypogonadism, Hypothyroidism, Growth Hormone Deficiency, Others}. The bifurcation of the global market is done based on its present and prospective inclinations. The regional bifurcation involves the present market scenario in the region along with the future projection of the global Hormone Replacement Therapy market. The global market report offers an overview of expected market conditions due to changes in the technological, topographical, and economic elements.

Questions answered in the report include

1. What is the expected market size by the end of the forecast period?2. What are the major factors initiating the global Hormone Replacement Therapy market growth?3. What are the latest developments and trending market strategies that are influencing the growth of the Hormone Replacement Therapy market?4. What are the key outcomes of the Hormone Replacement Therapy market developments?5. Who are the key players in the market?6. What are the opportunities and challenges faced by the key players?

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Global Hormone Replacement Therapy Market Recent Trends, Development, Growth and Forecast 2020-2027 - Eurowire

First of all it is important to make clear that andropause isn't the male version of menopause, says consultant urologist Dr Datesh Daneshwal.

"While all women go through menopause, all men do not experience andropause. It's not supposed to happen to every man and it only affects a very small percentage of men," he says.

Andropause is a condition where men experience a decrease in their testosterone levels that is not normal. While all men do start losing testosterone after the age of 30, the decrease isn't very significant (about 1% a year) and should not affect their well-being. Very different from menopause which signifies a sudden decrease in a womans hormone levels that causes ovulation to cease.

But sometimes, when a man's biochemical dip is more drastic, it can cause a broad range of symptoms that affect their overall health and temperament.

These symptoms include a decline in muscle mass and strength, a buildup of body fat, a loss of bone density, flagging energy, emotional instability, deranged sugar and cholesterol levels, lowered fertility and fading virility.

"A drop in testosterone coupled with these symptoms is what is classified as andropause. When it interferes with your well-being and health," explains Dr Datesh. "Many people have a misconception that testosterone is purely for sexual function which it is not. It is the elixir that keeps the brain sharp, affects one's mood, muscle bulk and weight management and also collesterol and sugar levels. Low testosterone can cause insomnia and depression and, of course, sexual dysfunction too. Men need a certain level of testosterone to function well in all aspects of their life and if it dips too low, their health is at risk," says Dr Datesh

Getting help

David was 38 when he started noticing the symptoms.

"I was experiencing a gradual but progressive decline of erectile function, decreased libido, frequent and more prolonged periods of low moods, decreased energy levels and frustration, sadness and despair that my interest in the opposite gender was not what it once was," says David who is now 61.

Although he initially started taking Viagra to help with his sexual dysfunction, David decided to consult a doctor when the symptoms persisted.

"For many years, l absorbed myself in my work and largely shrugged off and just accepted my symptoms without question. ince retiring a few years ago, l have had the time to become more aware of the physical and psychological fallout these symptoms have been having on me. The biggest psychological symptom was the diminishing confidence that l keenly felt in pursuing new relationships with women (l am, and always have been, a single guy) not least because l was conscious of the increasing difficulty of consummating such relationships.

"On a physical level, l felt myself becoming more anxious and subject to low moods as well as experiencing decreasing energy levels. I felt that l owed it to myself to get my symptoms properly evaluated by qualified professionals in this area," he said.

David was diagnosed with hypogonadism, a condition where the body doesn't produce enough testosterone which can occur from birth or later in life, often from injury or infection. He is currently on testosterone replacement treatment as well as medicine for erectile dysfunction which he says has helped him tremendously.

"Physically, l feel more energised, l have a stronger libido and my erectile functioning difficulties have been greatly improved, with further improvements anticipated after further testosterone injections. Psychologically, my confidence in interacting with women has been greatly boosted l think this is the most dramatic change l have notice.

"My advise to other men who are going through this is to not ignore the symptoms but to take action! Go and get specialist advice initially from your doctor and better still from a Urologist who has special expertise in this area. Please do not be embarrassed about talking through your symptoms with a doctor or urologist, particularly around erectile dysfunction. Remember that these medical people have seen and heard it all before many, many times. ln most cases your symptoms are likely to be physiological rather than psychological and can be resolved with treatment," says David.

Strength training exercises and a healthy lifestyle can stimulate the body's own production of testosterone. Photo: Pixabay

The stigma is real

Although there is a lot of literature available or andropause, men rarely seek medical help even when the symptoms can be affecting their life significantly, notes Dr Datesh.

"There is a stigma associated with this, unfortunately. And that's because we immediately associate testosterone with sexual function. That's why we need to raise awareness about how men need healthy levels of testosterone to lead a healthy life all around. If you are over 40 and are not feeling yourself notice that you put on weight, lose muscle bulk, emotional instability, find you are no longer attracted to your partner anymore, come and get tested. All it takes is a simple blood test and if it is because of low levels of testosterone, there is a solution now. You can get treated and change your life not just for yourself but for your family too," says the urologist from Prince Court Medical Centre.

Hormone replacement therapies for men come in the forms of pills, injections and gels although the most effective and popular option in Malaysia are thelong-term injections that are adinistered every three months.

"Hormone replacement is a science though and cannot be administered simply without ruling out a few things. First and most importantly, we have to make sure that the patient has no signs of prostate cancer because testosterone is fuel for prostate cancer cells. Second, while testosterone administered externally may help with a man's virility, it may affect his fertility. These things have to be discussed with the patient before he starts on treatment," says Dr Datesh.

How long a patient has to be on them really depends on the individual, he says.

I have had patients who, after a couple of doses, were feeling better and able to resume an active lifestyle which can stimulate the body's ability to produce it's own testosterone," he explains.

Men experiencing the symptoms of andropause are advised to make healthier lifestyle choices. Aerobic exercise to release endorphins that improve mood, strength training to increase blood flow and strengthen the hear as well a healthy diet and a decrease in alcohol and tobacco intake.

Muscle-building exercises, he says, can encourage the body's own production of testosterone.

"But a person experiencing andropause will not have the energy to do weight training - they'd need a boost of hormones get they them feeling energised enough to start exercising and building their body up," he says.

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Andropause: Not the same as menopause but needs to be addressed - The Star Online

Oct. 27, 2020 05:02 UTC

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ: EXEL) today announced that Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of CABOMETYX (cabozantinib) in Japan, and Ono Pharmaceutical Co., Ltd. (Ono), have submitted a supplemental application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for Manufacturing and Marketing approval of CABOMETYX in combination with OPDIVO (nivolumab) for the treatment of patients with unresectable, advanced or metastatic renal cell carcinoma (RCC).

Takeda and Onos application is based on the results of CheckMate -9ER, a phase 3 pivotal trial evaluating CABOMETYX in combination with OPDIVO in previously untreated patients with advanced or metastatic RCC compared with sunitinib. In CheckMate -9ER, CABOMETYX in combination with OPDIVO demonstrated superior overall survival, doubled median progression-free survival and objective response rate, and demonstrated a favorable safety profile versus sunitinib. These results were presented as a Proffered Paper during a Presidential Symposium at the European Society for Medical Oncology Virtual Congress 2020.

Following our recent announcement that the U.S. FDA accepted and granted Priority Review to our supplemental new drug application for CABOMETYX in combination with OPDIVO for the treatment of advanced renal cell carcinoma, were excited that our partner Takeda along with Ono have also advanced this combination regimen toward potential regulatory approval in Japan, said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. The results of the CheckMate -9ER trial suggest CABOMETYX in combination with OPDIVO may become an important new treatment option for patients with advanced kidney cancer in need of new therapies.

Per the terms of Exelixis and Takedas collaboration and license agreement, Exelixis is eligible to receive a $10 million milestone payment from Takeda as a result of this latest submission for RCC. Following the milestone associated with this regulatory filing, Exelixis will be eligible to receive a first-sale milestone payment of $20 million from Takeda related to the combination of CABOMETYX and OPDIVO for the treatment of RCC. Exelixis continues to be eligible to receive additional development, regulatory and first-sale milestones for potential future cabozantinib indications, and is also eligible for sales revenue milestones and royalties on net sales of cabozantinib in Japan. Takeda fully funds cabozantinib development activities that are exclusively for the benefit of Japan and has the opportunity to share the costs associated with global cabozantinib clinical trials, providing the company opts into those trials.

Takeda received approval in March 2020 from the Japanese MHLW to manufacture and market CABOMETYX as a treatment for patients with curatively unresectable or metastatic RCC.

About CheckMate -9ER

CheckMate -9ER is an open-label, randomized, multi-national phase 3 trial evaluating patients with previously untreated advanced or metastatic RCC. A total of 651 patients (23% favorable risk, 58% intermediate risk, 20% poor risk; 25% PD-L11%) were randomized to receive OPDIVO plus CABOMETYX (n=323) vs. sunitinib (n=328). The primary endpoint is progression-free survival. Secondary endpoints include overall survival and objective response rate. The primary efficacy analysis is comparing the doublet combination vs. sunitinib in all randomized patients. The trial is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co. and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.

About RCC

The American Cancer Societys 2020 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.1 Clear cell RCC is the most common type of kidney cancer in adults.2 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 12%.2 Approximately 32,000 patients in the U.S. and 71,000 worldwide will require systemic treatment for advanced kidney cancer in 2020.3

About 70% of RCC cases are known as clear cell carcinomas, based on histology.4 The majority of clear cell RCC tumors have below-normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL and VEGF.5,6 These proteins promote tumor angiogenesis (blood vessel growth), growth, invasiveness and metastasis.7,8,9,10 MET and AXL may provide escape pathways that drive resistance to VEGF receptor inhibitors.6,7

About CABOMETYX (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC and for the treatment of patients with HCC who have been previously treated with sorafenib. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.

CABOMETYX in combination with OPDIVO is not indicated for advanced RCC.

CABOMETYX Important Safety Information

Warnings and Precautions

Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of perforations and fistulas, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a Grade 4 fistula or a GI perforation.

Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic event requiring medical intervention.

Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension occurred in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.

Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Proteinuria: Proteinuria occurred in 7% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. Discontinue CABOMETYX in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold CABOMETYX for development of ONJ until complete resolution.

Impaired Wound Healing: Wound complications occurred with CABOMETYX. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer CABOMETYX for at least 2 weeks after major surgery and until adequate wound healing is observed. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic findings on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

The most commonly reported (25%) adverse reactions are: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, and vomiting.

Drug Interactions

Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.

Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. Johns wort.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.

Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.

Please see accompanying full Prescribing Information https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.

OPDIVO INDICATIONS

OPDIVO (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

OPDIVO (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not be inclusive of all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur at any time after starting or discontinuing YERVOY. Early identification and management are essential to ensure safe use of YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue YERVOY depending on severity. In general, if YERVOY requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less followed by corticosteroid taper for at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroid therapy. Institute hormone replacement therapy for endocrinopathies as warranted.

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 10% (5/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 4.4% (24/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of patients. In NSCLC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%) immune-mediated pneumonitis. Four patients (0.7%) died due to pneumonitis. The incidence and severity of immune-mediated pneumonitis in patients with NSCLC treated with OPDIVO 360 mg every 3 weeks in combination with YERVOY 1 mg/kg every 6 weeks and 2 cycles of platinum-doublet chemotherapy were comparable to treatment with OPDIVO in combination with YERVOY only. The incidence and severity of immune-mediated pneumonitis in patients with malignant pleural mesothelioma treated with OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks were similar to those occurring in NSCLC.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 10% (5/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 10% (52/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7% (8/119) of patients.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated diarrhea/colitis occurred in 12% (62/511) of patients, including Grade 3-5 (7%).

Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Addition of an alternative immunosuppressive agent to the corticosteroid therapy, or replacement of the corticosteroid therapy, should be considered in corticosteroid-refractory immune-mediated colitis if other causes are excluded.

Immune-Mediated Hepatitis

OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. For patients without HCC, withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4. For patients with HCC, withhold OPDIVO and administer corticosteroids if AST/ALT is within normal limits at baseline and increases to >3 and up to 5 times the upper limit of normal (ULN), if AST/ALT is >1 and up to 3 times ULN at baseline and increases to >5 and up to 10 times the ULN, and if AST/ALT is >3 and up to 5 times ULN at baseline and increases to >8 and up to 10 times the ULN. Permanently discontinue OPDIVO and administer corticosteroids if AST or ALT increases to >10 times the ULN or total bilirubin increases >3 times the ULN. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 13% (51/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 20% (10/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 7% (38/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 8% (10/119) of patients.

In Checkmate 040, immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% (8/154) of patients receiving OPDIVO.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 4.1% (21/511) of patients, including Grade 3-5 (1.6%).

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Withhold for Grades 2, 3, or 4 endocrinopathies if not clinically stable. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 9% (36/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 4% (2/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypophysitis occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hypophysitis occurred in 3.4% (4/119) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 5% (21/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 18% (9/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 7% (41/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 5.9% (7/119) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving this dose of OPDIVO with YERVOY. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (11/49) of patients. Hyperthyroidism occurred in 10% (5/49) of patients receiving this dose of OPDIVO with YERVOY. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (119/547) of patients. Hyperthyroidism occurred in 12% (66/547) of patients receiving this dose of OPDIVO with YERVOY. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 15% (18/119) of patients. Hyperthyroidism occurred in 12% (14/119) of patients. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, diabetes occurred in 1.5% (6/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, diabetes occurred in 2.7% (15/547) of patients.

In a separate Phase 3 trial of YERVOY 3 mg/kg, severe to life-threatening endocrinopathies occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 1.7% (2/119) of patients.

Immune-Mediated Skin and Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated rash occurred in 22.6% (92/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated rash occurred in 35% (17/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 16% (90/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 14% (17/119) of patients.

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous exfoliative rashes. Withhold YERVOY until specialist assessment for Grade 2 and permanently discontinue for Grade 3 or 4 exfoliative or bullous dermatologic conditions.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated rash occurred in 15% (76/511) of patients, including Grade 3-5 (2.5%).

Immune-Mediated Encephalitis

OPDIVO can cause immune-mediated encephalitis. Fatal cases have been reported. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one melanoma patient receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg (0.2%) after 1.7 months of exposure. Encephalitis occurred in one RCC patient receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg (0.2%) after approximately 4 months of exposure. Encephalitis occurred in one MSI-H/dMMR mCRC patient (0.8%) receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg after 15 days of exposure.

Other Immune-Mediated Adverse Reactions

Based on the severity of the adverse reaction, permanently discontinue or withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Dose modifications for YERVOY for adverse reactions that require management different from these general guidelines are summarized as follows. Withhold for Grade 2 and permanently discontinue YERVOY for Grade 3 or 4 neurological toxicities. Withhold for Grade 2 and permanently discontinue YERVOY for Grade 3 or 4 myocarditis. Permanently discontinue YERVOY for Grade 2, 3, or 4 ophthalmologic adverse reactions that do not improve to Grade 1 within 2 weeks while receiving topical therapy OR that require systemic therapy. Across clinical trials of OPDIVO monotherapy or in combination with YERVOY , the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1.0% of patients receiving OPDIVO: myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barr syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), motor dysfunction, vasculitis, aplastic anemia, pericarditis, myasthenic syndrome, hemophagocytic lymphohistiocytosis (HLH), and autoimmune hemolytic anemia. In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: autoimmune neuropathy (2%), meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, nerve paresis, angiopathy, temporal arteritis, pancreatitis (1.3%), arthritis, polymyositis, conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis, blepharitis, episcleritis, orbital myositis, scleritis, and solid organ transplant rejection. Some cases of ocular IMARs have been associated with retinal detachment.

If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving OPDIVO and YERVOY and may require treatment with systemic steroids to reduce the risk of permanent vision loss.

Infusion-Related Reactions

OPDIVO can cause severe infusion-related reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion-related reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. Severe infusion-related reactions can also occur with YERVOY. Discontinue YERVOY in patients with severe or life-threatening infusion reactions and interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, infusion-related reactions occurred in 8% (4/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 4.2% (5/119) of patients. In MPM patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, infusion-related reactions occurred in 12% (37/300) of patients.

In separate Phase 3 trials of YERVOY 3 mg/kg and 10 mg/kg, infusion-related reactions occurred in 2.9% (28/982).

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1 receptor blocking antibody or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1 or CTLA-4 receptor blockade and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1 receptor blocking antibody or YERVOY prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on mechanism of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO or YERVOY and for at least 5 months after the last dose.

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

In clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma 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.

Lactation

It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from OPDIVO or YERVOY, advise women not to breastfeed during treatment and for at least 5 months after the last dose.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in 2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure. In Checkmate 9LA, serious adverse reactions occurred in 57% of patients (n=358). The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure. Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia. In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 032, serious adverse reactions occurred in 45% of patients receiving OPDIVO (n=245). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration. In Checkmate 743, serious adverse reactions occurred in 54% of patients receiving OPDIVO plus YERVOY. The most frequent serious adverse reactions reported in 2% of patients were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism. Fatal adverse reactions occurred in 4 (1.3%) patients and included pneumonitis, acute heart failure, sepsis, and encephalitis. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in 2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY. The most frequent serious adverse reactions reported in 2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in 1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, serious adverse reactions occurred in 47% of patients. The most frequent serious adverse reactions reported in 2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=154). The most frequent serious adverse reactions reported in 2% of patients were pyrexia, ascites, back pain, general physical health deterioration, abdominal pain, pneumonia, and anemia. In Checkmate 040, serious adverse reactions occurred in 59% of patients receiving OPDIVO with YERVOY (n=49). Serious adverse reactions reported in 4% of patients were pyrexia, diarrhea, anemia, increased AST, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin, and pneumonitis. In Checkmate 238, Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in 2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. Serious adverse reactions occurred in 18% of OPDIVO-treated patients. In Attraction-3, serious adverse reactions occurred in 38% of patients receiving OPDIVO (n=209). Serious adverse reactions reported in 2% of patients who received OPDIVO were pneumonia, esophageal fistula, interstitial lung disease and pyrexia. The following fatal adverse reactions occurred in patients who received OPDIVO: interstitial lung disease or pneumonitis (1.4%), pneumonia (1.0%), septic shock (0.5%), esophageal fistula (0.5%), gastrointestinal hemorrhage (0.5%), pulmonary embolism (0.5%), and sudden death (0.5%).

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Exelixis Announces Takeda and Ono Submit Supplemental Application for CABOMETYX (cabozantinib) in Combination with OPDIVO (nivolumab) for the...

Hormone Replacement Drugs Market Insights, Forecast to 2026

Complete study of the global Hormone Replacement Drugs market is carried out by the analysts in this report, taking into consideration key factors like drivers, challenges, recent trends, opportunities, advancements, and competitive landscape. This report offers a clear understanding of the present as well as future scenario of the global Hormone Replacement Drugs industry. Research techniques like PESTLE and Porters Five Forces analysis have been deployed by the researchers. They have also provided accurate data on Hormone Replacement Drugs production, capacity, price, cost, margin, and revenue to help the players gain a clear understanding into the overall existing and future market situation.

Key companies operating in the global Hormone Replacement Drugs market include Eli Lilly, Pfizer, AbbVie, Novo Nordisk, Merck KGaA, Mylan, Bayer, Teva, Novartis, Abbott, Roche, Endo International, Ipsen, ANI Pharmaceuticals, TherapeuticsMD

Get PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :

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Segmental Analysis

The report has classified the global Hormone Replacement Drugs industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Hormone Replacement Drugs manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Hormone Replacement Drugs industry.

Segmentation

Description

By Product Type

Hormone replacement drugs refers to the treatment of the patients with hormone deficiency due to conditions such as dwarfism or women nearing menopause, which requires replacement of hormones in the body whose levels have become low.Market Analysis and Insights: Global Hormone Replacement Drugs MarketThe global Hormone Replacement Drugs market size is projected to reach US$ XX million by 2026, from US$ XX million in 2020, at a CAGR of XX%% during 2021-2026.Global Hormone Replacement Drugs Scope and SegmentThe global Hormone Replacement Drugs market is segmented by company, region (country), by Type, and

By Application

Hormone replacement drugs refers to the treatment of the patients with hormone deficiency due to conditions such as dwarfism or women nearing menopause, which requires replacement of hormones in the body whose levels have become low.Market Analysis and Insights: Global Hormone Replacement Drugs MarketThe global Hormone Replacement Drugs market size is projected to reach US$ XX million by 2026, from US$ XX million in 2020, at a CAGR of XX%% during 2021-2026.Global Hormone Replacement Drugs Scope and SegmentThe global Hormone Replacement Drugs market is segmented by company, region (country), by Type, and by Application. Players, stakeholders, and other participants in the global Hormone Replacement Drugs market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on revenue and forecast by region (country), by Type, and by Application for the period 2015-2026.The major regions covered in the report are North America, Europe, China, Rest of Asia Pacific, Central & South America, Middle East & Africa, etc. It includes revenue analysis of each region for the year 2015 to 2026.By the type, the market is primarily split into, Estrogen Hormone, Growth Hormone, Thyroid Hormone, Testosterone HormoneBy the application, this report covers the following segments, Menopause, Hypothyroidism, Growth Hormone Deficiency, Male Hypogonadism, Other DiseasesCompetitive Landscape:The Hormone Replacement Drugs key manufacturers in this market include:, Eli Lilly, Pfizer, AbbVie, Novo Nordisk, Merck KGaA, Mylan, Bayer, Teva, Novartis, Abbott, Roche, Endo International, Ipsen, ANI Pharmaceuticals, TherapeuticsMD

Some of the Top Key player Operating in The Report Are

Eli Lilly, Pfizer, AbbVie, Novo Nordisk, Merck KGaA, Mylan, Bayer, Teva, Novartis, Abbott, Roche, Endo International, Ipsen, ANI Pharmaceuticals, TherapeuticsMD

By Region

North America

oU.S.

oCanada

Europe

oGermany

oU.K.

oFrance

oItaly

oSpain

oRest of Europe

Asia Pacific

oChina

oIndia

oJapan

oRest of Asia Pacific

Middle East & Africa

oGCC

oSouth Africa

oRest of Middle East & Africa

Latin America

oBrazil

oMexico

oRest of Latin America

Competitive Landscape

It is important for every market participant to be familiar with the competitive scenario in the global Hormone Replacement Drugs industry. In order to fulfill the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key questions answered in the report:

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Table of Contents

1 Market Overview of Hormone Replacement Drugs1.1 Hormone Replacement Drugs Market Overview1.1.1 Hormone Replacement Drugs Product Scope1.1.2 Market Status and Outlook1.2 Global Hormone Replacement Drugs Market Size Overview by Region 2015 VS 2020 VS 20261.3 Global Hormone Replacement Drugs Market Size by Region (2015-2026)1.4 Global Hormone Replacement Drugs Historic Market Size by Region (2015-2020)1.5 Global Hormone Replacement Drugs Market Size Forecast by Region (2021-2026)1.6 Key Regions, Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.1 North America Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.2 Europe Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.3 China Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.4 Rest of Asia Pacific Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.5 Latin America Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.6 Middle East & Africa Hormone Replacement Drugs Market Size YoY Growth (2015-2026)

2 Hormone Replacement Drugs Market Overview by Type2.1 Global Hormone Replacement Drugs Market Size by Type: 2015 VS 2020 VS 20262.2 Global Hormone Replacement Drugs Historic Market Size by Type (2015-2020)2.3 Global Hormone Replacement Drugs Forecasted Market Size by Type (2021-2026)2.4 Estrogen Hormone2.5 Growth Hormone2.6 Thyroid Hormone2.7 Testosterone Hormone

3 Hormone Replacement Drugs Market Overview by Application3.1 Global Hormone Replacement Drugs Market Size by Application: 2015 VS 2020 VS 20263.2 Global Hormone Replacement Drugs Historic Market Size by Application (2015-2020)3.3 Global Hormone Replacement Drugs Forecasted Market Size by Application (2021-2026)3.4 Menopause3.5 Hypothyroidism3.6 Growth Hormone Deficiency3.7 Male Hypogonadism3.8 Other Diseases

4 Global Hormone Replacement Drugs Competition Analysis by Players4.1 Global Hormone Replacement Drugs Market Size (Million US$) by Players (2015-2020)4.2 Global Top Manufacturers by Company Type (Tier 1, Tier 2 and Tier 3) (based on the Revenue in Hormone Replacement Drugs as of 2019)4.3 Date of Key Manufacturers Enter into Hormone Replacement Drugs Market4.4 Global Top Players Hormone Replacement Drugs Headquarters and Area Served4.5 Key Players Hormone Replacement Drugs Product Solution and Service4.6 Competitive Status4.6.1 Hormone Replacement Drugs Market Concentration Rate4.6.2 Mergers & Acquisitions, Expansion Plans

5 Company (Top Players) Profiles and Key Data5.1 Eli Lilly5.1.1 Eli Lilly Profile5.1.2 Eli Lilly Main Business and Companys Total Revenue5.1.3 Eli Lilly Products, Services and Solutions5.1.4 Eli Lilly Revenue (US$ Million) (2015-2020)5.1.5 Eli Lilly Recent Development and Reaction to Covid-195.2 Pfizer5.2.1 Pfizer Profile5.2.2 Pfizer Main Business and Companys Total Revenue5.2.3 Pfizer Products, Services and Solutions5.2.4 Pfizer Revenue (US$ Million) (2015-2020)5.2.5 Pfizer Recent Development and Reaction to Covid-195.3 AbbVie5.5.1 AbbVie Profile5.3.2 AbbVie Main Business and Companys Total Revenue5.3.3 AbbVie Products, Services and Solutions5.3.4 AbbVie Revenue (US$ Million) (2015-2020)5.3.5 Novo Nordisk Recent Development and Reaction to Covid-195.4 Novo Nordisk5.4.1 Novo Nordisk Profile5.4.2 Novo Nordisk Main Business and Companys Total Revenue5.4.3 Novo Nordisk Products, Services and Solutions5.4.4 Novo Nordisk Revenue (US$ Million) (2015-2020)5.4.5 Novo Nordisk Recent Development and Reaction to Covid-195.5 Merck KGaA5.5.1 Merck KGaA Profile5.5.2 Merck KGaA Main Business and Companys Total Revenue5.5.3 Merck KGaA Products, Services and Solutions5.5.4 Merck KGaA Revenue (US$ Million) (2015-2020)5.5.5 Merck KGaA Recent Development and Reaction to Covid-195.6 Mylan5.6.1 Mylan Profile5.6.2 Mylan Main Business and Companys Total Revenue5.6.3 Mylan Products, Services and Solutions5.6.4 Mylan Revenue (US$ Million) (2015-2020)5.6.5 Mylan Recent Development and Reaction to Covid-195.7 Bayer5.7.1 Bayer Profile5.7.2 Bayer Main Business and Companys Total Revenue5.7.3 Bayer Products, Services and Solutions5.7.4 Bayer Revenue (US$ Million) (2015-2020)5.7.5 Bayer Recent Development and Reaction to Covid-195.8 Teva5.8.1 Teva Profile5.8.2 Teva Main Business and Companys Total Revenue5.8.3 Teva Products, Services and Solutions5.8.4 Teva Revenue (US$ Million) (2015-2020)5.8.5 Teva Recent Development and Reaction to Covid-195.9 Novartis5.9.1 Novartis Profile5.9.2 Novartis Main Business and Companys Total Revenue5.9.3 Novartis Products, Services and Solutions5.9.4 Novartis Revenue (US$ Million) (2015-2020)5.9.5 Novartis Recent Development and Reaction to Covid-195.10 Abbott5.10.1 Abbott Profile5.10.2 Abbott Main Business and Companys Total Revenue5.10.3 Abbott Products, Services and Solutions5.10.4 Abbott Revenue (US$ Million) (2015-2020)5.10.5 Abbott Recent Development and Reaction to Covid-195.11 Roche5.11.1 Roche Profile5.11.2 Roche Main Business and Companys Total Revenue5.11.3 Roche Products, Services and Solutions5.11.4 Roche Revenue (US$ Million) (2015-2020)5.11.5 Roche Recent Development and Reaction to Covid-195.12 Endo International5.12.1 Endo International Profile5.12.2 Endo International Main Business and Companys Total Revenue5.12.3 Endo International Products, Services and Solutions5.12.4 Endo International Revenue (US$ Million) (2015-2020)5.12.5 Endo International Recent Development and Reaction to Covid-195.13 Ipsen5.13.1 Ipsen Profile5.13.2 Ipsen Main Business and Companys Total Revenue5.13.3 Ipsen Products, Services and Solutions5.13.4 Ipsen Revenue (US$ Million) (2015-2020)5.13.5 Ipsen Recent Development and Reaction to Covid-195.14 ANI Pharmaceuticals5.14.1 ANI Pharmaceuticals Profile5.14.2 ANI Pharmaceuticals Main Business and Companys Total Revenue5.14.3 ANI Pharmaceuticals Products, Services and Solutions5.14.4 ANI Pharmaceuticals Revenue (US$ Million) (2015-2020)5.14.5 ANI Pharmaceuticals Recent Development and Reaction to Covid-195.15 TherapeuticsMD5.15.1 TherapeuticsMD Profile5.15.2 TherapeuticsMD Main Business and Companys Total Revenue5.15.3 TherapeuticsMD Products, Services and Solutions5.15.4 TherapeuticsMD Revenue (US$ Million) (2015-2020)5.15.5 TherapeuticsMD Recent Development and Reaction to Covid-19

6 North America Hormone Replacement Drugs by Players and by Application6.1 North America Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)6.2 North America Hormone Replacement Drugs Market Size by Application (2015-2020)

7 Europe Hormone Replacement Drugs by Players and by Application7.1 Europe Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)7.2 Europe Hormone Replacement Drugs Market Size by Application (2015-2020)

8 China Hormone Replacement Drugs by Players and by Application8.1 China Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)8.2 China Hormone Replacement Drugs Market Size by Application (2015-2020)

9 Rest of Asia Pacific Hormone Replacement Drugs by Players and by Application9.1 Rest of Asia Pacific Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)9.2 Rest of Asia Pacific Hormone Replacement Drugs Market Size by Application (2015-2020)

10 Latin America Hormone Replacement Drugs by Players and by Application10.1 Latin America Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)10.2 Latin America Hormone Replacement Drugs Market Size by Application (2015-2020)

11 Middle East & Africa Hormone Replacement Drugs by Players and by Application11.1 Middle East & Africa Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)11.2 Middle East & Africa Hormone Replacement Drugs Market Size by Application (2015-2020)

12 Hormone Replacement Drugs Market Dynamics12.1 Covid-19 Impact: Industry Trends12.2 Covid-19 Impact: Market Drivers12.3 Covid-19 Impact: Market Challenges12.4 Porters Five Forces Analysis

13 Research Finding /Conclusion

14 Methodology and Data Source14.1 Methodology/Research Approach14.1.1 Research Programs/Design14.1.2 Market Size Estimation14.1.3 Market Breakdown and Data Triangulation14.2 Data Source14.2.1 Secondary Sources14.2.2 Primary Sources14.3 Disclaimer14.4 Author List

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Hormone Replacement Drugs Market Overview With Detailed Analysis, Competitive Landscape, Forecast to 2026|Eli Lilly, Pfizer, AbbVie - Eurowire