Category Archives: Hormone Replacement Therapy

Transgender youth tend to suffer from higher rates of anxiety, depression, self-harm, and thoughts of suicide than their peers. But a new study published in Pediatrics found that early gender-affirming care may have a direct, positive impact on mental health.

The study, which surveyed 300 transgender children aged between 10 and 17 years old at the Hospital for Sick Children in Toronto, Canada, found transgender youth who received transitionary care such as hormone blockers and hormone replacement therapy at earlier ages reported lower rates of depression, self-harm, and suicidal thoughts.

Researchers say this is likely because younger trans youth, defined by the study as being under 15 years old, have yet to go through puberty-induced bodily changes that can cause gender dysphoria, or the distress that occurs when one's body does not reflect the gender identity they are.

Getting gender-affirming care before puberty can slow or stop some of the changes that are more difficult to reverse like voice deepening, hair growth, and fat distribution.

"Our data add to the existing literature, suggesting that distress may be particularly profound among [trans youth] who present for care at older ages and with more advanced puberty," researchers wrote.

The researchers found that, among children under 15 who received gender-affirming medical care, 3o% reported depression, compared to 45% of those who received care later. They were also less likely to report suicidal ideations (40% compared to 52%), and less likely to have engaged in self-harm (28% compared to 40%).

Younger children who received care between the ages of 10 to 15, rather than over 15, were also far less likely to attempt suicide (9% did, compared to 17% of those who received care later).

The data underscore existing best medical practices that state transgender youth should receive transitionary care regardless of their age, as gender-affirming care can be the difference between life and death.

Donald Iain Smith/Getty Images

This study is not the first to link gender affirmation, whether it be medical or social, to better mental health outcomes for trans youth.

A PNAS study published in November 2019 found transgender children who were able to live as the gender they were rather than the gender they were assigned developed their gender identity, likes, and interests at the same time their cisgender peers did.

Another study published in Pediatrics in March 2016 found transgender children who were able to socially transition or live as the gender they are rather than the one they were assigned through pronouns, name, and gender presentation had lower rates of anxiety and depression later in life.

Children who were able to use their chosen name rather than the name they were assigned at birth as part of their transition had lower rates of suicidal ideations and attempted suicide than children who were not supported in their transition, according to a study published in the Journal of Adolescent Health in 2018.

The findings are especially significant in light of local state legislatures like South Dakota, Idaho, and Florida attempting to pass age restrictions that would make it illegal for doctors to provide gender-affirming care like HRT and hormone blockers to anyone under 18.

"Gender-affirming health care saves lives," Shawn Meerkamper and Dale Melchert, senior staff attorney and staff attorney for the Transgender Law Center who were not involved in the study, previously told Insider.

Read More:

South Dakota doctors who offer transgender kids hormone treatments and puberty blockers could face jail time if lawmakers pass a new bill

A Georgia lawmaker wants to make treatments for transgender kids a felony, but doctors say that could put lives at risk

Transgender kids aren't just 'going through a phase' and develop like their non-trans peers, researchers say

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I wasnt pregnant, overweight or too thin. I wasnt exercising too much or eating too little. From all appearances, I was a normal, healthy woman, but by the time I was in my mid-20s, I hadnt menstruated in four years.

My periods had never been regular, but I was accustomed to getting one at least three to four times a year. My doctors told me that I was a normal, healthy woman, at least in reproductive terms. But I was desperate to discover where my absent monthly visitor had gone, and why. My blood tests showed that my female sex hormonesestradiol and progesteronewere near menopausal levels, which put me at a risk for osteoporosis. I knew menopause could come early, but I was just 24.

To get answers, I turned to the internet late one Saturday night. Menopause, it told me, is the time when there have been no menstrual periods for 12 consecutive months, with no other biological or physiological cause identified. Using that definition as a guide, I was already in my fourth year of menopause, at least two decades early.

Most of my friends were well into their womanhood, seemingly in control of their regular periods and at the peak of their fertility. And then there was me. I wasnt a part of the menstruation camaraderie shared between many women. Instead, I identified more with women my mothers age.

Much of my early twenties was spent visiting doctors offices in search of answers. One doctor feared I had a tumor in my pituitary gland, a pea-sized organ in the brain that regulates vital body functions and general wellbeing. I was injected with a gadolinium-based contrast agent and had an MRI of my brain that, thankfully, came out negative. Another doctor misdiagnosed me with an underactive thyroid and prescribed thyroid medication. Even if that had been the problem, she also overmedicated me, throwing me into a fit of uncontrollable anxiety with equal parts impending doom, rapid heartbeat and shortness of breath. I lived in that state for several manic weeks.

My friends were well into their womanhood, seemingly in control of their regular periods. And then there was me. ... I identified more with women my mothers age.

It was hard to trust specialists after that experience, so I returned to my 62-year-old gynecologist, who had also been my mothers. (Technically, we had first met when he pulled me out of her.) I felt he was someone who would tell me the truth. Honey, relax, he told me. Theres no medical reason why you need to have a period. Most women would love to have your problem! While I pushed back against his supposed wisdom, he prepped me for an ultrasound.

Next thing I knew, I was lying on my back with my feet pressed against elevated, chilly metal stirrups. This will feel cold, an ultrasound technician said as she moved the wand around inside of me. Clenching my jaw and bunching the medical exam tissue paper beneath me, I did my best to relax. The technician, meanwhile, casually displayed my ovaries on a screen next to us.

I hoped the images of my insides would reveal the mystery of my missing periods. The technician used a digital ruler to measure many black ovals, some over an inch in size. She described them as a string of pearls. Confused, all I could do was make a joke: I didnt imagine my first set of pearls to look like this!

My doctor later looked at the images and my lab work and diagnosed me with Polycystic Ovarian Syndrome. Unlike most people who face a diagnosis with an odd acronym, PCOS was actually on my radar. My mother had suffered from it for decades. So why did it take years to figure out that I had the same thing? In part, it is because our symptoms are entirely different. For her, PCOS explained her extremely heavy periods that left her in crippling pain. But that had never been my problem.

I had so many questions for my doctors: How can my mom and I have the same diagnosis, but diametrically opposing experiences with menstruation? Is there any treatment? Is this the reason Ive been feeling so depressed and anxious? Will I be able to have kids one day?

While I finally had a diagnosis, it was oddly vague. It all left me wondering what, exactly, do I suffer from?

Instead of answering them, my doctor picked up his pen, scribbled some notes and sent me on my way with a prescription for anti-depressants and oral contraceptives. I had no history of clinical depression and in retrospect, the anxiety was probably from the sudden chaos inside me that the diagnoses triggered. As for the birth control pills, he said it was the only treatment for the newly diagnosed syndrome Id been living with for years.

Unsatisfied with his answers (or lack thereof), I emailed my general practitioner to express my concerns. While I was used to him speaking in terse, broken sentences, I expected a bit more guidance. If not sexually active, don't worry about periods for now, he wrote. Enjoy life and use condoms if needed. You should be doing that anyway. Not uncommon for periods to disappear from time to time. Don't lose any sleep over it.

But, of course, I lost a whole lot of it as I spent hours digging to the depths of the internet to research my condition each night. I discovered that there is no single test to definitively diagnose PCOS and there is no universally accepted definition. In fact, the diagnostic criteria have actually expanded in recent years, according to the American College of Obstetricians and Gynecologists. So, while I finally had a diagnosis, it was oddly vague. And because my symptoms were not as extreme as some of my fellow cysters, I felt a sense of shame amid my struggle. It all left me wondering what, exactly, do I suffer from?

Much to my dismay, this wasnt something Google could answer. Though I did learn that PCOS is one of the most common causes of female infertility, affecting five to 10 percent of women of childbearing age in the United States. Despite the syndromes prevalence, it is regarded as one of the most neglected public health issues. Women with PCOS are more prone to diabetes, sleep apnea, and heart disease, and three times more likely to get endometrial cancer.

Given the stakes, I couldnt believe physicians werent more attuned to the symptoms. I wasnt alone in that sentiment. Surveys show that women with the syndrome have a very high degree of dissatisfaction with their diagnostic experience. In a survey of 1,385 PCOS sufferers from 48 different countrieshalf from the United Statesresearchers at Monash University found that one in three women had suffered for more than two years before receiving a diagnosis. They also went to three or more medical providers with different specialties in the process.

Anti-depressants, metformin, spironolactone, herbal supplements, birth controlyou name it, I tried it. Despite having the correct diagnosis, I never received the right care. That was until my first gynecologist referred me to a reproductive endocrinologist, Sharon Winer.

Anti-depressants, metformin, spironolactone, herbal supplements, birth controlyou name it, I tried it. Despite having the correct diagnosis, I never received the right care.

Dr. Winer spent two hours looking over all my tests and writing down details of my saga. Most importantly, she helped me digest and understand medical terms in a way no other doctor had ever attempted. I learned that my body produced too much testosteronethe male sex hormoneand insulin, the hormone that manages our blood sugar levels. This, in conjunction with my low levels of estrogen, were likely the reason behind my missing period, weight gain and fatigue. I learned that insulin resistance is very much associated with PCOS, even though its not currently one of the diagnostic criteria.

Winer explained that birth control was not the right treatment for me because it was further suppressing my hormones by continuing to switch them off. After careful consideration, she prescribed me Hormone Replacement Therapy, known as HRT, to be taken cyclically to mimic a real menstrual cycle. This is a common menopause treatment, but in my case, the doctor hoped it would wake my endocrine system up and cause it to produce these hormones.

Two months later, I got my first period in four and a half years. It wasnt much, but in a way, it was everything. It proved to me that my body wasnt broken. I weaned off the hormones six months later, only to see my body working as it should. It was capable all along. It just needed the right guidance. I called my mom and we both cried.

After six years, three misdiagnoses, and countless ups and downs, I have finally found a way to manage my symptoms through medication, diet, and exerciseall without surrendering to a one-pill fix. Some people keep track of the miles they run every week, others count calories; for me, the anchor that defines whether Im in good health stems from the monthly rhythm of my menses.

Two years and three months later, I can safely say that tapping the add cycle button on my period tracker phone app never gets old.

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Global Hormone Replacement TherapyMarket report forecast 2020-2025 investigate the market size, manufactures, types, applications and key regions like North America, Europe, Asia Pacific, Central & South America and Middle East & Africa, focuses on the consumption of Hormone Replacement Therapy market in these regions. This report also covers the global Hormone Replacement Therapy market share, competition landscape, status share, growth rate, future trends, market drivers, opportunities and challenges, sales channels and distributors.

Global Hormone Replacement Therapy Market are mentioned in the competition landscape, company overview, financials, recent developments and long-term investments. Various parameters have been studied while estimating the market size. The revenue generated by the leading industry participants in the sales of the Hormone Replacement Therapy markethas been calculated through primary and secondary research.

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Top Key players profiled in the Hormone Replacement Therapy market report include:F. Hoffmann-La Roche, Merck Serono, Novartis, Novo Nordisk, Pfizer, Abbott Laboratories, ANI Pharmaceuticals, Bayer, Eli Lilly, Hisamitsu Pharmaceutical, Merck, Mylan Laboratories and More

Market Segment By Type:Estrogen replacement therapyGrowth hormone replacement therapyMarket Segment By Application:OralParenteralTransdermal

global Hormone Replacement Therapy market report also highlights key insights on the factors that drive the growth of the market as well as key challenges that are required to Hormone Replacement Therapy market growth in the projection period. Here provide the perspectives for the impact of COVID-19 from the long and short term. Hormone Replacement Therapy market contain the influence of the crisis on the industry chain, especially for marketing channels. Update the industry economic revitalization plan of the country-wise government.

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Years Considered to Estimate the Market Size:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year: 2020-2025

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Key point summary of the Global Hormone Replacement Therapy Market report:

Detailed TOC of Hormone Replacement Therapy Market Report 2020-2025:

1 COVID-19 Impact on Hormone Replacement Therapy Market Overview

1.1 Product Definition and Market Characteristics

1.2 Global Hormone Replacement Therapy Market Size

1.3 Hormone Replacement Therapy market Segmentation

1.4 Global Macroeconomic Analysis

1.5 SWOT Analysis

2 COVID-19 Impact on Hormone Replacement Therapy Market Dynamics

2.1 Hormone Replacement Therapy Market Drivers

2.2 Hormone Replacement Therapy Market Constraints and Challenges

2.3 Emerging Market Trends

2.4 Impact of COVID-19

2.4.1 Short-term Impact

2.4.2 Long-term Impact

3 Associated Industry Assessment

3.1 Supply Chain Analysis

3.2 Industry Active Participants

3.2.1 Suppliers of Raw Materials

3.2.2 Key Distributors/Retailers

3.3 Alternative Analysis

3.4 The Impact of Covid-19 From the Perspective of Industry Chain

4 Hormone Replacement Therapy Market Competitive Landscape

4.1 Industry Leading Players

4.2 Industry News

4.2.1 Key Product Launch News

4.2.2 M&A and Expansion Plans

5 Analysis of Leading Companies

5.1 Company A

5.1. Company Profile

5.1.2 Business Overview

5.1.3 Hormone Replacement Therapy market Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)

5.1.4 Hormone Replacement Therapy market Products Introduction

5.2 Company B

5.2.1 Company Profile

5.2.2 Business Overview

5.2.3 Hormone Replacement Therapy market Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)

5.2.4 Hormone Replacement Therapy market Products Introduction

6 Hormone Replacement Therapy Market Analysis and Forecast, By Product Types

6.1 Global Hormone Replacement Therapy Market Sales, Revenue and Market Share by Types (2015-2020)

6.2 Global Hormone Replacement Therapy Market Forecast by Types (2020-2025)

6.3 Global Hormone Replacement Therapy Market Sales, Price and Growth Rate by Types (2015-2020)

6.4 Global Hormone Replacement Therapy Market Revenue and Sales Forecast, by Types (2020-2025)

7 Hormone Replacement Therapy Market Analysis and Forecast, By Applications

7.1 Global Hormone Replacement Therapy Market Sales, Revenue and Market Share by Applications (2015-2020)

7.2 Global Hormone Replacement Therapy Market Forecast by Applications (2020-2025)

7.3 Global Hormone Replacement Therapy Market Revenue, Sales and Growth Rate by Applications (2015-2020)

7.4 Global Hormone Replacement Therapy Market Revenue and Sales Forecast, by Applications (2020-2025)

Continued

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Hormone Replacement Therapy Market share forecast to witness considerable growth from 2020 to 2025 | By Top Leading Vendors F. Hoffmann-La Roche,...

Pune, Sept. 29, 2020 (GLOBE NEWSWIRE) -- The global genomics market size is projected to reach USD 82.60 billion by the end of 2027. The massive investments in the research and development of efficient products will have a massive impact on the growth of the market in the coming years.

According to a report published by Fortune Business Insights, titled Genomics Market Size, Share & COVID-19 Impact Analysis, By Type (Products (Instruments & Software and Consumables) and Services), By Technology (Polymerase Chain Reaction (PCR), Next Generation Sequencing (NGS), Microarray, Sanger Sequencing, and Others), By Application (Diagnostics, Research, and Others), By End User (Research Institutes, Healthcare Facilities & Diagnostic Centers, Pharmaceutical & Biotechnological Companies, Contract Research Organization (CROs)), and Regional Forecast, 2020-2027, the market was worth USD 18.85 billion in 2019 and will exhibit a CAGR of 19.5% during the forecast period 2020-2027.

Genomics is a concept that involves the human gene and sequencing for treatment and study of several diseases or potential diseases. The study of human genetics helps identify and track critical diseases, with equal focus on the qualities and behaviour of a specific individual. In the past few years, genomics has contributed to the growth of numerous similar branches including the popular precision medicine.

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The massive investments in the research and development of genomics and genomic sequencing will have a positive impact on the growth of the overall market in the coming years. The presence of several large scale companies has had a massive impact on the growth of the market in recent years and the influx of start-ups will create opportunities for growth in the foreseeable future.

Recent Clinical Studies have Indicated the Potential of Genomics to Tracking Patterns of Covid-19 Spread

The recent coronavirus outbreak has created a sense of panic among businesses across the world. Although healthcare industry has witnessed a contrasting impact, as compared to a few other sectors, there has been a recent surge in the need for healthcare professionals. The lack of skilled labour is consequential to the hesitancy among workers due to the severity of the disease. Although there are several ongoing research activities associated with the treatment of the coronavirus, there has been little success in this field.

Accounting to increasing cases of Covid-19 across the world, researchers are focusing on implementing preventive and precautionary measures through newer concepts. The excessive research associated with the use of genomics in Covid-19 pandemic has yielded a few successful measures. As a result, genomics has recently attracted attention from across the world.

The whole world is fighting the novel coronavirus. Sectors and industries are devasted due to the major loss caused by COVID-19 in business. The authorities of several countries have initiated lockdown to prevent the spread of this deadly virus. Such plans have caused disturbances in the production and supply chain. But, with time and resolution, we will be able to combat this stern time and get back to normality. Our well-revised reports will help companies to receive in-depth information about the present scenario of every market so that you can adopt the necessary strategies accordingly.

To get to know more about the short-term and long-term impacts of COVID-19 on this market, please visit: https://www.fortunebusinessinsights.com/industry-reports/genomics-market-100941

Constant Product Innovations are Consequential to Increasing R&D Efforts

The report encompasses several factors that have contributed to the growth of the overall market in recent years. Among all factors, the increasing number of product innovations, driven by rising investments in the research and development of the product, has made the highest impact on the growth of the market. In April 2020, Eurofins announced the launch of a new product in the genome sequencing space.

The company introduced SARS-CoV 2 full length genome sequencing, a product that is categorized under the next-generation (NGS) sequencing category. Increasing number of such product innovations will have a positive impact on the growth of the overall market in the coming years.

North America to Emerge Dominant; Increasing Activities associated with Whole-genome Sequencing will Emerge in Favor of Market Growth

The report analyses the ongoing market trends across five major regions, including North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. Among all regions, the market in North America is projected to emerge dominant in the coming years. The increasing research activities associated with whole-genome sequencing by private companies as well as government organizations will contribute to the growth of the regional market.

As of 2019, the market in North America was worth USD 8.27 billion and this value is projected to rise at a considerable pace in the coming years. The market in Asia Pacific will derive growth form the efforts put in towards genetic sequencing by countries such as China.

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List of companies profiled in the Genomics Market report:

Industry Developments:

February 2020: Nebula Genomic announced the launch of a new product that will offer whole genome sequencing at US$ 299 to its customers.

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Have a Look at Related Reports:

Next-Generation Sequencing (NGS) Market Share and Global Trend By Type (Products, Instruments & Software, Consumables, Services), By Application (Diagnostics, Research), By End User (Research Institutes, Healthcare Facilities & Diagnostic Centres, Pharmaceutical & Biotechnological Companies, Contract Research Organization) & Geography Forecast till 2026

Molecular Diagnostics Market Share and Global Trend By Product Type (Instruments Reagents & Consumables), Application (Infectious Disease, Blood Screening, Histology & Oncology), Technique (Hospitals Amplification, Hybridization & Sequencing Techniques), End User (Hospitals, Clinical & Pathology Labs) and Geography Forecast till 2025

Polymerase Chain Reaction (PCR) Market Share & Industry Analysis, By Type (Standard PCR, Real-time PCR, and Digital PCR), By Product (Instruments and Reagents & Consumables), By Indication (Infectious Diseases, Oncology, Genetic Disorders, and Others), By End User (Hospitals & Clinics, Pharmaceutical & Biotechnology Industries, Diagnostic Centers, and Academic & Research Organizations), and Regional Forecast, 2019-2026

Hormone Replacement Therapy (HRT) Market Share & Industry Analysis, By Therapy Type (Estrogen and Combinations Replacement Therapy, Growth Hormone Replacement Therapy, Thyroid Hormone Replacement Therapy), By Indication (Menopause, Hypothyroidism, Male Hypogonadism, and Growth Hormone Deficiency), By Route of Administration (Oral, Transdermal, and Parenteral), By Distribution Channel (Hospital Pharmacies), and Regional Forecast, 2019-2026

Heart Valves Market Share & Industry Analysis, By Product Type (Replacement (Aortic, Mitral, and Others), and Repair), By Valve Type (Tissue Valve and Mechanical Valve), By Procedure (Surgical and Transcatheter), By End User (Hospitals, and Specialty Clinics & Others), and Regional Forecast, 2019-2026

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Genomics Market to Rise at 19.5% CAGR and Reach USD 82.60 Billion by 2027; Advances in Diagnostic Applications will Lead to a Wider Product Adoption,...

Contrary to prior understanding, many hormones related to spermatogenesis take longer to recover than previously thought, and up to 3 years in some cases after anabolic steroid misuse, according to a fertility expert speaking at the Royal Society of Medicine webinar series.

Dr Channa Jayasena, consultant in reproductive endocrinology and andrology at Imperial College and Hammersmith Hospital, London, gave a talk on male hypogonadism that he admitted might seem provocative to some people but addresses issues that extend current knowledge. The three key issues discussed were: how quickly can men recover fertility after androgen use; how to assist azoospermic men with Klinefelter syndrome (or XXY) father children; and whether testosterone therapy affects progression to diabetes in obese men.

Dr Jayasena spoke at last weeks 3-day webinar held by the Royal Society of Medicine, Endocrinology and Diabetes section, entitled, EDN50:What's new in endocrinology and diabetes 2020?

He began by asking how quicky do men who take anabolic steroids recover fertility? "This has never been studied to much extent."

Self-confessed steroid user and reality television star, Spencer Matthews, said in a tabloid newspaper article that the UK is in the grips of an epidemic of anabolic steroid use, Dr Jayasena remarked. "I see men who take anabolic steroids but then they want a baby and want to know whats next?"

The nearest data to understanding recovery from anabolic steroids comes from studies of the male pill, said the andrologist. This involves giving a high level of progesterone to suppress luteinising hormone and follicle stimulating hormone (in effect the male pill), and then giving the men testosterone replacement. A Lancet paper (Liu at al 2006) involving this regimen looked at the time from stopping the male pill to recovery of sperm. It shows that, by 12 months, all participants had recovered some sperm function, with 80% recovering to the pre-treatment semen level, explained Dr Jayasena. "This has long been presumed to be the measure of recovery. However, this does not resonate with reality and the observation that actually there are many people who dont recover within this time frame and take a lot longer, some with azoospermia[semen containing no sperm]," he pointed out.

Another cross-sectional observational study looked at 41 current users of anabolic steroids, 31 recent ( 3 months since last use), and 21 healthy eugonadal men. All were 18-55 years, exercising at least three times a week. "The critical strength of this study is that these men were all clinically indistinct," Dr Jayasena remarked. "This matching of baseline characteristics is critical for interpretation of the data. Due to recruitment issues, weve never had such a good look at recovery in this way before."

The study looked at the reproductive endocrine profiles including the levels of luteinising hormone, follicle stimulating hormone, and testosterone. In current users, the former two were suppressed and the testosterone level was high, as expected, displaying a hypogonadatropic profile. "Past users and non-users have very similar profiles, suggesting reversible luteinising hormone and follicle stimulating hormone suppression," said Dr Jayasena, adding, "this is really interesting and looking at acne, gynaecomastia, hair loss and smaller testicles all classical features of androgen abuse - appear to persist in many of the men who are past users. Its important we counsel these men that we, the clinicians, are not really clear about how long these side effects will persist."

Results also showed low HDL cholesterol and high triglycerides in users, but not in non-users or past users, and cardiac hypertrophy in users but not past users. "The latter finding is encouraging," Dr Jayasena pointed out.

Regarding fertility, the study by Shankara-Naranya found that when comparing non-users to users of anabolic steroids, it took a mean of 10.7 months for users to recover their luteinising hormone levels to the mean luteinising hormone of a non-user. "But recovery time is highly variable. Luteinising hormone (and testosterone by inference), and sperm concentration seem to recover within a year, with a mean of 10 months, but all the other hormones that are important for spermatogenesis take much longer to recover so follicle stimulating hormone was 20 months, inhibin B was 32 months, sperm motility was 38 months, up to 3 years to recover. This is critical and we didnt know this," reported Dr Jaysena.

"In answer to what is the prognosis for recovery in men after androgen misuse? The endocrine system mostly recovers in the first year but sperm take much longer to recover," he concluded.

Along with Downs syndrome, Klinefelter is the most common chromosomal disorder in men, affecting 1 in 500 men. A total of 90% of those with Klinefelter syndrome are azoospermic, and it has long been assumed to be incompatible with fatherhood.

"Things have changed, and Id like to ask what is the chance of fatherhood for a man with XXY undergoing microdissection testicular sperm extraction (mTESE)?" said Dr Jayasena. "This can be done by dissecting open a testicle and looking for an engorged seminiferous tubule that is likely to be full of sperm," he explained. "If this is confirmed, after some processing, the sperm can be used in intracytoplasmicsperm injection (ICSI)."

It has been known that it was possible for patients with Klinefelter syndrome to father children for the past 20 years, but, asked Dr Jayasena, how successful is it? "Its still an embryonic field," he noted. Referring to a meta-analysis of 37 studies, Dr Jayasena said 40% of men with Klinefelters syndrome had sperm retrieved, and of these 40%, an average of nearly 50% of men had live births after ICSI. But some studies reported 10% and others 90%.

In conclusion, the chances of fatherhood in XXY men undergoing mTESE, is around 20% but a large randomised controlled trial (RCT) is needed to confirm this, said Dr Jayasena.

Finally, the researcher moved on to the third topic of whether testosterone therapy improves the effectiveness of weight loss in men over 50 years with type 2 diabetes. Referring to outcomes of the largest, as yet unpublished, testosterone trial ever, in more than 1000 men by Dr Gary Wittert, from the University of Adelaide, Dr Jayasena described the study.

Most importantly, they did not select men with hypogonadism these results are not valid for hypogonadism because not all men had hypogonadism, explained Dr Jayasena. Two-hour plasma glucose was 7.8 to 15 mmol/l. The men were randomised to Weight Watchers weight loss programme plus placebo versus the same weight loss programme plus testosterone. They also excluded men with high cardiovascular risk, due to a Food and Drug Administration [FDA] unproven concern about cardiovascular risk. "Testosterone may be dangerous in some of these men (59-75 years and obese) in real life," he pointed out.

The paper is currently in review but some preliminary findings were presented at a conference earlier this year. Dr Jayasena says: "If testosterone improves the prevention of type 2 diabetes during weight loss in men without hypogonadism, then that would challenge our understanding of how it works. However, testosterone is still not a treatment to prevent type 2 diabetes,"

To answer the question definitively, said Dr Jayasena, confirmatory data, mechanistic data, and safety data are needed.

COI: Dr Jayasena received an honorarium for speaking during a debate organised by the Society for Endocrinology and sponsored by Besins Healthcare. He has an investigator-led grant by Logixx Pharma Ltd.

Presented at the Royal Society of Medicine, Endocrinology and Diabetes section, entitled, EDN50: What's new in endocrinology and diabetes 2020? , Day 3. September 23, 2020

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Ovarian cancer progression can be controlled if diagnosed early. Symptoms of ovarian cancer should not be ignored. Here's everything you need to know about ovarian cancer diagnosis.

Ovarian cancer: Family history of ovarian cancer can increase your risk

Women have to deal with a complete set of gynaecological cancers unique to their biology. These include cancers of the female reproductive system namely the uterus, cervix and ovaries. Ovarian cancer is the 5th most common cause of cancer deaths in women globally. It also has the highest death rate among all gynaecological cancer. There are various risk factors for ovarian cancer, some of the important ones include family history, 65 years of age, early onset menstrual cycle, late menopause, infertility, obesity, women on hormone replacement therapy and those who have breast care or are above the age of 65 years.

Signs and symptoms of ovarian cancer are frequently absent or very subtle in the early stages. Hence, most women are diagnosed with cancer only at a later stage.

Ovarian cancer may lead to abdominal swellingPhoto Credit: iStock

1. CA-125 is a screening and monitoring test. It should be noted that CA-125 may also be elevated in cancers of pancreas, breast, bladder, lung and in benign conditions like menstruation, pregnancy, fibroids, ovarian cysts, pelvic inflammation and endometriosis. Levels of CA 125 are high in about 85% women with ovarian cancer. If the CA125 value is greater than 200 u/ml and 35 u/ml in premenopausal and postmenopausal women respectively, then the likelihood of the disease is unlikely. CA125 is usually combined with transvaginal sonography or rectovaginal pelvic examination for a more accurate diagnosis.

Also read:How Is Ovarian Cancer Diagnosed? Everything You Need To Know

2. ROMA index: Risk of ovarian malignancy algorithm

It is the most promising marker for ovarian cancer. The ROMA score can be used by a healthcare practitioner prior to surgery to help determine whether a lump in the pelvis (pelvic mass) is likely to be malignant or not. The test is not intended to be used for screening. The test assigns a risk value that is numerical basis the below parameters

A change in HE4 level of less than or equal to 25% is considered significant. Elevated HE4 levels are associated with ovarian cancer but are not disease-specific. It can also rise in healthy women with hypertension and non-cancerous gynaecological diseases.

ROMA is applied for women who meet the following criteria:

The ROMA assessment is to be interpreted in conjunction with clinical and radiological assessment.

3. CA-72.4: It is elevated in cancer of pancreas, stomach, gall bladder, colon, ovaries, cervix and endometrium. It is an independent marker for the therapeutic monitoring and follow up care of ovarian patients and in particular CA125 negative patients.

4 CEA: It is a non-specific marker which is increased in ovarian tumours, along with tumours of lung, breast, and liver.

Also read:Ovarian Cancer Is Deadly, But New Tests, Treatments Start To Emerge

5. Peritoneal wash and histopathological examination of ovarian cancer: Examination of fluid collected in abdominal cavity to look for tumour cells, histopathological examination of tumour mass and immunohistochemistry for staging and grading of tumour for appropriate therapy.

6. NGS for hereditary breast and ovarian cancer syndrome (HBOC):

The syndrome is characterised by early onset cancers of breast, ovary and other organs like pancreas, prostate, melanomas. It is associated with over 2600 mutations in BRCA 1 and 2 genes. It is helpful in early detection and screening of family members of affected individuals, early clinical intervention, and benefits of certain specific treatment modalities. Pre and post-test genetic counselling are very important before and after BRCA analysis.

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(Dr. Kirti Chadha isHistopathologist/Surgical Pathologist andSenior Vice President, Medical Affairs, Metropolis)

Disclaimer: The opinions expressed within this article are the personal opinions of the author. NDTV is not responsible for the accuracy, completeness, suitability, or validity of any information on this article. All information is provided on an as-is basis. The information, facts or opinions appearing in the article do not reflect the views of NDTV and NDTV does not assume any responsibility or liability for the same.

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Everything You Need To Know About Ovarian Cancer Diagnosis - NDTV Doctor

The presented market report on the global Hormone Replacement Therapy market published by Fact.MR is a comprehensive analysis of the leading parameters that are likely to determine the growth of the Hormone Replacement Therapy market in the forthcoming decade. Further, the study dives in deep to investigate the micro and macro-economic factors that are projected to influence the global scenario of the Hormone Replacement Therapy market during the forecast period (2019-2029).

The market study reveals that the Hormone Replacement Therapy market is expected to grow at a CAGR of ~XX% and reach a value of ~USXX by the end of 2029. The report examines the current trends, growth opportunities, restraints, and market drivers that are projected to influence the overall dynamics of the Hormone Replacement Therapy market in the assessment period. The market study predicts the course of the global Hormone Replacement Therapy market post the COVID-19 pandemic and offers resourceful insights to market players pertaining to their business continuity strategies and more.

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Hormone Replacement Therapy Market Segmentation

The report bifurcates the Hormone Replacement Therapy market into multiple segments to provide a clear picture of the Hormone Replacement Therapy market at a granular level. The key segments covered in the report include region, product type, application, and more.

Competitive Landscape

The report on hormone replacement therapy market offers intelligence on key participants in the hormone replacement therapy market. The key companies involved in the formulation of hormone replacement therapy products are thoroughly assessed and profiled in the report. Various facets of competition including SWOT analysis, product portfolio analysis, drug developments and innovations, strategies and key financials are covered. Key companies profiled in the report include Novartis AG, Novo Nordisk A/S, Teva Pharmaceuticals, Mylan N.V and Pfizer Inc.

Major companies in the hormone replacement therapy market are concentrating on expanding their current product portfolio. New hormone replacement therapy formulations being the core focus, companies are carrying out trials and gain FDA approvals. For instance, Novartis AGs research and development department delivered 6 critical FDA breakthrough therapy designations and 16 submissions in 2017. In May 2017, Novartis AG announced U.S. FDAs approval for its hormone replacement therapy tablets for hormone receptor positive and metastatic breast cancer treatment in postmenopausal women.

In February 2018, Novo Nordisk A/S concluded main phase of REAL 1 the pivotal phase 3 trial along with somapacitan, a long-acting growth hormone to treat adults with growth hormone deficiency.

Teva Pharmaceuticals Industries Ltd. introduced Vagifem in 2017 for the treatment of atrophic vaginitis. In January 2018, the company launched Estrace cream to treat moderate and severe symptoms of vaginal and vulgar atrophy occurring due to menopause. Likewise, Mylan N.V expanded its US portfolio in the womens healthcare range with U.S. FDA approval for Estradiol Vaginal Cream to treat vaginal atrophy.

Private equity firms are focused on acquiring emerging participants that are involved in drug delivery systems in the hormone replacement therapy space. For instance, Riverside Company has acquired DoseLogix in a bid to provide innovative dosing dispensers for ensuring accurate dosing medications of hormone replacement therapy and other conditions.

Click to know more on competitive scenario in the hormone replacement therapy market to understand key strategies of market participants

Definition

Hormone replacement therapy, also referred to as menopausal hormone therapy, is used to treat various symptoms related to menopause among women. Hormone replacement therapy replaces hormones that are low in level as women near menopause. There are various types of hormone replacement therapy such as estrogen hormone replacement therapy, thyroid hormone replacement therapy and growth hormone replacement therapy.

About the Report

The report on hormone replacement therapy market provides incisive insights on all aspects influencing growth in demand for hormone replacement therapy worldwide. The report provides a thorough analysis on demand of hormone replacement therapy across key regions in the globe along with sales of various hormone replacement therapy products.

Key drivers, challenges, trends and opportunities shaping the growth of the hormone replacement therapy market are also covered in the hormone replacement therapy market report. The hormone replacement therapy market report provides historical data assessment on use of hormone replacement therapy, current hormone replacement therapy scenario and future demand of hormone replacement therapy. The forecast projections provided cover a timeline of 10 years (2018-2028).

Market Structure

The hormone replacement therapy market is segmented in detail to cover every angle of the hormone replacement therapy space. The hormone replacement therapy market has been segmented on the basis of product type, by dosage form, by indication, by distribution channel and by region.

Various hormone replacement therapy products such as estrogen hormone replacement therapy, thyroid hormone replacement therapy and growth hormone replacement therapy is covered. By dosage form, hormone replacement therapy market is segmented into tablets, patches, injections, implants and creams. By indications, hormone replacement therapy market is categorized into menopause, osteoporosis, thyroid and growth hormone deficiency. By distribution channel, it is segmented by hospital pharmacies, clinics, retail pharmacies and online pharmacies.

The hormone replacement therapy market is assessed across key regions such as North America, Latin America, Europe, Asia Pacific excluding Japan (APEJ), Middle East and Africa (MEA) and Japan.

Additional Questions Answered

Apart from key findings mentioned above, the hormone replacement therapy market report also answers additional questions such as:

Research Methodology

The hormone replacement therapy market is drafted using a unique research methodology comprising of a combination of secondary and primary research methodologies. The data gleaned from primary and secondary research is assessed along with information from external sources. All the statistics are compiled using triangulation method to gain highly accurate projections on hormone replacement therapy market.

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The growth projection of each of these segments and sub-segments is accurately tracked in the report along with east-to-understand graphs and tables. Further, the market share, size, value, and Y-o-Y growth of the Hormone Replacement Therapy market segments are included in the report.

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Essential Takeaways from the Hormone Replacement Therapy Market Report

Important queries related to the Hormone Replacement Therapy market addressed in the report:

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Hormone Replacement Therapy Market Progresses for Huge Profits During 2018 to 2028 - The Daily Chronicle

Keith Roach, To Your Health Published 8:25 p.m. ET Sept. 13, 2020

Dear Dr. Roach: If women are prescribed a hormone replacement for hot flashes, do the hot flashes return once the medicine is discontinued. If you take hormone replacement therapy, are you just delaying the symptoms for a while and will have to deal with hot flashes either way?

C.H.

Dear C.H.: Hot flashes are a common symptom when women go into menopause -- 60% to 80% of women will experience them. About half of women will stop having hot flashes after about five years. The remainder will have a longer duration. A third of women will still experience them after 10 years, and in about 10%, they continue for 20 or more years after menopause.

Dr. Keith Roach(Photo: Reed Brennan)

The most effective treatment is hormone replacement therapy -- specifically, estrogen. But estrogen should not be given without a progestin in women who have a uterus, i.e., those who have not had a hysterectomy. HRT neither shortens nor lengthens the duration of symptoms. If a woman was destined to have hot flashes for seven years, and takes HRT for five years with relief, she will still have two more years of hot flashes.

Although women are generally not treated with HRT for longer than five years, some choose to continue treatment longer, even knowing that HRT increases risk of blood clotting and may increase risk of breast cancer and heart disease. The degree of risk is debated and likely depends on many factors.

Dear Dr. Roach: I am a 63-year-old female who has suffered with Epstein-Barr virus twice in the past two years. My understanding is that for many people, this virus lies dormant until a trigger, such as stress, causes it to emerge.

My symptoms consisted of fever, extreme exhaustion and weakness. After three weeks, I am slowly feeling better. I never want to feel like this again! Aside from maintaining a healthy diet, exercising and stressing less, do you have any suggestions as to how I can stay symptom-free in the future?

R.K.

Dear R.K.: Epstein-Barr virus is the classic cause of infectious mononucleosis, which is a common condition in children and adolescents. Its symptoms of early fever followed by days or weeks of fatigue are nonspecific. Other viruses and even a parasite can cause a similar symptoms. Blood testing can confirm the diagnosis.

EBV is in the herpes family, and like all herpesviruses, it does lay dormant in the body. Unlike herpes simplex or varicella-zoster, it is very unlikely to recur. It is very rare to get mononucleosis from EBV more than once, although it happens occasionally if the immune system is severely depleted, such as in advanced HIV. It is almost unheard-of to get it at age 63.

Blood test results for EBV can be misinterpreted. If you ever had EBV -- say, in childhood -- you will have a positive antibody test for the IgG antibodies. Active infection stimulates the IgM antibodies. I suspect you may have had the IgG antibodies that were misinterpreted as active infection. If you really had recurrent EBV with positive IgM antibodies (or other, more precise tests of viral activity), then a visit with an immunologist and an infectious disease specialist is wise.

Your own advice -- healthy diet, regular exercise, decreasing stress -- are all good, commonsense ways of improving your immune system. I would add regular sleep to the list, and unless you really have had active EBV, which would surprise me, you shouldnt need more than that.

Readers may email questions to ToYourGoodHealth@med.cornell.edu

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Dr. Roach: Does HRT affect the duration of hot flashes? - The Detroit News

Study on the Global Hormone Replacement Therapy Market

Fact.MR, recently published a market study which indicates that the global Hormone Replacement Therapy market is anticipated to grow at a CAGR of ~XX% during the forecast period (2018-2028). The growth of the Hormone Replacement Therapy market is predominantly driven by rising demand for Hormone Replacement Therapy from multiple end-use industries.

Due to the pandemic, we have remembered an uncommon segment for the Impact of COVID 19 on the Scientific Research Satellites Services Market which would make reference to How the Covid-19 is influencing the Market Trends and Potential Opportunities in the COVID-19 Landscape, Covid-19 Impact on Key Regions and Proposal for Hormone Replacement Therapy Market Players to Combat Covid-19 Impact.

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The presented study addresses the following queries related to the Hormone Replacement Therapy market:

Competitive Landscape

The presented market report dives deep into understanding the business strategies adopted by leading market players in the global Hormone Replacement Therapy market. Further, the SWOT analysis for leading market players is enclosed in the report along with the revenue share, pricing analysis, and product overview of each company.

Detailed profiles of the providers are also included in the scope of the report to evaluate their long-term and short-term strategies, product portfolio of Hormone Replacement Therapy manufacturers, and recent developments in the Hormone Replacement Therapy market space. Some of the key players analyzed are:

Global Hormone Replacement Therapy Market By Product

Global Hormone Replacement Therapy Market By End Use

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Global Hormone Replacement Therapy Market By Region

The data scrutiny for the global Hormone Replacement Therapy market is estimated in terms of value and volume consumption. To arrive at the volume consumption of Hormone Replacement Therapy, production data of countries producing raw materials across the globe has been taken into consideration. In addition, the production of application of Hormone Replacement Therapy in top producing countries is also tracked for benchmarking purposes. Furthermore, Fact.MR estimated volume data on the consumption of Hormone Replacement Therapy for several countries by understanding the demand and supply of Hormone Replacement Therapy. It includes production, growth, volume and value sales, transition, pricing, population, consumer preference, and consumption of Hormone Replacement Therapy among end user verticals.

Fact.MR then determined the volume consumption of Hormone Replacement Therapy across various regions such as North America, Latin America, Europe, Asia Pacific, and Middle East and Africa. Forecasting is done on an internal proprietary model using different macro-economic, industry-based demand driving factors impacting the market and its forecast trends, by identifying and allocating a weighted score to the forecast factors that influence the demand for Hormone Replacement Therapy. These factors were the representative of an entire value chain, as well as macro-economic indicators such as production have been taken into consideration to arrive at the volume consumption of Hormone Replacement Therapy in respective countries.

The weighted average selling price for Hormone Replacement Therapy was considered to estimate the market size for top Hormone Replacement Therapy consuming countries. These prices were captured in their respective countries, and then converted into USD to offer forecasts in one consistent currency standard.

Given the characteristics of the market, Fact.MR triangulated the data based on supply side, demand side, and dynamics of the global Hormone Replacement Therapy market. To develop the global Hormone Replacement Therapy market forecast, Fact.MR analyzed various factors to understand their respective impact on the target market. However, quantifying the market across the abovementioned segments is more a matter of quantifying expectations and identifying opportunities rather than rationalizing them after the forecast has been completed.

It is imperative to note that, in an ever-fluctuating economy, we not only provide forecasts in terms of CAGR but also analyze on the basis of key parameters, such as year-on-year (Y-o-Y) growth, to understand the predictability of the market and identify the right opportunities.

Another key feature of this report is the analysis of the global Hormone Replacement Therapy market and the corresponding revenue forecast in terms of absolute dollar opportunity. This is usually overlooked while forecasting the market. However, absolute dollar opportunity is critical in assessing the level of opportunity that a provider can look to achieve, as well as to identify potential resources from a sales perspective in the global Hormone Replacement Therapy market.

To understand key segments in terms of their growth and performance in the global Hormone Replacement Therapy market, Transparency Market Research has also presented a market attractiveness index. The resulting index should help providers identify existing market opportunities in the global Hormone Replacement Therapy market.

The report covers an in-depth analysis of all components of the value chain in the global Hormone Replacement Therapy market. In the final section of the report on the global Hormone Replacement Therapy market, a competitive landscape is included to provide a dashboard view of global Hormone Replacement Therapy manufacturers.

Regional Assessment

The extensive study on the Hormone Replacement Therapy market pinpoints the different factors that are likely to influence the prospects of the Hormone Replacement Therapy market in each region. The different regions covered in the report include:

Application Analysis

The report offers crucial insights related to the various applications of the Hormone Replacement Therapy along with the Year-on-Year growth analysis of each application.

Decisive Information Enclosed in the report:

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Assessing the COVID-19 Effect: Hormone Replacement Therapy Production Moderately Disrupted by Labor Shortages of Labor in Pandemic, Says Fact.MR - The...

ROCKLAND, Mass. and NEW YORK, Sept. 18, 2020 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced the publication of detailed results from the Phase III JAVELIN Bladder 100 study online ahead of print in The New England Journal of Medicine. These results were published simultaneously with additional analyses being presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 and describe the efficacy of BAVENCIO(avelumab) as a first-line maintenance treatment across various subgroups of patients with locally advanced or metastatic urothelial carcinoma (UC) and highlight exploratory biomarkers as well as patient-reported outcomes. In June, the US Food and Drug Administration (FDA) approved BAVENCIO for the maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy based on the JAVELIN Bladder 100 results.

In the JAVELIN Bladder 100 study, BAVENCIO plus best supportive care (BSC) significantly extended overall survival (OS) compared with BSC alone in the two primary populations of all randomized patients and patients whose tumors were PD-L1+, and significantly more patients who received BAVENCIO as first-line maintenance were alive at one year.1 The clinical benefits of BAVENCIO were seen across a range of patient populations.1,2

"These data, which supported the recent FDA approval and updates to NCCN and ESMO guidelines, establish that BAVENCIO first-line maintenance treatment could fundamentally change clinical practice for the treatment of patients with locally advanced or metastatic urothelial carcinoma," said Thomas Powles, MBBS, MRCP, MD, Professor of Genitourinary Oncology, Lead for Solid Tumour Research at Barts Cancer Institute, Queen Mary University of London, and Director of Barts Cancer Centre, London, UK. "It is notable that the longer overall survival with BAVENCIO maintenance therapy was observed across all pre-specified subgroups examined and that this prolonged overall survival was gained without a detrimental impact on patients' quality of life."

Primary AnalysisIn the JAVELIN Bladder 100 study, OS was significantly longer with BAVENCIO plus BSC compared to BSC alone in the primary population of all randomized patients (n=700) whose disease had not progressed on first-line platinum-containing chemotherapy:

In the other primary population of patients with PD-L1+ tumors (n=358):

All endpoints were measured from the time of randomization, after completion of four to six cycles of chemotherapy.

Subgroup AnalysisResults of an exploratory subgroup analysis show that consistent results were observed with the JAVELIN Bladder regimen of BAVENCIO first-line maintenance across pre-specified subgroups, including best response to first-line chemotherapy, type of chemotherapy regimen, site of baseline metastasis, and other baseline factors.1 In particular, hazard ratios for OS based on response to first-line chemotherapy were as follows:

With regard to first-line chemotherapy regimen, hazard ratios were as follows:

Further detail from the subgroup analysis were presented in an on-demand mini oral session at the meeting (Presentation #704MO). Additional data evaluating the association between clinical outcomes and exploratory biomarkers will be presented in the Proffered Paper 1 - GU, non prostate session on Saturday, September 19 (Presentation #699O), and patient-reported outcomes are featured in an on-demand e-poster display (Presentation #745P).

Safety No new safety signals were identified in the JAVELIN Bladder 100 study, and the safety profile was consistent with previous studies of BAVENCIO monotherapy.1 Treatment-related adverse events of grade 3 or higher occurred in 57 patients (16.6%) treated with BAVENCIO plus BSC; no grade 3 or higher treatment-related events occurred in the control arm.1 No grade 4 or fatal immune-related adverse events occurred.1 Investigators attributed two patient deaths in the BAVENCIO plus BSC arm (0.6%), due to sepsis and ischemic stroke, to study treatment toxicity.1

About JAVELIN Bladder 100JAVELIN Bladder 100 (NCT02603432) is a Phase III, multicenter, multinational, randomized, open-label, parallel-arm study investigating first-line maintenance treatment with BAVENCIO plus BSC versus BSC alone in patients with locally advanced or metastatic UC. The primary endpoint was OS in the two primary populations of all patients and patients with PD-L1+ tumors defined by the Ventana SP263 assay. Secondary endpoints included progression-free survival, anti-tumor activity, safety, pharmacokinetics, immunogenicity, predictive biomarkers and patient-reported outcomes in the co-primary populations. All primary and secondary endpoints are measured from the time of randomization.

About Urothelial Carcinoma Bladder cancer is the tenth most common cancer worldwide.4 In 2018, there were over half a million new cases of bladder cancer diagnosed, with around 200,000 deaths from the disease globally.4 In the US, an estimated 80,470 cases of bladder cancer were diagnosed in 2019, with around 12,500 locally advanced or metastatic cases presented annually.5,6 UC, which accounts for about 90% of all bladder cancers,7 becomes harder to treat as it advances, spreading through the layers of the bladder wall.8 Only 25% to 55% of patients receive any second-line therapy after first-line chemotherapy.9-15 In the US and EU5 markets, approximately 40% to 50% of patients receive an immune checkpoint inhibitor in second-line therapy.3 For patients with advanced UC, the five-year survival rate is 5%.5

About BAVENCIO (avelumab)BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.16-18 In November 2014, Merck KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved IndicationsBAVENCIO (avelumab) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC 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.

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

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A fatal adverse reaction (sepsis) occurred in one (0.3%) patient with locally advanced or metastatic urothelial carcinoma (UC) receiving BAVENCIO plus best supportive care (BSC) as first-line maintenance treatment. In patients with previously treated locally advanced or metastatic UC, fourteen patients (6%) who were treated with BAVENCIO experienced either pneumonitis, respiratory failure, sepsis/urosepsis, cerebrovascular accident, or gastrointestinal adverse events, which led to death.

The most common adverse reactions (all grades, 20%) in patients with locally advanced or metastatic UC receiving BAVENCIO plus BSC (vs BSC alone) as first-line maintenance treatment were fatigue (35% vs 13%), musculoskeletal pain (24% vs 15%), urinary tract infection (20% vs 11%), and rash (20% vs 2.3%). In patients with previously treated locally advanced or metastatic UC receiving BAVENCIO, the most common adverse reactions (all grades, 20%) were fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection.

Selected laboratory abnormalities (all grades, 20%) in patients with locally advanced or metastatic UC receiving BAVENCIO plus BSC (vs BSC alone) as first-line maintenance treatment were blood triglycerides increased (34% vs 28%), alkaline phosphate increased (30% vs 20%), blood sodium decreased (28% vs 20%), lipase increased (25% vs 16%), aspartate aminotransferase (AST) increased (24% vs 12%), blood potassium increased (24% vs 16%), alanine aminotransferase (ALT) increased (24% vs 12%), blood cholesterol increased (22% vs 16%), serum amylase increased (21% vs 12%), hemoglobin decreased (28% vs 18%), and white blood cell decreased (20% vs 10%).

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

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

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

Please see full US Prescribing Informationand Medication Guideavailable at http://www.BAVENCIO.com.

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

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

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

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

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

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

Pfizer Disclosure Notice The information contained in this release is as of September 18, 2020. Pfizer assumes no obligation to update forward-looking statementscontained in this release as the result of new information or future events or developments.

This release contains forward-looking information about BAVENCIO (avelumab), including an indication for first-line maintenance therapy for BAVENCIO for the treatment of patients with locally advanced or metastatic urothelial carcinoma, the alliance between Merck KGaA, Darmstadt, Germanyand Pfizer involving BAVENCIO and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BAVENCIO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and whenany drug applications may be filed in any other jurisdictions for BAVENCIO for first-line maintenance therapy for locally advanced or metastatic urothelial carcinoma in any jurisdictions or for any other potential indications for BAVENCIO or combination therapies in any jurisdictions; whether and when regulatory authorities in any jurisdictions where any applications are pending or may be submitted for BAVENCIO or combination therapies, including BAVENCIO for locally advanced or metastatic urothelial carcinoma may approve any such applications, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy, and, if approved, whether they will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of BAVENCIO, including BAVENCIO for locally advanced or metastatic urothelial carcinoma; the impact of COVID-19 on our business, operations and financial results; and competitive developments.

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

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Original post:
BAVENCIO Pivotal Phase III JAVELIN Bladder 100 Results Published in The New England Journal of Medicine - PRNewswire