Category Archives: Hormone Replacement Therapy

Alabama's Senate Health Committee approved a bill that would make providing transgender minors with hormone replacement therapy (HRT) or puberty blockers a felony with an 11-2 vote in favor of the legislation.

SB-10, the Vulnerable Child Compassion and Protection Act, would punish doctors for providing transitionary care to transgender youth with up to 10 years in prison.

If passed through the State Senate and House of Representatives, SB-10 would make Alabama the first US state to enact an official transgender medical ban.

The ban is one of eight anti-trans pieces of legislation being considered by state legislatures across the country this week.

Medical experts and transgender advocates warn criminalizing transgender medical care could lead to a spike in suicides and mental health problems among trans youth.

"All of these measures run counter to medical science, prevailing standards of treatment for transgender youth, and basic human dignity. Research has shown that transgender youth have the best outcomes when they are affirmed in their gender identity through supportive families, medical providers, and communities," stated Alabama's ACLU chapter.

There is no shortage of studies finding that transgender youth suffer from disproportionate rates of depression, anxiety, and suicidal ideations. This is in large part due to gender dysphoria, a deep anxiety, discomfort, and pain caused by someone's body not corresponding with their gender.

Going through puberty and growing unwanted body hair, breasts, or muscles can be traumatic for trans youth and trigger more intense forms of dysphoria. Doctors typically prescribe a medication commonly called hormone blockers to press pause on puberty for trans youth until they decide to go on HRT or not later in life.

The American College of Obstetricians and Gynecologists medical best practices advise physicians to prescribe hormone blockers to trans youth until they turn 16, in which a child and their parents can decide if HRT would be the next best step.

Advocates say prohibiting these treatments goes directly against best care guidelines and research that state transitionary care is life-saving for trans youth.

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Alabama just approved a bill that would make it illegal for doctors to treat trans teenagers - Insider

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New Jersey, United States,- The Market Research Intellect report predicts that the Hormone Replacement Therapy (HRT) Market will find players focused on new product development in order to secure a solid position in terms of revenue distribution. Strategic partnerships can be a powerful way to bring new products to market. The level of competition in the market can increase.

This research report categorizes the global market by player/brand, region, type, and application. The report also analyzes the state of the global market, the competitive landscape, market share, growth rates, future trends, market drivers, opportunities and challenges, sales channels, five forces of dealers and carriers.

The latest 2021 revision of this report reserves the right to provide additional comments on the latest scenarios, the recession, and the impact of COVID-19 on the entire industry. It also provides high-quality information on when the industry can reconsider the goals set for the situation and the possible actions.

The report provides a detailed analysis of the major market players along with an overview of their business, expansion plans, and strategies. The main actors examined in the report include:

Hormone Replacement Therapy (HRT) Market Segment Analysis

The study report contains certain segments by type and application. Each type provides information on products in the forecast period from 2015 to 2027. The application segment also provides consumption information for the forecast period from 2015 to 2027. Understanding the segments will help determine the importance of various factors for market growth.

The report further studies the market segmentation based on the types of products offered in the market and their end-uses/uses.

While segmenting the Market by Hormone Replacement Therapy (HRT) Types, the Report includes:

While segmenting the Market by Hormone Replacement Therapy (HRT) Applications, the report covers the following application areas:

Hormone Replacement Therapy (HRT) Market Report Scope

The study analyzes the following key aspects of the business:

Leading Player Strategy Analysis: With this analysis, market participants can gain a competitive advantage over their competitors in the Hormone Replacement Therapy (HRT) market.

Study of Key Market Trends: This section of the report provides an in-depth analysis of the recent and future trends in the Hormone Replacement Therapy (HRT) market.

Market Forecasts: Buyers of the report will have access to accurate and validated estimates of the overall market size in terms of value and volume. The report also provides forecast of consumption, production, revenue, and other projections for the Hormone Replacement Therapy (HRT) market.

Regional growth analysis: The report covers all major regions and countries. The regional analysis will help market participants to enter unexplored regional markets, prepare specific strategies for target regions and compare the growth of all regional markets.

Segment analysis:The report provides accurate and reliable market share forecast for key Hormone Replacement Therapy (HRT) market segments. Market participants can use this analysis to make strategic investments in key Hormone Replacement Therapy (HRT) market segments.

Business opportunities in the following regions and countries:

? North America (USA, Canada and Mexico)

? Europe (Germany, Great Britain, France, Italy, Russia, Spain and Benelux countries)

? Asia Pacific (China, Japan, India, Southeast Asia, and Australia)

? Latin America (Brazil, Argentina and Colombia)

How will the report help your business grow?

? This document provides statistics on the value (in USD) and size (in units) of the Hormone Replacement Therapy (HRT) industry from 2021 to 2027.

? The report also details major competitors in the market that will have a greater impact on Hormone Replacement Therapy (HRT)s business.

? Comprehensive understanding of the fundamental trends affecting each sector despite the greatest threat, the latest technologies and opportunities that can create a global Hormone Replacement Therapy (HRT) market for both supply and demand.

? The report will help the client identify the key results of the major market players or rulers of the Hormone Replacement Therapy (HRT) sector.

Visualize Hormone Replacement Therapy (HRT) Market using Verified Market Intelligence:-

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Hormone Replacement Therapy (HRT) Market Size and Forecast (2021-2027) | By Top Leading Players Novartis, Abbott Laboratories, Pfizer, Mylan...

By IANS Feb 15, 2021

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Some people use the term "male menopause" to refer to hormonal changes that men experience as they get older.

Men experience symptoms resulting from a decrease in the male hormone called as "testosterone". This condition is referred to as andropause or in other words it is called as male menopause.

It affects up to 30 percent of men in their 50s and becomes more prevalent with age, says Dr Chandrika Kulkarni, Consultant Obstetrician Gynaecologist and fertility specialist.

"Unlike menopause in women, when hormone production stops completely, testosterone decline in men is a slower process. The testes, unlike the ovaries, do not run out of the substance it needs to make testosterone.

However, subtle changes in the function of the testes may occur as early as age 45 to 50 and more dramatically after the age of 70 in some men," the doctor tells IANSlife.

Male menopause differs from female menopause in several ways. Not all men experience andropause and also it doesn't involve a complete shutdown of the reproductive organs.

Sexual complications may arise as a result of lowered hormone levels. Male menopause can cause physical, sexual, and psychological problems. The symptoms typically worsen as one gets older, she warns.

Watch out for the symptoms

The doctor points out: "The symptom most associated with hypogonadism (low level of hormones) is low libido. Other manifestations of hypogonadism include: erectile dysfunction, decreased muscle mass and strength, increased body fat, decreased bone mineral density and osteoporosis, and decreased vitality and depressed mood. Osteoporosis is twice more common in hypogonadal (low level of hormones) men as compared to eugonadal (normal level of hormones) men (6 vs 2.8 percent)."

How is Andropause diagnosed and what is its treatment? Dr Kulkarni answers:

It is recommended to test older men for low testosterone levels only if they have signs or symptoms. If an initial test shows low testosterone, the test should be repeated to confirm the results.

The initial treatment for symptoms of male menopause is making healthier lifestyle choices.

These lifestyle habits can benefit all men. After adopting these habits, men who are experiencing symptoms of male menopause may see a dramatic change in their overall health. It's normal to experience a decline in testosterone levels as one gets older.

For many men, the symptoms are manageable even without treatment. If the symptoms are cause hardship, consultation with the specialist is advised. They can provide recommendations to help manage or treat symptoms.

Hormone replacement therapy is another treatment option. However, testosterone replacement therapy has its own potential risks and side effects.

Replacing testosterone may worsen prostate cancer and increase the risk of heart disease.

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Have you heard of male menopause? Andropause explained by an expert - IOL

The Hormone Replacement Therapy (HRT) Market grew in 2019, as compared to 2018, according to our report, Hormone Replacement Therapy (HRT) Market is likely to have subdued growth in 2020 due to weak demand on account of reduced industry spending post Covid-19 outbreak. Further, Hormone Replacement Therapy (HRT) Market will begin picking up momentum gradually from 2021 onwards and grow at a healthy CAGR between 2021-2025.

Deep analysis about Hormone Replacement Therapy (HRT) Market status (2016-2019), competition pattern, advantages and disadvantages of products, industry development trends (2019-2025), regional industrial layout characteristics and macroeconomic policies, industrial policy has also been included. From raw materials to downstream buyers of this industry have been analysed scientifically. This report will help you to establish comprehensive overview of the Hormone Replacement Therapy (HRT) Market

Get a Sample Copy of the Report at: https://i2iresearch.com/download-sample/?id=13188

The Hormone Replacement Therapy (HRT) Market is analysed based on product types, major applications and key players

Key product type:OralParenteralTransdermalOthers

Key applications:MenopauseHypothyroidismMale HypogonadismGrowth Hormone DeficiencyOthers

Key players or companies covered are:Abbott LaboratoriesNovartisPfizerMylan LaboratoriesMerck & Co.AmgenNovo NordiskBayerEli LilyWyethGenentech

The report provides analysis & data at a regional level (North America, Europe, Asia Pacific, Middle East & Africa , Rest of the world) & Country level (13 key countries The U.S, Canada, Germany, France, UK, Italy, China, Japan, India, Middle East, Africa, South America)

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Key questions answered in the report:1. What is the current size of the Hormone Replacement Therapy (HRT) Market, at a global, regional & country level?2. How is the market segmented, who are the key end user segments?3. What are the key drivers, challenges & trends that is likely to impact businesses in the Hormone Replacement Therapy (HRT) Market?4. What is the likely market forecast & how will be Hormone Replacement Therapy (HRT) Market impacted?5. What is the competitive landscape, who are the key players?6. What are some of the recent M&A, PE / VC deals that have happened in the Hormone Replacement Therapy (HRT) Market?

The report also analysis the impact of COVID 19 based on a scenario-based modelling. This provides a clear view of how has COVID impacted the growth cycle & when is the likely recovery of the industry is expected to pre-covid levels.

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Studies have shown that men over the age of 65 may benefit from taking the hormone testosterone. According toDr. Mirkin.comstudies have shown that testosterone increases bone density, raises hemoglobin levels in men with anemia, and improves sexual function. Reviews were mixed on whether testosterone improved heart health, however.

According to a study published in JAMA, testosterone significantly increased plaque in the arteries that lead to the heart. However, another study found that using testosterone gel for threeyears reduced the rate of heart attacks in men by 25%.

Dr. David B. Samadhi, a board-certified urologist, a Newsmax contributor, the director of Mens Health and Urologic Oncology at St. Francis Hospital in Roselyn, New York, and the author ofThe Ultimate MANual: Dr. Samadhis Guide to Mens Health and Wellness, tells Newsmaxthat the hormone is quite often overused because of its macho man association.

Of course, testosterone is a necessary and potent chemical messenger that indeed directly influences many physiological processes in a mans body, Samadi explains. Testosterone influences mens sex drive, bone mass, fat distribution, and muscle mass and strength, among other things. What man doesnt want to look strong, muscular, and ready for sex at the drop of a hat?

But the expert warns that advertisers understand this and play upon this notion by touting unproven products.

I remember a 2014 Time magazine cover story titled, Manopause that featured aprovocative cover and delved into the clever marketing and tons of money spent into making men believe that more testosterone is their quick fix and best remedy for remaining youthful and virile.

Thats why on any given day of the year, you see or hear commercials hawking a testosterone supplement promising to bring back mens youthful vigor, says Samadi.

As a urologist and prostate cancer surgeon, my advice to men is stay away from any spa, TV ads or any nonmedical person selling supplements for low T, he says. Testing testosterone and getting an accurate measurement can be tricky since levels fluctuate during the day.Only a doctor should be checking a mans testosterone levels. Testosterone levels should be checked before 9:00 a.m. when levels are their highest. Also, two tests are necessary to check for accuracy.

Samadi says that testosterone deficiency may or may not have symptoms.

But I can tell you, men with low T are like a car thats run out of gas they may be depressed, lack energy, motivation, and self-confidence, have reduced muscle mass and increased fat mass, loss of body hair, hot flashes, fewer spontaneous erections or difficulty sustaining erections, and have little interest in sex, he adds.

For any man who does have low testosterone, the benefits of hormone replacement therapy usually outweigh the risk., advises the expert. When men are selected correctly for using this therapy, it can be very helpful. Testosterone therapy for these men can help maintain muscle mass, slow osteoporosis, boost energy and stamina, and bring back their love life. But, I stress, its critical these men must be under surveillance with their doctor. Testosterone levels must be checked regularly as one possible side effect of testosterone therapy is it could stimulate the growth of prostate cancer cells.

Men who think they have low T, should talk to their doctor, get tested, and if therapy is needed, follow-up with their doctor periodically to have testosterone levels checked making sure the therapy is not causing any health problems, says Samadhi.

2021 NewsmaxHealth. All rights reserved.

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Expert Reveals Key Information That Men Need to Know About Testosterone - KMJ Now

ALAMEDA, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (NASDAQ: EXEL) today announced positive final data for a phase 1 trial sponsored and conducted by the U.S. National Cancer Institute (NCI), including seven expansion cohorts, evaluating cabozantinib in combination with either nivolumab or nivolumab plus ipilimumab in patients with refractory metastatic genitourinary (GU) tumors. The data will be presented as part of the Rapid Abstract Session: Urothelial Carcinoma and Rare Tumors from 2:15 p.m. 3:05 p.m. PT on Friday, February 12 at the 2021 American Society of Clinical Oncologys Genitourinary Cancers Symposium (ASCO GU), which is being held virtually, February 11-13, 2021.

In the study, cabozantinib in combination with either nivolumab alone (n=64) or nivolumab plus ipilimumab (n=56) demonstrated an objective response rate (ORR) for all evaluable patients (n=108) of 38%, with an 11.1% complete response (CR) rate per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

For the 33 patients with previously treated metastatic urothelial carcinoma (UC), the ORR was 42.4%, and the CR rate was 21%. The ORR for the 16 patients with previously treated metastatic renal cell carcinoma (RCC) was 62.5%. The ORR was 20% for patients with urachal adenocarcinoma (n=15), 85.7% for squamous cell carcinoma of the bladder (n=7) and 44.4% for penile carcinoma (n=9).

The median overall survival for the entire population was 15.9 months. Median progression-free survival was 5.5 months, and median duration of response was 22.8 months.

We see a significant level of anti-tumor activity with an acceptable tolerability profile for the combination of cabozantinib with nivolumab or nivolumab and ipilimumab for this early phase trial across a broad range of GU malignancies, said Andrea Apolo, M.D., Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health and the principal investigator of the trial. This phase 1 studys early results provided important information for the development of the phase 3 CheckMate -9ER study sponsored by Bristol Myers Squibb, of cabozantinib plus nivolumab versus sunitinib that recently reported improved progression-free survival, overall response, and overall response rate, leading to last months U.S. approval of the combination therapy of cabozantinib and nivolumab in first-line advanced renal cell carcinoma. The additional activity seen in other GU tumors support further research into the potential of cabozantinib combinations with immune checkpoint inhibitors in other advanced, intractable GU cancers.

These clinical data were the result of a productive collaboration between the investigators leading the trial, NCI-CTEP, the trial sponsor, and both Exelixis and Bristol Myers Squibb. We would like to thank the patients who generously agreed to participate in the trial, said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. The combination of cabozantinib with immune checkpoint inhibitors continues to demonstrate positive outcomes for patients with difficult-to-treat advanced genitourinary malignancies such as renal cell and urothelial carcinomas. Going forward, we will continue our work to uncover the potential of cabozantinib in combination with immunotherapies to provide further treatment options to patients with cancer in need.

Treatment-related grade 3 or 4 adverse events (>5% of patients) observed in the doublet cabozantinib and nivolumab group included fatigue (13%), hypertension (13%), dehydration (6%) and thromboembolic event (6%). Immune-related grade 3 or 4 adverse events (>5% of patients) were not observed in this group. Treatment-related grade 3 or 4 adverse events (>5% of patients) observed in the triplet cabozantinib plus nivolumab and ipilimumab group included fatigue (16%), hypertension (11%), dehydration (5.3%) and thromboembolic event (5.3%). Immune-related grade 3 or 4 adverse events (>5% of patients) for this group included hepatitis (7%) and colitis (7%).

About the Trial

The trial was sponsored by the U.S. NCI through Cooperative Research and Development Agreements between the NCIs Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis, and both Exelixis and Bristol Myers Squibb. Andrea Apolo, M.D., of the NCIs Genitourinary Malignancies Branch, is the principal investigator. The trial was conducted by the NCI and includes centers from its Experimental Therapeutics Clinical Trials Network.

This open label, non-randomized phase 1 trial was divided into two parts: a dose-escalation phase and an expansion cohort phase. The primary endpoint of the phase 1 trial was to determine the dose-limiting toxicity and recommended doses of the doublet and triplet combinations for later stage clinical studies. The secondary endpoint is ORR as assessed per RECIST version 1.1.

Once the recommended doses were determined for the combinations of cabozantinib plus nivolumab and of cabozantinib plus nivolumab and ipilimumab, the trial enrolled seven subsequent expansion cohorts. The cabozantinib plus nivolumab expansion cohorts included patients with UC, RCC, bladder adenocarcinoma and other rare metastatic GU tumors. The cabozantinib plus nivolumab and ipilimumab expansion cohorts included UC, RCC and penile carcinoma. The objectives of the trial were to determine the clinical activity, safety and tolerability of both combinations in multiple metastatic GU tumors.

The recommended phase 2 doses determined for the combination of cabozantinib plus nivolumab were cabozantinib 40 mg daily and 3 mg/kg of nivolumab every two weeks. The recommended phase 2 doses determined for the combination of cabozantinib plus nivolumab and ipilimumab were cabozantinib 40 mg daily, 3 mg/kg of nivolumab every two weeks and 1 mg/kg ipilimumab every three weeks.

More information about the trial is available at ClinicalTrials.gov.

About Genitourinary Cancers

Genitourinary cancers are those that affect the urinary tract, bladder, kidneys, ureter, prostate, testicles, penis or adrenal glands parts of the body involved in reproduction and excretion and include RCC, castration-resistant prostate cancer (CRPC) and UC.1

The American Cancer Societys (ACS) 2021 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.2 Clear cell RCC is the most common type of kidney cancer in adults.3 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 13%.2 Approximately 32,000 patients in the U.S. and over 71,000 worldwide will require systemic treatment for advanced kidney cancer in 2021, with nearly 15,000 patients in need of a first-line treatment in the U.S.4

According to the ACS, in 2021, approximately 250,000 new cases of prostate cancer will be diagnosed, and 34,000 people will die from the disease.2 Prostate cancer that has spread beyond the prostate and does not respond to androgen-suppression therapies a common treatment for prostate cancer is known as metastatic CRPC.5 Researchers estimate that in 2020, 43,000 people were diagnosed with metastatic CRPC, which has a median survival of less than two years.6,7,8

Urothelial cancers encompass carcinomas of the bladder, ureter and renal pelvis at a ratio of 50:3:1, respectively.9 Bladder cancer occurs mainly in older people, with 90% of patients aged 55 or older.10 With an estimated 84,000 new cases expected to be diagnosed in 2021, bladder cancer accounts for about 5% of all new cases of cancer in the U.S. each year.11 It is the fourth most common cancer in men.2

About CABOMETYX (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC; for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib; and for patients with advanced RCC as a first-line treatment in combination with nivolumab. 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.

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: Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of fistulas and perforations, 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 events that require medical intervention.

Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension was reported 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.

Hepatotoxicity: CABOMETYX in combination with nivolumab can cause hepatic toxicity with higher frequencies of Grades 3 and 4 ALT and AST elevations compared to CABOMETYX alone.

Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes than when the drugs are administered as single agents. For elevated liver enzymes, interrupt CABOMETYX and nivolumab and consider administering corticosteroids.

With the combination of CABOMETYX and nivolumab, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. ALT or AST >3 times ULN (Grade 2) was reported in 83 patients, of whom 23 (28%) received systemic corticosteroids; ALT or AST resolved to Grades 0-1 in 74 (89%). Among the 44 patients with Grade 2 increased ALT or AST who were rechallenged with either CABOMETYX (n=9) or nivolumab (n=11) as a single agent or with both (n=24), recurrence of Grade 2 increased ALT or AST was observed in 2 patients receiving CABOMETYX, 2 patients receiving nivolumab, and 7 patients receiving both CABOMETYX and nivolumab.

Adrenal Insufficiency: CABOMETYX in combination with nivolumab can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold CABOMETYX and/or nivolumab depending on severity.

Adrenal insufficiency occurred in 4.7% (15/320) of patients with RCC who received CABOMETYX with nivolumab, including Grade 3 (2.2%), and Grade 2 (1.9%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of CABOMETYX and nivolumab in 0.9% and withholding of CABOMETYX and nivolumab in 2.8% of patients with RCC.

Approximately 80% (12/15) of patients with adrenal insufficiency received hormone replacement therapy, including systemic corticosteroids. Adrenal insufficiency resolved in 27% (n=4) of the 15 patients. Of the 9 patients in whom CABOMETYX with nivolumab was withheld for adrenal insufficiency, 6 reinstated treatment after symptom improvement; of these, all (n=6) received hormone replacement therapy and 2 had recurrence of adrenal insufficiency.

Proteinuria: Proteinuria was observed 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 common (20%) adverse reactions are:

CABOMETYX as a single agent: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, vomiting, weight decreased, constipation, and dysphonia.

CABOMETYX in combination with nivolumab: diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.

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. Avoid CABOMETYX in patients with severe hepatic impairment.

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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.FDA.gov/medwatch or call 1-800-FDA-1088.

About Exelixis

Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX (cabozantinib), COMETRIQ (cabozantinib), COTELLIC (cobimetinib) and MINNEBRO (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poors (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. In November 2020, the company was named to Fortunes 100 Fastest-Growing Companies list for the first time, ranking 17th overall and the third-highest biopharmaceutical company. For more information about Exelixis, please visit http://www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: the presentation of data from a phase 1 study evaluating cabozantinib in combination with either nivolumab or nivolumab plus ipilimumab in patients with refractory metastatic GU tumors at ASCO GU; the therapeutic potential of cabozantinib combinations with immune checkpoint inhibitors in advanced, intractable GU cancers; and Exelixis plans to reinvest in its business to maximize the potential of the companys pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the availability of data at the referenced times; the potential failure of cabozantinib to demonstrate safety and/or efficacy in future trials; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating CABOMETYX; Exelixis continuing compliance with applicable legal and regulatory requirements; Exelixis dependence on third-party vendors for the development, manufacture and supply of cabozantinib; Exelixis ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of CABOMETYX; changes in economic and business conditions, including as a result of the COVID-19 pandemic; and other factors affecting Exelixis and its development programs discussed under the caption Risk Factors in Exelixis Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 10, 2021, and in Exelixis future filings with the SEC. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a Japanese trademark.

1 National Cancer Institute Dictionary of Cancer Terms. Genitourinary System. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/genitourinary-system. Accessed February 2021.2 American Cancer Society: Cancer Facts & Figures 2021. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2021/cancer-facts-and-figures-2021.pdf Accessed February 2021.3 Jonasch, E., Gao, J., Rathmell, W., Renal cell carcinoma. BMJ. 2014; 349:g4797.4 Decision Resources Report: Renal Cell Carcinoma. October 2014 (internal data on file).5 American Society of Clinical Oncology. Cancer.Net. Treatment of Metastatic Castration-Resistant Prostate Cancer. September 8, 2014. Available at: https://www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/treatment-metastatic-castration-resistant-prostate-cancer. Accessed February 2021.6 Scher, H.I., Solo, K., Valant, J., Todd, M.B., Mehra, M. Prevalence of Prostate Cancer Clinical States and Mortality in the United States: Estimates Using a Dynamic Progression Model. PLOS ONE. 2015; 10: e0139440.7 American Urological Association. Prostate Cancer: Castration Resistant Guideline. 2018. Available at: https://www.auanet.org/guidelines/prostate-cancer-castration-resistant-guideline. Accessed February 2021.8 Moreira, D. M., Howard, L. E., Sourbeer, K. N., et al. Predicting Time From Metastasis to Overall Survival in Castration-Resistant Prostate Cancer: Results From SEARCH. Clin Genitourin Cancer. 2017; 15: 6066.e2.9 Hurwitz, M. et al. Urothelial and Kidney Cancers. Cancer Management. http://www.cancernetwork.com/cancer-management/urothelial-and-kidney-cancers. Accessed February 2021.10 American Cancer Society. Bladder Cancer Key Statistics. https://www.cancer.org/cancer/bladdercancer/detailedguide/bladder-cancer-key-statistics. Accessed February 2021.11 National Cancer Institute. SEER Stat Fact Sheets: Bladder Cancer. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed February 2021.

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Exelixis Announces Final Phase 1 Results from Clinical Trial Sponsored by the National Cancer Institute at ASCO GU for Cabozantinib in Combination...

The Global Hormone Replacement Therapy (HRT) market study is an intelligent and informative evaluation method as well as a great resource that will help you secure a place of strength in the global market. In order to equip your company with vital knowledge and comparative data about the Global Hormone Replacement Therapy (HRT) Industry, it requires Porters Five Forces and PESTLE study. To give you a full picture of the current and future competitive scenarios of the global market for Hormone Replacement Therapy (HRT), we have presented a deep overview of the vendor landscape. In order to prepare detailed and reliable Hormone Replacement Therapy (HRT) market research reports, our analysts use the latest primary and secondary research techniques and instruments.

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Novartis, Mylan Laboratories, Genentech, Bayer, Amgen, Wyeth, Abbott Laboratories, Novo Nordisk, Eli Lily, Pfizer, Merck & Co.

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ChinaEUUSAJapanIndiaSoutheast AsiaSouth America

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Hormone Replacement Therapy (HRT) Market Industry Insights, Future Opportunities, Growth Rate, Demand, Share and Forecast to 2026 The Bisouv Network...

Hormone replacement therapy (HRT) tablets marketis expected to rise with a substantial CAGR in the forecast period of 2019-2026. This rise in market value can be attributed to the increased development of drugs with better therapeutic profiles. The report contains data of the base year 2018 and historic year 2017.

Hormone Replacement Therapy (HRT) Tablets market research report bestows with the strength to any kind of business whether it is large, medium or small for surviving and succeeding in the market. This report gives broader perspective of the market place with its all-inclusive market insights and analysis. The report also estimates CAGR (compound annual growth rate) values along with its fluctuations for the definite forecast period. The estimations of CAGR values are quite essential which helps businesses decide upon the investment value over the time period. The report carefully studies market definition, market segmentation, competitive analysis and key developments in the market.

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Few of the major competitors currently working in the global hormone replacement therapy (HRT) tablets market areALLERGAN, Novo Nordisk A/S, Sanofi, Abbott, TherapeuticsMD, Inc., Mithra Pharmaceuticals among others.

Market Drivers:

Market Restraints:

Key Development in the Market:

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Segmentation: Global Hormone Replacement Therapy (HRT) Tablets Market

By Type of Disease

By Treatment Type

By End-User

By Distribution Channel

By Geography

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In-depth analysis of the market

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Global Hormone Replacement Therapy (HRT) Tablets Market Players, Applications, Trends And Forecasts 2026 The Courier - The Courier

Toronto, Canada: Global Hormone Replacement Therapy Market research report offers extensive research and analysis of key aspects of the global Hormone Replacement Therapy industry. Report provides holistic analysis of the market allowing companies to take decisions according to the changing market trends. It contains market overview providing basic understanding about what the market is. This market is fragmented into various segments, such as type, applications, end-users, and distribution channel. Furthermore, report contains competitive analysis and provide company profiling of key players involved in market. This provide deeper understanding of the competitive landscape and its future scenarios, crucial dynamics, and leading segments of the global Hormone Replacement Therapy market. In addition, report includes regional analysis and market dynamics. For instance, report involves detailed analysis about the factors responsible for the growth of market along with factors that can hamper the growth of market.

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Global Hormone Replacement Therapy Market Analysis Report By Product [Estrogen, Human Growth], By Route Of Administration [Oral, Parenteral], By Type Of Disease- Global Forecast to 2026Hormone Replacement Therapy Market is valued at 21.90 USD Billion in 2019 and expected to reach USD 37.03 Billion by 2026 with the CAGR of 7.8% over the forecast period.

Scope of the reportThis report analyses the global market for Hormone Replacement Therapy. The report will enable the user to understand and gain insights into the current and forecast market situation. The market is comprehensively analyzed by geography to give complete information on the global scenario. The qualitative and quantitative data provided in this study can help user understand which market segments, regions are expected to grow at higher rates, factors affecting the market and key opportunity areas. The report also includes competitive landscape of

Segmentation by Type:

o Menopauseo Hypothyroidismo Male Hypogonadismo Growth Hormone Deficiency

Segmentation by Application:

o Oralo Parenteralo Transdermal

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Table of Contents

Report Overview: It includes six chapters, viz. research scope, major manufacturers covered, market segments by type, Hormone Replacement Therapy market segments by application, study objectives, and years considered.

Global Growth Trends: There are three chapters included in this section, i.e. industry trends, the growth rate of key producers, and production analysis.

Hormone Replacement Therapy Market Share by Manufacturer: Here, production, revenue, and price analysis by the manufacturer are included along with other chapters such as expansion plans and merger and acquisition, products offered by key manufacturers, and areas served and headquarters distribution.

Market Size by Type: It includes analysis of price, production value market share, and production market share by type.

Market Size by Application: This section includes Hormone Replacement Therapy market consumption analysis by application.

Profiles of Manufacturers:Here, leading players of the global Hormone Replacement Therapy market are studied based on sales area, key products, gross margin, revenue, price, and production.

Hormone Replacement Therapy Market Value Chain and Sales Channel Analysis: It includes customer, distributor, Hormone Replacement Therapy market value chain, and sales channel analysis.

Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

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Covid-19 impact on Hormone Replacement Therapy Market Key Vendors, Regional Analysis and Competitive Landscape Forecast by 2026| Pfizer, BioSante...

This February, which is recognised as Reproductive Health Month, the spotlight has fallen on another 21st century crisis- plummeting fertility rates. Fertility levels worldwide have plunged to an historic low with scientists predicting that by 2025, almost 10 million couples will struggle to conceive.

South Africa faces the same conundrum, with already more than 20 percent of couples struggling to conceive naturally. This wasnt the case 20 to 30 years ago.

Experts attribute the decline to economic prosperity, urbanisation and the changing models of family life as leading factors. Modern-day couples are delaying having children due to increased educational and professional opportunities, wanting to acquire wealth, travel and explore the world before having children.

As a result, more women are having their first baby in their late twenties to early thirties.

But the increasingly low fertility rate is not just a female issue. According to the Infertility Awareness Association of SA (IFAASA), an estimated 40 percent of infertility issues can be attributed to men, a further 40 percent to women, and the remaining 20 percent are a combination of both.

Dr Crystal Meletiou, a therapist specialising in supporting women with fertility and menopausal challenges, shared that it is a common misconception that male fertility will continue well past a womans decline in fertility.

While the effects of age on female fertility have been known for some time, more recent studies have found that the age of a male partner also affects the chance of conceiving. In women, fertility generally starts to decline in their 30s, while in men it starts to drop from age 40 when sperm quality and motility decreases, she explained.

Aside from getting the timing right, health also plays an important role in getting pregnant.

Quitting smoking, limiting alcohol intake, getting adequate rest and exercise, along with eating a nutritionally balanced diet, rich in antioxidants are some of the natural ways in which you can help boost fertility, advised Dr Meletiou.

She stated that the benefits of natural products and antioxidants in the treatment of infertility in both male and female patients are supported in several studies. One study in particular, published by a team of gynaecologists, obstetricians, urologists, nutritionists and other specialists from the International Islamic University of Malaysia, discusses the benefits of antioxidants on sperm production and quality, she added.

Besides being an advocate for emotional well-being when trying to conceive, Dr Meletiou is a firm believer that the properties of natural remedies can play a significant role in the struggle of infertility. One such a natural remedy may be the indigenous rooibos tea.

Adele du Toit, spokesperson for the SA Rooibos Council (SARC) referred to several papers which point to how rooibos could benefit reproductive health in both men and women.

The tea may also hold advantages for women, she noted. Researchers from Stellenbosch University also confirmed rooibos phytoestrogenic properties.

Phytoestrogens are naturally occurring plant estrogens that have a similar chemical structure to human estrogen. The interest in plant-based estrogens or phytoestrogens, as an alternative to hormone replacement therapy (HRT) or estrogen replacement therapy (ERT) is on the increase as many women are reluctant to take conventional medication to reduce menopausal symptoms, which makes this finding significant.

Du Toit mentioned that although many of these studies were conducted in rodents, rooibos could potentially have the same positive effect in humans. As with everything, moderation is key, but up to six cups of rooibos can be consumed daily, she concluded.

Link:
A cup of rooibos a day- good for reproductive health - Rising Sun Chatsworth