Category Archives: Hormone Replacement Therapy

Hormone Replacement Therapy Market

DataIntelo, 19-10-2020: The research report on the Hormone Replacement Therapy Market is a deep analysis of the market. This is a latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. Experts have studied the historical data and compared it with the changing market situations. The report covers all the necessary information required by new entrants as well as the existing players to gain deeper insight.

Furthermore, the statistical survey in the report focuses on product specifications, costs, production capacities, marketing channels, and market players. Upstream raw materials, downstream demand analysis, and a list of end-user industries have been studied systematically, along with the suppliers in this market. The product flow and distribution channel have also been presented in this research report.

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The Major Manufacturers Covered in this Report:F. Hoffmann-La RocheNovartisNovo NordiskAmgenANI PharmaceuticalsBayerEli LillyHisamitsu PharmaceuticalIpsenMerckMylan LaboratoriesOrionQuatRx PharmaceuticalsTeva Pharmaceutical IndustriesTherapeuticsMD

The Research Study Focuses on:

By Types:Estrogen Replacement TherapyGrowth Hormone Replacement Therapy

By Applications:MenopauseHypothyroidismMale HypogonadismGrowth Hormone Deficiency

By Regions:

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The Hormone Replacement Therapy Market Report Consists of the Following Points:

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In conclusion, the Hormone Replacement Therapy Market report is a reliable source for accessing the research data that is projected to exponentially accelerate your business. The report provides information such as economic scenarios, benefits, limits, trends, market growth rate, and figures. SWOT analysis is also incorporated in the report along with speculation attainability investigation and venture return investigation.

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Hormone Replacement Therapy Market Demand (2020-2026) | Covering Products, Financial Information, Developments, Swot Analysis And Strategies |...

Global Hormone Replacement Therapy (HRT) Market report presents the fundamental industry insights and market statistics. The latest developments, plans and policies, growth opportunities and challenges to Hormone Replacement Therapy (HRT) market are described in this report. The two crucial factors analyzed in this report include market revenue in (USD Million) and market size (k MT). The development scope, feasibility study, Hormone Replacement Therapy (HRT) market concentration, and maturity analysis is elaborated in this report.

An all-inclusive study on Hormone Replacement Therapy (HRT) market presents the industry insights across various geographies like North America, South America, Europe, Asia-Pacific, Middle East & Africa. The leading Hormone Replacement Therapy (HRT) industry players, their SWOT analysis and business strategies are covered in this report. The product portfolio covers the definition, type, application, and pricing structure. Hormone Replacement Therapy (HRT) market is segmented based on type, applications, and research regions.

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Major players covered in this report:

NovartisMylan LaboratoriesGenentechBayerAmgenWyethAbbott LaboratoriesNovo NordiskEli LilyPfizerMerck & Co.

Market Segmentation:

By Type:

OralParenteralTransdermalOthers

By Application:

MenopauseHypothyroidismMale HypogonadismGrowth Hormone DeficiencyOthers

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For each region analyzed in this report production value and growth rate is determined from 2015-2019. Market dynamics studied in this report describes the emerging segments of Hormone Replacement Therapy (HRT), market growth, limitations, opportunities, industry plans and policies across different regions. The competitive landscape analysis, industry chain analysis, and value chain analysis is presented in this report. Under industry chain analysis, various segments like upstream raw materials, manufacturing base, production process, cost of raw materials and labor cost is elaborated. Also, marketing channels and downstream buyers analysis of Hormone Replacement Therapy (HRT) is conducted.

A pin-point analysis is conducted to describe the value, market share, consumption, growth rate of Hormone Replacement Therapy (HRT). Market share of Hormone Replacement Therapy (HRT) and gross margin analysis is presented in this report. The key industry players on the global and regional level are studied in this report. The import-export details, market value, consumption, and volume forecast of Hormone Replacement Therapy (HRT) from 2019-2026 is covered.

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A brief summary of research methodology followed:

The research methodology comprises of primary and secondary research. The paid primary interviews, surveys, telephonic discussions are conducted with manufacturers, distributors, and suppliers of Hormone Replacement Therapy (HRT). Secondary research includes the data gathered from annual reports, press releases, national customs paid database, the industry journal, and associations. All the gathered data is profiled and validated to ensure the accuracy and reliability.

Hormone Replacement Therapy (HRT) Report can be divided into below segments:

1. Hormone Replacement Therapy (HRT) Industry Overview, Market Scope, Size Estimation, and Segmentation.

2. Hormone Replacement Therapy (HRT) Growth Drivers, Opportunities, Emerging Segments, and Industry Plans and Policies are explained.

3. Industry Chain Analysis Explaining Manufacturing Base, Market Share, Product Type, Upstream Raw Materials Suppliers, and Downstream Buyers Is Covered.

4. Hormone Replacement Therapy (HRT) segmentation by type explains growth rate , and value from 2015-2019

5. Hormone Replacement Therapy (HRT) segmentation by application and regions covers consumption, growth rate, market share, price, and gross margin analysis.

6. Production, Consumption, Import-Export analysis of Hormone Replacement Therapy (HRT) by regions is explained.

7. Market Status and regional SWOT analysis are described under this segment.

8. Competitive landscape structure of top Hormone Replacement Therapy (HRT) players, gross margin analysis, price, and production value is specified.

9. Hormone Replacement Therapy (HRT) market analysis forecast by volume, value, consumption from 2019-2026 is provided for type, application, and region.

10. Market maturity analysis, consumption forecast, feasibility study, and valuable conclusions are offered.

Significant Features Of Hormone Replacement Therapy (HRT) Report:

All inclusive market study which presents market statistics and competitive market scenario globally

Insights into the forecast market scenario lead to the analysis of growth opportunities, market scope, development threats, and market risks

Major regions, countries, type and Hormone Replacement Therapy (HRT) applications are covered to offer complete industry picture

Comprehensive research techniques are implemented to provide reliable and accurate results

The SWOT analysis, business tactics of key players, industry plans and policies will ease the business decisions

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Global Hormone Replacement Therapy (HRT) Market By Manufacturers, Development Strategy, Upcoming Trends and Huge Growth By 2026 - PRnews Leader

Susan Hammerling-Hodgers, Special to FLORIDA TODAY Published 9:31 a.m. ET Oct. 20, 2020

October is Breast Cancer Awareness Month. Most people have had a friend or family member who has been diagnosed, has survived, or passed away from breast cancer.(Photo: Getty Images/iStockphoto)

Barbara, a retired teacher, for months had an on-and-off itchy rash onher breast.She tried treating it with over-the-counter cortisone cream without success.

John, a surfer, had a small lump that appeared on his chest that he thought was a cyst. It was not bothersome until he went to the doctor to have it removed because it kept rubbing on the surfboard while he was lying down.

Both Barbara and John went to the Dermatologist seeking evaluation and treatment of these lesions.

Unfortunately, both Barbara and John got a punch biopsy of the unknown lesions which turned out to be breast cancer.

Susan Hammerling-Hodgers(Photo: TIM SHORTT/FLORIDA TODAY)

October is Breast Cancer Awareness Month.

Most of us have had a friend or family member who hasbeen diagnosed, has survived, or passed away from breast cancer.

Breast cancer affects both men and women of all races.

Breast cancer is a disease where abnormal cells grow and can spread throughout the body. There are several types of breast cancer such as Ductal cell carcinoma, Lobular carcinoma, Pagets diseaseand inflammatory breast cancer.

Various signs and symptoms of breast cancer can includethickening or swelling of the breast, a non-healing red flaky rash, nipple dischargeor a new lump.

Certain risk factors for breast cancer include being a woman and aging. Some patients will develop breast cancer without any risk factors. Most women have some risk factors, but most women will not develop breast cancer.

As we age, the risk for developing breast cancer increases. Most breast cancers are diagnosed after age 50,

A family history of breast cancer can increase your risk of testing positive for BRCA1 and BRAC2. Or if a patient has a family history of breast or ovarian cancer, this raises the risk.

Looking at an individuals reproductive history also can give clues if there is an increased risk for breast cancer. Specific examples are if menstrual periods occur before the age of 12 or starting menopause after 55 years old.

Unfortunately, having dense breasts can make it difficult to find tumors on a mammogram. For some reason, women with dense breasts or have fibrocystic breasts are more likely to get breast cancer.

More: Hammerling-Hodgers: Knowing the signs of suicide is key to stopping it

More: Hammerling-Hodgers: Psoriasis can affect more than the skin; it also affects self-esteem

More: Hammerling-Hodgers: Telemedicine is changing how health care is done

Risk factors that can be changed to decrease the chance of developing breast cancer are discontinuing smoking, become physically active and not being overweight, decrease the amount of alcohol consumption, try to avoid taking hormone replacement therapy or certain birth control pills.

One thing breast cancer has taught me was to think like The little Engine that could,' saidCarol Ellis of Suntree, a breast cancer survivor."I went from 'I think I can'to 'I know I can'beat this cancer.

"Dr. Sharon Norri refused to allow any negative thoughts to enter my mind and always impressed on me that every thing would be fine. I know Im truly blessed to be over four years cancer free and count every day as a gift."

Even though it's rare, men can get breast cancer too. In the United States, almost 1 in 100 breast cancers are found in men.

Diagnosis of breast cancer in men is the same as in women by getting a mammogram or breast ultrasound. After a lesion is found, a breast biopsy can be done to determine what the mass is. Usually a needle biopsy is performed. There are various types of biopsies depending on the situation.

A nipple discharge test can look to see if cancer cells are present.

Almost every family is impacted by this insidious disease, whether it be a mother, sister, aunt or cousin," saidBrevard County Commissioner Curt Smith, who is an ambassador for the American Cancer Society's "Real Men Wear Pink."

"Even men can be affected," he said. "I had a high school buddy that died from breast cancer at age 58. We are asking everyone to make a difference with a donation, no matter how small.Lots of small donations can add up to a large amount."

During your monthly self-examination of the breasts, if you find a rash or lump, make sure to seek medical evaluation and treatment from your healthcare provider.

Do not be afraid to discuss with your provider or get a second opinion. Make sure that you are comfortable with your dermatologist, internal medicine physician or Ob-Gyn and follow up annually by asking them questions on breast cancer.

Susan Hammerling-Hodgers, a Member of the National Psoriasis Foundation, is aPA-C (Certified PhysicianAssistant) andMPAS (Master of Physician Assistant Studies) and works atBrevard Skin and Cancer at the Merritt Island and Rockledge offices.

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Hammerling-Hodgers: Don't delay if you have any signs of breast cancer - Florida Today

As I approach my 43rd birthday, I've decided it's finally time to talk about the 'm' word: menopause.

Girlfriends, colleagues, mentors, sisters and doctors have always shared their wisdom on what I can expect from different stages of my life, but when it comes to this universal female experience, the silence is deafening. Apparently, society still views the menopause as an embarrassing affliction to be kept under wraps.

Yet with three in five menopausal women reporting that their symptoms are having a negative impact on them at work, this is clearly an issues that calls for an urgent conversation. "Menopause remains a taboo for everyone; most of us don't know the facts about it," says Saska Graville, the co-founder of MPowered Women, a community of doctors and wellbeing experts dedicated to providing support for this stage of women's lives. "We tend to sleepwalk into it in our mid-forties, having no idea what symptoms to look out for." Hot flushes may be familiar from popular culture, but there are in fact 37 possible side effects, including brain fog, loss of confidence and aching bones, not to mention changes to the skin and hair.

The entrepreneur Rebekah Brown was so disappointed by the paucity of intelligent treatments for these symptoms that she decided to launch her own supplement brand, MPowder. "I was turned away from the doctor for being too young," she recalls, "but equally, I found it so confusing having to search through the dusty shelves of Holland & Barrett for remedies to ease hormonal changes." With women over 45 making up more than 58 per cent of beauty consumers, which is a 27 billion industry, Brown spotted a huge gap in a growing market. "After all, we are the first generation that will be post-menopausal for half of our lives," she points out.

Even the school curriculum now includes a requirement to teach pupils about the menopause, yet the beauty sector still appears to shy away from the issue: in fact, 74 per cent of women say its advertising fails to portray the experience of menopause with any sensitivity, according to a 2018 study. The truth is that not all of us want to hear about 'anti-ageing': we simply what to find ways to make the most of what could be the most joyful years of our lives. "Women entering their fifties are achieving more than ever before - they're more likely to start businesses, follow new paths and find fulfilment," says Brown. "Who would be "anti" that?"

Rather than presenting the process as something to fear, beauty brands have a responsibility (and, in fact, a commercial incentive) to offer a more open and upbeat image of getting older, and to develop products that truly meet women's needs. Preparation is everything: so, whatever your age, here are some trusted recommendations from the industry's most forward-thinking experts.

Lee Mullins, founder, Workshop Gymnasium

Exercises that incorporate some sort of resistance training work well for anyone going through the menopause, as they build strength and lean muscle, improve bone density and metabolic rate, and boost mental health. This could include weight lifting, TRX, kettlebells and body-weight training. Many women struggle with weight gain during menopause, so keeping active is essential: try to take at least 10,000 steps a day. Eating within a 12-hour window is another easy strategy to maintain calorie intake, while giving your gut a rest from digestion.

As ever, regular sleep is paramount, because it helps regulate hormones, appetite and food cravings. Focus on getting at least seven hours - this will set you up in the best way possible to combat the challenges that come during menopause.

Anabel Kingsley, trichologist

Tricho 7 Volumising Hair and Scalp Treatment

50.00

The shifting balance of oestrogens (female hormones) and androgens (male hormones) can cause hair loss during the menopause. This may be stressful, but there are things you can do. To treat thinning, apply anti-androgenic scalp drops every day, such as Tricho 7, which limits the effects of testosterone (responsible for reducing hair density) on follicles. Remember that your hair depends on what you eat in order to grow, and even the smallest deficiencies can have an impact. Get the nutrients you need with a diet rich in protein, vitamin B12, zinc, iron and complex carbohydrates. Proteins are the building blocks of your hair, so it's vital to consume enough of these every day.

Dr Sam Bunting, cosmetic dermatologist

Oestrogen is essential to maintaining a healthy skin barrier, producing regular collagen and hyaluronic acid, and balancing the impact of our blemish-promoting hormones. So when levels start to tank during the menopause, it's best to have a plan - we lose as much as 30 per cent of collagen in the first five years.

Dr Tara Swart, neuroscientist and author

Many women don't know that anxiety can be the first and only sign of perimenopuase, before any physical symptoms. Depression can also occur, but it's important to understand that this is normal and temporary. After menopause, some women report memory loss, especially verbal recall, which can prompt misplaced fears of early dementia. These symptoms generally improve with oestrogen replacement, while a healthy diet, gentle aerobic exercise and reducing alcohol consumption all help.

Testosterone levels become dominant after oestrogen and progesterone have declined. The good news is that some women find they have increased drive and ambition for their career.

Agata Pospieszynska for Harper's Bazaar

Professor Janice Rymer, consultant gynaecologist

The perimenopause usually starts in our forties and is experienced very differently from woman to woman. Some may notice changes such as hot flushes, breast tenderness, fatigue and mood swings for years prior to their last period, while others may have minimal symptoms and for a short amount of time. Going through menopause, which happens to the average woman at the age of 51, can be challenging both mentally and physically, but there are a number of treatment options available. These include medication (the most effective is Hormone Replacement Therapy) and holistic strategies such as exercise, healthy eating and talking therapies. It is helpful for women to keep track of their menstrual cycle and noted own any symptoms to assist with diagnosis.

Eve Kalinik, nutritional therapist

Because the decline in oestrogen can affect bone density, an adequate intake of calcium during the menopause is important. The most easily absorbed forms include full-fat live yoghurt, cheese and kefir, while plant-based fortified milks are good for people who avoid dairy. Omega 3-rich foods may also help balance hormones eat oily fish (salmon, mackerel, sardines) and flaxseeds.

Try to incorporate a sufficient amount of fibre into your diet from a variety of fruits, vegetables, nuts, seeds and wholegrains: you should aim for six different types a day. In real terms, this could equate to adding berries and nut butter to porridge or sprinkling seeds over soups and salads. Foods rich in phytoestrogen soy (in the form of tempeh, miso or tofu), flaxseeds, sesame seeds and chickpeas may be beneficial, as they mimic oestrogen. Herbs that have shown to have some efficacy include sage, black cohosh and red clover.

Finally, looking after the health of the adrenals (the glands that produce stress hormones such as cortisol) is vital when transitioning into the menopause. Supplements can help try magnesium or B and C vitamins as can plants such as ashwagandha and rhodiola, classified as adaptogens, which can stabilise the adrenals and enable you to manage the response to stress better.

Dr Barbara Sturm, aesthetics doctor

Low oestrogen levels can diminish blood flow to the epidermis, leading to dry, itchy and irritated skin. As hormone levels decline, skin can look tired, develop more fine lines, and lose elasticity and glow. Many women also experience acne and skin-pigment changes; menopausal skin is more susceptible to UV damage, with a fall in melanocytes (the cells that produce the pigment melanin) causing deeper wrinkling and sun damage.

Skin Food supplement

60.00

To counteract this, a good hydration-boosting moisturiser is essential, as is a broad-spectrum sunscreen to protect against UVA and UVB rays. My Skin Food supplement contains a powdered mixture of the plant extract purslane, an anti-ageing powerhouse packed with omega 3 fatty acids and vitamin C that promotes skin renewal and hydration, boosting collagen and reducing signs of irritation. Kudzu root can help reduce hot flushes, while glucosamine may relieve aches and pains.

Cal Wansbrough, acupuncturist

In Chinese medicine, the menopause is believed to result from a decline in the cooling, moistening and calming effects of the kidney yin, or essence, resulting in heat, drying and anxiety. Overactivity can further deplete these resources, so rest is vital to reduce the intensity and frequency of the flushes you are likely to experience. Meditation or calming yoga are great, but you can also minimise your consumption of alcohol and coffee, and foods that heat you up, such as red meat, curries, anything fatty or fried and, sadly, chocolate. Remember to decompress and cool off in the emotional sense too repressed feelings can build up heat in our body. You may find that writing a journal helps, as can conversational therapy.

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Managing the menopause: symptoms, treatments and advice from the experts - harpersbazaar.com

New Study Reports Hormone Replacement Therapy Market 2020 Global Market Opportunities, Challenges, Strategies and Forecasts 2026 has been Added on Fact.MR.OverviewStarting from the fundamental details, the report provides a complete overview of the industry along with a proper market profile. The details provided here about the crucial technologies used for manufacturing and product management purpose makes it easier to have a thorough insight into the Global Hormone Replacement Therapy Market. Based on the information obtained, the market has been segmented into various categories. It predicts the growth rate of the Global Hormone Replacement Therapy Market in between the forecasted period, having a base year as 2020.

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This report focuses Global Hormone Replacement Therapy market, it covers details as following: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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Market DynamicsThe report identifies all the key aspects that drive the super-fast growth of the international Global Hormone Replacement Therapy Market. In this context, it identifies the crucial aspects regarding the pricing part of the concerned product. It analyses the market value of each of the products and services as well in the report, including the various kinds of volume trends. Prime aspects that are covered in this report range from the effect of growing population at international level, accelerating technological growth, and the analysis of level of demand and supply as evident in the Global Hormone Replacement Therapy Market. The report also covers extensive studies regarding various effects in relation to the initiatives taken by the government and the competitive platform that is there in the Global Hormone Replacement Therapy Market in between the forecasted period. Segmental AnalysisThe report does thorough segmentation of international Global Hormone Replacement Therapy Market upon taking various factors associated with the growth of the market. It does a thorough regional segmentation. These segmentation based studies are done with an intention of achieving a thorough and specific insight of the Global Hormone Replacement Therapy Market. The report does a regional analysis of the key zones of the world, starting from the US, North America, Latin America, Middle East & Africa, and Asia. Modes of researchThe research being done by experienced experts has done a comprehensive analysis of Global Hormone Replacement Therapy Market based on Porters Five Force Model, taking the assessment period between 2020-2026 into account. Additionally, a deep SWOT analysis is done to facilitate quick decision making for the associated people in the Global Hormone Replacement Therapy Market.

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Report covers:Comprehensive research methodology of Global Hormone Replacement Therapy Market.This report also includes detailed and extensive market overview with gap analysis, historical analysis & key analyst insights.An exhaustive analysis of macro and micro factors influencing the market guided by key recommendations.Analysis of regional regulations and other government policies impacting the Global Hormone Replacement Therapy Market.Insights about market determinants which are stimulating the Global Hormone Replacement Therapy Market.Detailed and extensive market segments with regional distribution of forecasted revenuesExtensive profiles and recent developments of market players

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Hormone Replacement Therapy Market to Witness Exponential Growth by 2018 to 2028 - Aerospace Journal

Hormone Replacement Therapy market report provides a detailed insight into the global market landscape and has an in-detail evaluation of the key market prospects. Growth dynamics and leading trends and other essential market prospects have been assessed in order to give the clients an in-depth understanding of the Hormone Replacement Therapy market. The report has a detailed forecast up to 2026 and a historical overview of the Hormone Replacement Therapy market.

Key Market Players mentioned are:F. Hoffmann-La RocheMerck SeronoNovartisNovo NordiskPfizerAbbott LaboratoriesANI PharmaceuticalsBayerEli LillyHisamitsu PharmaceuticalMerckMylan Laboratories

The report details and accounts for important and essential factors crucial to mapping a successful business plan and crafting strategies to ensure a profitable growth curve for the Hormone Replacement Therapy Market. Clients can get a detailed assessment of aspects such as revenue, growth, trends, scope, opportunities, risks, etc. to create a much stronger and effective business canvas. Stakeholders as well as the new players in the Hormone Replacement Therapy market can utilize this report and maximize their revenue generation potential and secure dominance in the global Hormone Replacement Therapy Market.

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Description:

This report on the Hormone Replacement Therapy market can be a complete guide to navigate our clients through the Hormone Replacement Therapy market and aid you in accordance with all the essential data required to establish dominance or sustain dominance in the Hormone Replacement Therapy market. The analysts have prepared a detailed and descriptive account of the market in the given report.

Clients through this report can strategize an effective and essential business plan and create an extensive business model to sustain over a long period of time. The report utilizes most of the in demand analyses and has been equipped with the most up to date data to give a complete understanding of the Hormone Replacement Therapy market. Business development, opportunities, dynamics, and expansion all can be navigated through the use of this latest report on the Hormone Replacement Therapy market.

The report is assessed using analyses such as SWOT analysis, Porters Analysis, predictive analysis, mechanistic analysis, and other essential analyses which are crucial to a good market research report. The report is perfectly suitable for all kinds of work approaches and is customizable to ensure maximum efficiency in the workflow.

Hormone Replacement Therapy Market Type Coverage: Estrogen replacement therapyGrowth hormone replacement therapy

Hormone Replacement Therapy Market Application Coverage: OralParenteralTransdermal

Market Segment by Regions and Nations included:

North America Country (United States, Canada)South AmericaAsia Country (China, Japan, India, Korea)Europe Country (Germany, UK, France, Italy)Other Country (Middle East, Africa)

Competitive Analysis:

The report has up to date data required to gain an edge over the different competitors in the Hormone Replacement Therapy market. The report has discussed in detail the mergers and acquisitions currently in place in the Hormone Replacement Therapy market landscape. The report illustrates an extensive account of the competitive landscape of the global market. The report will help our clients to navigate and emerge among the frontrunners of the market and for the current key players they will be able to sustain their lead in the market for a longer duration through the use of this report.

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Hormone Replacement Therapy Market 2020 Global Analysis By Application, End-User, Market Share, Demand, Supply, Technological Trends And Forecast Till...

Exclusive Interview with Dr. Zainab Mogul-Ashraf (Dr. Z) of Hebe Medical SpaInterview and Photography by Maxwell Alexander

Maxwell: Thank you for the interview opportunity and an amazing photoshoot, Dr. Z! I must say you are a natural when it comes to modeling. Great job! Please tell us a little bit about yourself and how did the idea of Hebe Medical Spa manifest in your life.

Dr. Z: Well thank you! We have done a few photoshoots the last couple of years and I can say I definitely feel more comfortable with it now! Not so much in the beginning.

I am an internist and I have always been interested in aesthetics, beauty, and fashion. I grew up with 3 sisters and we always played with makeup and were always interested in skincare. I also found great satisfaction in helping people feel better about their appearance and felt getting into aesthetics was a natural progression for me. I felt my training as an internist led med to look at the body as a whole and focus on wellness and beauty from the inside out. This gives me a different perspective and approach when it comes to working with my clients. About 3 years ago I met my business partner Irina in the gym. We were the only 2 women at 5 am in the morning pumping some serious iron. One day we started talking and we clicked and found so many things in common. We were both professional women, we were both into a healthy lifestyle and also believed in empowering men and women to be the best version of themselves. We formed a close friendship and one day I shared with her the idea I had to open a medical spa and I asked her if she would be interested to be my business partner and help me bring this idea to life. And the rest is history

Maxwell: Wow! Great story and a testimony to the fact that great minds think alike! Today Id like to talk to you about the concept of eternal beauty and what it means to you as a beauty industry expert. Looking at the beautiful masterpieces of art, like the Mona Lisa by Leonardo Da Vinci, that depicted beauty in his time, we all can see that the definition of ideal human body composition has evolved dramatically throughout the history of civilization. At the same time, we can draw some parallels that do stay current and priceless even today. What is your take on that?

Dr. Z: We believe that beauty comes from the inside out and outside in. What I mean by that is that for one to be the best version of themselves they have to feel good on the inside. They can achieve that through a wholesome diet, exercise, and daily meditation, or any other form of relaxation and self-development. There is also a lot to be said about waking up, looking in the mirror, and loving what you see. A lot of our clients come to us and one thing they say they want is to have clear skin so they dont have to wear makeup. Clear skin is youthful skin. Having flawless skin, less fine and wrinkles and feeling youthful and beautiful is such a confidence booster. This is where we come! When a person feels good about themselves, they are more motivated to do better in all areas of their lives. Our clients age ranges from the early 20s to the 80s. The young ladies in their 20s and 30s understand the importance of prevention and they start their Botox and care for their skin with facials, lasers, and good medically graded skin care products. We have a lot of clients in their 50s that come to us and their goal is to look as refreshed and youthful as possible. We can help with injectables, laser skin rejuvenation, and correction of sun damage, tone, and texture of the skin. For our ladies in their 60s and 70s, getting old is a gift, and bc we are getting old it doesnt mean we cant feel vibrant and beautiful.

Maxwell: Seems like our generation has gotten a lot closer to finding that elusive fountain of youth, I guess But what about some other natural beauty concepts that you come across in your line of work?

Dr. Z:Hebe Medical Spa is one of the best spas in the Hudson Valley and we offer numerous treatments from any injectable neuromodulators, dermal fillers, injectable bio stimulators, hair restoration, bioidentical hormone replacement therapy, laser skin rejuvenation, robotic micro-needling, laser hair removal, body contouring, weight loss program, IV vitamin therapy and more. When a client comes for a consultation I start with what their concerns are and figure out what treatments will be the best suited for them to help with those concerns. I always prioritize the treatments by safety first, second is downtime and last is cost. Also, I always think about not only delivering short term results for my clients but also long term effects of the treatments. I spend a lot of time and resources getting trained by the best injectors in the world and keep up with the latest injectable techniques because I always strive to deliver the best and most natural results for my clients.

One of the treatments that have gained tremendous interest lately is lip enhancements. I think thanks to IG and the Kardashians big luscious lips have become quite of a trend nowadays. I love doing lips, I take my time to make sure I create size and shape that enhances my clients facial structure. The smile on their faces when I am done is very gratifying. We have a sign in the spa that says you live once, buy yourself lips I think that sums it all.

Maxwell: Fascinating! And yes, I can relate to some of that myself, but thats going to be another story Talking about your clients the general assumption is that its the ladies who are so particular about their looks and the appearance of age, but what about the guys? What are they into when it comes to your services?

Dr. Z: You will be surprised to know but men are one of the fastest-growing patient segments in aesthetics and why shouldnt they be??? Men, just like women want to look like the best version of themselves and age gracefully. Taking care of their skin has become part of their grooming. Botox and dermal fillers for men can reduce the signs of aging. Of course, the approach to male aesthetics differs from that of females. Men have a squarer face, a more angled and larger jaw, and equally balanced upper and lower facial proportions. Facial muscle mass, subcutaneous tissue, and blood vessel density are also increased in men relative to women. So the techniques and amount of injectables I use are different for men and women. Men are great candidates for laser skin rejuvenation, laser hair removal, IV vitamin therapy, hair restoration, and bio-identical hormone replacement therapy. We also do regular facials. So if someone has no experience and is not sure where to start a facial membership is a great start and build from there.

Maxwell: Im on it, Dr. Z! Now I know that its never too early to start on my Botox shots When is your next Botox party? Anyways, in an interview a couple of years ago Hebe Med Spa had a goal of bringing all the state of the art beauty treatments to its clients in Fishkill, New York, today your clients are coming not only from all over the Hudson Valley, but all the way from New York City and even from across the country! What happened here?

Dr. Z: You got it right! One of the things I am very proud of is the reputation we have developed as skin and beauty experts in the area and I think a good reputation travels very fast nowadays. Hebe Med Spa has established itself as an expert in medical-grade beauty treatments and thanks to our big following and overwhelming support from social media we see more and more clients from beyond the Hudson Valley region. We also get tons of client referrals, which to us is the biggest compliment we can get and we truly appreciate the support! We have a big range of treatments form the state of the art equipment for skin rejuvenation, body contouring, robotic micro-needling, laser hair removal, bio-identical hormone replacement therapy, IV Vitamins, hair restoration, ample assortment of dermal fillers, Botox, collagen-stimulating injectables, PDO threads for non-surgical facelifts using the latest and most advanced techniques to create beautiful and natural results. We also have facial and laser memberships that are very affordable and make achieving and maintaining beautiful skin accessible to everyone. This month we are also launching Botox and filler membership and we are very excited about it. Taking care of your skin and staying fresh and youthful should be a part of your grooming and the memberships make that available to a lot more people.

Maxwell: Just wow! And the way to go! So whats next? What new beauty treatments should we discuss in our next sit down?

Dr. Z: As you know we are committed to always bringing the best, most advanced, non-invasive devices and procedures that deliver amazing results in the safest way possible. Here at Hebe, the best medical spa in Hudson Valley, our ethos is clear skin is youthful skin! No matter how much filler and Botox we inject in your face if your skin is not up to par you will never be completely satisfied with your results. But if you get your sun damage and pigmentation cleared, shrink the size of your pores, improve the tone and texture of your skin and minimize your fine lines and wrinkles that will make a permanent improvement. And this is where the lasers come in very handy. We have different devices that address different skin concerns. For example, our newest device is a skin resurfacing laser that resurfaces the top layer of the skin, its a beautiful treatment for fine lines and wrinkles, moderate sun damage, tone, and texture of the skin. The results are amazing and it is minimal downtime. We just introduced PDO Threads for facelift and collagen building. We are the only provider in the area that offers the PDO threads. We also have a Botox and filler membership that we are introducing in the month of October that will allow our clients to stay on schedule with their treatments without breaking the bank. I think the culture is changing the services we offer are no longer a luxury, they are becoming part of our grooming. We love what we do and we love our clients! We have created a beautiful environment for our clients and we have an amazing team! Please, come and let us be the one helping you with your pro-aging journey to become the best version of yourself.

Maxwell: Thank you so much, Dr. Z and I cant wait for our next story about the laser skincare treatments, it feels like the future is already here

Original post:
Exclusive Interview with Dr. Zainab Mogul-Ashraf (Dr. Z) of Hebe Medical Spa - Hudson Valley Style Magazine

Oct. 19, 2020 10:59 UTC

PRINCETON, N.J. & ALAMEDA, Calif.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (NASDAQ: EXEL) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) and supplemental New Drug Application (sNDA), respectively, for OPDIVO (nivolumab) in combination with CABOMETYX (cabozantinib) for patients with advanced renal cell carcinoma (RCC). The FDA granted Priority Review to both applications and assigned a Prescription Drug User Fee Act (PDUFA) goal date, or target action date, of February 20, 2021.

These filings were based on results from the Phase 3 CheckMate -9ER trial, which evaluated OPDIVO in combination with CABOMETYX in patients with previously untreated advanced RCC versus sunitinib. In CheckMate -9ER, OPDIVO in combination with CABOMETYX demonstrated significant improvements across all efficacy endpoints, including overall survival (OS), progression-free survival (PFS) and objective response rate (ORR), versus the comparator, sunitinib.

We have witnessed practice-changing advancements in the treatment of renal cell carcinoma in recent years, but we recognize the importance of providing patients and physicians with additional options that can help them take control of the disease, said Mark Rutstein, vice president, development program lead, OPDIVO, Bristol Myers Squibb. In the CheckMate -9ER trial, combining OPDIVO and CABOMETYX, two proven agents with strong clinical legacies in advanced renal cell carcinoma, led to superior efficacy across all endpoints. We look forward to working with the FDA to bring this potential treatment option to physicians and their patients who choose an immunotherapy plus tyrosine kinase inhibitor regimen.

With their complementary mechanisms of action and evidence that CABOMETYX may promote a more immune-permissive environment, we believe there is opportunity for additive or synergistic effects with this potential combination regimen, said Gisela Schwab, M.D., president, product development and medical affairs and chief medical officer, Exelixis. Based on strong supporting data from CheckMate -9ER, the acceptance of our application is important progress in our efforts to make CABOMETYX in combination with OPDIVO available to patients with advanced kidney cancer who need additional treatment options. We look forward to working with the FDA throughout the ongoing review process.

The combination of OPDIVO plus CABOMETYX was well tolerated, with a low rate of treatment-related discontinuations, and reflected the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in patients with previously untreated advanced RCC. In addition, patient-reported outcomes data from CheckMate -9ER showed that OPDIVO in combination with CABOMETYX was associated with statistically significant improvements in health-related quality of life at most time points versus sunitinib. On September 19, 2020, results from the trial were presented as a Proffered Paper during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Bristol Myers Squibb and Exelixis thank the patients and investigators who were involved in the CheckMate -9ER clinical trial.

About CheckMate -9ER

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

About Renal Cell Carcinoma

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 140,000 deaths worldwide each year. RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. The five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 12.1%.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the bodys own immune system to help restore anti-tumor immune response. By harnessing the bodys own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivos leading global development program is based on Bristol Myers Squibbs scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Companys Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

About CABOMETYX

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC and for the treatment of patients with HCC who have been previously treated with sorafenib. CABOMETYX tablets have also received regulatory approvals in the European Union, Japan 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.

OPDIVO INDICATIONS

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

OPDIVO IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

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

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

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

Immune-Mediated Pneumonitis

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

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

Immune-Mediated Colitis

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

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

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

Immune-Mediated Hepatitis

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

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

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

Immune-Mediated Endocrinopathies

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

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

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

Immune-Mediated Nephritis and Renal Dysfunction

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

Immune-Mediated Skin and Dermatologic Adverse Reactions

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

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

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

Immune-Mediated Encephalitis

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

Other Immune-Mediated Adverse Reactions

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

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

Infusion-Related Reactions

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

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

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

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

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

Embryo-Fetal Toxicity

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

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

In clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Lactation

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

Serious Adverse Reactions

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

Common Adverse Reactions

In Checkmate 037, the most common adverse reaction (20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067, the most common (20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%). In Checkmate 227, the most common (20%) adverse reactions were fatigue (44%), rash (34%), decreased appetite (31%), musculoskeletal pain (27%), diarrhea/colitis (26%), dyspnea (26%), cough (23%), hepatitis (21%), nausea (21%), and pruritus (21%). In Checkmate 9LA, the most common (>20%) adverse reactions were fatigue (49%), musculoskeletal pain (39%), nausea (32%), diarrhea (31%), rash (30%), decreased appetite (28%), constipation (21%), and pruritus (21%). In Checkmate 017 and 057, the most common adverse reactions (20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 032, the most common adverse reactions (20%) in patients receiving OPDIVO (n=245) were fatigue (45%), decreased appetite (27%), musculoskeletal pain (25%), dyspnea (22%), nausea (22%), diarrhea (21%), constipation (20%), and cough (20%). In Checkmate 743, the most common adverse reactions (20%) in patients receiving OPDIVO and YERVOY were fatigue (43%), musculoskeletal pain (38%), rash (34%), diarrhea (32%), dyspnea (27%), nausea (24%), decreased appetite (24%), cough (23%), and pruritus (21%). In Checkmate 025, the most common adverse reactions (20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 214, the most common adverse reactions (20%) reported in patients treated with OPDIVO plus YERVOY (n=547) were fatigue (58%), rash (39%), diarrhea (38%), musculoskeletal pain (37%), pruritus (33%), nausea (30%), cough (28%), pyrexia (25%), arthralgia (23%), decreased appetite (21%), dyspnea (20%), and vomiting (20%). In Checkmate 205 and 039, the most common adverse reactions (20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (10%) in patients receiving OPDIVO (n=236) were cough and dyspnea at a higher incidence than investigators choice. In Checkmate 275, the most common adverse reactions (20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO as a single agent, the most common adverse reactions (20%) were fatigue (54%), diarrhea (43%), abdominal pain (34%), nausea (34%), vomiting (28%), musculoskeletal pain (28%), cough (26%), pyrexia (24%), rash (23%), constipation (20%), and upper respiratory tract infection (20%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, the most common adverse reactions (20%) were fatigue (49%), diarrhea (45%), pyrexia (36%), musculoskeletal pain (36%), abdominal pain (30%), pruritus (28%), nausea (26%), rash (25%), decreased appetite (20%), and vomiting (20%). In Checkmate 040, the most common adverse reactions (20%) in patients receiving OPDIVO (n=154) were fatigue (38%), musculoskeletal pain (36%), abdominal pain (34%), pruritus (27%), diarrhea (27%), rash (26%), cough (23%), and decreased appetite (22%). In Checkmate 040, the most common adverse reactions (20%) in patients receiving OPDIVO with YERVOY (n=49), were rash (53%), pruritus (53%), musculoskeletal pain (41%), diarrhea (39%), cough (37%), decreased appetite (35%), fatigue (27%), pyrexia (27%), abdominal pain (22%), headache (22%), nausea (20%), dizziness (20%), hypothyroidism (20%), and weight decreased (20%). In Checkmate 238, the most common adverse reactions (20%) reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). The most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%). In Attraction-3, the most common adverse reactions occurring in 20% of OPDIVO-treated patients (n=209) were rash (22%) and decreased appetite (21%).

In a separate Phase 3 trial of YERVOY 3 mg/kg, the most common adverse reactions (5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).

Please see U.S. Full Prescribing Information for OPDIVO and YERVOY.

Checkmate Trials and Patient Populations

Checkmate 037previously treated metastatic melanoma; Checkmate 066previously untreated metastatic melanoma; Checkmate 067previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 227previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; Checkmate 9LApreviously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology; Checkmate 017second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 032small cell lung cancer; Checkmate 743 previously untreated unresectable malignant pleural mesothelioma, in combination with YERVOY; Checkmate 025previously treated renal cell carcinoma; Checkmate 214previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 205/039classical Hodgkin lymphoma; Checkmate 141recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 275urothelial carcinoma; Checkmate 142MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 040hepatocellular carcinoma, as a single agent or in combination with YERVOY; Checkmate 238adjuvant treatment of melanoma; Attraction-3esophageal squamous cell carcinoma

CABOMETYX Important Safety Information

Warnings and Precautions

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

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

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

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

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

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

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

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

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Womens Health Diagnostics Market: Introduction

According to the report, the globalwomens health diagnostics marketwas valued at ~US$ 30.7 Bnin2018and is projected to expand at a CAGR of~6%from2019to2027.Rise in prevalence of menopause, favorable incentive and reimbursement policies for UTIs, and technical advancements are anticipated to augment the global market from 2019 to 2027. North America and Western Europe are expected to account for significant shares of the global womens health diagnostics market. Asia Pacific is projected to be a highly lucrative market for womens health diagnostics in the next few years. However, high competition is anticipated to restrain the growth of the global womens health diagnostics market.

Rise in Number of Menopausal Women to Propel Market

Menopause is defined as a permanent cessation of menstruation resulting from loss of activity of ovarian follicles. In a majority of women, menopause is a natural event occurring at the age of around 51.3 years. The number of women entering the menopause stage is increasing due to unhealthy lifestyle and different environmental factors. Presently, over5 millionwomen in Canada aged between 45 and 65 either have gone through menopause or will soon do. The average age of menopause in Canada is 51 years.

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Favorable Incentive and Reimbursement Policies for UTIs to Augment Market

Incentive policies for antibiotic consumption are favoring the urinary tract infection (UTI) treatment market, as governments of most countries approve the use of antibiotics in UTI treatment and provide reimbursement for it. Economic incentives are also provided all along the supply chain, which consists of distributors, suppliers, hospitals, clinics, and communities. Over80%of antibiotics are used in countries where purchasing of antibiotics without prescription is common. These include countries such as India, China, and other low- and middle-income countries.

Risk of Breast Cancer Due to HRT Treatment to Restrain Market

Risk of breast cancer associated with hormone replacement therapy (HRT) treatment has been one of the leading challenges in the past few years. HRT is an effective short-term treatment for menopausal symptoms; however, it increases the risk of breast cancer. Incidence rate of breast cancer has dropped sharply in the U.S., as a large number of women have stopped using menopausal hormones. Decline in adoption of HRT treatment can negatively affect the global womens health diagnostics market.

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Asia Pacific Womens Health Diagnostics Market to Expand Significantly

Rise in prevalence of cancer & infectious diseases, increase in collaborations between hospitals and tissue banks, and surge in investments in research & development are likely to drive the womens health diagnostics market in Asia Pacific during the forecast period. This market in Asia Pacific is likely to expand at a high CAGR from2019to2027. Growth of the womens health diagnostics market in the region can be attributed to increase in health coverage, rise in healthcare expenditure, surge in awareness among people, and government initiatives

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Competition Landscape

The report also provides profiles of leading players operating in the global womens health diagnostics market. These include Abbott Laboratories, Becton, Dickinson and Company, bioMrieux SA, F. Hoffmann-La Roche AG, GE Healthcare, Hologic, Inc., Koninklijke Philips N.V., Quest Diagnostics, Inc., Cardinal Health, and Siemens AG.

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Women's Health Diagnostics Market projected to expand at a CAGR of ~6% from 2019 to 2027 - The Think Curiouser

Jammu: Directorate of School Education Jammu in collaboration with Medanta Hospital Gurugram organised a webinar on Breast Cancer Disease Early Detection Saves Lives for creating awareness about this disease among Adolescent Girls and Female Staff of School Education Department.Director School Education Jammu, Anuradha Gupta, presided over the session while Dr. Kanchan Kour, Director Medanta Divisional Health Services was the Resource Person. More than two thousand participants attended this session Live and subsequently many more took the benefit of the webinar through various other social media platforms which included HOIs, teachers, adolescent girls, students and members of the society.While inaugurating the session, Anuradha Gupta, Director School Education Jammu emphasised on the importance of the topic, saying that the awareness about breast cancer needs to be spread so that girls and women who are shy to discuss such issues openly may get acquainted about its early symptoms and share this knowledge with others, especially girls. She encouraged the participants to ask more and more questions about breast cancer without any hesitation from Dr. Kanchan Kour.Dr. Kanchan Kour, Director Medanta Divisional Health Services threw light on the causes, symptoms and treatment available for breast cancer. She stressed upon self-examination to be conducted by girls and women so as to know about any changes and consult the specialist on time.Queries raised by participants related to breastfeeding, oral contraceptives, hormone replacement therapy, breast reconstruction, treatment options,etc. were also addressed by the resource person .Romesh Sharma, Head Counselling Cell DSEJ coordinated this webinar whereas Alka Sharma, Team Member, Cultural and Educational Cell DSEJ moderated the proceedings of the session. Mr. Sohail Wani, incharge IT cell, provided the required technical support.

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DSEJ organises Webinar on Breast Cancer Disease- Early Detection Saves Lives - India Education Diary