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Aug 31

[PDF] Hormone Replacement Therapy Market to Reflect Steady Growth and Future Scope UNLV The Rebel Yell – UNLV The Rebel Yell

One of the key factors fueling the growth of the global hormone replacement therapy market is increasing acquisitions. Pfizer Inc., a pharmaceutical firm headquartered in the United States, combined with OPKO Health Inc., a business based in the U.S., in 2014 to create a long-acting growth hormone (hGH-CTP) and novel therapies for growth hormone deficient individuals. hGH-CTP is more convenient since patients just require one injection each week instead of daily dosages. In the U.S. and Europe, hGH-CTP has been designated as an orphan medication for children and adults with growth hormone deficiencies.

The expansion of the global hormone replacement therapy market is projected to be aided by a strong pipeline. In 2017, Novo Nordisk A/S, a Danish firm, completed phase 3 clinical studies for Somapacitan. This medication is used to treat adult testosterone deficiency.

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Major Company Profiles Covered in This Report:Novartis AG, Abbott Laboratories, Mylan N.V., Merck KgaA, Bayer AG, Pfizer Inc., Novo Nordisk A/S, QuatRx Pharmaceuticals, Teva Pharmaceutical Industries Ltd., Amgen, Inc., and Eli Lilly and Company.

The market for hormone replacement treatment is projected to expand due to the rising prevalence of various chronic diseases.

The market for hormone replacement treatment is projected to expand due to the rising prevalence of hypogonadism in adult males throughout the world. Hypogonadism affects 2.1 percent to 12.8 percent of middle-aged men, according to the European Association of Urologys 2016 study. In Europe, the prevalence of low testosterone and hypogonadism symptoms in males aged 40 to 79 ranges from 2.1 percent to 5.7 percent.

The expansion of the global hormone replacement therapy market is projected to be aided by easier access and government assistance for research and development efforts. NGOs such as the National Gaucher Society provide financial assistance to patients who require expensive insulin replacement treatment.

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Companies are concentrating their efforts on creating generic versions of numerous medications for the treatment of diseases that are more common in women, such as hypothyroidism. On July 24, 2017, Teva Pharmaceutical Industries Ltd. introduced a generic version of Vagifem, 10 mcg, in the United States. Estradiol vaginal inserts are a kind of oestrogen used to treat atrophic vaginitis caused by menopause.

Furthermore, Mylan N.V. received FDA clearance for its Abbreviated New Medication Application (ANDA) for Estradiol Vaginal Cream USP, 0.01 percent on December 29, 2017, and therefore marketed the drug in the U.S. This cream is the first generic alternative to Allergans Estrace Cream, which is used to treat vulvar and vaginal atrophy.

Mylan is one of the few firms that sells Estradiol in cream, gel, transdermal patch, and tablet form. This will benefit both healthcare personnel and patients, as well as ensuring the businesss long-term viability.

Major companies contributing in the global hormone replacement therapy market are Pfizer Inc., QuatRx Pharmaceuticals, Mylan N.V., Abbott Laboratories, Amgen, Inc., Novartis AG, Eli Lilly and Company, Bayer AG, Merck KgaA, Teva Pharmaceutical Industries Ltd., and Novo Nordisk A/S.

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Some Notable Offerings by Coherent Market Insights Report on Hormone Replacement Therapy market:

We will provide you an analysis of the extent to which this Hormone Replacement Therapy market research report acquires commercial characteristics along with examples or instances of information that helps you to understand it better.

We will also help to identify customary/ standard terms and conditions, as offers, worthiness, warranty, and others.

Also, this report will help you to identify any trends to forecast growth rates.

The analyzed report will forecast the general tendency for supply and demand.

Also, Research Report Examines:

Competitive companies and manufacturers in global market

By Product Type, Applications & Growth Factors

Industry Status and Outlook for Major Applications / End Users / Usage Area

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[PDF] Hormone Replacement Therapy Market to Reflect Steady Growth and Future Scope UNLV The Rebel Yell - UNLV The Rebel Yell


Aug 5

Human Growth Hormone (HGH) Market SWOT Analysis by Size, Status and Forecast to 2021-2027 The Manomet Current – The Manomet Current

The latest independent research document on Global Human Growth Hormone (HGH) examine investment inMarket. It describes how companies deploying these technologies across various industry verticals aim to explore its potential to become a major business disrupter. The Human Growth Hormone (HGH) study eludes very useful reviews & strategic assessment including the generic market trends, emerging technologies, industry drivers, challenges, regulatory policies that propel the market growth, along with major players profile and strategies. This version of Human Growth Hormone (HGH) market report advocates analysis of Sandoz International, Ipsen, GeneScience Pharmaceuticals, Anhui Anke Biotechnology (Group), BioPartners, Ferring Pharmaceuticals, F. Hoffmann-La Roche, Novo Nordisk, Merck Serono, LG Life Sciences, Teva Pharmaceutical Industries, Eli Lilly & Pfizer.

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As Human Growth Hormone (HGH) research and application [Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Insufficiency, Prader Willi Syndrome, Small for Gestational Age & SHOX Deficiency] continues to expand in scope, the market will see deeper integration and application of more technologies in the future. This commercialization of market is playing a positive role in accelerating Human Growth Hormone (HGH) business digitalization, improving industry chain structures and enhancing information use efficiency. The findings mainly focus on category or product type: , Powder & Solvent etc, which underpins many recent advances in the other Human Growth Hormone (HGH) technologies.

In order to provide a more informed view, Human Growth Hormone (HGH) research offers a snapshot of the current state of the rapidly changing industry, looking through the lenses of both end users and service provides/players ofto come up with a more robust view.

Market Scope

Based on the type of product, themarket segmented into :, Powder & Solvent

Based on the End use application, themarket segmented into :Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Insufficiency, Prader Willi Syndrome, Small for Gestational Age & SHOX Deficiency

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Regional Landscape

Geographically, the Human Growth Hormone (HGH) market size by revenue is broken down by 18+ countries fromNorth America, LATAM, the Middle East, Asia Pacific, Africa, and Europebased on various characteristics such as geographic footprints and business operation locations of players.

Analysts at HTF MI sheds light on Human Growth Hormone (HGH) market data by Country

Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, South Korea, Thailand, India, Indonesia, Australia and Others)Europe (Germany, Russia, the UK, Italy, France, Spain, Belgium, Netherlands, Switzerland, Nordic Nations, Rest of Europe.)North America (the United States, Mexico, and Canada)South America (Brazil, Argentina, Chile, Rest of South America)Middle East and Africa (GCC Countries, Turkey, Israel, South Africa, Egypt and Rest of MEA)

The Human Growth Hormone (HGH) study cites various market development activities and business strategies such as new product/services development, Joint Ventures, partnerships, mergers and acquisitions, etc that Industry players such as Sandoz International, Ipsen, GeneScience Pharmaceuticals, Anhui Anke Biotechnology (Group), BioPartners, Ferring Pharmaceuticals, F. Hoffmann-La Roche, Novo Nordisk, Merck Serono, LG Life Sciences, Teva Pharmaceutical Industries, Eli Lilly & Pfizer are utilizing to overcome macro-economic scenarios. The Human Growth Hormone (HGH) Market company profiles include Business Overview, Product / Service Offerings, SWOT Analysis, Segment & Total Revenue, Gross Margin and % Market Share.

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Extracts from Global Human Growth Hormone (HGH) Market Study

1. Market Snapshot2. Global Human Growth Hormone (HGH) Market Factor Analysis Value Chain Analysis Growth Drivers, Trends and Challenges Porters 5- Forces Analysis PESTEL Analysis3.Human Growth Hormone (HGH) Market by Type (2016-2026) [, Powder & Solvent]4. Market by Applications/ End Users (2016-2026) [Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Insufficiency, Prader Willi Syndrome, Small for Gestational Age & SHOX Deficiency]5.Human Growth Hormone (HGH) Market: Country Landscape6. Market Size Breakdown for Each Country7. Competitive Landscape Market Share Analysis by Players Company Profiles

.. Continued

Data Sources & Methodology

The primary sources involve the industry experts from the Global Human Growth Hormone (HGH) Market including the management organizations, processing organizations, service providers of the industrial value chain. In the extensive research process undertaken for this study, the primary sources considered such as Postal Surveys, telephone, Online & Face-to-Face Survey to obtain and verify both qualitative and quantitative aspects. When it comes to secondary sources Companys Annual reports, press Releases, Websites, Investor Presentation, Conference Call transcripts, Webinar, Journals, Regulators, National Customs and Industry Associations were used.

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Thanks for reading Human Growth Hormone (HGH) Industry research publication; you can opt for regional report version like Western Europe, USA, China, Southeast Asia, LATAM, APAC etc. Also, we can serve you with customize research services as HTF MI holds a database repository that includes Public organizations and Millions of Privately held companies with expertise across various Industry domains.

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Human Growth Hormone (HGH) Market SWOT Analysis by Size, Status and Forecast to 2021-2027 The Manomet Current - The Manomet Current


Aug 5

Home of Guiding Hands leader takes new job at San Diego Regional Center – The San Diego Union-Tribune

EL CAJON

Mark Klaus, president and CEO of the East County-based Home of Guiding Hands for the past 11 years, has been tapped to lead the San Diego Regional Center, one of the countys largest nonprofits.

Klaus is credited with helping Home of Guiding Hands, which serves people with developmental challenges, grow from 400 to 4,000 clients.

Starting Nov. 1, Klaus will take over as executive director of the San Diego Regional Center, which serves about 34,000 clients in San Diego and Imperial counties. Klaus was named the head of the SDRC on Tuesday by a unanimous vote of the centers governing board.

The SDRC is one of 21 similar centers in California, all of which work with community partners like Home of Guiding Hands to serve more than 380,000 individuals with developmental disabilities. The Regional Center works with families of individuals with developmental challenges to help them achieve their goals.

Klaus will follow Carlos Flores, 66, who started with the center in 1999, became executive director in 2007, and was set to retire early in 2020, right before the COVID-19 pandemic hit. He stayed to see the 650-employee center through the health emergency.

San Diego Regional Center Board Chair Shirley Nakawatase said Klaus is the perfect fit. She cited Klaus and Flores close working relationship as key to a seamless transition. The two leaders have taken many trips to state and national legislatures, lobbying for developmentally challenged persons, their caretakers and families.

Mark Klaus will be the new Executive Director at the San Diego Regional Center

(Nadia Borowski Scott/ Alchemy MediaWorks)

Among other accomplishments, under Klauss leadership, HGH developed a program that concentrates on helping families with newborns through age 3. He helped 60-year-old HGH advance more community-based services and navigate 30 residential homes for adults with developmental disabilities.

Klaus will earn about $360,000 in his new role at the Regional Center. The groups operating budget is about $70 million of its overall $600 million budget. The group operates its programs and eight offices seven in San Diego County, one in the city of Imperial through grants and government assistance, mostly from the state Department of Developmental Services.

Over the last 510 days, working even closer with Carlos and his staff, I saw firsthand their values, their culture, their desires and I saw they are really aligned with Home of Guiding Hands and what I believe in, said Klaus, 58. I am grateful to have the opportunity to have an even larger impact on the people we serve.

Klaus said that while a high school student in Illinois, he volunteered with a company that worked with individuals with disabilities, not thinking at the time that it would become his future avocation.

After earning a bachelors degree in economics from the University of Illinois, he started working in the field and worked his way up to President and Chief Executive Officer of Charleston Transitional Facility in Champaign, Ill. He later spent 10 years heading the nonprofit CTF Illinois, which provides programs and services for those with developmental disabilities and mental illness.

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Home of Guiding Hands leader takes new job at San Diego Regional Center - The San Diego Union-Tribune


Aug 5

Overview Infrared Line Scanners Market 2021-2026 Business Analysis by Top Companies like HGH INFRARED SYSTEMES, NDC Technologies, INTERMEC, Optris,…

The Infrared Line Scanners market report provides a detailed analysis of global market size, regional and country-level market size, segmentation market growth, market share, competitive Landscape, sales analysis, the impact of domestic and global market players like HGH INFRARED SYSTEMES, NDC Technologies, INTERMEC, Optris, Fluke, GESOTEC, etc., value chain optimization, trade regulations, recent developments, opportunities analysis, strategic market growth analysis, product launches, area marketplace expanding, and technological innovations.

The Key Areas That Have Been Focused in the Report:

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Infrared Line Scanners Market Segmentation:

Infrared Line Scanners market is split by Type and by Application. For the period 2016-2026, the growth among segments provides accurate calculations and forecasts for sales by Type and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.

Infrared Line Scanners Market Report based on Product Type:

Infrared Line Scanners Market Report based on Applications:

The key market players for global Infrared Line Scanners market are listed below:

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Promising Regions & Countries Mentioned in Infrared Line Scanners Market Report:

TABLE OF CONTENTS INCLUDE

Consumption Forecast, Market Opportunities & Challenges, Risks and Influences Factors Analysis, Market Size by Application, Market Size by Manufacturers, Market Size by Type, Infrared Line Scanners Consumption by Regions, Infrared Line Scanners Production by Regions, Production Forecasts, Value Chain and Sales Channels Analysis, Key Findings in the Global Infrared Line Scanners Study, Manufacturers Profiles

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Impact of COVID-19 on Infrared Line Scanners Market

The report also contains the effect of the ongoing worldwide pandemic, i.e., COVID-19, on the Infrared Line Scanners Market and what the future holds for it. It offers an analysis of the impacts of the epidemic on the international Market. The epidemic has immediately interrupted the requirement and supply series. The Infrared Line Scanners Market report also assesses the economic effect on firms and monetary markets. Futuristic Reports has accumulated advice from several delegates of this business and has engaged from the secondary and primary research to extend the customers with strategies and data to combat industry struggles throughout and after the COVID-19 pandemic.

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Overview Infrared Line Scanners Market 2021-2026 Business Analysis by Top Companies like HGH INFRARED SYSTEMES, NDC Technologies, INTERMEC, Optris,...


Jul 21

Still time to enter La Baie Run to raise funds for Hawkesbury and District General Hospital, United Way – The Review Newspaper

The virtual edition of La Baie Run begins this Friday, July 23, and participants can sign up and complete their runs anytime before July 31 in support of the Hawkesbury and District General Hospital (HGH) Foundation and the United Way East Ontario.

The event normally based out of LOrignal Park is once again virtual in 2021 and organizers are aiming to raise $25,000 for the two charity organizations. Held also as a virtual event in 2020, La Baie Run drew more than 300 participants and raised a total of $20,000 for the HGH Foundation. The initial live edition of the run raised $15,000 in 2019.

La Baie Run race participation kits can be picked up at Sports Experts in Hawkesbury this Thursday, July 22, from 3-8 p.m. There is a limit of 300 kits. Additional participants can still enter and complete their runs by July 31, but will not receive a race kit.

Signing up for the run is easy by just visiting http://www.labaierun.com. The cost is $40 and runners can enter right up until the final day of July 31.

The event is already well on its way to hitting its fundraising target, says Patrick Lalonde, owner of Lalonde Physio in LOrignal, one of the organizers of La Baie Run.

The corporate team challenge has had a lot of entries from local businesses, who have responded to the call to action, Lalonde said on Monday, July 19. We are expecting a large influx of entries this week, because it is the last week.

The fundraiser is looking very promising in terms of success.

Lalonde has announced he will run the entire 72-kilometre length of the Prescott-Russell Recreational Trail if the fundraising target of $25,000 is reached. It should not be a difficult time for the avid runner, who ran the full length of the trail after the event in 2020 and recently completed a 110-kilometre run in Gatineau Park.

Participants in the 2021 edition of La Baie Run have options to complete in either 1km, 5km, 10km, half marathon, full marathon or a 72-km ultra course. Distances are monitored using GPS tracking on the runners smart phones and once their race is completed times can be uploaded to SportStats, where the results will be included in the events final standings.

Participants can complete their walk or run anytime between July 23-31. There will be draws for multiple prizes for everyone taking part.

Originally organized by Lalonde Physio, La Baie Run has grown significantly over the past three years and is now organized by a committee of local volunteers. While the funds from the first two events went solely to the HGH Foundation, organizers have added the United Way East Ontario as a beneficiary of the funds from the 2021 event, along with the hospital foundation.

More information, photos and a complete list of the sponsors for the event can be found by visiting the 2020 La Baie Run Facebook page.

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Still time to enter La Baie Run to raise funds for Hawkesbury and District General Hospital, United Way - The Review Newspaper


Jul 7

The Importance Of The Human Growth Hormone For The Wellness Of Your Body – The Seeker Newsmagazine Cornwall – The Seeker

The pituitary glands produce hormones that are essential for the functioning of the body. These hormones ensure that the bodys metabolism, growth, fertility, immune system, etc., function optimally. Besides that, hormones are also responsible for other bodily functions like hunger, sexual desires, blood pressure, reproduction, repair for injury, etc. Hormones are active in a persons body even before birth and control the development of organs.

However, as we age, the hormone production in our body reduces and results in changes that we associate with aging. To battle these changes and ensure the hormone levels are restored to normalcy, people might opt for Human Growth Hormone (HGH) supplements. Read on to find out why HGH is important for your bodys functioning and overall well-being.

HGH is responsible for building muscles, increasing energy, and improved exercising ability. A person battling with growth hormone deficiency might notice an increase in weight gain, lack of energy, and low athletic ability. A study was conducted to understand the impact of GH. A group of 303 athletes was given Growth Hormone Injection for 20 days. At the end of the study, the athletes experienced an increase in their lean body mass, increased ability to exercise, and an ability to retain fluid. These results were compared to the placebo group, and it was found that HGH injections can significantly increase athletic performance.

The pea-sized pituitary gland in the base of our brain produces the growth hormone. It fuels growth in childhood and maintains the health of tissues and organs throughout our lifetime. As we age, the growth hormone production starts to decline, which results in loss of muscle, a decreased aerobic capacity, and an increase in abdominal fat. As the presence of growth hormone reduces in the body, the skin loses its firmness, and we develop wrinkles, saggy skin, and look old.

Using HGH supplements restores the youthful glow, energy, and sexual drive and helps you feel a few years younger. As the HGH supplements boost metabolism, your body burns fat faster and slows down the signs of aging and age-related ailments. And thus, it helps you look and feel younger than your actual age.

The sexual organs need unimpeded blood flow for optimum functioning and sexual desire. The blood flow and hormone levels change in the body as we age. The testosterone levels in a persons body reduce with age and impact their libido. Regular intake of growth hormones increases sexual desire and the ability to perform sexual acts. Besides, it is also effective in treating erectile dysfunction, leaving the person feeling like they have reversed their aging and vigor clock. In other words, if you are battling low sperm count, erectile dysfunction, or any other sexual wellness problem, HGH therapy can come to your rescue.

While speaking of HGH, most people restrict the discussion to its benefits on how a person looks and their energy levels. But there is more to it than that. As the levels of growth hormone decrease in the person, it also impacts their mental health. A growth hormone deficiency increases the risk of anxiety and depression. Taking HGH supplements can effectively remedy this situation. The somatotropin in the growth hormone increases the dopamine and endorphin levels in the body, helps you calm down, and reduces anxiety and stress.

The B-endorphins produced in the body due to the supplements act as a natural anti-depressant and significantly reduce social anxiety. Several studies also found that supplements can regulate a persons sleep cycle, which also significantly improves a persons physical and mental health. However, the rush of hormones in the body while taking supplements could result in behavioral changes and anger issues.

As we age, the calcium density in the bones reduces. This leads to conditions like Osteoporosis, where the bones become weak and brittle, making them susceptible to breakage and fracture. There have been instances where people with Osteoporosis have broken their bones while performing simple acts like coughing or bending over.

While a healthy diet and medication can treat the condition, it is impossible to restore bone health to normalcy unless the hormones in the body are replenished.HGH stimulates bone health by increasing bone mineral density and makes your bones stronger. With regular intake, growth hormones can accelerate the process of healing broken bones and builds bone mass. This ensures that your body is strong from within and protects you from fracture risks in the future.

HGH is instrumental in maintaining our overall well-being. To ensure that you are taking the right supplements in the correct dosage, consult your doctor.

The information contained in this article is for informational purposes only and is not in any way intended to substitute medical care or advice from your doctor.

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The Importance Of The Human Growth Hormone For The Wellness Of Your Body - The Seeker Newsmagazine Cornwall - The Seeker


Jul 7

The Global Endocrinology Drugs Market is expected to grow by $ 25.25 bn during 2021-2025, progressing at a CAGR of over 6% during the forecast period…

Global Endocrinology Drugs Market 2021-2025 The analyst has been monitoring the endocrinology drugs market and it is poised to grow by $ 25. 25 bn during 2021-2025, progressing at a CAGR of over 6% during the forecast period.

New York, July 05, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Endocrinology Drugs Market 2021-2025" - https://www.reportlinker.com/p03793964/?utm_source=GNW Our report on endocrinology drugs market provides a holistic analysis, market size and forecast, trends, growth drivers, and challenges, as well as vendor analysis covering around 25 vendors.The report offers an up-to-date analysis regarding the current global market scenario, latest trends and drivers, and the overall market environment. The market is driven by the increase in the incidence of endocrine disorders and promising pipeline for endocrinology. In addition, an increase in the incidence of endocrine disorders is anticipated to boost the growth of the market as well.The endocrinology drugs market analysis includes therapy area segment and geographic landscape.

The endocrinology drugs market is segmented as below:By Therapy Area Diabetes drugs hGH Thyroid hormone disorders Others

By Geography North America Europe Asia ROW

This study identifies the research in novel dosage formulations and drug delivery systems as one of the prime reasons driving the endocrinology drugs market growth during the next few years.

The analyst presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources by an analysis of key parameters. Our report on endocrinology drugs market covers the following areas: Endocrinology drugs market sizing Endocrinology drugs market forecast Endocrinology drugs market industry analysis

This robust vendor analysis is designed to help clients improve their market position, and in line with this, this report provides a detailed analysis of several leading endocrinology drugs market vendors that include Acerus Pharmaceuticals Corp., Beta Cell NV, Eli Lilly and Co., GlaxoSmithKline Plc, Ipsen Pharma SA, Merck and Co. Inc., Novartis AG, Novo Nordisk AS, Pfizer Inc., and Sanofi SA. Also, the endocrinology drugs market analysis report includes information on upcoming trends and challenges that will influence market growth. This is to help companies strategize and leverage all forthcoming growth opportunities.The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to an analysis of the key vendors.

The analyst presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources by an analysis of key parameters such as profit, pricing, competition, and promotions. It presents various market facets by identifying the key industry influencers. The data presented is comprehensive, reliable, and a result of extensive research - both primary and secondary. Technavios market research reports provide a complete competitive landscape and an in-depth vendor selection methodology and analysis using qualitative and quantitative research to forecast the accurate market growth.Read the full report: https://www.reportlinker.com/p03793964/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The Global Endocrinology Drugs Market is expected to grow by $ 25.25 bn during 2021-2025, progressing at a CAGR of over 6% during the forecast period...


Jul 7

Hallelujah, the MLB announced there will be no sticky-substance checks at the All-Star Game, a game which literally does not matter – Golf Digest

Believe it or not, the MLBs All-Star weekend is less than two weeks away. Maybe youve been busy getting back to life, or maybe youve been distracted by baseballs Controversy Du Jour, which just so happens to be Sticky Substances. In mid-June, the MLB officially began in-game checks on pitchers for long-accepted substances used to help apply spin to the baseball and avoid career-altering injury in doing so. The midseason 180 has generated plenty of backlash from pitchers and fans alike, and has led to countless surprisingly creepy interruptions to your regularly scheduled baseball programming.

But we have spectacular news, anti-anti-stickies: This week the MLB made the HUGE announcement that it will take a ONE-NIGHT ONLY break from foreign-substance checks for the comprehensively meaningless All-Star Game. Wow. What can we say. We are truly blessed to be a part of such a wonderful sport run so wisely by the great and all-knowing Mr. Robert Manfred. Glory be!

Industrial-grade sarcasm aside, it really makes you wonder what the thought processif there is oneis here. At the height of the steroid era, the MLB didnt make the All-Star Game free HGH night. During the juiced ball era, they didnt give the Home Run Derby participants Superballs to hit. When it comes to watching Jacob DeGrom throw exactly two-thirds of an inning of consequenceless baseball, however, theyre relaxing their own hastily established rules in the name of, um, more strikeouts?

If that sounds dumb to you, thats because it is dumb. Welcome to baseball. Youre going to love it here.

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Hallelujah, the MLB announced there will be no sticky-substance checks at the All-Star Game, a game which literally does not matter - Golf Digest


Jul 7

Ascendis Pharma A/S Announces Target Enrollment Achieved in the Phase 3 PaTHway Trial of TransCon PTH – GuruFocus.com

Ascendis expects to complete enrollment of subjects still in screening within one week

PaTHway top-line data now anticipated in Q1 2022 and submission of a New Drug Application (NDA) in mid-2022

Announces design of PaTHway Japan Trial and receipt of Orphan Drug Designation (ODD) from the Japanese Ministry of Health, Labor and Welfare (MHLW)

Defined pathway for global regulatory filings

COPENHAGEN, Denmark, July 06, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S ( ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create new product candidates that address unmet medical needs, today announced it has reached the target enrollment in the phase 3 PaTHway Trial, a trial evaluating the safety, tolerability, and efficacy of TransCon PTH (palopegteriparatide) in addition to providing a comprehensive global clinical program update.

The durable benefit demonstrated in our phase 2 PaTH Forward Trial Week 58 data supports the use of TransCon PTH as a potential new treatment paradigm for adults with HP. We are committed to bringing TransCon PTH as quickly as possible to all patients with HP independent of etiology, said Jan Mikkelsen, Ascendis Pharmas President and Chief Executive Officer. Given the strong demand and our commitment to patients and clinical investigators, although we stopped screening new subjects in early June, if any subject had started the screening process by June 7th, they will be enrolled in the phase 3 PaTHway Trial if all the criteria are met. We anticipate announcing top-line results from the PaTHway Trial in the first quarter of 2022, and if successful, followed by an expected NDA submission in mid-2022.

We are pleased to continue extending the global clinical reach for TransCon PTH for all HP patients as a key component of our Vision 3x3. With recent acceptances from regulatory authorities relating to the PaTHway Japan Trial and the PaTHway China Trial through VISEN Pharmaceuticals (VISEN), we believe we now have a defined pathway to obtain regulatory approval in countries representing over 400,000 patients, continued Mr. Mikkelsen.

The PaTHway Trial is a phase 3, randomized, double-blind, placebo-controlled trial in North America and Europe evaluating the safety, tolerability, and efficacy of palopegteriparatide in adults with HP. The primary efficacy endpoint is the proportion of subjects with albumin-adjusted serum calcium within the normal range, and independent from active vitamin D and therapeutic doses of calcium ( 600 mg/day) at 26 weeks. If successful, Ascendis expects to submit an NDA to the U.S. Food and Drug Administration (FDA) in mid-2022 and subsequently submit a Marketing Authorisation Application to the European Medicines Agency.

Ascendis also announced the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) acceptance of the clinical trial notification for the PaTHway Japan Trial, a single-arm, phase 3 trial of palopegteriparatide in a minimum of 12 Japanese subjects with HP. Subjects will start with an 18 g dose of palopegteriparatide and be followed over a 26-week period during which they will be titrated to an optimal dose. In addition, MHLW granted ODD to palopegteriparatide for the treatment of HP. In Japan, ODD is granted to therapies intended for use in less than 50,000 patients in Japan and for which significant unmet medical need exists. The designation is granted by the MHLW based on the opinion of the Pharmaceutical Affairs and Food Sanitation Council.

In Greater China, VISEN recently announced that they obtained the IND approval from the Center for Drug Evaluation of the National Medical Products Administration for the phase 3 China clinical trial (PaTHway China Trial) of TransCon PTH on June 1, 2021 and is soon expected to initiate the study of TransCon PTH in patients with HP in China. The design of the PaTHway China Trial mirrors the design of the PaTHway Trial.

All subjects from phase 3 PaTHway trials in North America, Europe, Japan and Greater China will be eligible to enter into open-label extensions to collect long-term follow-up data.

Palopegteriparatide was granted ODD from the FDA in June 2018 and from the European Commission in October 2020.

About Ascendis Pharma A/S

Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon technologies to create new and potentially best-in-class therapies.

Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates and one oncology product candidate in clinical development. The company continues to expand into additional therapeutic areas to address unmet patient needs.

Ascendis is headquartered in Copenhagen, Denmark, with additional facilities in Heidelberg and Berlin, Germany, in Palo Alto and Redwood City, California, and in Princeton, New Jersey.

Please visit http://www.ascendispharma.com (for global information) or http://www.ascendispharma.us (for U.S. information).

About TransCon PTH1

TransCon PTH is an investigational once-daily long-acting prodrug of parathyroid hormone (PTH[1-34]) in development as a treatment for adult HP designed to restore PTH at physiologic levels for 24 hours each day to address both the short-term symptoms and long-term complications of the disease. TransCon PTH was granted ODD by the FDA in June 2018, in October 2020 was granted Orphan Designation by the European Commission for the treatment of HP, and in June 2021 was granted ODD by the MHLW.

About Hypoparathyroidism (HP) 2,3,4,5,6,7

HP is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone (PTH), resulting in low calcium and elevated phosphate levels in the blood. HP affects approximately 400,000 patients in the United States, Europe, Japan, South Korea and Greater China, the majority of whom develop the condition following damage or accidental removal of the parathyroid glands during thyroid surgery. Patients often experience decreased quality of life. In the short term, symptoms include weakness, severe muscle cramps (tetany), abnormal sensations such as tingling, burning and numbness (paresthesia), memory loss, impaired judgment and headache. Over the long term, this complex disorder can increase risk of major complications, such as extraskeletal calcium depositions occurring within the brain, lens of the eye, and kidneys, which can lead to impaired renal function.

HP remains among the few hormonal insufficiency states without a replacement therapy that restores the missing hormone at physiologic levels. Standard of care with active vitamin D analogs and calcium supplementation do not fully control the disease and may contribute to risk of renal disease. As a result, patients with HP have an estimated 4-fold to 8-fold greater risk of renal disease compared to healthy controls.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) the timing of expected completion of enrollment in the phase 3 PaTHway Trial, (ii) the expected timing of reporting PaTHway top-line data and, if successful, the expected timing of a submission of an NDA and MAA for TransCon PTH, (iii) the eligibility of subjects from the phase 3 PaTHway trial in North America, Europe, Japan and Greater China to enter into open-label extensions to collect long-term follow-up data, (iv) Ascendis ability to apply its platform technology to build a leading, fully integrated biopharma company, (v) Ascendis product pipeline and expansion into additional therapeutic areas and (vi) Ascendis expectations regarding its ability to utilize its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: unforeseen safety or efficacy results in its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development and potential commercialization of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs, selling, general and administrative expenses, other research and development expenses and Ascendis business generally; delays in the development of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; Ascendis ability to obtain additional funding, if needed, to support its business activities and the effects on its business from the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis business in general, see Ascendis Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on March 10, 2021 and Ascendis other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.

Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma Group. July 2021 Ascendis Pharma A/S.

1 Karpf DB, et al. J Bone Miner Res. 2020; x:1-11.2 Mannstadt M, et al. Nature Reviews 2017, 3: 170553 Ascendis Pharma HP Patient Experience Research.4 Hadker N, et al. Endo Pract. 2014, 20(7);671-679. 5 Powers J, et al. J Bone Miner Res 2013, 28: 2570-2576.6 Mitchell DM, et al. J Clin Endocrinol Metab 2012, 97(12): 4507-45147 Underbjerg L, et al. J Bone Miner Res 2013, 28: 2277-2285

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Ascendis Pharma A/S Announces Target Enrollment Achieved in the Phase 3 PaTHway Trial of TransCon PTH - GuruFocus.com


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