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Category Archives: Testosterone
Testosterone Replacement Therapy Market is Anticipated to Register an Exponential Growth | AbbVie, Inc., Bayer AG, Endo Pharmaceuticals, Inc., Eli…
Posted: February 26, 2020 at 1:45 am
Coherent Market Insightsa new study titledGlobal Testosterone Replacement Therapy Market Forecast 2020-2026which is an in-depth study and analysis of the market, shading light on many noteworthy points and trends. Our industry experts, with unique domain knowledge, have developed this report to offer analysis of Market Size, Share, Future Growth, and Opportunity.
Testosterone Replacement Therapy Market report provides key statistics on the market status of the Testosterone Replacement Therapy manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry. The report also presents the vendor landscape and a corresponding detailed analysis of the major vendors operating in the market.
The Testosterone Replacement Therapy report stresses the most recent advancements, development, new chances, and lethargic traps. It gives a comprehensive position of the Testosterone Replacement Therapy. The Testosterone Replacement Therapy research report covers the present scenario and the growth prospects of the Global Testosterone Replacement Therapy Industry for 2020-2026. The report enlists several important factors, starting from the basics to advanced market intelligence which plays a crucial part in strategizing. Testosterone Replacement Therapy manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the Testosterone Replacement Therapy industry. An inclusive and decision-making data in this report will be useful for your esteemed clients.
Free Sample Copy of This Report @ https://www.coherentmarketinsights.com/insight/request-sample/2024
The study report validates the evaluation and volume of theTestosterone Replacement Therapy for the forthcoming years.Further it covers regions and country wise data that show a regional development status including market size, volume, value, and price. Then, the manufacturers data such as revenue, shipment, price, gross profit, interview record, and business distribution are also added. The aforementioned market is anticipated to reflect a positive growth trend between the years 2020-2026.
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The report then analyzes advancement and estimates development of the key players using the SWOT analysis. It also covers product categories, segments, competitive structure, new marketing plans, and collaborations. A detailed investigation on segments by market players, types, application, and geographical areas is also given in the report.
For competitor segment, the report includes global key players of Testosterone Replacement Therapy as well as some small players. The details for each competitor include:
Main Business Information
SWOT Analysis
Sales, Revenue, Price and Gross Margin
Market Share
The market is controlled by these Renowned Players:
This report offers examination of the market in these districts covering, North America (U.S., Canada, Mexico), Europe (Germany, U.K., France, Italy, Russia, Spain etc.), Asia-Pacific (China, India, Japan, Southeast Asia etc.), South America (Brazil, Argentina etc.), Middle East & Africa (Saudi Arabia, South Africa etc.)with their crucial positions, size, production, consumption, revenue, and market share.
Market Segmented on the basis of Applications, size, product tye, technology amoung others.
Key Offerings of This Report:
Competitor Analysis Include:
Regional Market Analysis Market Analysis Market Overview 2012-2016 Local Supply, Import, Export, Local Consumption Analysis 2012-2017 Sales Price Analysis 2019 Market Share Analysis 2020-2026 Market Forecast, Growth, Opportunity
The report offers research conclusions, findingswhich can offer a summarized view of the Testosterone Replacement Therapy. It then serves SWOT examination and venture return investigation, and other aspects such as the principle locale, economic situations with benefit, generation, demand, limit, supply, and market development rate and figure. The overall data was gathered by using many effective inquisitive tools like market attractiveness study, feasibility analyses, and predictable investment returns estimations.In short, the report encompasses all key entities regarding overall consequential study of the market.
Testosterone Replacement Therapy MarketGrowth Analysis by Top Key Manufacturers that definitely Up your businessAbbVie, Inc., Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin International plc, Pfizer, Inc., Acerus Pharmaceuticals Corporation, and Perrigo Company plc.
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Will These Penny Stocks Make New Highs This Week? – Penny Stocks
Posted: February 26, 2020 at 1:45 am
List Of Penny Stocks To Watch Making Bigger Moves Right now
While some may avoid penny stocks because they dont understand risk, others jump headfirst. But why? For the most part, someone trading penny stocks enjoys volatility. With that comes greater levels of riskiness. Where you could buy one share of Facebook for around $200, you could pick up 10,000 shares of a $0.02 stock.
Youre probably thinking, Thats how math works and youd be correct. But while it takes Facebook $200 to return 100% on your investment, the penny stock only needs to move a few pennies. Given the fact that it took 6 years to rise $200 per share, the penny stock could present a much more near-term opportunity to double that initial investment.
On the flip side, Facebook isnt likely to drop $200 a share in the near term. In this case, you wouldnt likely see your entire investment dissolve into thin air. With the penny stock, a drop of even one cent means you lost half your capital.
This is where your risk profile is important. Most traders will only risk what they can comfortably afford to lose. If that is $100 or $100,000, its completely based on each persons individual financial state. With this said, if youre still interested in penny stocks, and have a good understanding of the basics, weve got a list of penny stocks to watch right now. These have started making bigger moves at the end of the month. But are they going to be the best to watch before the beginning of March?
One of the penny stocks to watch for the last year has been ADDvantge Technologies (AEY Free Report). We first reported on it last May in the article 5 Penny Stocks To Watch That Just Made New Highs This Month. Since then, ADDvantage stock has jumped nearly 290%. While weve tracked the progress along the way, this year has been even bigger for AEY stock. The company distributes and services a line of electronics and hardware for cable and telecom.
Most recently the company saw a transition in its CFO position. This came after the company reported strong earnings for its first quarter of fiscal 2020. Joe Hart, President and CEO stated in a press release, The steps taken in the second half of 2019 to prepare the company for future growth are beginning to yield results as we have a robust pipeline of opportunities and continue to see a significant market opportunity with 5G across all of ADDvantages businesses.
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Obviously the 5G topic is one of the hottest in tech right now. After the T-Mobile and Sprint merger was confirmed, the conversation began to heat up once again. The company reported a 105% increase in revenue for Q1 of its fiscal 2020. This was greatly aided by its acquisition of Fulton Technologies to create our Wireless Segment last year.
Next is a penny stock that was beaten up for quite some time. But Document Security Systems (DSS Free Report) has started to show some signs of life over the last few days. The penny stock dipped to new 52-week lows on February 21. This came after pricing a $4 million offering at $0.18. Considering the penny stock traded around $0.25 at the time, the near 30% discount didnt present itself well to the public.
However, since the dust had settled, shares started to climb and with record share volume. Since hitting $0.167 on Friday, DSS stock has recovered by as much as 31%. In light of the raise, there could be a viable use of proceeds to keep in mind down the road. The company plans to use the $4 million proceeds to fund the development of new business lines and to upgrade machinery and facilities.
Document Security Systems focuses on anti-counterfeit, authentication, and brand protection solutions. Its AuthentiGuard(R) is the companys flagship product and provides authentication capability. This is done through a smartphone application so businesses can empower a wide range of personnel to track their brands and verify authenticity.
One of the penny stocks that felt the burn last year was Lipocine Inc. (LPCN Free Report). The company enjoyed a great rally to highs of over $3.40 until it reported really bad news. How bad? Well, when it comes to biotechs with lead treatments missing the mark, it was bad. Its TLANDO treatment is an oral testosterone product candidate for testosterone replacement therapy. It didnt meet the 3 secondary endpoints for maximal testosterone concentrations.
But you could say theres a chance after this month. For those looking for beaten-down penny stocks, LPCN might fit the mold. This week, however, the company started off reported that it received some insight from the FDA. The agency indicated Lipocines approach to addressing the single remaining deficiency through the reanalysis of existing data in accordance with FDA feedback appears to be a reasonable path forward. The FDA requested that the information generated by the reanalysis be submitted as part of an NDA resubmission with a six-month Prescription Drug User Fee Act clock.
[Read More] Penny Stocks On Robinhood To Buy For Under $2
Long story, short is that Lipocine aims for this quarter to submit the TLANDO NDA. Given this event, the market appears to have reacted favorably. The pressures on now, though because after the flop from November, there could be even more weight riding on the next round of results.
Vaxart Inc. (VXRT Free Report) caught som wind on Monday kickstarting the week. Shares of the company jumped to highs of $1.35 during premarket trading. But something youll see when you pull up this symbol is that there hasnt been much news. Also, if youre new to PennyStocks.com, you probably havent read any of our past articles on the company.
As discussed in one of the other posts on the site today, Vaxart could be moving in sympathy with other coronavirus penny stocks today. In late January the company announced the initiation of a coronavirus vaccine program. Sean Tucker, Ph.D., chief scientific officer of Vaxart. The results of our recently published influenza challenge study demonstrated that our oral tablet vaccine primarily protects through mucosal immunity, a potential key factor when targeting mucosal pathogens such as this new coronavirus.
With the latest surge in new COVID-19 cases, it makes sense that penny stocks like this are moving today. There havent been any new updates on progress of the program, however. So it will be interesting to see how things pan out for Vaxart along the way. In any case, its one. of the few coronavirus penny stocks that have some new updates related to coronavirus. Other sympathy stocks havent had anything but speculation based on information from corporate websites.
Finally, Allied Healthcare Products, Inc. (AHPI Free Report) rounds out this list of penny stocks. If this one seems kind of familiar, thats because we started looking at this one earlier in February. Similar to Vaxart, Allied has benefited from the latest surge in coronavirus cases.
While were happy to see AHPI stock has continued higher since we began discussing it, there are some things to take note of. The company sells respiratory products and other healthcare items. Beyond its relation to treating symptoms of the virus, AHPI hasnt released any news. So while this momentum appears strong, it could be a direct result of COVID-19 speculation.
Remember in the case of Vaxart, it came out and specifically reported its intentions related to the virus. Allied has not. So keep this in mind if AHPI is on your list of penny stocks to watch this week.
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In the Wrong Body – Teen Girl to Teen Boy – Deutsche Welle
Posted: February 22, 2020 at 12:45 pm
What do parents do when they learn their daughter suddenly wants to be a boy? When Rene entered puberty, she began to change, her hair becoming shorter and shorter, her dress more androgynous. Parents Birgid and Michael initially thought she was just trying things out, until one day Rene outed herself as transgender during a family walk. Her parents were relieved, but also very worried about what it could mean for the future. They found an experienced youth psychotherapist to accompany Rene closely for the next few years as she became Ren. After a year of psychotherapy, the therapist recommended hormone replacement therapy. The testosterone quickly changed Rens body: his voice broke, his hair became thicker and his whole posture more male. For him it was a liberation, but Birgid has to struggle with the loss of a daughter for good. How will Ren develop now? What other changes will hormone therapy bring, and what will it do to him? Its the start of a long journey for Ren and his parents.
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In the Wrong Body - Teen Girl to Teen Boy - Deutsche Welle
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Man Accused Of Running Illegal Long Island Health Clinic – Daily Voice
Posted: February 22, 2020 at 12:45 pm
A Long Island man is facing a host of charges for allegedly posing as a medical professional and running an illegal health clinic, where he treated patients.
Brian Michael Kaufman, 45, of Smithtown, allegedly ran Mens Health Solution of Smithtown on Middle Country Road, despite not having a medical license, Suffolk County DA Tim Sini announced.
He allegedly treated patients, including testosterone and steroid injections.
The investigation into Kaufmans practice determined that he allegedly has been operating the medical practice since at least August last year.
When he was arrested, Kaufman admitted to investigators that he was not licensed to practice any medical profession and had no training to provide medical services or provide testosterone replacement therapy, the DA said.
Mens Health Solution of Smithtown has since shuttered its doors.
"This individual put lives in danger and posed a clear threat to public health by masquerading as a medical practitioner," Sini said in a statement. "He did not have patients; he had victims. We are asking those victims to please contact the District Attorney's Office with any information they may have about Kaufman's alleged scam."
Kaufman has been charged with:
"This case is significant because it unearthed a convicted felon playing doctor who jeopardized his 'patients' lives," DEA agent Ray Donovan said. "In order to safeguard our communities, law enforcement has to act fast when they see someone threatening public health and safety.
"In this case, Brian Kaufman's alleged testosterone trafficking ring put people in harm's way while committing several crimes."
If convicted, Kaufman faces up to seven years in prison on the top count. He was arraigned this week and released with a GPS monitoring device. He will also be subjected to drug testing and is under travel restrictions.
Anyone who has received medical services from Kaufman or at Mens Health of Smithtown has been asked to contact the Suffolk County District Attorneys Office by calling (631) 853-8087.
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Testosterone Replacement Therapy analysis by stage of development – TechNews.mobi
Posted: February 22, 2020 at 12:45 pm
This intelligence report provides a comprehensive analysis of the Testosterone Replacement Therapy Market. This includes Investigation of past progress, ongoing market scenarios, and future prospects. Data True to market on the products, strategies and market share of leading companies of this particular market are mentioned. Its a 360-degree overview of the global markets competitive landscape. The report further predicts the size and valuation of the global market during the forecast period.
Testosterone is responsible for the development of male sexual characteristics and this hormone formed by the testicles. Insufficient production of testosterone causes erectile dysfunction. Testosterone Replacement Therapy (TRT) is generally termed as hormone therapy for men, designed to counteract the effects of reduced activity in the gonads or hypogonadism. Hypogonadism in men is clinical syndrome, which results in the failure of the testes to produce physiological levels of testosterone. Erectile dysfunction arises due to reduce testosterone production to overcome this testosterone replacement therapy is used to improve the problem.
Major Players in this Report Include,
AbbVie Inc. (United States), Endo International (Ireland), Eli Lilly and Company (United States), Pfizer (United States), Bayer (Germany), Actavis (Allergan) (United States), Novartis (Switzerland), Teva (Israel), Ferring Pharmaceuticals (Switzerland), Kyowa Kirin (Japan) and Mylan (United States).
Free Sample Report + All Related Graphs & Charts: https://www.advancemarketanalytics.com/sample-report/46424-global-testosterone-replacement-therapy-market
Each segment and sub-segment is analyzed in the research report. The competitive landscape of the market has been elaborated by studying a number of factors such as the best manufacturers, prices and revenues. Global Testosterone Replacement Therapy Market is accessible to readers in a logical, wise format. Driving and restraining factors are listed in this study report to help you understand the positive and negative aspects in front of your business.
This study mainly helps understand which market segments or Region or Country they should focus in coming years to channelize their efforts and investments to maximize growth and profitability. The report presents the market competitive landscape and a consistent in depth analysis of the major vendor/key players in the market.
Market Drivers
Market Trend
Restraints
Opportunities
Challenges
Furthermore, the years considered for the study are as follows:
Historical year 2013-2017
Base year 2018
Forecast period** 2019 to 2025 [** unless otherwise stated]
**Moreover, it will also include the opportunities available in micro markets for stakeholders to invest, detailed analysis of competitive landscape and product services of key players.
The titled segments and Market Data Breakdown are illuminated below:
By Type: Creams or Gels, Patches, Injections, Buccal Adhesives, Implants, Oral
Application: Hospitals, Clinics
For Early Buyers | Get Up to 20% Discount on This Premium Report: https://www.advancemarketanalytics.com/request-discount/46424-global-testosterone-replacement-therapy-market
Region Included are: North America, Europe, Asia Pacific, Oceania, South America, Middle East & Africa
Country Level Break-Up: United States, Canada, Mexico, Brazil, Argentina, Colombia, Chile, South Africa, Nigeria, Tunisia, Morocco, Germany, United Kingdom (UK), the Netherlands, Spain, Italy, Belgium, Austria, Turkey, Russia, France, Poland, Israel, United Arab Emirates, Qatar, Saudi Arabia, China, Japan, Taiwan, South Korea, Singapore, India, Australia and New Zealand etc.
Strategic Points Covered in Table of Content of Testosterone Replacement Therapy Market:
Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Testosterone Replacement Therapy Market.
Chapter 2: Exclusive Summary the basic information of the Testosterone Replacement Therapy Market.
Chapter 3: Displaying the Market Dynamics- Drivers, Trends and Challenges of the Testosterone Replacement Therapy
Chapter 4: Presenting the Testosterone Replacement Therapy Market Factor Analysis Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.
Chapter 5: Displaying the by Type, End User and Region 2013-2018
Chapter 6: Evaluating the leading manufacturers of the Testosterone Replacement Therapy market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company Profile
Chapter 7: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions.
Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source
Finally, Testosterone Replacement Therapy Market is a valuable source of guidance for individuals and companies.
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Tags: Global Testosterone Replacement Therapy MarketTestosterone Replacement Therapy MarketTestosterone Replacement Therapy Market GrowthTestosterone Replacement Therapy Market ShareTestosterone Replacement Therapy Market SizeTestosterone Replacement Therapy Market Trends
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Once-Weekly Treatment for Adult GH Deficiency Effective in Phase 3 Trial – Endocrinology Advisor
Posted: February 22, 2020 at 12:45 pm
In a multinational randomized phase 3 trial, once-weekly somapacitan demonstrated superiority over placebo for treatment of patients with adult growth hormone (GH) deficiency, according to study results published in The Journal of Clinical Endocrinology & Metabolism.
Hormone replacement is a common component of care for patients with hypopituitarism, but its daily subcutaneous injections can be burdensome for some patients. This burden may result in reduced compliance or adherence or in an unwillingness on the part of physicians to add to their patients treatment burden. Long-acting alternatives to daily injections could reduce the burden of treatment and thus lower the barrier to therapy.
Somapacitan is a novel once-weekly reversible albumin-binding GH derivative, with a similar long-lasting mechanism as insulin detemir. Studies have shown once-weekly somapacitan to be well tolerated in healthy adults, but none have examined its efficacy in adult GH deficiency treatment.
To evaluate this, researchers randomly assigned 301 patients with adult GH deficiency at 92 sites in 17 countries in a 2:1:2 ratio to receive once-weekly somapacitan, once-weekly placebo, or daily GH for 34 weeks. Patients 23 to 79 years of age with a diagnosis of adult- (69.7%) or childhood-onset (30.3%) adult GH deficiency who were naive to GH treatment or had no exposure to GH therapy for 180 days prior to treatment assignment were included. This main period of 34 weeks was followed by an extension period to examine longer-term use.
The main period was double blinded for the somapacitan and placebo cohorts but open label for daily GH use. Investigators and trial sites remained blinded throughout the entire trial. Dose titration occurred during the first 8 weeks of the main trial until a steady state insulinlike growth factor-1 (IGF-1) standard deviation score (SDS) of -0.5 to +1.75 was achieved. The remaining 26 weeks consisted of fixed-dose treatment.
The 52-week open-label extension period allowed for evaluation of efficacy and safety of somapacitan for up to 86 weeks of treatment. Patients who had been receiving somapacitan continued to do so (somapacitan/somapacitan group), those receiving placebo were switched to somapacitan (placebo/somapacitan group), and those receiving daily GH were randomly assigned 1:1 to continue with daily GH (daily GH/daily GH group) or to switch to somapacitan (daily GH/somapacitan group).
At week 34, somapacitan reduced truncal fat percentage from baseline by 1.06% compared with a 0.47% increase for placebo (estimated treatment difference, -1.53%; 95% CI, -2.68 to -0.38; P =.009), demonstrating superiority over placebo. Compared with placebo, the somapacitan group also had decreased visceral fat and increased lean body mass and appendicular skeletal muscle mass at week 34.
Similar changes in visceral fat, total lean body mass, and appendicular skeletal muscle mass were observed in the somapacitan and daily GH groups at week 34. A less pronounced reduction in truncal fat percentage was observed with somapacitan treatment compared with daily GH treatment at week 34. No significant difference in body weight from baseline to week 34 was observed for the somapacitan (+1.40 kg) or placebo (+0.39 kg) groups, but was observed between somapacitan and daily GH (+0.27 kg; estimated treatment difference, 1.13 kg; 95% CI, 0.13-2.12) groups.
At week 86, there were no notable differences between the somapacitan and daily GH groups for percentage change in visceral fat, lean body mass, or appendicular skeletal muscle mass, and improvements in visceral fat and lean body mass were maintained. However, treatment effects on other body composition measures were less pronounced with somapacitan treatment vs daily GH therapy. For patients who switched from placebo to somapacitan in the extension period, improvements were observed in all body composition measures to a similar degree as with long-term daily GH treatment.
No significant differences in mean levels of corrected total bone mineral content or density from baseline to week 86 in the somapacitan and daily GH groups were observed, nor was there a significant difference in these levels between these 2 groups.
Two individuals had severe adverse events that were possibly related to trial products during the study period. One was a patient in the daily GH/no treatment group, who was also receiving testosterone and suffered a life-threatening hemoconcentration, but recovered with treatment. The other patient was in the daily GH/somapacitan group and was diagnosed with bladder transitional cell carcinoma in week 80, but went on to complete the trial.
One of the concerns about continuous exposure to GH is that it may result in negative effects on insulin sensitivity and glucose metabolism. In this trial, fasting plasma glucose and hemoglobin A1c values did not increase over 86 weeks, and there were no new cases of diabetes in patients treated with somapacitan. The limited negative effects paired with somapacitans potentially superior effects on visceral fat reduction vs placebo by week 34 of treatment suggest that somapacitan may provide an effective alternative to daily GH in adults with GH deficiency.
Some limitations of this study included the reliance on patient reporting for adherence to treatment as well as the open-label nature of the daily GH treatment group. In addition, some patients in the active drug groups had IGF-1 SDS values below -2 at the end of the titration period and so may not have received the full benefit of GH replacement. Finally, the less pronounced effect of somapacitan on truncal fat and body weight when compared with daily GH over the long term cannot be explained by a different response in IGF-1 SDS, as mean levels and distributions were similar.
Disclosure: This study was funded by Novo Nordisk, the manufacturer of somapacitan. All but one author on the study has received either employment, contract work, or funding from Novo Nordisk.
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Reference
Johannsson G, Gordon MB, Rasmussen MH, et al. Once-weekly somapacitan is effective and well tolerated in adults with GH deficiency: a randomized phase 3 trial [published online February 5, 2020]. J Clin Endocrinol Metab. doi:10.1210/clinem/dgaa049
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Latest Study explores the Fire Damper Market Witness Highest Growth in near futu – ITResearchBrief.com
Posted: February 21, 2020 at 10:49 am
The ' Fire Damper market' research report now available with Market Study Report, LLC, is a compilation of pivotal insights pertaining to market size, competitive spectrum, geographical outlook, contender share, and consumption trends of this industry. The report also highlights the key drivers and challenges influencing the revenue graph of this vertical along with strategies adopted by distinguished players to enhance their footprints in the Fire Damper market.
The recent study of the Fire Damper market is an exhaustive examination of this industry, and contains insights pertaining to important parameters of this business space. The research report provides details about the prevailing market share, industry trends, market size, renumeration estimates, periodic deliverables, and price projections over the analysis period.
Request a sample Report of Fire Damper Market at:https://www.marketstudyreport.com/request-a-sample/2498823?utm_source=itresearchbrief.com&utm_medium=Abhijeet
The document gives credible data regarding the key investment pockets of the Fire Damper market, alongside the growth pattern followed by the industry over the forecast period. Having said that the report focuses on the challenges present in the industry and growth projections which are anticipated to dictate this industry in the coming years.
Key highlights of the Fire Damper market report:
Exploring the geographical hierarchy of the Fire Damper market:
Fire Damper Market segmentation:
Key takeaways of regional assessment presented in Fire Damper market study:
Product type and application scope of Fire Damper market:
Product scope:
Product types:
Top pointers listed in the report:
Application scope:
Application partition:
Insights entailed in the report:
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Analyzing the competitive backdrop of Fire Damper market:
Industry majors:
Key parameters included in the report which define the competitive spectrum:
Other takeaways from the Fire Damper market report:
For More Details On this Report:https://www.marketstudyreport.com/reports/global-fire-damper-market-growth-2020-2025
Some of the Major Highlights of TOC covers:
Executive Summary
Manufacturing Cost Structure Analysis
Development and Manufacturing Plants Analysis of Fire Damper
Key Figures of Major Manufacturers
Related Reports:
2. Global Air Separation Plant Market Growth 2020-2025Air Separation Plant Market report begins from overview of Industry Chain structure, and describes industry environment, then analyses market size and forecast of Air Separation Plant by product, region and application, in addition, this report introduces market competition situation among the vendors and company profile, besides, market price analysis and value chain features are covered in this report.Read More: https://www.marketstudyreport.com/reports/global-air-separation-plant-market-growth-2020-2025
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Clarus Therapeutics Lauches JATENZO – Oral Testosterone Replacement Therapy – MedicalResearch.com
Posted: February 20, 2020 at 6:46 am
MedicalResearch.com Interview with:
Robert E. Dudley, Ph.D.Chairman, Chief Executive Officer and PresidentClarus Therapeutics
Dr. Dudley discusses the recent announcement that Clarus Therapeutics, Inc. has launched JATENZO (testosterone undecanoate) capsules for the treatment of appropriate men with testosterone deficiency (hypogonadism):
MedicalResearch.com: What is the background for this announcement?
Response: JATENZOis the first and only oral softgel testosterone undecanoate and the first oral testosterone product approved by the U.S. FDA in more than 60 years.JATENZO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
The launch of JATENZO means that physicians and men living with testosterone deficiency due to genetic or structural abnormalities finally have a safe and effective oral testosterone replacement therapy. We are proud to commercially launch this unique oral formulation to healthcare providers and the appropriate patients who they treat. JATENZO is now available at pharmacies across the country.
MedicalResearch.com: What are the main findings of the underlying studies?
Response: JATENZO was evaluated in a Phase 3 pivotal trial among 166 adult, hypogonadal men in a 4-month, open-label study with a topical testosterone comparator arm. The starting dose was 237 mg twice daily (BID) with meals. Dose adjustments (minimum 158 mg BID; maximum 396 mg BID) were made roughly 3 and 7 weeks after initiation of JATENZO based on average circulating testosterone concentration levels. 87% of JATENZO patients reached testosterone levels within the normal eugonadal range at the end of the study; peak testosterone levels were in close alignment with FDA targets.
Across all Phase 2 and Phase 3 trials combined, the safety of JATENZO has been evaluated in 569 patients who were treated with JATENZO for up to two (2) years. Liver toxicity was not observed with JATENZO in clinical trials.
Mild gastrointestinal adverse events observed with JATENZO were transient, manageable and did not lead to discontinuation.Decreased HDL cholesterol and increased hematocrit were associated with JATENZO use but did not lead to discontinuation of JATENZO. Only three of the 166 patients (1.8%) in the 4-month study experienced adverse reactions that led to premature discontinuation from the study, including rash (n=1) and headache (n=2). JATENZO was associated with an increase in systolic blood pressure. A boxed warning about the potential risks associated with elevated blood pressure appears on JATENZO labeling. Patients on JATENZO should have their blood pressure monitored.
Among the 569 patients who received JATENZO in all Phase 2 and 3 trials combined, the following adverse reactions were reported in >2% of patients: polycythemia, diarrhea, dyspepsia, eructation (i.e., burping), peripheral edema, nausea, increased hematocrit, headache, prostatomegaly (i.e., enlarged prostate), and hypertension.
MedicalResearch.com: How doesJATENZO differ from other treatments for testosterone deficiency?
Response: The launch of JATENZO is an important step forward in testosterone replacement therapy. The only other oral testosterone replacement therapy product ever approved by the FDA is methyltestosterone (an alkylated androgen) that has been associated with serious liver toxicity and is rarely, if ever, used today. Because JATENZO is formulated as a lipophilic prodrug, it bypasses the first-pass hepatic metabolism. No liver toxicity-related events were observed in clinical studies of JATENZO including in patients who took JATENZO at higher doses than recommended in current product labeling for two (2) years.
We believe JATENZO addresses a long-standing need for a safe and effective oral testosterone replacement product that meets current day FDA safety and efficacy standards. JATENZO enters a market where the vast majority of hypogonadal men are treated with injectable or topical testosterone products. JATENZO avoids administration challenges seen with these non-oral treatments it presents no injection site pain, no transfer risk, no mess, no skin irritation and no surgical procedure. Therefore, we believe a significant number of hypogonadal men will prefer JATENZO as an alternative to other forms of testosterone therapy.
MedicalResearch.com: How are men tested to determine ifJATENZO therapy is appropriate for them?
Response: According to the American Urological Association and Endocrine Society clinical guidelines, diagnosis of hypogonadism is determined by both the identification of symptoms and/or signs consistent with hypogonadism and blood test measurement of low morning total serum testosterone concentration (defined as <300 ng/dL, on two separate days). Healthcare providers should assess each patient individually for the appropriateness of JATENZO to treat their clinical hypogonadism.
MedicalResearch.com: What else should readers take away from your report?
Response: Clinical hypogonadism can be more complex than most people realize and left untreated, can have a profound negative impact for the individual. Men with the symptoms of hypogonadism have a real medical need that deserves appropriate diagnosis and treatment.
Any disclosures?
Pleaseclick herefor full Prescribing Information, including BOXED WARNING on increases in blood pressure.
Citation:
CLARUS THERAPEUTICS ANNOUNCES COMMERCIAL LAUNCH AND AVAILABILITY OF JATENZO (TESTOSTERONE UNDECANOATE) CAPSULES, CIII FOR THE TREATMENT OF HYPOGONADISM
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Feb 19, 2020 @ 12:05 pm
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Clarus Therapeutics Lauches JATENZO - Oral Testosterone Replacement Therapy - MedicalResearch.com
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Jatenzo, an Oral Testosterone Replacement Therapy, Now Available – Renal and Urology News
Posted: February 19, 2020 at 10:45 am
Jatenzo (testosterone undecanoate; Clarus Therapeutics), an oral testosterone replacement therapy, is now available for the treatment of hypogonadism.
Specifically, Jatenzo is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Jatenzo is not intended for use in males with age-related hypogonadism and its safety and efficacy have not been established in males <18 years old.
The treatment carries a Boxed Warning related to blood pressure (BP) increases that could potentially increase the risk of major adverse cardiovascular events. In a clinical trial, Jatenzo increased systolic BP during 4 months of treatment by an average of 4.9 mmHg based on ambulatory BP monitoring and by an average of 2.8 mmHg from baseline based on BP cuff measurements. For this reason, baseline cardiovascular risk should be considered before initiating therapy and BP should be adequately controlled. Among study patients treated with Jatenzo, 7% were started on antihypertensive medications or required intensification of their antihypertensive medication regimen during the 4-month trial.
Jatenzo, a Schedule III controlled substance, is available in 158mg, 198mg, and 237mg softgels. Dosage should be individualized based on serum testosterone concentrations.
Jatenzo offers patients a convenient softgel formulation, and eliminates the worry of gel transference, skin irritation from patches, or pain from injections that other testosterone treatments carry, said Dr Ronald S. Swerdloff, lead investigator of the inTUne trial, the pivotal study that established the safety and efficacy of the treatment.
For more information visit jatenzo.com.
This article originally appeared on MPR
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Testosterone Replacement Therapy Market Overview 2027 | Leading AbbVie, Inc., Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin…
Posted: February 18, 2020 at 2:45 pm
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Testosterone Replacement Therapy Market Overview 2027 | Leading AbbVie, Inc., Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin...
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