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Monthly Archives: June 2020
Testosterone replacement therapy | Valley Health – Mat-Su Valley Frontiersman
Posted: June 25, 2020 at 1:50 pm
Testosterone levels begin to decline in men at about 40 years of age. Testosterone levels drop about 1% per year- unlike the rapid, dramatic decline in estrogen that women experience at menopause. Over time, the decline is significant and can be clinically important. However, at least 75% of older men continue to maintain their levels within the normal range. Among men that would benefit from testosterone therapy, the Institute of Medicine estimates that only 5% are on treatment.
Symptoms of a low testosterone may include changes in sexual function including reduced sexual desire, fewer spontaneous erections and infertility. It is rarely the cause of erectile dysfunction. Even among men with low testosterone that have erectile dysfunction, only a very small number see this improve with testosterone therapy. Other symptoms include, decrease in muscle mass and strength, decrease in bone density, anemia (low numbers of red blood cells) and increase in body fat. Some men may also experience depression, decreased motivation and a decline in their memory.
Testosterone levels vary by time of day. The highest levels are at 8 am. The normal range for testosterone is based on blood tests draw at 8 am. Therefore, if you have your levels drawn to evaluate your need for therapy, make sure they are drawn at 8 am. Low values are defined as levels below 200 ng/dL. If you value is low, a second level is required to confirm the diagnosis and to qualify you to have your insurance company pay for therapy. Testosterone is a controlled substance and its use is tightly regulated by the Food and Drug Administration. You must have clearly abnormal values in order to qualify to receive treatment.
A small number of men experience immediate side effects including: acne, breast enlargement or tenderness and swelling in the ankles. Red blood cell counts may also rise that increase your risk of blood clotting. Finally, testosterone can worsen sleep apnea a condition that causes severe snoring and cause you stop breathing for short-intervals during the night. You should not start testosterone if you have sleep apnea and are not on treatment for it.
Long-term complications may include an increase in healthy prostate tissue cause symptoms of obstruction. It does not cause prostate cancer, but is cancer is present, it will stimulate it to grow. Finally, there are concerns that testosterone may cause an increase in heart attacks, strokes and death from cardiovascular disease. The data on this are mixed and large scale studies are currently underway in an attempt to see if it truly increases the risk of cardiovascular disease and death.
Your therapy is monitored at 6-month intervals with blood tests for testosterone levels, blood counts and cholesterol levels. Prostate specific antigen (a protein that reflects the amount of prostate tissue) is monitored annually looking for an increase in prostate tissue both healthy are cancer. You may require further evaluation if this level rises too far or too fast. With proper monitoring, testosterone therapy can be safe and effective.
Dr. Samuel Abbate is a local physician practicing in Wasilla.
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Testosterone replacement therapy | Valley Health - Mat-Su Valley Frontiersman
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Impact Analysis of Covid-19 On Testosterone Replacement Therapy Market Driver, Trends, Applications & Business Strategy Forecast 2027 | Endo…
Posted: June 25, 2020 at 1:50 pm
A new business intelligence report released by CMI with title Global Testosterone Replacement Therapy Market Insights, Forecast to 2027 that targets and provides comprehensive market analysis with future prospects to 2024. The analysts of the study have garnered extensive research methodologies and data sources (i.e. Secondary & Primary Sources) in order to generate collective and useful information that delivers latest market undercurrents and industry trends.
If you are involved in the Global Testosterone Replacement Therapy industry or intend to be, then this study will provide you comprehensive outlook. Its vital you keep your market knowledge up to date segmented by major players. If you have a different set of players/manufacturers according to geography or needs regional or country segmented reports we can provide customization according to your requirement.
We Do Offer Sample of this report. Kindly go through the follow information in order to access sample copy.
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Brief Introduction to the research report.
Table of Contents (Scope covered as a part of the study)
Top players in the market
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Research methodology adopted by Coherent Market Insights
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This study categorizes the global Testosterone Replacement Therapy breakdown data by manufacturers, region, type and application, also analyzes the market status, market share, growth rate, future trends, market drivers, opportunities and challenges, risks and entry barriers, sales channels, distributors and Porters Five Forces Analysis. Global Testosterone Replacement Therapy market size will increase to Million US$ by 2027, from Million US$ in 2017, at a CAGR of during the forecast period. In this study, 2017 has been considered as the base year and 2020 to 2027 as the forecast period to estimate the market size for Testosterone Replacement Therapy. This report focuses on the top manufacturers Testosterone Replacement Therapy capacity, production, value, price and market share of Testosterone Replacement Therapy in global market. The following manufacturers are
Competition Analysis:
Some of key competitors or manufacturers included in the study are AbbVie, Inc., Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin International plc, Pfizer, Inc., Acerus Pharmaceuticals Corporation, and Perrigo Company plc.
Detailed Segmentation:
By Active Ingredient TypeTestosteroneMethyl TestosteroneTestosterone UndecanoateTestosterone EnanthateTestosterone CypionateBy Route of AdministrationInjectablesParenteral
Market Analysis by Geographies:
This report is segmented into key Regions to identify significant trends and factors driving or inhibiting the market growth. To analyze the opportunities in the market for stakeholders by identifying the high growth segments., To strategically analyze each submarket with respect to individual growth trend and their contribution to the market. & to analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market. With Production Development, Sales, and Regional Trade & Forecast.
Stay up-to-date with Global Testosterone Replacement Therapy market research offered by CMI. Check how key trends and emerging drivers are shaping this industry growth as the study avails you with market characteristics, size and growth, segmentation, regional breakdowns, competitive landscape, shares, trend and strategies for this market. In the Testosterone Replacement Therapy Market Analysis & Forecast 2020-2027, the revenue is valued at USD XX million in 2017 and is expected to reach USD XX million by the end of 2027, growing at a CAGR of XX% between 2020 and 2027. The production is estimated at XX million in 2017 and is forecasted to reach XX million by the end of 2027, growing at a CAGR of XX% between 2020 and 2027.
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Some of the Points cover in Global Testosterone Replacement Therapy Market Research Report is:
Chapter 1: Overview of Global Testosterone Replacement Therapy Market (2020-2027)
Chapter 2: Market Competition by Players/Suppliers 2015 and 2020
Chapter 3: Sales (Volume) and Revenue (Value) by Region (2015-2020)
Chapter 4, 5 and 6: Global Testosterone Replacement Therapy Market by Type, Application & Players/Suppliers Profiles (2015-2020)
Chapter 7, 8 and 9: Global Testosterone Replacement Therapy Manufacturing Cost, Sourcing & Marketing Strategy Analysis
Chapter 10 and 11: Testosterone Replacement Therapy Market Effect Factors Analysis and Market Size (Value and Volume) Forecast (2020-2027)
Chapter 12, 13, 14 and 15: Global Testosterone Replacement Therapy Market Research Findings and Conclusion, appendix and data source
Some of the key questions answered in this report:
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Impact Analysis of Covid-19 On Testosterone Replacement Therapy Market Driver, Trends, Applications & Business Strategy Forecast 2027 | Endo...
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Global Testosterone Replacement Therapy Market to reach US$ 1300 mn by 2025 – Jewish Life News
Posted: June 25, 2020 at 1:50 pm
Los Angeles, United State: Complete study of the global Testosterone Replacement Therapy market is carried out by the analysts in this report, taking into consideration key factors like drivers, challenges, recent trends, opportunities, advancements, and competitive landscape. This report offers a clear understanding of the present as well as future scenario of the global Testosterone Replacement Therapy industry. Research techniques like PESTLE and Porters Five Forces analysis have been deployed by the researchers. They have also provided accurate data on Testosterone Replacement Therapy production, capacity, price, cost, margin, and revenue to help the players gain a clear understanding into the overall existing and future market situation.
Segmental Analysis
The report has classified the global Testosterone Replacement Therapy industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Testosterone Replacement Therapy manufacturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Testosterone Replacement Therapy industry.
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Global Testosterone Replacement Therapy Market by Product Type: Gels, Injections, Patches, Other
Global Testosterone Replacement Therapy Market Application: Hospitals, Clinics, Others
Competitive Landscape
It is important for every market participant to be familiar with the competitive scenario in the global Testosterone Replacement Therapy industry. In order to fulfil the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.
Key companies operating in the global Testosterone Replacement Therapy market include: AbbVie, Endo International, Eli lilly, Pfizer, Actavis (Allergan), Bayer, Novartis, Teva, Mylan, Upsher-Smith, Ferring Pharmaceuticals, Kyowa Kirin, Acerus Pharmaceuticals
Key questions answered in the report:
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Global Testosterone Replacement Therapy Market to reach US$ 1300 mn by 2025 - Jewish Life News
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GLOBAL TESTOSTERONE REPLACEMENT THERAPY MARKET 2020 BY LATEST TECHNOLOGIES, APPLICATIONS, KEY COMPANIES, PRODUCTS, REVENUE AND GROWTH OPPORTUNITIES…
Posted: June 25, 2020 at 1:50 pm
In this report, our team research the global Testosterone Replacement Therapy market by type, application, region and manufacturer 2014-2019 and forcast 2020-2025. For the region, type and application, the sales, revenue and their market share, growth rate are key research objects; we can research the manufacturers sales, price, revenue, cost and gross profit and their changes. Whats more, we will display the main consumers, raw material manufacturers, distributors, etc.
To access the sample report of the Testosterone Replacement Therapy market visit at:https://www.orbisresearch.com/contacts/request-sample/4257835
Global Testosterone Replacement Therapy market competition by top manufacturers/players, with 1% Biotin sales volume, price, revenue (Million USD) and market share for each manufacturer/player; the top players including
AbbVieEndo InternationalEli lillyPfizerActavis (Allergan)BayerNovartisTevaMylanUpsher-SmithFerring PharmaceuticalsKyowa KirinAcerus Pharmaceuticals
On the basis of product, this report displays the sales volume (K Units), revenue (Million USD), product price (USD/Unit), market share and growth rate of each type, primarily split into
GelsInjectionsPatchesOther
On the basis on the end users/applications, this report focuses on the status and outlook for major applications/end users, sales volume (K Units), market share and growth rate of Testosterone Replacement Therapy for each application, including
HospitalsClinicsOthers
Geographically, this report split Global into several key Regions, with sales (K Units), revenue (Million USD), market share and growth rate of 1% Biotin for these regions, from 2012 to 2023 (forecast), including
ChinaUSAEuropeJapanKoreaIndiaSoutheast AsiaSouth America
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Table of Contents:
1 Report Overview2 Market Analysis by Types3 Product Application Market4 Manufacturers Profiles/Analysis5 Market Performance for Manufacturers6 Regions Market Performance for Manufacturers7 Global Testosterone Replacement Therapy Market Performance (Sales Point)8 Development Trend for Regions (Sales Point)9 Upstream Source, Technology and Cost10 Channel Analysis11 Consumer Analysis12 Market Forecast 2020-202513 Conclusion
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Impact of COVID-19 on Testosterone Replacement Therapy Market Analysis, Growth, Vendors, Shares, Trends, Challenges with Forecast to 2027 | Endo…
Posted: June 25, 2020 at 1:50 pm
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The report offers a systematic presentation of the existing trends, growth opportunities, market dynamics that are expected to shape the growth of the Testosterone Replacement Therapy market. The various research methods and tools were involved in the market analysis, to uncover crucial information about the market such as current & future trends, opportunities, business strategies and more, which in turn will aid the business decision-makers to make the right decision in future.
This Report Covers Leading Companies Associated in Worldwide Testosterone Replacement Therapy Market: AbbVie, Inc., Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin International plc, Pfizer, Inc., Acerus Pharmaceuticals Corporation, and Perrigo Company plc.
We Do Offer Sample of this report. Kindly go through the follow information in order to access sample copy.
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The report begins with a brief introduction and market overview of the Testosterone Replacement Therapy industry followed by its market scope and size. Next, the report provides an overview of market segmentation such as type, application, and region. The drivers, limitations, and opportunities for the market are also listed along with current trends and policies in the industry.
The key players profiled in this report include: AbbVie, Inc., Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin International plc, Pfizer, Inc., Acerus Pharmaceuticals Corporation, and Perrigo Company plc.
Regions included:
o North America (United States, Canada, and Mexico)
o Europe (Germany, France, UK, Russia, and Italy)
o Asia-Pacific (China, Japan, Korea, India, and Southeast Asia)
o South America (Brazil, Argentina, Colombia)
o Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)
The PDF Research only provides Table of Contents (ToC), scope of the report and research framework of the report.
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Key Benefits:
o This study gives a detailed analysis of drivers and factors limiting the market expansion of Testosterone Replacement Therapy
o The micro-level analysis is conducted based on its product types, end-user applications, and geographies
o Porters five forces model gives an in-depth analysis of buyers and suppliers, threats of new entrants & substitutes and competition amongst the key market players
o By understanding the value chain analysis, the stakeholders can get a clear and detailed picture of this Testosterone Replacement Therapy market
The research study can answer the following Key questions:
Table of Contents
Report Overview: It includes the Testosterone Replacement Therapy market study scope, players covered, key market segments, market analysis by application, market analysis by type, and other chapters that give an overview of the research study.
Executive Summary: This section of the report gives information about Testosterone Replacement Therapy market trends and shares, market size analysis by region and analysis of global market size. Under market size analysis by region, analysis of market share and growth rate by region is provided.
Profiles of International Players: Here, key players of the Testosterone Replacement Therapy market are studied on the basis of gross margin, price, revenue, corporate sales, and production. This section gives a business overview of the players and shares their important company details.
Regional Study: All of the regions and countries analyzed in the Testosterone Replacement Therapy market report is studied on the basis of market size by application, the market size by product, key players, and market forecast.
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The Future of Steroids and Performance Enhancers – Muscle & Fitness
Posted: June 25, 2020 at 1:50 pm
As Ben Pakulski contemplates the future of steroids in bodybuilding and powerlifting, he evokes the 2011 Bradley Cooper movie Limitless. In the film, Coopers character, a struggling writer, takes a pill that expands the limits of his mental capabilities. Its certainly not as simple as Hollywood made it out to be, but for Pakulski, a former IFBB Pro League bodybuilder who hosts the popular Muscle Expert Podcast, the central premise of the film provides at least a loose template for what the future might look like. Imagine a performance enhancing drug that can heal wounds or soothe sore muscles almost instantly, or imagine a pill that can directly trigger muscle growth and fat loss. Thats what some athletes and bodybuilders are looking for in steroids.
As science and genetics develop, Pakulski and other experts believe that the steroids of today, which have lingered in the background of competitive powerlifting and bodybuilding for decades, will soon be a thing of the past. Today, these drugs broadly target muscle-building pathways in the body and often come with crippling hormonal side effects that doctors like Thomas OConnor, aka the Anabolic Doc, have to confront in his office multiple times per day. Those compounds, which date back to the mid20th century, are always going to be around, OConnor says, because they work, phenomenally, and theyre accessible on the internet.
The future, however, points toward more specialized drugs, which can be tailored to the bodys specific needs. Right now, those next-gen performance enhancing drugs include SARMs (selective androgen receptor modulators), which are essentially anabolic compounds that promise fewer steroid-related side effects; designer steroids, which are specially formulated by chemists in labs; peptides, which are molecules that activate hormone pathways in the body; and also testosterone replacement therapy, nootropic compounds designed to maximize brain function, and eveneventuallythe idea of editing genes to maximize performance.
How safe are all these things? Thats something we cant really say for certain at this point, in part because the science is still in its early stages, and in part because its difficult to study them too closely because theyre still viewed as tabooparticularly within competitive sports. And the potential for abuse, especially among amateurs who may not have the proper knowledge or the professional guidance, is still a serious concern.
Some of these new things have created a lower barrier for abuse, says one well-known powerlifter and strength coach, who prefers to remain anonymous. Its kind of like they get their toes wet with this stuff, and it becomes a gateway into them taking something more potent.
In an effort to understand what the future might look like, we spoke to several experts about what they see on the horizonand how best to understand the benefits and the risks.
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The Future of Steroids and Performance Enhancers - Muscle & Fitness
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The Alliance for Regenerative Medicine Announces Its 2020 Cell & Gene Meeting on the Mesa Goes Virtual – GlobeNewswire
Posted: June 25, 2020 at 1:48 pm
Washington, DC, June 24, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- The Alliance for Regenerative Medicine (ARM), an international multi-stakeholder advocacy organization representing the regenerative medicine and advanced therapy sector, today announced a new virtual format for its annual Cell & Gene Meeting on the Mesa, which will take place October 12-16, 2020.
ARM's leadership and Board of Directors arrived at the decision to host the 2020 Cell & Gene Meeting on the Mesa virtually after consulting with numerous ARM members and gathering information from various health authorities. Ultimately, hosting the meeting virtually will be the safest and most inclusive solution, allowing attendees to connect with potential partners globally while avoiding any risk to safety.
This year's Cell & Gene Meeting on the Mesa will bring together senior executives from leading cell therapy, gene therapy, and tissue engineering companies worldwide, large pharma and biotech, institutional investors, academic research institutions, patient foundations and disease philanthropies, life science media, and more.
During this unprecedented period of social distancing, ARM continues to provide members with avenues to engage and connect, said ARM CEO Janet Lambert. Our virtual Meeting on the Mesa is an invaluable opportunity for stakeholders from across the sector to convene, to network, and to continue to work to ensure innovative cell and gene therapies reach patients in need.
The conference, which will now take place over five days, includes a virtual form of the meetings signature partnering system, expected to facilitate more than 3,000 one-to-one meetings between industry leaders. The program will include 15+ digital panels and workshops featuring key industry leaders discussing issues and trends in the regenerative medicine and advanced therapy sector, from market access to the latest discoveries in gene editing. Representatives from more than 80 prominent public and private companies will deliver on-demand presentations highlighting their clinical and commercial progress to interested partners and investors.
Additional event details will be updated regularly on the event website http://www.meetingonthemesa.com.
Registration is currently open, with discounted early-bird rates available through July 24. Registration is complimentary for investors and credentialed members of the media. To learn more and to register, please visitwww.meetingonthemesa.com. For members of the media interested in attending, please contact Kaitlyn (Donaldson) Dupont atkdonaldson@alliancerm.org.
For interested organizations looking to increase exposure to this fields top decision-makers via sponsorship, please contact Laura Stringham at lparsons@alliancerm.org for additional information.
About the Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory, and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors, and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 350 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visithttp://www.alliancerm.org.
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Update on FDAs Comprehensive Regenerative Medicine Framework: Looming November 2020 Deadline Preceded by a Flurry of Letters from CBER and a New JAMA…
Posted: June 25, 2020 at 1:48 pm
As we discussed in our last update on the Food and Drug Administrations Comprehensive Regenerative Medicine Policy Framework back in December 2019 (during the much simpler, pre-COVID-19 world), this coming November will conclude the three-year period of enforcement discretion announced by the agency when it first articulated the policies and goals of this comprehensive framework. In particular, under the dual-track program announced in 2017, the Food and Drug Administration (FDA) has been focused on: (1) clarifying the regulatory criteria for product marketing through guidance and providing support to legitimate product developers through formal and informal interactions; and (2) removing unapproved, unproven, and potentially unsafe products from the U.S. market.
None of the COVID-19-related operational updates provided by the FDA generally or by the Center for Biologics Evaluation and Research (CBER) in recent months has suggested that the November 2020 deadline will be extended or otherwise altered as a result of the ongoing public health emergency, even as certain other enforcement discretion policies have been put into place. Additionally, a recent editorial published by agency leadership and a noticeable increase in Warning/Untitled Letters to persons offering unapproved cellular therapy products, taken together, strongly suggest that folks in this industry that are currently operating outside of the applicable regulatory framework should not expect to be given any additional time to come into compliance.
June 2020 JAMA Editorial Strong Language and No Sign of a Deadline Extension
Multiple statements on the topic of regenerative medicine have been issued by the governing FDA Commissioner as well as CBER Director Peter Marks over the past several years, which indicates how important this area is to the agencys broader public health priorities at the start of the 21st century. The most recent salvo from agency leadership came in the form of an editorial published online by JAMA on June 17, 2020, authored by Dr. Marks and Commissioner Stephen Hahn, who has been in his new job for about six months. Their editorial includes some of the strongest language we have seen to date on the topic of unapproved regenerative medicine products. For example, Dr. Marks and Dr. Hahn state that [d]espite assertions by some individuals to the contrary, these products, whether autologous or allogeneic, are not inherently safe and may be associated with serious adverse consequences. They assert that [t]he increasing number of adverse events being reported following the widespread use of unapproved regenerative medicine therapies at hundreds of clinics across the country make it necessary for the FDA to act to prevent harm to individuals receiving them.
Drs. Marks and Hahn briefly highlight some of the enforcement that the agency has undertaken in this space since 2017 and ask for engagement from both clinicians and patients to help to ensure that instead of remaining unintentionally or intentionally hidden, potentially harmful unapproved regenerative medicine therapies are identified and removed from the market. They then provide basic guidelines for patients and caregivers to use when assessing whether a cellular therapy product is being offered in compliance with applicable laws and FDA regulations. Specifically, they recommend the following key considerations for anyone considering treatment with a cellular product:
Nothing in this newly-published editorial suggests that FDA/CBER will be taking its proverbial foot off the pedal to slow down its efforts towards further oversight of the private stem cell clinic industry after November 2020. To the contrary, the piece could represent one of the last informal warnings those businesses get from the agency before they receive a customized Warning or Untitled Letter or become subject to whatever increased enforcement activity the federal government initiates in this area in 2021 and beyond.
Relatively Large Number of Warning Letters Sent Since January 2020
We previously noted that FDA/CBER appeared to have increased the pace of issuing Warning and Untitled Letters to sellers of unapproved stem cell products during the second half of 2019, with many of those letters involving companies that processed and marketed unapproved umbilical cord blood-derived cellular products. We also reported that the agency had issued a Public Safety Notification on Exosome Products on December 6, 2019, informing the public of multiple reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes. That safety alert also described the unscrupulous conduct of sellers of such products in forceful and direct language, similar to the language used by Dr. Marks and Commissioner Hahn in this months editorial piece.
Over the first half of this year, as we get yet closer to the November 2020 deadline for stem cell clinics and medical practitioners to come into compliance with federal law, there has been a more noticeable increase in the Warning/Untitled Letters issues regarding the marketing of unapproved products that put patients at risk. These include at least nine Untitled Letters issued since January 2020 (which can each be accessed from this CBER webpage) and at least two Warning Letters, one from March and one from June. The Warning Letters in particular include charges that the firms in question were violating current good manufacturing practices (CGMPs) and current good tissue practices (CGTPs) for human cells and tissue products, putting patient safety at risk.
Interestingly, the most recent FDA Warning Letter issued on June 4, 2020 not only cites the recipient for marketing unapproved stem cell products and an unapproved exosome product, but it also states that the unapproved exosome product was being marketed for the treatment and prevention of COVID-19 something the June 17 Marks/Hahn JAMA editorial alluded to generally as well. Given that there are currently no FDA-approved products to prevent or treat COVID-19, any such claims will automatically heighten the enforcement risk to a company or physician engaged in the sale of products for those intended uses.
In addition to the work being done by FDA, moreover, the Federal Trade Commission (FTC) has also been monitoring the commercial marketplace closely and taking various actions to protect consumers from fraudulent COVID-19 products, including a few marketed by stem cell clinics. So far this month, FTC announced on June 4, 2020 that it had issued a 35 warning letters and an additional 30 warning letters on June 18, 2020. The first batch of these FTC warning letters notably included one to a stem cell clinic that, among other things, had claimed that stem cells can be administered intravenously and by inhalation through a nebulizer to treat lung damage caused by COVID-19 without scientific evidence to support the efficacy claim, while the second batch included two letters addressed to marketers of stem cell products.
FDA and the FTC coordinate quite closely on consumer protection matters that implicate both agencies primary missions, as is apparent from the large number of COVID-19 Warning Letters that have been jointly issued by the two agencies since March 2020. So they may very well be coordinating more actively now on the monitoring of stem cell clinics and individual physicians offering unapproved cellular therapies to the general public, as the focus shifts to the next phase of the Comprehensive Regenerative Medicine Policy Framework. The next five or six months should offer everyone more insight into what the enforcement landscape is likely to evolve into once the FDAs enforcement discretion period ends in November. As always, well keep our readers apprised of any notable developments.
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Update on FDAs Comprehensive Regenerative Medicine Framework: Looming November 2020 Deadline Preceded by a Flurry of Letters from CBER and a New JAMA...
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$3 million grant awarded to Loma Linda University School of Medicine researchers for maternal hypoxia study – Loma Linda University Health
Posted: June 25, 2020 at 1:48 pm
The National Heart, Lung and Blood Institute awarded $3.05 million to researchers from theLawrence D. Longo, MD Center for Perinatal Biologyat Loma Linda University School of Medicine, allowing investigators to add a new element to their study portfolio of exploring the effects of oxygen deprivation or hypoxia on mother and baby during pregnancy.
Investigators will use the four-year grant toward the centers research project, titled "Gestational Hypoxia and Programming of Maternal, Fetal and Newborn Vascular Function. Starting in July 2020, researchers will use the funds to search for mechanisms causing pregnancy complications of preeclampsia and developmental programming of cardiovascular disease from gestational hypoxia.
Hypoxia during gestation has profound adverse effects on the mothers health and fetal development. Hypoxia is one of the most frequent and severe stresses on an organism's body regulation of metabolism, temperature, fluid composition, blood sugar, blood flow and blood pressure. Worldwide, more than 140 million people live at risk of hypoxia in high altitude environments.In addition, a large portion of pregnancy complications, including preeclampsia, smoking and placental insufficiency, expose the fetus to chronic hypoxia.
The studys principal investigator, Lubo Zhang, PhD, director of the Lawrence D. Longo Center for Perinatal Biology, said he and his team look forward to making additional strides toward meaningful discoveries that could be life-saving for families.
We are pleased and honored to receive this grant because the research it supports can change the lives of mothers and babies, Zhang said. The teams overall vision is to build on the centers prior accomplishments to formulate a highly innovative program for advancing and transforming the research field in the understanding maternal, fetal and newborn vascular function in response to hypoxia during gestation.
In addition to this new research project, the investigator team headed by Zhang is currently conducting four studies on the effects of hypoxia. Those studies are funded by a Program Project grant from the National Institutes of Health (NIH). In 2016, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, an NIH entity,awarded the center a $6.29 million grant to work on discoveries revealing oxygen deprivations effects on uterine blood flow, fetal cerebral circulation, and the impact of hypoxia on fat cell and metabolism.
Investigators found high altitude hypoxia during gestation decreased uterine blood flow and increased the mothers systemic arterial blood pressure. Researchers came to this conclusion after using an animal model of pregnant sheep acclimatized to high altitude above 10,000 feet. In addition to maternal cardiovascular complications, the studies revealed that newborn lambs at high altitude showed significantly increased risk of persistent pulmonary hypertension similar to humans. Investigators also found pregnancy complications and fetal hypoxia were associated with dysregulation of cerebral blood flow and increased risk of bleeding in the developing brain.
The five-year NIH grant will expire in March of 2021. With this looming expiration, the research team is looking forward to continue exploring the topic for another four years.
The new grant was secured with help from Congressman Pete Aguilar, U.S. representative for the congressional district.
Loma Linda University Health is a point of pride for our region, and the lifesaving research of Dr. Zhang and his team is exciting and inspiring, Aguilar said. As Vice Chair of the House Appropriations Committee, and LLUHs representative in Congress, Im proud to support their work and will continue to advocate for the funding that makes these groundbreaking studies possible.
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Stem Cell And Regenerative Therapy Market : Segmentation, Industry Trends and Development size COVID-19 2024 – 3rd Watch News
Posted: June 25, 2020 at 1:48 pm
he globalstem cell and regenerative medicines marketshould grow from $21.8 billion in 2019 to reach $55.0 billion by 2024 at a compound annual growth rate (CAGR) of 20.4% for the period of 2019-2024.
Report Scope:
The scope of this report is broad and covers various type of product available in the stem cell and regenerative medicines market and potential application sectors across various industries. The current report offers a detailed analysis of the stem cell and regenerative medicines market.
The report highlights the current and future market potential of stem cell and regenerative medicines and provides a detailed analysis of the competitive environment, recent development, merger and acquisition, drivers, restraints, and technology background in the market. The report also covers market projections through 2024.
The report details market shares of stem cell and regenerative medicines based on products, application, and geography. Based on product the market is segmented into therapeutic products, cell banking, tools and reagents. The therapeutics products segments include cell therapy, tissue engineering and gene therapy. By application, the market is segmented into oncology, cardiovascular disorders, dermatology, orthopedic applications, central nervous system disorders, diabetes, others
The market is segmented by geography into the following regions: North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The report presents detailed analyses of major countries such as the U.S., Canada, Mexico, Germany, the U.K. France, Japan, China and India. For market estimates, data is provided for 2018 as the base year, with forecasts for 2019 through 2024. Estimated values are based on product manufacturers total revenues. Projected and forecasted revenue values are in constant U.S. dollars, unadjusted for inflation.
Request for Report Sample:https://www.trendsmarketresearch.com/report/sample/11723
Report Includes:
28 data tables An overview of global markets for stem cell and regenerative medicines Analyses of global market trends, with data from 2018, estimates for 2019, and projections of compound annual growth rates (CAGRs) through 2024 Details of historic background and description of embryonic and adult stem cells Information on stem cell banking and stem cell research A look at the growing research & development activities in regenerative medicine Coverage of ethical issues in stem cell research & regulatory constraints on biopharmaceuticals Comprehensive company profiles of key players in the market, including Aldagen Inc., Caladrius Biosciences Inc., Daiichi Sankyo Co. Ltd., Gamida Cell Ltd. and Novartis AG
Summary
The global market for stem cell and regenerative medicines was valued at REDACTED billion in 2018. The market is expected to grow at a compound annual growth rate (CAGR) of REDACTED to reach approximately REDACTED billion by 2024. Growth of the global market is attributed to the factors such as growingprevalence of cancer, technological advancement in product, growing adoption of novel therapeuticssuch as cell therapy, gene therapy in treatment of chronic diseases and increasing investment fromprivate players in cell-based therapies.
In the global market, North America held the highest market share in 2018. The Asia-Pacific region is anticipated to grow at the highest CAGR during the forecast period. The growing government funding for regenerative medicines in research institutes along with the growing number of clinical trials based on cell-based therapy and investment in R&D activities is expected to supplement the growth of the stem cell and regenerative market in Asia-Pacific region during the forecast period.
Reasons for Doing This Study
Global stem cell and regenerative medicines market comprises of various products for novel therapeutics that are adopted across various applications. New advancement and product launches have influenced the stem cell and regenerative medicines market and it is expected to grow in the near future. The biopharmaceutical companies are investing significantly in cell-based therapeutics. The government organizations are funding research and development activities related to stem cell research. These factors are impacting the stem cell and regenerative medicines market positively and augmenting the demand of stem cell and regenerative therapy among different application segments. The market is impacted through adoption of stem cell therapy. The key players in the market are investing in development of innovative products. The stem cell therapy market is likely to grow during the forecast period owing to growing investment from private companies, increasing in regulatory approval of stem cell-based therapeutics for treatment of chronic diseases and growth in commercial applications of regenerative medicine.
Products based on stem cells do not yet form an established market, but unlike some other potential applications of bioscience, stem cell technology has already produced many significant products in important therapeutic areas. The potential scope of the stem cell market is now becoming clear, and it is appropriate to review the technology, see its current practical applications, evaluate the participating companies and look to its future.
The report provides the reader with a background on stem cell and regenerative therapy, analyzes the current factors influencing the market, provides decision-makers the tools that inform decisions about expansion and penetration in this market.
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Stem Cell And Regenerative Therapy Market : Segmentation, Industry Trends and Development size COVID-19 2024 - 3rd Watch News
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