Sanofi chair Serge Weinberg on Thursday walked back entirely his CEO Paul Hudsons remarks that the US would have the right to the largest pre-order of the French drugmakers Covid-19 vaccine, should it be complete.

There will be no particular advance given to any country, Weinberg told France 2 television, according toReuters. The comments of our CEO have been altered. We consider vaccines as a common good.

Weinbergs comments joined a chorus among the board and the French government over the comments made Wednesday by Hudson, who insists he was misunderstood and had been calling only for Europe to take stronger action to support the development of a vaccine.

Remarking that a vaccine should be for the public good and that Hudsons comments affected French President Emmanuel Macron, a government official toldBloombergHudson and other Sanofi leadership were called to the presidential residence at the lyse Palace for a meeting. Earlier Thursday morning, when news of Macrons dissatisfaction first surfaced, Hudson said in an interview for the Financial Times Global Boardroom that it was news to him that the president wanted a meeting.

French Prime Minister douard Philippe also spoke out, saying on Twitter that a vaccine against Covid-19 should be a public good for the world.

After the company issued an initial statement walking back Hudsons comments on Wednesday saying that US production will be mainly for the US and ex-US production for Europe and the globe Weinberg and other members of Sanofis board spoke out out in greater force on Thursday.

Olivier Bogillot, chairman of Sanofis French unit, appeared on BFM Television and said there was no question about what would happen.

Obviously, if Sanofi makes a breakthrough on a vaccine for Covid-19 and it is effective, it will be made available to all, he said.

Hudson, appearing for a scheduled interview at the FT virtual conference, tried to clarify his remarks. The still relatively new CEO had toldBloombergthat the US would get the largest pre-order because the US bio-defense agency BARDA had financed their Covid-19 effort, backing it with a $30 million grant this year. He urged Europe to make a similar effort so countries on the continent dont get left behind.

What Im trying to say everywhere I go is that the US has BARDA, which is like a biological research group that gets ahead of these things earlier to get people ready and to try to make sure the necessary capacity is built and the risks are shared, he said. My comments are really around what do we need to do to make sure were in a similar position in Europe. It was never a choice. We need to get vaccines to everybody.

Experts warn, though, that when Covid-19 vaccines do arrive, they will come in batches, forcing potentially difficult decisions about who gets the first doses. AstraZeneca CEO Pascal Soriot said last month that the UK would get early access to the vaccine they are producing with Oxford University.

Ousted BARDA chief Rick Bright said at a whistleblower hearing Thursday that the US has a placeholder to order doses from some of the vaccine companies it funded. The agency has put around $1 billion to back J&J and Modernas efforts. In addition to the $30 million this spring, the agency has given Sanofi and its recombinant vaccine subsidiary Protein Sciences hundreds of millions in grants over the last 15 years.

The United States has a placeholder with some of those companies to be able to place orders for those vaccines when they are available, Bright said. And we did everything possible to ensure that those investments were in companies that would build capacity in the United States to manufacture those vaccines. We had to get in line first.

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ReportsnReports recently added a detailed overview and industry professional survey report on the global Longevity and Anti-senescence Therapy Market. In this report, titled Longevity and Anti-senescence Therapy Market Size, Share and Industry Analysis by Technologies, By Product, By Application, By Distribution Channel, and Regional Forecast 2019-2026.

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The scope of the report encompasses the major types of Longevity and Anti-senescence Therapy Market that have been used, as well as the major applications being developed by industry, academic researchers and their commercialization offices, and government agencies. It analyzes the current market status, examines future market drivers, and presents forecasts of growth over the next five years. Technology developments, including the latest trends, are discussed. Other influential factors such as screening strategies for pharmaceuticals have also been included.

The global Longevity and Anti-senescence Therapy Market is comprehensively profiled in the report, including a detailed study of the markets key drivers and restraints, major market players, and leading segments.

Report Scope:

The scope of this report is broad and covers various therapies currently under trials in the global longevity and anti-senescence therapy market. The market estimation has been performed with consideration for revenue generation in the forecast years 2018-2023 after the expected availability of products in the market by 2023. The global longevity and anti-senescence therapy market has been segmented by the following therapies: Senolytic drug therapy, Gene therapy, Immunotherapy and Other therapies which includes stem cell-based therapies, etc.

Revenue forecasts from 2028 to 2023 are given for each therapy and application, with estimated values derived from the expected revenue generation in the first year of launch.

The report also includes a discussion of the major players performing research or the potential players across each regional longevity and anti-senescence therapy market. Further, it explains the major drivers and regional dynamics of the global longevity and anti-senescence therapy market and current trends within the industry.

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Report Includes:

71 data tables and 40 additional tables An overview of the global longevity and anti-senescence therapy market Analyses of global market trends, with data from 2017 and 2018, and projections of compound annual growth rates (CAGRs) through 2023 Country specific data and analysis for the United States, Canada, Japan, China, India, U.K., France, Germany, Spain, Australia, Middle East and Africa Detailed description of various anti-senescence therapies, such as senolytic drug therapy, gene therapy, immunotherapy and other stem cell therapies, and their influence in slowing down aging or reverse aging process Coverage of various therapeutic drugs, devices and technologies and information on compounds used for the development of anti-ageing therapeutics A look at the clinical trials and expected launch of anti-senescence products Detailed profiles of the market leading companies and potential entrants in the global longevity and anti-senescence therapy market, including AgeX Therapeutics, CohBar Inc., PowerVision Inc., T.A. Sciences and Unity Biotechnology

Summary:

Global longevity and anti-senescence therapy market deals in the adoption of different therapies and treatment options used to extend human longevity and lifespan. ?Human longevity is typically used to describe the length of an individuals lifetime and is sometimes used as a synonym for ?life expectancy in the demography. ?Anti-senescence is the process by which cells stop dividing irreversibly and enter a stage of permanent growth arrest, eliminating cell death. Anti-senescence therapy is used in the treatment of senescence induced through unrepaired DNA damage or other cellular stresses.

Global longevity and anti-senescence market will witness rapid growth over the forecast period (2018-2023) owing to an increasing emphasis on Stem Cell Research and an increasing demand for cell-based assays in research and development.

An increasing geriatric population across the globe and a rising awareness of antiaging products among generation Y and later generations are the major factors expected to promote the growth of global longevity and anti-senescence market. Factors such as a surging level of disposable income and increasing advancements in anti-senescence technologies are also providing traction to the global longevity and anti-senescence market growth over the forecast period (2018-2023).

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According to the National Institutes of Health (NIH), the total geriatric population across the globe in 2016 was over REDACTED. By 2022, the global geriatric population (65 years and above) is anticipated to reach over REDACTED. An increasing geriatric population across the globe will generate huge growth prospectus to the market.

Senolytics, placenta stem cells and blood transfusions are some of the hot technologies picking up pace in the longevity and anti-anti-senescence market. Companies and start-ups across the globe such as Unity Biotechnology, Human Longevity Inc., Calico Life Sciences, Acorda Therapeutics, etc. are working extensively in this field for the extension of human longevity by focusing on study of genomics, microbiome, bioinformatics and stem cell therapies, etc. These factors are poised to drive market growth over the forecast period.

Global longevity and anti-senescence market is projected to rise at a CAGR of REDACTED during the forecast period of 2018 through 2023. In 2023, total revenues are expected to reach REDACTED, registering REDACTED in growth from REDACTED in 2018.

The report provides analysis based on each market segment including therapies and application. The therapies segment is further sub-segmented into Senolytic drug therapy, Gene therapy, Immunotherapy and Others. Senolytic drug therapy held the largest market revenue share of REDACTED in 2017. By 2023, total revenue from senolytic drug therapy is expected to reach REDACTED. Gene therapy segment is estimated to rise at the highest CAGR of REDACTED till 2023. The fastest growth of the gene therapy segment is due to the Large investments in genomics. For Instance; The National Human Genome Research Institute (U.S.) had a budget grant of REDACTED for REDACTED research projects in 2015, thus increasing funding to REDACTED for approximately REDACTED projects in 2016.

The latest Longevity and Anti-senescence Therapy Market report provides readers with a deeper understanding of potential target consumers to create a lucrative marketing strategy for the 2019-2026 forecast period. For entrepreneurs seeking information about potential customers, it will be particularly helpful. Selective statements provided by leading vendors would allow entrepreneurs to gain a deeper understanding of the local market and prospective customers.

Table of Contents:

Chapter 1 Introduction

Study Background

Study Goals and Objectives

Reasons for Doing This Study

Scope of Report

Methodology and Information Sources

Geographic Breakdown

Market Breakdown

Analysts Credentials

.Continued

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Longevity and Anti-senescence Therapy Market Projected to Experience Major Revenue Boost During the Forecast Period Between 2020-2026 | Covid-19...

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The worldwide for Gene Therapy marketis expected to grow at a CAGR of roughly +33% over the next five years.

Gene therapy is a test treatment that includes bringing genetic material into an individuals phones to battle or counteract ailment. Specialists are reading gene therapy for various maladies, for example, extreme joined immuno-insufficiencies, hemophilia, Parkinsons infection, disease and even HIV, through various methodologies. A gene can be conveyed to a cell utilizing a bearer known as a vector. The most widely recognized kinds of vectors utilized in gene therapy are infections. The infections utilized in gene therapy are modified to make them safe, albeit a few dangers still exist with gene therapy. The innovation is still in its infancy

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The key players covered in this study:

Market segment by Type, the product can be split into

Market segment by Application, split into

Different global regions such as North America, Latin America, Europe, Asia-Pacific, Africa, and India have been examined to get a better understanding of the competitive landscape.

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Hormonal therapy industry market is considered to be a very small market because of the unlimited scopes as well as Limited market size which is only focused to was helping with being a substitute of the biotechnology and Clinical Research

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Gene Therapy Market Aims to Expand at Double-Digit Growth Rate|Novartis AG, Gilead Sciences Inc., UniQure NV, Spark Therapeutics LLC, Bluebird Bio,...

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ReportsnReports recently added a detailed overview and industry professional survey report on the global Stem Cell and Regenerative Therapy Market. In this report, titled Stem Cell and Regenerative Therapy Market Size, Share and Industry Analysis by Technologies, By Product, By Application, By Distribution Channel, and Regional Forecast 2019-2026.

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The global Stem Cell and Regenerative Therapy Market is comprehensively profiled in the report, including a detailed study of the markets key drivers and restraints, major market players, and leading segments.

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.

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

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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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The latest Stem Cell and Regenerative Therapy Market report provides readers with a deeper understanding of potential target consumers to create a lucrative marketing strategy for the 2019-2026 forecast period. For entrepreneurs seeking information about potential customers, it will be particularly helpful. Selective statements provided by leading vendors would allow entrepreneurs to gain a deeper understanding of the local market and prospective customers.

Table of Contents:

Chapter 1 Introduction

Study Background

Study Goals and Objectives

Reasons for Doing This Study

Scope of Report

Methodology and Information Sources

Geographic Breakdown

Market Breakdown

Analysts Credentials

.Continued

About Us: ReportsnReports.com is your single source for all market research needs. Our database includes 500,000+ market research reports from over 95 leading global publishers & in-depth market research studies of over 5000 micro markets.We provide 24/7 online and offline support to our customers.

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AAI Rejuvenation Clinic is breaking the mold. In a very short period, we have brought our ranking position to be noted as one of the best hormone health centers in existence. A quick Google search for best hormone clinic in the country yields first page results containing AAI Clinics as one of the first brick and mortar locations available for selection.

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Patients do not only receive hormones You cannot help heal 1 million different peoples health problems with a group of only 15 basic medications and hormones. Other compounds are necessary and vary from person to person. We supply these.

Therapy-supporting nutraceuticals Depending on patient goals and individual ailments, targeted supplements are also prescribed to maximize results and the efficiency of therapy. We practice focused healing and goal achieving.

Most competitive pricing in the industry From inception, we have known this industry is saturated with overpriced margins. We knew providing exceptional patient care in conjunction with the best available pricing was an impermeable recipe for everybodys success.

Healing from the core Foods are medicine. We provide information on symptom-focused healing foods, including viable recipes and food per item nutritional details and medicinal property explanations. Eating the right foods to heal your body and reach your goals is one of the biggest kept secrets, yet fastest ways to obtain lasting results.

Hassle free

1. Patients only need three simple documents for qualification. 2. Patients never need to leave their city. 3. Individualized assistance via assigned medical professional 7 days a week from 9 AM to 10 PM EST. 4. Prescription fills delivered to home or office in discrete packaging.5. Prescribing Physicians online or phone consults available. 6. For our busy patients, a physicians visit to their home or office can be organized.

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AAI Rejuvenation Clinic - Best Hormone Clinic in the USA ...

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Thyroid Hormone Disorder Drug Market

DataIntelo, 14-05-2020: The research report on the Thyroid Hormone Disorder Drug Market is a deep analysis of the market. This is a latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. Experts have studied the historical data and compared it with the changing market situations. The report covers all the necessary information required by new entrants as well as the existing players to gain deeper insight.

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Thyroid Hormone Disorder Drug Market 2020 Global Share, Growth, Size, Opportunities, Trends, Regional Overview, Leading Company Analysis And Forecast...

Recommendation and review posted by Bethany Smith

Abstract: 5514

NUBEQA (darolutamide) plus androgen deprivation therapy (ADT) is shown to significantly improve overall survival (OS) compared to ADT alone, in men with non-metastatic castration-resistant prostate cancer (nmCRPC).1 These data from the pre-specified final OS analysis of the Phase III ARAMIS trial will be presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, which takes place from May 29-31, 2020.

Previously published results in 1,509 patients from the Phase III ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months (n=955) with NUBEQA plus ADT, compared to 18.4 months (n=554) for placebo plus ADT (p<0.001); however OS data were not yet mature at the time of the MFS analysis.2 MFS is defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first. Adverse reactions occurring more frequently in the NUBEQA arm (2 percent over placebo) were fatigue (16 percent versus 11 percent), pain in extremity (6 percent versus 3 percent) and rash (3 percent versus 1 percent).2 NUBEQA was not studied in women and there is a warning and precaution for embryo-fetal toxicity.2

"Men with nmCRPC typically do not have cancer symptoms. In selecting a treatment for these patients, my goal as a clinician is to improve their overall survival while limiting side effects and drug interactions," said Karim Fizazi, M.D., Ph.D., Professor of Medicine at the Institut Gustave Roussy, Villejuif, France. "These data add to the growing evidence for darolutamide as an effective treatment option with proven tolerability that extends patients lives and delays cancer symptoms."

Final OS Analysis Presented at ASCO Virtual Scientific Program

Men receiving NUBEQA plus ADT showed a statistically significant improvement in the secondary endpoint of OS compared to ADT alone, with a 31 percent reduction in risk of death (HR=0.69, 95% CI 0.53-0.88; p=0.003).1

With extended follow-up, any grade treatment-emergent adverse events (AEs) at final analysis were generally consistent with the primary analysis of the Phase III ARAMIS trial.1,2 Previously, in the primary analysis, any grade AEs occurred in 83.2 percent who received NUBEQA plus ADT and 76.9 percent who received ADT alone.2 Grade 3 or 4 AEs occurred in 24.7 percent who received NUBEQA plus ADT and 19.5 percent who received ADT alone.2 Grade 5 AEs occurred in 3.9 percent who received NUBEQA plus ADT and 3.2 percent who received ADT alone.2 Serious AEs occurred in 24.8 percent receiving NUBEQA plus ADT and in 20.0 percent receiving ADT alone.2 The percentage who discontinued the trial regimen because of AEs was 8.9 percent in the NUBEQA plus ADT group and 8.7 percent in the ADT group.2

Previously, OS data were not mature at the time of MFS analysis (57 percent of the required number of events).2 Secondary endpoints were evaluated in a hierarchical order, with a significance level of 0.05 split between the primary analysis and final analysis (planned to occur after 240 deaths from any cause) of secondary endpoints.1,2 The endpoint OS was used to determine the alpha spend and significance threshold for each of the secondary endpoints.2 Given the OS analysis did not meet the threshold for statistical significance, this prevented all of the secondary endpoints from meeting the criteria for statistical significance at the interim analysis.2

In the follow-up analysis of the same secondary endpoints, all were statistically significant.1 NUBEQA plus ADT showed statistical significance in delaying time to pain progression (HR=0.65, 95% CI 0.53-0.79; p<0.001), time to first initiation of treatment with cytotoxic chemotherapy (HR=0.58, 95% CI 0.44-0.76; p<0.001) and time to first symptomatic skeletal event (SSE) (HR=0.48, 95% CI 0.29-0.82; p=0.005) versus ADT alone.1

Time to pain progression was defined as at least a 2-point worsening from baseline of the pain score on Brief Pain Inventory-Short Form or initiation of opioids, in patients treated with NUBEQA as compared to ADT alone. Pain progression was reported in 28 percent of all patients at the interim analysis.

Story continues

About NUBEQA (darolutamide)3

NUBEQA is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.3 A Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS) is ongoing. Information about this trial can be found at http://www.clinicaltrials.gov.

On July 30th, 2019, the FDA approved NUBEQA (darolutamide) based on the ARAMIS trial, a randomized, double-blind, placebo-controlled, multi-center Phase III study, which evaluated the safety and efficacy of oral NUBEQA in patients with nmCRPC who were receiving a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of NUBEQA orally twice daily or ADT alone. The primary efficacy endpoint was MFS.

Adverse reactions occurring more frequently in the NUBEQA arm (2 % over placebo) were fatigue (16% versus 11%), pain in extremity (6% versus 3%) and rash (3% versus 1%). NUBEQA was not studied in women and there is a warning and precaution for embryo-fetal toxicity.

Developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, NUBEQA is indicated for the treatment of men with nmCRPC.3 The approvals of NUBEQA in the U.S., European Union (EU), Australia, Brazil, Canada, and Japan have been based on the pivotal Phase III ARAMIS trial data evaluating the efficacy and safety of NUBEQA plus ADT compared to ADT alone.3 Filings in other regions are underway or planned.

INDICATION

NUBEQA is approved for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).3

IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in 1 % of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Adverse reactions occurring more frequently in the NUBEQA arm (2% over placebo) were fatigue (16% vs. 11%), pain in extremity (6% vs. 3%) and rash (3% vs. 1%).

Clinically significant adverse reactions occurring in 2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs. 3.4% on placebo) and heart failure (2.1% vs. 0.9% on placebo).

Drug Interactions

Effect of Other Drugs on NUBEQA Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure, which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers.

Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure, which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed.

Effects of NUBEQA on Other Drugs NUBEQA is an inhibitor of breast cancer resistance protein (BCRP) transporter. Concomitant use of NUBEQA increases the exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug. Consult the approved product labeling of the BCRP substrate when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Prostate Cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.4 In 2020, about 192,000 men in the U.S. will be diagnosed with prostate cancer and an estimated 33,000 will die from the disease.5 Prostate cancer is the fifth leading cause of death from cancer in men.4 Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a mans reproductive system.6 It mainly affects men over the age of 50, and the risk increases with age.7

Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location.8 However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.9

Castration-resistant prostate cancer (CRPC) is an advanced form of the disease where the cancer keeps progressing even when the amount of testosterone is reduced to very low levels in the body. The field of treatment options for castration-resistant patients is evolving rapidly for CRPC patients who have prostate cancer that has not spread to other parts of the body with rising prostate-specific antigen (PSA) levels despite a castrate testosterone level, which is called non-metastatic castration-resistant prostate cancer, or nmCRPC.10,11 About one-third of men with nmCRPC go on to develop metastases within two years.12 In men with progressive nmCRPC, a short PSA doubling time is correlated with shortened time to first metastasis and death.11

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the companys approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to http://www.bayer.us.

2020 BayerBAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayers public reports which are available on the Bayer website at http://www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

_______________________________________________________________________________________________

References

PP-NUB-US-0303-1

05/20

View source version on businesswire.com: https://www.businesswire.com/news/home/20200513005848/en/

Contacts

Media Contact:Rose Talarico, Tel. +1 862.404.5302 E-Mail: rose.talarico@bayer.com

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NUBEQA (darolutamide) Plus Androgen Deprivation Therapy Showed a Statistically Significant Improvement in Overall Survival with Proven Efficacy and...

Recommendation and review posted by Bethany Smith

New York University (NYU) Langone researchers find that elevated levels of toxic chemicals from pesticides, nonstick cookware, and fire retardants are associated with an increased risk of developing celiac disease.

Celiac disease is an autoimmune disease where the ingestion of gluten leads to damage in the small intestines, Dr. Patrick Fratellone, RH FIM, an integrative physician and adjunct professor at the University of Bridgeport College of Naturopathic Medicine, told Healthline.

For this study published May 11 in the journal Environmental Research, researchers examined levels of toxic chemicals in the blood of 30 children and young adults, from 3 to 21 years old, and recently diagnosed with celiac disease at NYU Langone Hassenfeld Childrens Hospital.

Chemical levels were compared to those of 60 other participants of similar age, gender, and race without celiac disease.

The NYU team discovered that children and young adults who have high levels of pesticides and other chemicals called dichlorodiphenyldichloroethylenes (DDEs) had double the chance of being diagnosed with celiac disease than those who didnt.

The study also found that gender plays a role in how chemicals influence celiac risk.

For females, higher-than-normal pesticide exposure meant they were at least eight times more likely to become gluten intolerant.

But elevated levels of nonstick chemicals (perfluoroalkyls, or PFAs), including products like Teflon, were up to nine times more likely to have celiac disease.

On the other hand, young males with elevated blood levels of fire-retardant chemicals called polybrominated diphenyl ethers (PBDEs) were only twice as likely to be diagnosed with the condition.

The endocrine system, also called the hormone system, is made up of glands located throughout the body.

Theres emerging science that certain chemicals disrupt immune function, and not just hormonal function, said study co-investigator and health epidemiologist Dr. Leonardo Trasande, MPP, professor of pediatrics at NYU Langone.

He added theres already some suggestive evidence that endocrine-disrupting chemicals contribute to celiac disease and are associated with other diseases, like Crohns disease.

Trasande emphasized theres a lot of cross-talk between the endocrine system and the immune system, in the context of celiac disease and other autoimmune conditions.

According to the Environmental Protection Agency (EPA), persistent organic pollutants (POPs) include thousands of synthetic chemicals widely used during the industrial production boom after the Second World War.

Although many POPs have been phased out of use, these chemicals remain in the environment, as they are resistant to degradation and tend to accumulate in animal and human tissue, the study authors wrote.

Some well-known POPs include polychlorinated biphenyls (PCBs), the pesticide DDT, and dioxins which come from chlorine bleaching of paper pulp, the manufacturing of some herbicides and pesticides, and other industrial processes.

DDE is a metabolite of the long-standing pesticide DDT, which of course has been banned, except for some use in malaria prevention in parts of Africa, said Trasande. But theres legacy contamination, such that we werent surprised to detect many of the metabolites [in study participants].

He emphasized that there are steps we can take to reduce our exposure to these chemicals.

People can do things like simply clearing the air by opening windows every day, and using a wet mop to sop up persistent pollutants that can accumulate in dust.

Trasande asserted that this study adds to others raising concerns about nonstick chemicals.

One simple way to cut down on exposure to these chemicals is to switch out Teflon pans for cast-iron pans, which if properly seasoned can result in a nonstick like surface without these chemicals.

This isnt the first study to find a link between commonly used chemicals and celiac disease.

A 2013 study published in the journal Interdisciplinary Toxicology concluded that glyphosate, the active ingredient in herbicides like Roundup, is the most important causal factor in celiac disease.

But Trasandes study is the first to measure an association between chemical exposure and the condition.

Our study establishes the first measurable tie-in between environmental exposure to toxic chemicals and celiac disease, said senior study investigator and pediatric gastroenterologist Dr. Jeremiah Levine in a statement. These results also raise the question of whether there are potential links between these chemicals and other autoimmune bowel diseases, which all warrant close monitoring and further study.

The National Institutes of Health (NIH) list symptoms of celiac disease that include:

However, some people with the disease may not have symptoms at all. According to the NIH, celiac disease can also prevent children from absorbing nutrients, which may lead to issues like slowed growth, weight loss, damaged tooth enamel, and delayed puberty.

It affects 1 in 100 individuals, said Fratellone. These individuals are genetically predisposed, and it is estimated that there are over 2 million Americans who are undiagnosed and at risk for long-term complications,

Fratellone explained that gluten is an umbrella name for proteins known as prolamins, which are primarily made up of glutenin and gliadin. This substance is found in grains that include wheat, rye, and barley.

The best way to treat a celiac patient is to educate him or her on avoiding wheat gluten. There are also blood tests to determine if you have a gluten allergy or have celiac disease, he said.

The Mayo Clinic cautions that before starting a gluten-free diet, you should be tested for celiac disease first because eliminating gluten could make the tests appear normal.

There are two blood tests available to diagnose it: serology testing, which looks for certain antibodies in your blood, and genetic testing. Some gastroenterologists believe you must have a biopsy. I do recommend food allergy testing, said Fratellone.

If youre gluten intolerant, the Mayo Clinic advises you to avoid all foods and drinks containing wheat, rye, barley, triticale (a cross between wheat and rye), and in some cases, oats, if there is a chance they were contaminated during production with gluten-containing grains.

For the first time, a study has measured the association between exposure to toxic chemicals, like pesticides and industrial chemicals, and celiac disease risk.

Researchers say that the findings raise the question of whether there are potential links between these chemicals and other autoimmune bowel diseases.

Celiac disease can lead to serious health issues in children, but experts say its important to get tested before starting a gluten-free diet.

Visit link:
Pesticides, Nonstick Pans and Celiac Disease: How They Are Linked - Healthline

Recommendation and review posted by Bethany Smith

High blood pressure gradually increases the pressure of blood flowing through your arteries. Over time, this pressure can cause your arteries to lose their elasticity and narrow. Flexible arteries allow blood to flow unimpeded to vital organs so if the channel becomes rigid, this restricts the amount of blood flowing around the body.

Eventually, the heart may be starved of the blood it needs to function - this could trigger a heart attack.

Unfortunately, there is no obvious way of spotting this process.

To stave off the threat of high blood pressure, you must therefore take proactive steps to keep your reading in check.

It is well documented that committing to healthy lifestyle decisions, such as eating a healthy, balanced diet and exercising regularly, will keep your blood pressure under control.

READ MORE: High blood pressure warning - the exercise you should avoid or risk deadly hypertension

Evidence has also identified some novel ways of lowering blood pressure.

An unusual activity that stands out is listening to classical music.

A small study, published in journal Deutsches Arzteblatt International, found that listening to Mozart for 25 minutes reduced high blood pressure in participants.

The research found that listening to music by Mozart and Strauss for 25 minutes lowered both systolic blood pressure and diastolic blood pressure.

DON'T MISSHair loss treatment - the essential oil that could boost hair growth at home by five times[TIPS]How to sleep: Eat this food one hour before bedtime to promote sleep[TIPS]Bowel cancer warning: Does your poo look like this? What your stool says about your health[INSIGHT]

Systolic and diastolic blood pressure are the two numbers used to record your blood pressure.

Systolic blood pressure, which indicates how much pressure your blood is exerting against your artery walls when the heart beats, is generally regarded as more important because it indicates your risk of heart disease.

The benefits listening to music brought to blood pressure were not confined to classical music, however.

If particularly regularly listened to Mozart, Strauss or ABBA it still reduced their blood pressure in the study, although pop music seemed to have a more modest effect.

Listening to Mozart or Strauss reduced their systolic blood pressure by 4.7mmHg and 3.7mmHg and diastolic blood pressure by 2.1mmHg and 2.9mmHg.

In contrast, music by ABBA reduced systolic blood pressure by a modest 1.7mmHg and had a very small effect on diastolic blood pressure.

Strengthening the finding, levels of the stress hormone cortisol fell in all three groups.

According to Mayo Clinic, hormones such cortisol temporarily increase your blood pressure by causing your heart to beat faster and your blood vessels to narrow.

The researchers suggested that, in order for music to reduce blood pressure, it should have no lyrics, have few changes in volume or rhythm, have harmonies that "are not rousing", and that certain parts of the music should be repeated in intervals.

General tips to lower blood pressure

According to the NHS, general tips to lower blood pressure include:

Cut your salt intake to less than six grams (0.2oz) a day, which is about a teaspoonful find out how you can reduce the amount of salt in your diet

"You can take these steps today, regardless of whether or not you're taking blood pressure medicines," says the NHS.

It adds: "In fact, by making these changes early on you may be able to avoid needing medicines."

Read more:
High blood pressure: Listen to this genre of music for 25 minutes a day to lower reading - Express.co.uk

Recommendation and review posted by Bethany Smith

This research report covers all the quantitative as well as qualitative aspects about the Endometriosis Therapies markets across the globe. The report is also inclusive of different market segmentation, business models and market forecasts. This market analysis enables the manufacturers with impending market trends. A thorough scrutiny of prominent market players or industrialists are vital aspects for planning a business in the market. The Global Endometriosis Therapies market report covers deep insights of various vital aspects of the market. Moreover, in past few years, the market of Endometriosis Therapies has recorded a significant development and is anticipated to further rise.

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Market research report for every industry is based on various important factors, for example demand & supply, market trends, revenue growth patterns and market shares. Report on the Global Endometriosis Therapies market is made after a comprehensive research conducted by a systematized methodology. These techniques are helpful for analyzing the market on the terms of research guidelines. Basically, research reports covers all the information about the consumers, vendors, manufactures, research papers, products and many more. They provide a range of marketing as well as business research solutions basically designed for the readers looking forward to invest in the market. Also, study about the rivals enables in attaining valuable data about the strategies, companys models for business, revenue growth as well as statistics for the individuals attracted towards the market. This report is very useful for the new entrants as it offers them with the idea about the different approaches towards the market.

Major companies of this report:

Endometriosis TherapiesAbbVieEli LillyAstraZenecaBayerAstellas PharmaMeditrina PharmaceuticalsPfizerNeurocrine BiosciencesTakeda Pharmaceutical

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This section majorly focuses over several developments taking place in the region including substantial development and how are these developments affecting the market. Regional analysis provides a thorough knowledge about the opportunities in business, market status & forecast, possibility of generating revenue, regional market by different end users as well as types and future forecast of upcoming years.

Segmentation by Type:

Hormonal ContraceptivesGonadotropin-releasing Hormone (Gn-RH) AgonistsProgestin TherapyAromatase Inhibitors

Segmentation by Application:

HospitalClinicOther

The Global Endometriosis Therapies market research report delivers deep insights about the different market segments based on the end-use, types and geography. One of the most crucial features of any report is its geographical segmentation of the market that consists of all the key regions. The key factor important for making any new business effective is advancement or making impactful modifications in the business. Report on Global Endometriosis Therapies market, is an extensive papers that covers all the aspects of the market analysis and enables a comprehensive summary to its readers. In a nutshell, the Endometriosis Therapies market research reports is a one-stop solution for all requirements by the in-house experts.

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According to latest figures, it is estimated that 1 in 6 Irish couples trying to conceive will now have difficulty becoming pregnant.

However, natural Fertility Specialist, Jessica Bourke wants women to be more informed so they can take back the power when it comes to their fertility and avoid unnecessary issues that could cause heartache and stress down the line.

One aspect of this, is knowing the basic tests you and your partner can do to get a snapshot into your fertility and at what point you need to seek further assistance.

While it is personal preference, Jessica admits that ideally couples should consider basic tests before trying to concieve. I would say get your full bloods done, check youre both in good health, that there is no secondary health conditions.

The blood tests are about 30 in your GP, thats nothing in comparison to fertility treatment down the line. So I would be of the belief that it's better to be safe than sorry.

So what tests should you have done? Women who have a regular cycle should get the day 3 and 21 blood tests to assess their hormonal balance (i.e. FSH, LH and oestradiol on day 3, progesterone on day 21), Jessica advises.

However, she notes that for those with a history of PCOS or an irregular cycle, it would be best to proceed with the day 3 bloods, with the addition of prolactin and testosterone, to see if those hormones are raised, as this could impact your ability to ovulate.

Both men and women should also request a standard full blood count, with the addition of vitamin D. While men should also request a semen analysis combined with sperm DNA fragmentation testing.

The AMH test, which has long been a popular tool in assessing a womans fertility, has become increasingly controversial, and Jessica thinks the value of this test has been greatly overstated.

I get messages from women all the time panicking about AMH results. Its so important women understand that AMH is just one teeny tiny part of the puzzle she explains.

The AMH result can go up, as well as down, contrary to what you may have been told.

It only provides you with a vague approximation of egg quantity, it tells you nothing about the quality of your eggs, which is what really matters when trying to conceive.

I had a woman last year whose AMH was 6, which was low, but in six months after minding her diet and doing acupuncture it went up to 12.5 and that is far from an isolated case Ive seen that a number of times over my career.

Ive had so many women in front of me in tears, thinking they need to get donor eggs, or that they need to freeze their eggs.

"This is often times, unfounded, so its important to get a full picture of your fertility potential. The AMH is just a snapshot.

Follicle tracking scans can be as much, if not more useful than the AMH test says Jessica, as it shows you how many antral follicles are developing on given cycle, as well as whether the lining is thickening as it should be and being able to see if you actually ovulated.

The AMH test is variable, which means that the same woman could see different AMH levels, within the same menstrual cycle.

"A low AMH reading can cause pronounced anxiety for many women and it is not on that women are being unnecessarily scaremongered about their fertility when I have not seen that to be the case" she says.

"The biggest misconception is that women think that it means their eggs are bad, that is not true. This is a test that is of huge profit and gain to the fertility industry and thats what it is about, you have young women being left terrified so they go in and freeze their eggs."

"If they go for IVF and they have low AMH they might be told to go for donor eggs, thats more money for the clinics.

"I'm sorry to be cynical about it but its absolutely madness that any clinic should be encouraging women to freeze their eggs based on one test."

"If your AMH result is particularly good for your age, then it would be important to rule out any tendency towards PCOS, as this is a gynaecological condition that if evident, could hamper your fertility potential."

Jessica is keen to stress that AMH is just one hormone. There are many others to consider, which would have a bearing not just on your ability to conceive, but also on whether you could be at an increased risk for miscarriage. For example, thyroid markers, prolactin, testosterone, cortisol, DHEA, melatonin, FSH, LH, oestradiol, progesterone etc.

"I had a case about two years ago with a couple, where the women at 33 years old had been told she needed to go for donor eggs" Jessica reveals.

"And I asked the partner about his sperm tests and he had been told his DNA fragmentation was high but the clinic said they would work with it. When I saw the results, his results were 42%, anything over 30% is considered severe."

"I said no sorry guys the problem guys here is the sperm. And he immediately said he had brought up a bad kick he got years earlier playing football and a whole litany of health issues he had over the years."

"That is the level of diservice that is being done to women. So women really need to get that message that the AMH is just one part of the picture. Im not saying it is useless but it is very unwise to make a big decision about your fertility based on just one marker."

The standard advice is to seek help if youve been trying to conceive for a year and are under 35, or if youve been trying for 6 months and are over 35 says Jessica.

However, she advises that it really depends on the invididual couple.

"If you have a history of gynaecological issues, whether it be chronic UTIs, PCOS, endometriosis, or indeed, any other chronic health issue e.g. auto-immune conditions, hypothyroidism, known blood clotting issues etc. then I would recommend seeking help at the 3-6 month mark, regardless of your age" she says.

"Over 80% of couples are typically pregnant within 1 year of trying, so there is usually only cause for concern once it goes over that time-frame."

"Im not saying it is useless but it is very unwise to make a big decision about your fertility based on just one marker" says Jessica.

"Never panic when it comes to anything to fertility In my line of work, it has been the case that there is always something that can be done. In 15 years Ive only had one case where the male and the female both had extremely complicated genetic issues."

"If a man gets a DNA fragmentation test and its bad dont panic.However, the clinics will say theres nothing they can do about the sperm but its fine because they can do ICSI or screen the embryos."

"However that is nonsense, you have to find out the reason why. All the background health issues, any medication they are on, past injuries, if there is any infection in the body, if there is inflammation in the area. There are multitudes of things that can be ruled out. But men have more control when they realise there is a lot they can do about it, and big improvements can be made with diet and lifestyle too."

"With fertility we are always looking for that smoking gun", Jessica admits. "'Oh it's the sperm or its the AMH level', but its very rare that I see just one factor. In 90 per cent the cases I deal with it is a combination of smaller factors."

Read the rest here:
Basic fertility tests your GP can do, when they need to be done and what the results can tell you - RSVP Live

Recommendation and review posted by Bethany Smith

In a new episode of his Instagram series 'Conscious Living', Novak Djokovic spoke with countryman Dr. Dragan Ivanov about the benefits of healthy eating. But the Serb also made some interesting revelations about his own diet - including the fact that he has made a habit out of starving himself.

Novak Djokovic shared a video of the interaction on his profile, saying that he was happy to learn the basics of diet and nutrition from Dr. Ivanov.

The English translation of the said post written in Serbian reads:

Professor Ivanov, a vegetarian, informed Novak Djokovic about the foods that are best for the brain, and also said that breakfast is the most important meal of the day. The specialist in internal medicine further stated that a vegetarian diet is the best source of energy and protein for the body.

During the chat with Dr. Ivanov, Novak Djokovic talked about the unusual dietary practices he follows in order to achieve peak fitness.

Despite being a top athlete who needs heavy doses of energy, Djokovic said that he goes 16 hours without eating everyday. This is part of a process called 'autophagy', and it has seemingly been working wonders for Djokovic over the last one and a half years.

The 33-year-old told Dr. Ivanov:

It has been medically proven by Japanese Nobel laureate Yoshinori Oshumi that after 12 to 16 hours of starvation,the process of autophagy begins. In this process, the body starts consuming its own tissue for metabolism, which in turn has a healing effect on the individual.

On being asked about his views on autophagy, Dr. Ivanov elaborated:

Dr. Ivanov further stated that autophagy is turned 'on' at night, when the body secretes a hormone called melatonin due to the intestine being empty.

Novak Djokovic's comments about autophagy or self-starving are the latest in a series of seemingly bizarre revelations over the last few weeks.

In a chat with Chervin Jafarieh last week, Djokovic said the molecular structure of water can be changed through emotions. And a few days before that he had expressed reservations about the coronavirus vaccine being made mandatory for ATP players, prompting many to believe he is an anti-vaxxer.

This latest revelation, however, might be the least controversial of all. Djokovic's claims are backed by the findings of a Nobel Prize-winning scientist, and the Serb also has his unreal fitness on the court to show for his efforts.

Novak Djokovic has also been following a plant-based diet over the last few years.

It seems that the Serb has arrived at the perfect dietary combination for his body: veganism paired with regular fasting or starving. And considering he has become the World No. 1 and a 17-time Slam champion through this unusual regimen, many other athletes might follow in his footsteps soon.

See original here:
Novak Djokovic reveals he goes 16 hours without eating everyday - Sportskeeda

Recommendation and review posted by Bethany Smith

Global Facial Injectable Market Trends, Growth and Share Analysis by Type (Botulinum Toxin, Hyaluronic Acid, Polymers and Particles and Collagen), Application (Facial Line Correction Treatment, Face Lift and Lip Treatments), End User (Hospitals, Specialty Clinics and Spa & Beauty Clinic) and Region (North America, Europe, Asia-Pacific and Middle East & Africa) Forecast till 2025

Thefacial injectable market analysisis been driven by numerous factors. However rising proportion and absolute numbers of older people led by baby boomers generation with good incomes are the critical driving factor for the global facial injectable market. According to the World Health Organization estimates between 2015 and 2050, the proportion of the worlds population over 60 years will double from 12% to 22% which will be a positive development for the market.

Another critical driver and the motive behind the market is the primal desire to remain young. The extension of life has been a primal desire of humanity and a mainstay motif in the history of scientific pursuits and ideas throughout history, from the Egyptian Smith medical papyrus, Ayurveda practitioners, alchemists, etc. This primal desire for youth has driven the market for anti-ageing drugs since time immemorial.

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Anti-ageing, face rejuvenation and cosmetic treatments have changed the rules of engagement and reinvention. Today, its possible to change the basic elements of yourself to fulfil the basic desire of humans to be young.

The growing influence of lifestyle, fashion and film industry have led to rising demand of medications to slow the ageing and its signs. Health and youth wellness have become a status symbol and youthful appearance is penetrating peoples life and there is increasing consumerization of youth. The growth of media such as television and lifestyle magazines have led to a craze for youthful appearance.

Other driving factors are primal desire of humans to remain young, influence of lifestyle industry and rising awareness about wellbeing, high levels of disposable incomes etc. The market restraints are skepticism and concerns of safety regarding the unrestricted use of anti-ageing drugs without greater and clearer experimental validation. Ambiguity of the definition of anti-ageing drugs is also a cause of concern. For example, numerous cosmetics have been included or claimed to have anti-aging effects and have been termed as Cosmeceuticals. Cosmeceutical is defined by the cosmetic industry as cosmetic products that have medicinal or drug like effects which is not supported by the U.S. Food and Drug Administration (FDA) or the Food, Drug and Cosmetic Act.

The facial injectable market is a technological oriented market having a high research and development potential due to advancement in technologies and cellular understanding which are keys to unravel the exact mechanism of ageing. Gene therapy, stem cell technology and targeted delivery of nutrients using biotechnology are expected to open the gates for anti-ageing drugs. The development of biomarkers for physiochemical modifications in the body such as alteration of concentration of an enzyme or hormone provides another exiting avenue for the future market. For example, levels of homocysteine has been proposed as a marker of age related changes in the body so as to compensate the change by drugs.

From a market perspective the facial injectable market is ripe with mergers, acquisitions and partnerships. For example, in 2017, cosmetic giant LOral acquired skincare brands such as CeraVe, AcneFree and Ambi from Valeant Pharmaceuticals at ~ $1.25 billion. In 2016, Johnson & Johnson acquired Vogue International LLC, for greater than $3 billion to strengthen its consumer segment. Thus, partnerships seem to be a good strategy to curtail the developmental cost of any new facial injectable drug. Acquisition of other companies also leads to expansion of product lines which improves market penetration and exposure.

The global market for facial injectable is expected to reach USD 9.04 billion by the end of the forecasted period 2023 and is expected to grow at a CAGR of 13.2%

Global facial injectable market is segment by types and applications. Based on types the market is sub-segmented as botulinum toxin, hyaluronic acid, polymers & particles, and collagen. On the basis of application, the market is sub-segmented into facial line correction treatment, face-lift, lip treatments and others.

The key players in his market are Allergan, Galderma, Integra Lifesciences, Merz Pharma, Sanofi, SciVision Biotech Inc, Sinclair. Suneva Medical and Valeant Pharmaceuticals.

Regional outlook for the facial injectable market

Thefacial injectable marketis dominated by North America. The U.S. is the prime mover of the facial injectable market. However, it has to be noted that Latin America despite its lower per capita income has a disproportionate share of the market. It is estimated that Latin America will be the fastest in the future. As of the present the European regions is expected to be the second largest market globally, with countries like Germany, UK and France playing a prominent role in the market. Germany accounts for both the largest and the fastest growing nation in the European region facial injectable market, followed by France.

Asia Pacific market is expected to be the fastest future growing market during the forecast period 2016-2023. The Asia Pacific region will be led by countries such as China and India. However the greatest hindering reasons for the Asia pacific region market is the poor per capita income and the high cost of treatment. Nations such as Thailand etc. have a disproportionate share of Asia Pacific market considering their low income as compared to the U.S. The market of these nations is influenced to a considerable degree by the tourism and fashion industry. Advertisement and greater exposure seems to be the best strategy to be a market leader along with product development. The return on investment for advertisement and publicity is very high for the cosmetic surgery market.

There has been a definite shift of the cosmetic surgery market from the developed regions to the developing ones particularly Latin America and Asia Pacific countries such as Thailand. The market represents a clustered outlook with urban metropolitan cities especially with adjoining tourism and fashion industry having an extreme lead over the rural areas. Large tourism clusters such as Miami, Bangkok, Bali etc. have a disproportionate share of the market due to the large volume of cosmetic surgeries.

The porn industry also is affecting the market and it has been seen that the rise of cosmetic surgeries has a linear relationship with the quality and bandwidth of the internet. Thus cities such as Los Angeles, Las Vegas etc. are the leading clusters of cosmetic surgery market.

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Facial Injectable Market Analysis Landscape, Overview and Segmentation | Forecast to 2025 - stopthefud

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BIRMINGHAM, Ala. Seniors Raena Eldridge and Benjamin Walker of the Texas A&M womens and mens swimming & diving programs have been nominated for the H. Boyd McWhorter Scholar-Athlete Post-Graduate Scholarship.

The H. Boyd McWhorter Scholar-Athlete Post-Graduate Scholarship has been presented by the Southeastern Conference since 1986 to the league's top male and female scholar-athletes. The SEC will name the 2020 recipients, chosen by a committee of Faculty Athletics Representatives from the 14 SEC institutions, in late May.

Eldridge recently earned her degrees from A&M, majoring in animal science and genetics. The Rockwall, Texas, native has garnered CSCAA Scholar All-America honors every year of her career, while also being named to the SEC Academic Honor Roll each season. For the second straight year, Eldridge was awarded Bill Erwin Scholar-Athlete of the Year honors, recognizing the top male and female student-athletes at Texas A&M who balance athletics and academics while maintaining above a 3.25 GPA, at the recent Building Champions Awards. Eldridge has served as a project leader for the Aggie Research Scholars Program and as a Student Technician of the Genetics Research Lab. Eldridge captained the womens squad as a junior and senior, and earned CSCAA All-America honors twice, while helping her team to three straight SEC Championships.

Walker recently earned his degree in accounting from the Mays Business School. He was a two-time CSCAA Scholar All-American and has earned a spot on the SEC Academic Honor Roll in each year of his career. Walker, who hails from The Woodlands, Texas, made A&M history as a junior when he became the program's first individual swimming SEC Champion, winning the 200 Breast. He again claimed gold in the event with a school-record time of 1:51.92, while helping both medley relay teams to podium finishes at the 2020 SEC Championships. The three-time CSCAA All-American also holds the Texas A&M all-time school record in the 100 Breast, and was part of the record-holding 200 and 400 medley relay teams, both setting a new program mark at this year's SEC Championships. A team captain in his final season, Walker helped A&M move up the dual meet rankings, rising as high as fourth for the team's highest ranking since the 2001 season.

The SEC provides the league's male and female McWhorter Scholar-Athlete of the Year Post-Graduate Scholarship recipients with a $20,000 post-graduate scholarship. The 26 remaining male and female finalists for the award will also receive a $10,000 post-graduate scholarship.

Link:
Eldridge, Walker Named McWhorter Scholar-Athlete of the Year Nominees - KBTX

Recommendation and review posted by Bethany Smith

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This massive, flightless emu-like creature has been called "the most dangerous bird in the world." The reason is that this exotic bird can seriously injure or kill a human or dog in an instant with its deadly claws. In fact, cassowaries are listed as Class II animals (along with alligators and wild cats) in Florida due to the risk they pose, which means anyone who wishes to own one must pass numerous tests and get a special permit from local authorities. And even then, tragedies still can occur, as happened to the 75-year-old Florida man who was attacked by at least one of the birds he rears on his properties and later succumbed to his injuries in the hospital.

So, what exactly is a cassowary? Like their cousins the emu, they are ratites, or birds that have flat breastbones and are unable to fly, native to tropical forests of Australia and Southeast Asia. As far as this striking bird's appearance, it boasts bristly feathers, a vivid blue face, a duo of red flaps of skin, known as wattles, hanging from its neck and a prominent helmet (or casque) atop its head. Although size varies across the three different species of cassowaries the Southern, Northern and Dwarf they can stand up to 6 feet, 6 inches (2 meters) tall and weigh as much as 132 pounds (60 kilograms). For a comparison, you can think of one as being the equivalent of six swans.

The portion of their body that makes them so dangerous? Muscular legs with three claw-tipped toes that can pack a pretty powerful punch, including lethal wounds to internal organs and severe bleeding. "The claw on the inner toe of each foot is what is so impressive," says Rick Schwartz, a global ambassador for California's San Diego Zoo, which currently houses several Southern cassowaries in its Safari Park, in an email interview. "Between the three species, that claw is very sharp, and can range from 3 to 5 inches (7 to 12 centimeters) long. The cassowary will use these sharp claws and their powerful kick to defend themselves. It is often stated that they can eviscerate a human in a single kick, though there is no record of this happening."

The good news, according to Guinness World Records, is that you're far more likely to suffer a snake bite or even an infection transmitted by a dog than you are injury by one of these birds. In fact, the most dangerous animal of all is no bigger than a thumb nail. By transmitting disease-causing pathogens, mosquitoes are estimated to be responsible for between 725,000 and 1 million human deaths per year, making them far and away the most lethal animal on Earth.

Now that you know you probably shouldn't provoke a cassowary or a mosquito, for that matter here are 10 other interesting facts about this unusual bird.

While a cassowary is not an emu, both emus and cassowaries can be considered related in taxonomy (the science of classification of living and extinct species), according to Schwartz. "They share the same scientific order [Casuariiformes]," he explains. "But, within that order, they are in different scientific families."

"Cassowaries are the heaviest bird in Australia, and the Southern cassowary is the second-heaviest in the world (the world's heaviest bird is the ostrich)," says Schwartz. "With that in mind, they also have very small wings. When stretched out, their wings extend less than a foot (0.3 meters) from their body." According to Schwartz, Southern cassowary females can weigh up to 170 pounds (79 kilograms) and males up to 125 pounds (56 kilograms); Northern females can weigh up to 128 pounds (58 kilograms) and males up to 80 pounds (36 kilograms); and Dwarf females can weigh up to 55 pounds (24 kilograms) and males up to 40 pounds (18 kilograms).

A cassowary has dense, black feathers that are long and thin compared with the wide and shapely feathers of a flighted bird, according to Schwartz. "From a distance, some people even say the feathers of the cassowary look more like hair," he adds. "The cassowary's feathers are not suitable for flight, but they work very well for a ground-dwelling bird living in a forest ecosystem. The longer, thinner feathers help direct water away from the body, and also protect the bird's body from low branches, sharp twigs and thorns."

It's made of keratin, the same protein that the bird's feathers, nails and beak are made of, according to Schwartz. "The outer covering is thick and hard, but the inside is very porous. The purpose of the casque is not completely understood, but several theories exist including that it can help amplify vocalizations, serve as head protection as the bird pushes headfirst through the dense forest, or it may be another way for the birds to display age and vitality."

"Of the three species of cassowaries, only the Northern and Southern cassowaries have wattles," says Schwartz. As with the casque, there are a few theories on the purpose of the brightly colored wattles, he adds. Among them: "It is thought that they can help communicate the bird's current demeanor; indicate an individual bird's vitality to other cassowaries; or give other cues and communications only known by cassowaries at this time," says Schwartz.

That means they feed on fruits, which makes them very important to their surrounding ecosystem, according to Schwartz. "As they eat fruit, they walk around and pass the seeds through their digestive tract," he explains. "Thus, their droppings deposit seeds that are surrounded in natural fertilizer, helping to spread the diversity of plants in their region."

"With their excellent hearing, they will hear you coming long before you even know they are there, and they will most likely disappear into the forest to avoid you," says Schwartz. "However, should you ever come across one in the wild, it is best to give them plenty of room and not approach them or try to feed them."

In several species of animals, the male participates in incubation and care for the young after the eggs are laid, according to Schwartz. "The female returns to her solitary life, and does not participate in incubating the eggs or caring for the young," he says. "This may be a way to allow her to have several clutches of eggs in one breeding season with different males, thus diversifying her genetics into the next generation."

The most impressive, according to Schwartz? "A deep, low-frequency booming sound," he says. "It's the lowest known call of any bird, and it's so low that it borders on being inaudible to the human ear. If you are nearby when it does this call, you can feel the vibrations in your chest."

Per the International Union for Conservation of Nature (IUCN) Red List of Threatened Species (the world's most comprehensive inventory of the global conservation status of plant and animal species), all three species are listed as either Vulnerable or Near Threatened. "Like many species, their biggest challenges are the loss of habitat due human population growth; roads being built (causing car strikes); and human-introduced species of animals raiding nests," says Schwartz. "The good news is that the governments of the countries cassowaries call home are stepping up their conservation efforts."

There are less than 1,000 cassowaries left in the wild, according to Rainforest Rescue. Toward that end, the Australian-based group works to protect and restore the cassowary's habitat, as well as to create safe passage for these and other rainforest creatures via strategic buy-back of rainforest properties and regenerating damaged rainforest.

Visit link:
The Cassowary Is the World's Most Dangerous Bird - HowStuffWorks

Recommendation and review posted by Bethany Smith

Under the cover of night, two large leopard slugs begin to court, circling each other, before climbing single-file up a tree or onto a rock. They lower themselves on a mucus rope, while entwining their bodies in a strictly anti-clockwise fashion.

Both slugs then push out and entwine two overly-sized penises from openings on the side of their head, before exchanging sperm that may later fertilise each of their eggs. Or, perhaps be eaten. Eventually, one slug crawls off and the other follows, eating the mucus trapeze as it goes.

The astonishing sex lives of leopard slugs, or Limax maximus, have long been recognised by naturalists and frequently feature in wildlife documentaries. But while their carnal dance has mesmerised millions, nobody knows why they mate in this most bizarre way.

This is because slug sex science has rarely attracted anything other than observational study. Fortunately for our curiosity, there are a few noble individuals who have taken time to understand the mating habits of snails and slugs, and whose research can give us some valuable clues.

Its well known that leopard slugs, like the majority of land-based snails and slugs, are hermaphrodites meaning that both sexual organs are contained in the same individual. Yet, self-fertilisation is generally not the preferred option. This is likely because natural selection favours mating with another individual to avoid the loss of health, fertility and fitness associated with inbreeding.

Even though they can choose whether to mate as male or female, most slugs and snails mate as male and female at the same time. They can also store sperm for months and even years, and so dont always need to receive sperm if they have previously mated with a better partner. They can have the best of both worlds by choosing to eat and digest most of the sperm, while retaining just enough to fertilise their eggs.

We also know why leopard slugs turn anti-clockwise when mating. Just like human hearts are nearly always to the left hand side in our bodies, a slugs body is also asymmetric. This is most obvious during mating, when the genitals emerge from the right side of the head. This asymmetry makes leopard slugs turn anti-clockwise in synchrony during courting and mating and is also what made rare left-coiling snail Jeremy a media sensation in his/her search for love.

The rest of their elaborate mating behaviour is less well understood. It might be that that communication and cooperation are important aspects of sexual behaviour in the mollusc world, beginning with the head-to-tail trail-following. The long mucus trapeze could be an example of sexual evolution going into overdrive to signify commitment to whats to come, making sure that any mating efforts wont be wasted. The spiral entwinement between mating slugs may also facilitate close physical contact and commitment, minimising the risk of sudden withdrawal.

But this behaviour is also more sinister than it first appears. Some slugs and snails engage in hormone warfare or sexual conflict to increase their chances of fertilising their mate. For example, as artistically interpreted by Isabella Rossellini, many snails (including the common garden variety) stab each with love-darts, transferring hormones to improve the chances that sperm are used for fertilisation. The field slug Deroceras, seen below, flicks and strokes its partner with what looks like a sticky slug blanket for the same reason.

The leopard slugs beautiful entwinement could be another manifestation of this sexual coercion, maximising surface area for hormone transfer. The long penises which can be 60 to 90cm long in one Italian version of the leopard slug may also be another extreme result of an evolutionary arms race to improve the prospects of fertilisation.

Why they intertwine so intricately is another matter. It could be that the beautiful complexity makes it more difficult for one slug to cheat by giving sperm and then not receiving some in return.

In the absence of direct study, the above explanations can only be considered speculation. The truth is that science doesnt yet have a firm handle on the fascinating sex rituals of leopard slugs.

Scientists are not just being voyeuristic when we say wed like to unravel the mysteries of slug sex. Aside from just understanding the wonder and beauty of the behaviour, there are potential benefits.

Some species of slugs are farm and garden pests, eating holes in leaves, stems, flowers, tubers and bulbs and causing particular damage to new growth. With the pending ban of key pesticides for agricultural use in some countries, including the active ingredient in slug pellets, there is growing pressure to find other ways to control their spread. One way could be to identify otherwise harmless chemicals that interfere with their sex lives. A contraceptive sheath for slugs, so to speak.

Another approach could be to question why some of the slugs that cause the most agricultural nuisance forgo sex completely, especially in northern latitudes. Lack of sex reduces genetic variation, which causes crops such as potatoes and bananas to suffer from disease outbreaks. Studying the self-contained reproductive habits of slugs may reveal a similar vulnerability that could be exploited to control their numbers.

There may of course also be benefits which we cant anticipate. So just as people champion trees, bees and butterflies, we need more slug enthusiasts of all kinds to help unravel their mucosal mysteries, including backyard explorers who can contribute to citizen science studies.

Of course, if you are already a convert, then how about a leopard slug sex ornament for the Christmas tree?

Angus Davison, Associate Professor and Reader in Evolutionary Genetics, University of Nottingham

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Read more:
Leopard Slugs Mate In The Most Beautifully Bizarre Way, And Nobody Knows Why - Gizmodo Australia

Recommendation and review posted by Bethany Smith

The Global Cryonics Technology Market Research Report 2020-2026 is a valuable source of insightful data for business strategists. It provides the industry overview with growth analysis and historical & futuristic cost, revenue, demand and supply data (as applicable). The research analysts provide an elaborate description of the value chain and its distributor analysis. This Market study provides comprehensive data which enhances the understanding, scope and application of this report.

Cryopreservation technology is used for the preservation of living cells and tissues at very low temperature.Cryonics technology adopted by medical sector to preserve living body organs which can boost the demand of this technology. Government investment in medical sector and increasing deaths caused by incurable diseases are the major driving factor for this industry.

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Top leading Companies of Global Cryonics Technology Market are Praxair, Cellulis, Cryologics, Cryotherm, KrioRus, VWR, Thermo Fisher Scientific, Custom Biogenic Systems, Oregon Cryonics, Alcor Life Extension Foundation, Osiris Cryonics, Sigma-Aldrich, Southern Cryonics and others.

This report segments the Cryonics Technology Market on the basis of by Type are:

Slow freezingVitrificationUltra-rapid

On the basis of By Application, the Cryonics Technology Market is segmented into:

Animal husbandryFishery scienceMedical sciencePreservation of microbiology cultureConserving plant biodiversity

Regional Analysis For Cryonics Technology Market:

For comprehensive understanding of market dynamics, the Cryonics Technology Market is analyzed across key geographies namely: United States, China, Europe, Japan, South-east Asia, India and others. Each of these regions is analyzed on basis of market findings across major countries in these regions for a macro-level understanding of the market.

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Quantitative market information and forecasts for the global Cryonics Technology industry, segmented by type, end use and geographic region.

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Cryonics Technology Market Growth, Analysis and Advancement Outlook 2020 to 2026 - Cole of Duty

Recommendation and review posted by Bethany Smith

Over the past six months, we have been able to deliver on our promise of bringing important new medicines to certain patients with HER2-positive metastatic breast cancer and metastatic urothelial cancer through two U.S. FDA approvals, said Clay Siegall, Ph.D., Chief Executive Officer at Seattle Genetics. We look forward to sharing data in the ASCO virtual scientific program that reinforce our ability to rapidly advance novel targeted agents across multiple tumor types.

An Expanding Portfolio of Marketed Therapies

Key data presentations will showcase progress for certain patients with HER2-positive metastatic breast cancer and metastatic urothelial cancer as well as for patients with classical Hodgkin lymphoma (HL). Highlights include:

TUKYSA Update in Patients with Brain Metastases

Results for TUKYSA in combination with trastuzumab and capecitabine in patients with brain metastases from the HER2CLIMB pivotal trial of previously treated patients with HER2-positive metastatic breast cancer will be featured in an oral session (Abstract #1005). Data will be presented from these exploratory analyses on findings from the TUKYSA arm of the study on reduction in the risk of death (OS), reduction in the risk of intracranial progression or death (CNS-PFS) and improvement of the intracranial confirmed objective response rate (ORR-IC) compared to trastuzumab and capecitabine. Data will be presented by Nancy U. Lin, Director of the Metastatic Breast Cancer Program in the Susan F. Smith Center for Womens Cancers at Dana-Farber in Boston, MA, during an oral presentation available on demand at 8:00 a.m. ET on May 29, 2020. A separate analysis of adverse events (AE) from the same trial will be presented (Abstract #1043; poster presentation).

PADCEV (enfortumab vedotin-ejfv) in Combination and in Other Solid Tumors

Additional results and durability data from the phase 1b EV-103 trial of PADCEV plus pembrolizumab in first-line metastatic urothelial cancer will be presented (Abstract #5044), and a separate Trials-in-Progress poster will provide details about a new randomized cohort added to the EV-103 study, Cohort K, which is evaluating PADCEV as monotherapy or in combination with pembrolizumab (#TPS5092). Both presentations will be featured in the Genitourinary CancerKidney and Bladder session. Data from the Cohort K, along with other data from the EV-103 trial evaluating PADCEV combined with pembrolizumab as first-line therapy for cisplatin-ineligible patients, could potentially support registration under accelerated approval regulations in the United States.

Additionally, information about the phase 2 EV-202 trial, which is studying PADCEV in six different types of locally advanced and metastatic solid tumors (HR-positive/HER2-negative and triple-negative breast cancers, squamous and non-squamous non-small cell lung cancers, head and neck cancer and gastroesophageal cancers), will be discussed in a Trials-in-Progress poster during the Developmental Therapeutics Molecularly Targeted Agents and Tumor Biology Poster Session (Abstracts #TPS3647).

ADCETRIS (brentuximab vedotin) Continues to Advance

Data to be presented on ADCETRIS will demonstrate the companys progress in efforts to continue expanding clinical research on combination regimens and monotherapy in a variety of HL and peripheral T-cell lymphoma (PTCL) patient populations, including in both older and younger disease settings. A poster presentation will highlight the potential of ADCETRIS in combination with nivolumab or dacarbazine and as a monotherapy for previously untreated older HL patients who typically have poorer outcomes than younger patients due to comorbidities and toxicities related to standard first-line chemotherapy (Abstract #8032). The primary analysis from an ongoing clinical trial evaluating ADCETRIS plus nivolumab in children, adolescents and young adults with standard-risk relapsed or refractory classical HL will also be presented (Abstract #8013; poster discussion). Lastly, two Trials-in-Progress poster presentations will highlight ongoing clinical trials evaluating ADCETRIS as a monotherapy in frontline older HL or CD30-expressing PTCL patients and in a combination regimen in frontline advanced-stage HL patients (Abstracts #TPS8069 and #TPS8068).

A Strong, Diverse Pipeline of Investigational Therapies

An additional four Trials-in-Progress posters for investigational therapies will showcase the companys continued clinical development of pipeline candidates in first-line cervical cancer (Abstract #TPS6095), metastatic breast cancer (Abstract #TPS1104), metastatic pancreatic ductal adenocarcinoma (PDAC) (Abstract #TPS4671) and other solid tumors (Abstract #TPS3652).

The abstracts published in advance of the ASCO meeting were made available today on the ASCO website. All data presentations will be available on-demand on May 29, 2020.

Details of Key Seattle Genetics Presentations at ASCO20 Virtual:

Abstract Title

Abstract #

Presentation Type

Presenter

ADCETRIS (brentuximab vedotin)

Nivolumab and brentuximab vedotin (BV)-based, responseadapted treatment in children, adolescents, and young adults (CAYA) with standard-risk relapsed/refractory classical Hodgkin lymphoma (R/R cHL): Primary analysis

8013

Poster discussion

P. Cole

Frontline Brentuximab Vedotin as Monotherapy or in Combination for Older Hodgkin Lymphoma Patients

8032

Poster presentation

C. Yasenchak

PADCEV (enfortumab vedotin-ejfv)

Study EV-103: Durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma

5044

Poster presentation

J. Rosenberg

TUKYSA (tucatinib)

Tucatinib vs Placebo Added to Trastuzumab and Capecitabine for Patients with Previously Treated HER2+ Metastatic Breast Cancer with Brain Metastases (HER2CLIMB)

1005

Oral presentation

N. Lin

Management of adverse events in patients with HER2+ metastatic breast cancer treated with tucatinib, trastuzumab, and capecitabine (HER2CLIMB)

1043

Poster presentation

A. Okines

Trials-in-Progress

ADCETRIS (brentuximab vedotin)

Frontline brentuximab vedotin in Hodgkin lymphoma and CD30-expressing peripheral T-cell lymphoma for older patients and those with comorbidities

TPS8069

Poster presentation

C. Yasenchak

Brentuximab Vedotin in Combination with Nivolumab, Doxorubucin, and Dacarbazine in Newly Diagnosed Patients with Advanced Stage Hodgkin Lymphoma

TPS8068

Poster presentation

J. Friedman

PADCEV (enfortumab vedotin-ejfv)

Study EV-103: New randomized cohort testing enfortumab vedotin as monotherapy or in combination with pembrolizumab for locally advanced or metastatic urothelial carcinoma

TPS5092

Poster presentation

N. Mar

EV-202: A Phase 2 Study of Enfortumab Vedotin in Patients With Select Previously Treated Locally Advanced or Metastatic Solid Tumors

TPS3647

Poster presentation

J. Bruce

Investigational Therapies

Phase 1b/2 trial of tisotumab vedotin (TV) bevacizumab (BEV), pembrolizumab (PEM), or carboplatin (CBP) in recurrent or metastatic cervical cancer (innovaTV 205/ENGOT-cx8/GOG-3024)

TPS6095

Poster presentation

I. Vergote

SGNLVA-001: A phase 1 open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer

TPS1104

Poster presentation

H. Beckwith

SGN228-001: A phase 1 open-label dose escalation and expansion study of SGN-CD228A in select advanced solid tumors

TPS3652

Poster presentation

A. Patnik

Phase 1 study of SEA-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab in patients (pts) with metastatic pancreatic ductal adenocarcinoma (PDAC)

TPS4671

Poster presentation

A. Coveler

About ADCETRIS (brentuximab vedotin)

ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. Seattle Genetics and Takeda are jointly developing ADCETRIS.

About PADCEV (enfortumab vedotin-ejfv)

PADCEV is an antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer. Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis). PADCEV is co-developed by Seattle Genetics and Astellas.

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.

ADCETRIS (brentuximab vedotin) U.S. Important Safety Information

BOXED WARNING

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

Contraindication

ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions

Administer G-CSF primary prophylaxis beginning with Cycle 1 for patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL.

Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.

Most Common (20% in any study) Adverse Reactions

Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, and mucositis.

Drug Interactions

Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).

Use in Specific Populations

Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.

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Seattle Genetics Highlights Data from Expanding Oncology Portfolio During Virtual Scientific Program of the 2020 ASCO Annual Meeting - BioSpace

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Between 2001 and 2016 in the United States, Asian/Pacific Islander men experienced the greatest increase in the incidence of testicular germ cell tumors (TGCT), followed by Hispanics and American Indians/Alaska Natives, according to a study published inCancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.

TGCT is the predominant form oftesticular cancer, which is the most frequently occurring cancer among men between the ages of 15 and 44 years in the U.S. The incidence of TGCT has been increasing since the mid-20thcentury, but the underlying reasons for the increase remain unclear. While risk factors are not well understood, TGCT is known to be associated with other male reproductive disorders. As such, increases in incidence can be indicative of problems in male reproductive health, explainedArmen Ghazarian, PhD, MPH, first author on the study and a program director in the Division of Cancer Control and Population Sciences at the National Cancer Institute (NCI) at the National Institutes of Health.

TGCT is most common among men of Northern European ancestry; however, a previousstudyfrom Ghazarian and colleagues revealed that rates increased among Hispanic men between 1998 and 2011. We have long known of the risk among men of Northern European ancestry, but the results of our previous study highlighted that rates were increasing among other racial/ethnic groups as well, said Ghazarian. The latest study builds on this work.

We expanded our analysis to include data from across the U.S., notedKatherine McGlynn, PhD, MPH, senior author on the study and a senior investigator in the Division of Cancer Epidemiology and Genetics at NCI. The goal was to determine if similar trends persisted in the more recent data. Monitoring trends is critical to building a better understanding of potential risk factors.

In this study, Ghazarian and McGlynn examined TGCT incidence data from the United States Cancer Statistics public use databases. The analysis included data on TGCT cases reported between 2001 and 2016 from registries in all 50 states and the District of Columbia.

The authors found that the incidence of TGCT was highest among non-Hispanic white men, followed by Hispanics, American Indians/Alaska Natives, Asians/Pacific Islanders, and non-Hispanic Black men.

While theincidence of TGCT increased across all racial/ethnic groups duringthis period, the authors found that Asian/Pacific Islander men experienced the greatest increase, with anannual percent change(APC) of 2.47, meaning that the incidence increased by 2.47 percent each year. All other racial/ethnic groups experienced annual rate increases as well: Hispanics APC = 2.10, American Indians/Alaska Natives APC = 1.71, non-Hispanic blacks APC = 1.28, and non-Hispanic whites APC = 0.41.

The authors also examined differences in TGCT incidence by geographic region as defined by the U.S. Census Bureau. They found that Asian/Pacific Islander, Hispanic, and American Indian/American Native men had the highest incidence of TGCT in the West, while non-Hispanic Black and non-Hispanic white men had the highest incidence in the Northeast.

While significant increases in incidence among Hispanic men were observed in all geographic regions, significant increases in incidence were observed for Asian/Pacific Islander men in the West, non-Hispanic Black men in the South, and non-Hispanic white men in the Northeast and Midwest. However, Ghazarian cautioned that these results may partially reflect the distribution of different racial/ethnic groups across the country.

A previousstudyexamining global trends did not find similar increases in TGCT incidence in Asian countries. Given the differences in trends, it would be interesting to examine U.S. trends using data on the birthplace of Asian/Pacific Islander men, as there could be an interplay between genetic and environmental risk factors, noted McGlynn. In her ongoing work, she aims to understand the contribution of environmental exposures, such as endocrine-disrupting chemicals, on TGCT risk.

I hope the results from this study will increase awareness of TGCT among men of all racial/ethnic groups, said McGlynn. While incidence remains highest among non-Hispanic white men, it is becoming increasingly clear that this disease does not just affect men of European ancestry.

A limitation of the study was that all Asian/Pacific Islanders were examined as a single group rather than by individual ancestry. This was also the case for Hispanic men. These groupings prevented the examination of whether risk was specific to men of certain ancestries. Another limitation was the lack of data regarding birthplace; incidence trends could be different for men who emigrated to the U.S. compared to men of the same racial/ethnic group who were born in the U.S.

The study was supported by the National Cancer Institute. Ghazarian and McGlynn declare no conflicts of interest.

This announcement was originally published on May 8, 2020, by the American Association for Cancer Research. It is republished with permission.

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Rates of Testicular Cancer are Rising Among Racial/Ethnic Minorities - Cancer Health Treatment News

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Despite his father having an "m-shaped" hairline, Alex Han from northeast China never thought he'd experience hair loss in his 20s.

While studies have suggested almost all Caucasian men will eventually face some degree of male pattern baldness -- and around half can expect to lose their hair by middle age -- Asian men, and East Asians in particular, have historically experienced the lowest incidence of hair loss in the world.

A 2010 study from six Chinese cities found that fewer than 3% of men aged 18-29, and just over 13% of those in their 30s, experienced male pattern baldness. Earlier research from South Korea suggested that only 14.1% of the entire male population was affected, while Japanese men were found to develop male pattern baldness approximately a decade later than their European counterparts.

But as Han, now 34, later discovered, genetics isn't everything. Stress, poor diet, lack of sleep and smoking can all contribute to hair loss. And with lifestyles in China changing dramatically in recent decades, so too are the country's hairlines.

"I was prepping my masters entrance examinations and there was a lot of pressure, so I probably didn't sleep very well," Han said in a phone interview. "At that time, (my receding hairline) was under control, but after three years in Beijing getting my masters, I moved to Germany for PHD study ... and not only me, but other Asian students there, had a problem with hair loss."

It's an issue faced by many in Han's generation, and younger. A 50,000-person survey by the China Association of Health Promotion and Education reportedly found that the country's 30-somethings were going bald faster than any other group. Almost a third of respondents who were born in or after 1990 reported thinning hair, according to Chinese state media. A similar poll by Beijing's prestigious Tsinghua University reportedly found that an astonishing 60% of students had experienced some degree of hair loss.

Chinese state broadcaster CGTN went so far as to describe hair loss among the young as an "epidemic." But lifestyle changes have been accompanied by transformations in both technology and disposable income. Hair transplants are a viable solution for a growing number of men, and the Chinese market for the procedure is expected to hit 20.8 billion yuan ($2.9 billion) in 2020, more than four times what it was four years ago, according to market research firm Statistica.

Han opted to travel to Thailand for the transplant, which sees thousands of hair follicles grafted from other parts of the body -- such as the chest, or back of the neck -- onto the head. The eight- to 10-hour procedure cost him around $9,000, though he found clinics in China quoting "a sixth of that." The transplant may take months to take effect, though Han expressed hope that he will "see the results and see my hair return to normal in the next two or three months," adding, "then I'll behave as if nothing has happened."

Navigating Stigmas

Han's fears mirror those experienced by men with receding hairlines around the world, namely the impact on his confidence, professional prospects and first impressions. "Hairstyles, for me, are critically important for men's first impressions," he said.

But losing your hair may be especially difficult in countries where it's less common. The male beauty standards in East Asian popular culture -- from Korean K-pop to Hong Kong's movie industry -- often favor big hair and boyish looks. "In Asian cultures the younger generation really like idols like (Chinese pop band) TFBoys," Han said, adding that standards for white or black men are often different.

For 37-year-old David Ko, a Seoul-based reporter who has previously written about his experience of hair loss, the lack of visibility of hairless men in South Korea "certainly plays a role in people feeling uncomfortable about going bald."

"Whenever there is a precedent, people tend to feel (more confident) to follow," he said in an email interview.

A Korean study in the International Journal of Dermatology found that balding men were considered older and less attractive by 90% of non-bald respondents. In 2018, National Human Rights Commission of Korea had to urge employers not to discriminate against hairless men, after a building management company was accused of asking a job applicant to wear a wig during his interview and rejecting him on account of his bald head, according to the Yonhap News Agency. (The unnamed company denied doing so).

Chinese American entrepreneur Saul Trejo, who has lived in various cities around Asia since 2011, began losing his hair while studying in Beijing. The 30-year-old said he "definitely noticed" the lower proportion of bald men in the city, compared to the US, and "it probably bothered me, but I tried to not let it." He also found that people were more comfortable than those in the West to pass comment -- even if in an entirely observational way.

"People will tell you straight out," he said in a phone interview from Taipei, recounting instances when his loss of hair was casually pointed out to him. "Normally when they're saying it they're not trying to be mean, they're just commenting, so I can't be mad. But you remember.

"I tried to shave my head, but I didn't think it was suitable for my head and body shape," he added, naming Dwayne "The Rock" Johnson and actor Jason Statham as non-Asians who can pull off the look. "I think Asian people, including myself, tend to be a little slimmer, so if I had to choose between bald and slim versus bald and athletic, or even muscular, then I think it looks better with the more size you have."

In 2018, Trejo underwent a hair transplant in Bangkok, where he was based at the time. While it took almost a year to see the final results, Trejo said his new hairline is "a major blessing," that "massively improved my dating life." Before-and-after images shared with CNN show a remarkable amount of hair restoration at the top and sides of his head.

The doctor behind Trejo's procedure, Damkerng Pathomvanich, is a leading researcher into hair loss. He said that the number of hair transplant clinics in Asia is "skyrocketing," and that business among Chinese patients at his clinic is "booming."

"We published data (in 2002) showing an alarming increase in male pattern baldness in Asians," he said over the phone, naming diet as a key driver for the change. "I had a lot of Caucasian patients saying to me, 'You Asians don't go bald,' but it's not true."

Alternative approaches

There are cheaper and less invasive treatments on the market. Chinese e-commerce giant Alibaba stocks thousands of restorative shampoos, serums and sprays, and has reported that more than 70% of customers buying anti-hair-loss products were born after 1980, according to the South China Morning Post (a newspaper owned by Alibaba).

Drugs like minoxidil and finasteride, available in the US since the 1980s and 1990s respectively, appear to be gaining traction in the region too. Sales of the former, which is commonly traded as Rogaine, are expected to grow 5% per year in Asia Pacific from 2018 to 2024, according to an industry report by Global Market Insights.

Then there are also purported natural remedies. In traditional Chinese medicine, for instance, various herbs and plant extracts have long been touted as solutions to hair loss, though their effectiveness remains a matter of debate (one of them, polygonum multiflorum, or tuber fleeceflower, can even induce hepatitis if over-consumed).

Why Women Feel Pressured to Shave

In Korea, meanwhile, houttuynia cordata -- also known as fish mint, or chameleon plant -- can be brewed into a black liquid that is applied to the scalp, according to the journalist, David Ko, who received some from his concerned mother-in-law.

"I used it like a shampoo whenever I washed my hair," he said. "After wetting my hair, I poured a handful of the plant-steeped water on my scalp, finger-massaged my scalp for about one minute, then rinsed it off with fresh water.

"But as time went by without seeing any clear sign of improvement, I got so tired of the remedy that I dumped more of (it) on my hair each time to finish the jar faster and get the practice over with." He then tried other suggested home remedies. "My wife also nudged me to sprinkle some sea salts over my scalp instead of the plant water, and one of my co-workers told me her balding father benefitted from eating lots of black sesame seeds as a snack."

A ground-breaking Japanese study, published last year, grew hair follicles from scratch using stem cells. They were then successfully transplanted onto the backs of mice, though any resulting therapies remain a long way from ever being approved for humans (and in many countries, stem cell treatments are either highly restricted or completely outlawed).

Other novel responses to hair loss are now available in Asia. Scalp micropigmentation, for instance, involves tattooing thousands of tiny dots on patients' heads to give the illusion of shaved hair. A South Korean study in the peer-reviewed International Journal of Dermatology described the process as "one of the most effective treatment methods" for hair loss, reporting an average satisfaction rate of 4.8 out of 5 among the 80 patients interviewed.

Like 'a Triad'

But, still, Asia poses unique challenges for receding men. Undergoing the scalp tattoo procedure requires patients to permanently sport a shaved-head look, which, as the Korean study suggested, may be "stereotyped in Asian cultures as (being like) a gangster or criminal." According to Ko, however, such labels are a thing of the past.

"Back in the day, when young males shaved their heads, seniors would mildly chide them with a totally unproven and absurd hypothesis," he said, suggesting that elders once saw a skinhead as a sign that someone was a rebel, or had "a problem with society."

"Nowadays (these attitudes) almost never exist, but it is still true people look at bald males with a certain awe."

Eric But of Synergy Model Management, which has offices in Hong Kong and Guangzhou, said that clients are still often looking for Asian models to be "cute (with) long hair -- that Korean drama, perfect boyfriend kind of look." But while he distinguishes between shaved and bald heads, the modeling agent said that the rise of street fashion is gradually normalizing the skinhead look in Asia.

"For our parents' generation, a skinhead in Asia is kind of like a gangster -- if you want to be a triad, or if you go to prison, you have to shave your head," he said over the phone. "But now, for people born in the '90s or later, they see having a skinhead as a streetwear trend. And streetwear is massive in Asia."

Even in the home of coiffed K-pop, visibility may be growing gradually. Ko cited restaurateur Hong Seok-cheon (below), rapper Gill and actor Kim Kwang-kyu as examples of a slowly-growing number of high-profile bald celebrities in South Korea.

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Asian Men Grapple With What it Means to be Bald as Hairlines are Receding Faster than Ever - News18

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By 2027, the global gene therapy market is estimated to reach a staggering value of $6.6B. With the number of successfully approved gene therapies increasing, the sector has moved from hype to hope. At the heart of gene therapy lie viral vectors, which are used to transport a gene into a target cell. Here we explore the current bottleneck in viral vector production, why viral vectors still outshine non-viral vector solutions, and what we can expect in the future.

The gene therapy field is gaining momentum. Investments are pouring in. The FDA is estimating that by 2025 it will approve between 10 and 20 cell and gene therapy products every year. This shows that a treatment, which started out as a hype, is now a real hope, says Ratish Krishnan, Associate Director of Cell and Gene Therapy Bioprocessing at MilliporeSigma*.

Today, a number of treatments have been approved, such as Spark Therapeutics LUXTURNA, the first FDA approved in vivo gene therapy, or Novartis Zolgensma, which gained US approval in 2019 and European approval in March 2020.

One of the key ingredients of gene therapies is the viral vector, which is used to transfer a gene of interest into a target cell. The most commonly used vector is that of the adeno-associated virus (AAV). But the manufacturing of viral vectors and scaling up their production remain difficult.

In upstream development, one challenge is the way viral vectors are produced. In a process called transient transfection, plasmids carrying the DNA of interest are introduced into host cells that will produce the viral vectors.

But host cells are commonly grown in adherent cell cultures, which are usually harder to reproduce at a large scale. So to scale-up and achieve high titers of virus particles, researchers are working on growing cells in suspension using large bioreactors instead.

We are facing several challenges at the moment and that is what keeps us on our toes, Krishnan adds. In upstream development, there is a desire to move towards suspension. Most processes use transient transfection methods using plasmids and the transfection step at a production scale of 500L or 2000L is extremely challenging.

In downstream development, researchers are studying the purity of capsids. The capsid is the protective shell of the virus enclosing the gene of interest. Related to this is an important discussion on the purity of viral vectors.

When you produce vectors, you will generally have a population of empty capsids, which is the viral AAV assembly without the genetic material inside, or partially-full capsids with only part of the DNA inside, Krishnan explains. We have to better understand the role of empty capsids inside the body. Are they needed as immune decoys or are they strictly considered impurities? In theory, you only need the ones with all the DNA inside, the full capsids.

But researchers have yet to discover the correct percentage of full capsids in a drug substance or product, Krishnan says. We dont have the answer yet. Typically, the strategy leans towards the enrichment of a percentage of full capsids as high as possible, while taking into account the data from clinical trials.

Questions about purity are difficult to answer because there is little or no regulatory guidance. For instance, compared to monoclonal antibodies (mAbs) for which the regulatory environment is well understood, the regulatory landscape for gene therapies remains largely unclear.

Through decades of research, mAb production also works through well-established and standardized platforms, whereas viral vectors are still in their infancy and cannot be produced using platform technologies yet although much is being done in this field and they are catching up fast.

Because of their longstanding history, we already have a lot of knowledge and research about mAbs, Krishnan explains. Lets say I want to start a biotech company or a CDMO that develops mAbs. I can rely on existing templates and get up and running much quicker than if I were developing viral vectors.

AAVs come in many different serotypes distinguishable strains which impact platform development. The scale-up is also challenging since the indications can be strikingly contrasting. For example, ocular indications need smaller viral drug substances compared to a muscular indication.

Manufacturing mAbs is better understood than manufacturing viral vectors. Viruses are a whole lot bigger and can be more complex than antibodies. While antibodies usually have a size around 10 nm, AAVs measure around 20nm and Lentiviruses around 100nm in size. Not only are antibodies produced at a larger scale than viral vectors, but their scalability is also more predictable due to the established platform technologies.

Despite these challenges, the increase in popularity, investments flooding in, and the promise of essential cures have led to a bottleneck in viral vector production for gene therapies. But many companies working in the gene therapy field are small or emerging biotechs that do not have the necessary resources and expertise in-house to tackle the challenges of viral vector production.

Lacking the facilities to do it themselves, small and emerging biotechs therefore turn to experienced contract development and manufacturing organizations (CDMOs), such as Merck BioReliance, to produce their gene therapies.

There are only a handful of CDMOs that have the capability and expertise to take on the complexities of gene therapy projects, Krishnan says. But there is currently a bottleneck in manufacturing slots. Manufacturing facilities can only work 24 hours a day, and if you are a small company and a CDMO has other clients waiting in line before you to have their therapies manufactured, you have no other option but to wait.

The problem with waiting, of course, is that the biotech runs the risk of falling behind its competition. Krishnan emphasizes, time is of the essence in gene therapy. There is no silver medal for developing a therapy for the same indication.

The key, says Krishnan, lies in much planning and close engagement with the CDMO partner. Biotechs should do an analysis of what they can perform in-house versus what they have to outsource early on. Engaging a CDMO is the route you want to take.

With decades of experience, Merck can support its biotech sponsors all the way to the clinic. We are big on the concept of integrated solutions, Krishnan explains. From clone to clinic to commercialization, Merck has the expertise, knowledge network, product, and services to help guide any customer to the finish line. We have the CDMO expertise with BioReliance, with testing services, gene therapy expertise, and regulatory support.

To circumvent the manufacturing bottleneck for viral vectors, some biotechs are looking at non-viral vector solutions for gene therapies. While traditional gene therapies use a viral vector, like AAV, to transfer a gene of interest into the patient, non-viral gene therapy deploys an alternative delivery system for the gene of interest.

Examples for non-viral delivery systems include physical force to deliver the gene through the cell membrane; injecting the gene with a needle into the target region; electroporation, which uses an electric current to produce pores in the cell membrane through which the gene can be inserted into the cell; and chemical vectors, such as lipid-, polymer-, or peptide-based particles.

Nevertheless, viral vectors, such as the AAV, remain the preferred path for most companies. The efficiency of delivery for non-viral vectors remains questionable. This means that there might be reactions in the immune system that get triggered, eliciting a dangerous, adverse response. AAVs, on the other hand, are well-engineered and safe, despite being novel.

Viral vectors have recently demonstrated success, Krishnan adds. Scientists are making advances in the non-viral area of gene therapy but they also come with a unique set of challenges. Questions, such as how do they interact with serum components in the body, how do they involve the immune system before reaching the target tissue, how do they interact with the surfaces of cells, remain.

Despite unaddressed challenges, gene therapy has definitely shifted from being a hope to carrying an expectation. This is reflected in the number of investments pouring into the sector.

Big pharma and biotech companies are heavily investing their resources into gene therapy, Krishnan says. Typically, companies have vaccines or mAbs in their portfolio. Now, gene therapy is becoming a major modality of interest as well.

While we are still far away from reaching the smooth manufacturing processes we have in place for antibodies, many companies are also looking into platform approaches for gene therapy. We would take a quantum leap if we developed a platform approach for upstream and downstream processes. That would significantly reduce the time to the clinic. Platform approaches are definitely being explored, Krishnan adds.

Vendors like Merck are playing a big role in developing fit-for-purpose products for gene therapies, Krishnan says. At the R&D level, researchers are also working on advances in capsid engineering. We already have synthetic capsids, and there are other tremendous advancements in capsid engineering, design, and purity, which are going to continue to evolve.

But, as Krishnan puts it, We are running a marathon at sprint speed. The journey is exciting and challenging, identical to the ride on a rollercoaster, but we are barely even at the tip of the iceberg. There are patients waiting for life-saving treatment, so gene therapies will definitely continue to be in the limelight, and for good reason.

Are you fighting to solve the bottleneck in viral vector production? Get in touch with the expert team at Merck and view their webinar on this topic!

*The life science business of Merck operates as MilliporeSigma in the U.S. and Canada.

Images via Shutterstock.com and Elena Resko

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The Roller Coaster of Gene Therapy... - Labiotech.eu

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Genespire and SR-Tiget announce strategic alliance for the development of transformative gene therapies for genetic diseases and disclose collaboration focus

Pre-clinical data from SR-Tiget, included in the alliance with Genespire, to be presented at ASGCT 23rd Annual Meeting

Italy, Milan, 13 May 2020: The San Raffaele Telethon Institute for Gene Therapy (SR-Tiget), one of the worlds leading gene therapy research institutes jointly managed by Fondazione Telethon and Ospedale San Raffaele and Genespire, a gene therapy company developing transformative therapies for genetic diseases, and spin-out of SR-Tiget, announced today their alliance on the research and development of candidate therapeutic products for people affected by primary immunodeficiencies and metabolic diseases based on novel gene editing and lentiviral vector technologies developed by SR-Tiget.

Genespire was co-founded in March 2020 by SR-Tiget director and gene therapy pioneer Prof. Luigi Naldini and Dr. Alessio Cantore, Fondazione Telethon and Ospedale San Raffaele. Genespire recently raised 16 million in a Series A financing round from Sofinnova Partners.

Under the terms of the alliance, Genespire and SR-Tiget will study and further develop novel gene therapies, which have the unique potential to address severe unmet medical need and exploit gene editing and lentiviral vector technologies developed by SR-Tiget.

Genespire was granted an exclusive global license for the research, development and commercialization of gene therapies for metabolic diseases based on SR-Tigets alloantigen free, microRNA-regulated lentiviral vectors, which allow for stable liver gene therapy even for diseases with early onset, requiring administration at a young age.

Genespire was also granted exclusive licenses and options to the results of a joint research and development program with SR-Tiget in the T-cell and Hematopoietic Stem Cells field to address genetic diseases, in particular primary immunodeficiencies, exploiting the ex vivo gene editing technology. SR-Tiget and Genespire will first collaborate to bring an ex-vivo autologous edited T-cell gene therapy for X-linked Hyper IgM syndrome (HIGM1) to the clinic, which becomes Genespires lead candidate product. HIGM1 is caused by inherited mutations of the CD40 ligand gene (CD40L), resulting in impaired antibody response and innate immunity, meaning that people find it difficult to fight off infections and eventually succumb to them. The treatment objective is to correct the defective gene through targeted editing of the endogenous locus, thereby maintaining physiological regulation of the CD40L gene, with the aim of improving the immune response of the patients.

Preclinical results of SR-Tiget on HIGM1 will be disclosed in an oral presentation at the American Society for Cell and Gene Therapy (ASGCT) 23rd Annual Meeting, taking place virtually from 12-15 May 2020 by SR-Tiget (details of Presentation 1 below). The presentation will outline the technology and its preclinical validation in the disease model and patient derived cells and discuss the potential of the gene edited T-cell treatment approach for patients with Hyper IgM.

Dr. Alessio Cantore will also present novel data related to the potential of the lentiviral vector platform for liver gene therapy in an oral presentation at ASGCT (details of Presentation 2 below). The presentation will focus on investigating the stability of lentiviral vector genetically modified liver cells following post-natal liver growth in mice, in view of its potential application to pediatric patients.

Luigi Naldini, Director of SR-Tiget and scientific co-founder of Genespire said: We are excited to have secured a path for bringing forward some of the gene therapy work pioneered at SR-Tiget to eventually help individuals affected by severe metabolic and immunodeficiency disorders. SR-Tigets alliance with Genespire will provide the means to progress effectively to clinical trials, with a strong view to develop efficacious and safe medicines ready for market access.

Julia Berretta, Chief Executive Officer of Genespire commented: SR-Tiget brings outstanding expertise and significant experience in developing gene therapies from bench to bedside. We believe that our strong partnership with SR-Tiget, led by internationally recognized experts Prof. Luigi Naldini and Dr. Alessio Cantore will be fundamental for Genespire to carry out its goal of translating pioneering science into transformative therapeutic solutionsfor patients.

-ENDS-

Oral presentation 1 details: Title: Modeling, Optimization and Comparative Efficacy of HSC- and T-cell Based Editing Strategies for Treating Hyper IgM Syndrome Authors: Valentina Vavassori, Elisabetta Mercuri, Genni Marcovecchio, Maria Carmina Castiello, Giulia Schiroli , Luisa Albano, Elena Fontana, Andrea Annoni, Valentina Capo, Carrie Margulies, Frank Buquicchio, Joseph Kovacs, Eugenio Scanziani, Cecilia Cotta-Ramusino, Anna Villa, Luigi Naldini, Pietro Genovese Date and time: May 14th 2020, 3:45 PM EDT Session: 354 Gene Therapies for Hemophilia and Immune Disorders Abstract #937 Oral Presentation 2 Details Title: Investigating the stability of lentiviral vector targeted liver cells during post-natal growth for in vivo gene therapy applications Authors: Michela Milani, Francesco Starinieri, Cesare Canepari, Tongyao Liu, Federica Moalli, Gioia Ambrosi, Tiziana Plati, Mauro Biffi, Cesare Covino, Timothy Nichols, Matteo Iannacone, Robert Peters, Luigi Naldini, Alessio Cantore Date and time: May 14th 2020, 4:15 pm EDT Session: 350 RNA Virus Vectors Abstract #911

Notes to Editors

About Hyper IgM Syndrome (HIGM)

Hyper IgM is a Primary Immune Deficiency affecting 1:250,000-500,000 patients. The disease is linked to mutations in the CD40L gene, which is expressed in activated CD4 T cells, and results in impaired antibody production and innate immunity. The current standard of care is constituted by continuous Ig replacement, and antibiotic-antifungal prophylaxis, but the disease is still linked to high morbidity and reduced life expectancy. Allogeneic hematopoietic stem cell transplant (HSCT) is potentially curative, but is limited by matched donor availability and is associated with high risk of graft versus host disease, infections and death. Thus, improved therapeutic alternatives are strongly needed.

About Genespire

Genespire is a biotechnology company focused on the development of transformative gene therapies for patients affected by genetic diseases, particularly primary immunodeficiencies and inherited metabolic diseases. Based in Milan, Italy, Genespire was founded in March 2020 by the gene therapy pioneer Prof. Luigi Naldini and Dr. Alessio Cantore, Fondazione Telethon and Ospedale San Raffaele. It is a spin-off of SR-Tiget, a world leading cell and gene therapy research institute and is backed by Sofinnova Partners. http://www.genespire.com

About SR-Tiget

Based in Milan, Italy, the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) is a joint venture between the Ospedale San Raffaele and Fondazione Telethon. SR-Tiget was established in 1995 to perform research on gene transfer and cell transplantation and translate its results into clinical applications of gene and cell therapies for different genetic diseases. Over the years, the Institute has given a pioneering contribution to the field with relevant discoveries in vector design, gene transfer strategies, stem cell biology, identity and mechanism of action of innate immune cells. SR-Tiget has also established the resources and framework for translating these advances into novel experimental therapies and has implemented several successful gene therapy clinical trials for inherited immunodeficiencies, blood and storage disorders, which have already treated >115 patients and have led through collaboration with industrial partners to the filing and approval of novel advanced gene therapy medicines.

About Fondazione Telethon

Fondazione Telethon is a non-profit organisation created in 1990 as a response to the appeals of a patient association group of stakeholders, who saw scientific research as the only real opportunity to effectively fight genetic diseases. Thanks to the funds raised through the television marathon, along with other initiatives and a network of partners and volunteers, Telethon finances the bestscientific research on rare genetic diseases, evaluated and selected by independent internationally renowned experts, with the ultimate objective of making the treatments developed available to everyone who needs them. Throughout its 30 years of activity, Fondazione Telethon has invested more than 528 million in funding more than 2.630 projects to study more than 570 diseases, involving over 1.600 scientists. Fondazione Telethon has made a significant contribution to the worldwide advancement of knowledge regarding rare genetic diseases and of academic research and drug development with a view to developing treatments. For more information, please visit:www.telethon.it

About Ospedale San Raffaele

Ospedale San Raffaele (OSR) is a clinical-research-university hospital established in 1971 to provide international-level specialised care for the most complex and difficult health conditions. OSR is part ofGruppo San Donato, the leading hospital group in Italy. The hospital is a multi-specialty center with over 60 clinical specialties; it is accredited by the Italian National Health System to provide care to both public and private, national and international patients. Research at OSR focuses on integrating basic, translational and clinical activities to provide the most advanced care to our patients. The institute is recognized as a global authority in molecular medicine and gene therapy, and is at the forefront of research in many other fields. Ospedale San Raffaele is a first-class institute which treats many diseases and stands out for the deep interaction between clinical and scientific area. This makes the transfer of scientific results from the laboratories to the patients bed easier. Its mission is to improve knowledge of diseases, identify new therapies and encourage young scientists and doctor to grow professionally. For more information, please visit:www.hsr.it

Enquiries: Genespire Julia Berretta, CEOTel: +39 02 83991300info@genespire.com Consilium Strategic Communications Amber Fennell / Matthew Neal Tel: +44 (0) 20 3709 5700genespire@consilium-comms.com

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Genespire and SR-Tiget announce strategic alliance for the development of transformative gene therapies for genetic diseases and disclose...

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Cutting-edge research on rewriting the genes responsible for Tay-Sachs disease, sickle-cell anemia, and other disorders will be presented at this weeks online annual meeting of the American Society for Gene and Cell Therapy. Originally planned as a Boston gathering, the scientific groups get-together became a virtual one because of the Covid-19 pandemic.

From Tuesday through Friday, academic researchers will be presenting their latest data online, along with updates from firms like Bluebird Bio (ticker: BLUE), Voyager Therapeutics (VYGR), Fate Therapeutics (FATE), Beam Therapeutics (BEAM), Axovant Gene Therapies (AXGT), and many others. Patients and their families have found their way to clinical trials through the societys website.

Bluebird plans presentations on its cell therapy against the blood cancer known as multiple myeloma. Using a technology known as CAR-T, the company creates supercharged versions of a patients immune cells that have halted disease progression in some of the 18 patients enrolled in a continuing Phase 1 trial.

Featured on Friday will be reports on the first babies treated with gene therapy for the debilitating neurodegenerative disorder Tay-Sachs. The treatment is being developed by the London-based Axovant under license from the University of Massachusetts Medical School.

Voyager will discuss its preclinical mouse studies on treating neurological disorders like amyotrophic lateral sclerosis and Huntingtons disease by using techniques that block the rogue signals generated by defective genes.

Fate Therapuetics is scheduled to show a new off-the-shelf CAR-T technology that it hopes will allow the immune system to target a broad range of solid tumors as well as multiple myeloma. The approach is licensed from Harvard Universitys Dana-Farber Cancer Institute.

Beam, meanwhile, will detail success it has shown in preclinical editing of the genetic defect that causes sickle-cell anemia. The company is developing a sharper-edged way of rewriting faulty genes than the widely used Crispr technology that Beam licensed from researchers at the Broad institute of Harvard and MIT. Beam founder and Crispr pioneer Feng Zhang will give a featured lecture as part of the online meeting on Thursday.

Write to Bill Alpert at william.alpert@barrons.com

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Gene-Therapy Treatments for Tay-Sachs, Sickle Cell to Be Featured in Online Gathering - Barron's

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