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Archive for the ‘Hypogonadism’ Category

Male Hypogonadism Market Key Players, Product and Production Information analys – News by aeresearch

The report on Male Hypogonadism Market delivers a succinct analysis on industry size, regional growth and revenue forecasts for the upcoming years. The report further sheds light on significant challenges and latest growth strategies adopted by manufacturers who are a part of the competitive spectrum of this business domain

The report commences with a concise introduction to the Male Hypogonadism market, as well as the present market scenario, market size, a summary of similar industries, and accurate market share estimates.

The driving factors influencing the profitability scale of this business space and the annual growth rate of this industry over the forecast duration have been enumerated in the report. Substantial data with reference to the consumption patterns and rates and patterns of Male Hypogonadism market in conjunction with a conclusive overview of the price analysis is also provided.

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A synopsis of the geographical gist of the geographical landscape unveiled:

Report Objectives:

What are the pivotal highlights of Male Hypogonadism market?

The Male Hypogonadism market report basically is a detailed study of business sphere with respect to the driving forces influencing the dynamics of this industry, consumption value across various geographies, import and export patterns and volumes, and the contribution of major participants toward the Male Hypogonadism market expansion.

The Report Answers the key Questions

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Male Hypogonadism Market Key Players, Product and Production Information analys - News by aeresearch

Aytu BioScience Signs Development Agreement with Sterling Medical Devices to Advance the Development of Healight as a Potential Coronavirus Treatment…

Company has Partnered with Sterling Medical to Finalize the Development of Cedars-Sinai-Developed 'Healight' Medical Device for Use in Patients with Coronavirus

ENGLEWOOD, CO / ACCESSWIRE / April 27, 2020 / Aytu BioScience, Inc. (AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it has signed an agreement with Sterling Medical Devices ("Sterling") to finalize the development of Healight, a novel endotracheal catheter, as a potential treatment for coronavirus.

The company announced last week that it licensed exclusive worldwide rights to the Healight technology from Cedars-Sinai for all endotracheal and nasopharyngeal indications. The patent-pending Healight Platform has been in development since 2016 by the Medically Associated Science and Technology (MAST) team at Cedars-Sinai. Following their pre-clinical findings that Healight may be a safe and effective antiviral and antibacterial treatment, the team engaged Sterling to rapidly develop a novel endotracheal device to help combat coronavirus.

"Sterling has been working with the Cedars-Sinai team for the past several weeks on a very accelerated schedule to develop this much needed device," said Dan Sterling, President of Sterling Medical Devices. "We are happy to now be partnering with Aytu to further advance this critical project as fast as we possibly can for the many patients in need."

"The Aytu team is very pleased to be working with Sterling Medical on this important development program and in the fight against coronavirus," stated Josh Disbrow, Chairman and CEO of Aytu BioScience. Disbrow further commented, "Sterling has a stellar reputation as a best-in-class medical device product firm with more than 21 years of experience, over 1,100 projects engineered, with none failing to receive FDA regulatory approval upon submission. Our team is actively engaged with our colleagues at Sterling in an effort to finalize the device development, with hope of enabling human use in the very near future."

The company believes the Healight platform technology has the potential to positively impact outcomes for critically ill patients infected with coronavirus and other infections. Aytu, with support of the team at Cedars-Sinai, is working with the FDA to determine an expedited regulatory process to potentially enable near-term use of the technology initially as a coronavirus intervention for critically ill intubated patients.

About Aytu BioScience, Inc.

Aytu BioScience, Inc. is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 126 patient clinical trial in China and has received CE marking.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human marketing and sales platform.

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Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the Company's consumer healthcare products.

About Sterling Medical Devices

Founded in 1998, Sterling Medical Devices (SMD), specializes in the product design and engineering of medical devices for the healthcare industry. Dedicated to resolving their clients' medical device design and engineering challenges, SMD addresses the whole development process, including, product design and human factors, systems, software, electronics, mechanical, quality, and compliance. The company utilizes the latest tools and technology to streamline the engineering process to speed regulatory approval of Class I, II and III devices. To date, the company has spearheaded the production of over 1,100 projects for more than 300 clients. SMD is internationally recognized and is FDA QSR 21, CFR 820, and 21 CFR Part 11 compliant, ISO 13485 registered, and IEC 62304, ISO 14971, IEC 60601, and IEC 62366 compliant. For more information, please visit http://www.sterlingmedicaldevices.com or call 201.227.7569 x2.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, our ability to enforce the exclusivity provisions of the distribution agreement, the reliability of serological testing in detecting COVID-19, shipping delays and their impact on our ability to introduce the COVID-19 Rapid Test, the ability of the COVID-19 Rapid Test to accurately and reliably test for COVID-19, the manufacturer of the COVID-19 Rapid Test's ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 Rapid Test Kit, the demand or lack thereof for the COVID-19 Rapid Test Kit, our ability to obtain additional COVID-19 Rapid Tests to meet demand, our ability to secure additional tests if the manufacture of the COVID-19 Rapid Tests is unable to meet demand, the effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization.

SOURCE: Aytu BioScience, Inc.

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Aytu BioScience Signs Development Agreement with Sterling Medical Devices to Advance the Development of Healight as a Potential Coronavirus Treatment...

Global Human Immunoglobulin (pH4) for Intravenous Injection (COVID-19) Market to Surpass US$ 99,772.2 Million by 2027 – CMI – GlobeNewswire

SEATTLE, April 23, 2020 (GLOBE NEWSWIRE) -- According to Coherent Market Insights, the global human immunoglobulin (pH4) for intravenous injection (COVID-19) market is estimated to be valued at US$ 43,205.8 million in 2020, and is expected to exhibit a CAGR of 12.7% during the forecast period (2020-2027).

Key Trends:

Key trends in the market include viral disease outbreaks, the increasing prevalence of chronic lymphocytic leukemia, and demand for immune globulin products in the market.

According to the American Cancer Society around 60,530 new cases of leukemia will be diagnosed in the U.S in 2020 out of which 21,040 new cases will be of chronic lymphocytic leukemia (CLL).

Similarly, according to the Cancer Research UK, around 3,500 new cases of chronic lymphocytic leukemia (CLL) were diagnosed in the U.K in 2017.

Request for Sample PDF copy @ https://www.coherentmarketinsights.com/insight/request-sample/3790

Moreover, the growing demand for immune globulin (IG) products is expected to drive the human immunoglobulin (ph4) for intravenous injection (COVID-19) market growth. For instance, on August 12, 2019, the U.S. Food and Drug Administration (FDA) confirmed that demand for immune globulin products has increased in recent years and there is a shortage of Immune Globulin (Subcutaneous) (IGSC) and Immune Globulin (Intravenous) (IGIV) products in the U.S. The U.S. Food and Drug Administration is working closely with manufacturers such as Asceniv, Bivigam, Octagam, Panzyga, Privigen and others of various immune globulin (intravenous) (IGIV) products to help mitigate the supply situation for IG products.

Key Market Takeaways:

Key players operating in market are

Takeda Pharmaceutical Company Limited, Baxter International Inc., CSL Behring, Bayer AG, Grifols, S.A., Octapharma AG, Shanghai RAAS Blood Products Co., Ltd., Hualan Biological Engineering Inc., China Biologic Products, Inc., Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd., Boya Bio-Pharmaceutical Group Co., Ltd., ADMA Biologics, Inc., and Sinopharm Group Co., Ltd.

Buy this Research Report @ https://www.coherentmarketinsights.com/insight/buy-now/3790

Market Segmentation:

Related Topics:

HEALTHCARE CONTRACT RESEARCH OUTSOURCING MARKET

Healthcare Contract Research Outsourcing is conducted by pharmaceutical and medical device sectors for development of new drugs and medical devices. Clinical trials form the key part of pharmaceutical drug and medical device development and in the current scenario clinical trials are conducted across multiple locations in various geographies. Increasing cost and time required for drug development is expected to propel growth of the global healthcare contract research outsourcing market over the forecast period.

Read more @ https://www.coherentmarketinsights.com/market-insight/healthcare-contract-research-outsourcing-market-3788

ANDROGEN REPLACEMENT THERAPY MARKET

Androgen replacement therapy (ART), often referred to as testosterone replacement therapy (TRT), is a form of hormone therapy, in which androgens, often testosterone, are replaced. ART is often prescribed to counter the effects of male hypogonadism. It typically involves the administration of testosterone through injections, skin creams, patches, gels, or subcutaneous pellets. Testosterone replacement therapy is a promising technology for improving symptoms of hypogonadism and to raise the testosterone level.

Read more @ https://www.coherentmarketinsights.com/market-insight/androgen-replacement-therapy-market-3787

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Global Human Immunoglobulin (pH4) for Intravenous Injection (COVID-19) Market to Surpass US$ 99,772.2 Million by 2027 - CMI - GlobeNewswire

Male Hypogonadism Market Analysis On Trends and Need 2025 – Latest Herald

Global Male Hypogonadism Market: Snapshot

Hypogonadism in males refers to a condition in the male body where the testes show a significantly reduced level of functioning than normal. The overall result of male hypogonadism is a reduction in the rate of biosynthesis of male sex hormones. This state is more commonly known as interrupted stage 1 puberty. Hypoandrogenism, or the low androgen or testosterone level in a male can vary in severity from person to person. It is often the cause of partial or complete infertility. There are multiple forms of male hypogonadism and even more ways to classify them. Most endocrinologists commonly classify male hypogonadism on the basis of the level of defectiveness of the male reproductive system.

In many cases, doctors also measure the level of gonadotropins to classify a patient between primary and secondary male hypogonadism. Primary male hypogonadism refers to the cause of the condition being due to defective gonads. There are different types of primary male hypogonadism, including Turner syndrome and Klinefelter syndrome. Secondary male hypogonadism is caused by defects in pituitary or hypothalamic glands. They include Kallmann syndrome and hypopituitarism.

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Global Male Hypogonadism Market: Overview

Male Hypogonadism refers to a clinical condition, wherein the testes fail to produce enough testosterone leading to delayed puberty or incomplete development. The condition is related to impaired development of muscle mass, development of breast tissues, impaired body hair growth, and lack of deepening of the voice.

The male Hypogonadism market can be segmented by therapy, type, drug delivery, and geography.

The report presents an in-depth analysis of the global male hypogonadism market with current trends and future estimates to explain the imminent investment pockets. The quantitative analysis of the market for the forecast period from 2017 to 2025 will enable stakeholders to capitalize on the prevailing growth opportunities.

Global Male Hypogonadism Market: Trends and Opportunities

The top driver of the male hypogonadism market includes rising prevalence of testosterone deficiency among men, increasing infertility rates, and increasing awareness among individuals about hypogonadism treatment due to awareness drives organized by several governments across the world. Moreover, high risk of hypogonadism among the geriatric population with obesity and diabetes, and increasing prevalence of chronic disorders among the geriatrics are further expected to boost the markets growth.

However, factors such as high side effects of testosterone products are challenging the growth of testosterone replacement therapy market. Top players in the market are focused on research and development to introduce newer products with fewer or negligible side effects and improved results. For example, LPCN 1111, a product which is under development from Lipocine Inc., is a newer testosterone prodrug that utilizes Lipral technology for enhanced systemic absorption and for enhanced solubility of testosterone. Nevertheless, technological advancements are anticipated to extend new opportunities to the markets growth.

Global Male Hypogonadism Market: Regional Overview

The global male Hypogonadism market can be analyzed with respect to the regional segments of North America, Asia Pacific, Europe, Latin America, and the Middle East and Africa. North America held the majority share of the global market in the recent past and is expected to retain its dominant position in the near future. This is mainly due to the rise in the number of individuals suffering from primary and secondary conditions of hypogonadism, and rising awareness among individuals about treatment options for the condition. Moreover, the presence of ultra-modern healthcare infrastructure and increasing popularity of technologically advanced products are expected to offer new opportunities for top players in this market. The region is closely followed by Europe.

Asia Pacific is expected to offer lucrative opportunities to this market due to the modernization of the healthcare infrastructure in the emerging economies of India and China and the increasing awareness about the treatment for the condition. In Asia Pacific, the increasing prevalence of hypogonadism and infertility rates along with the rising geriatric population base with diabetes and obesity are propelling the growth of this market. China, Taiwan, and Malaysia are some of the countries that display the highest rate of male hypogonadism.

Major Companies Mentioned in Report

Some of the key players in the male Hypogonadism market include AbbVie Inc., Astrazeneca plc, Eli Lilly and Company Ltd., Merck & Co. Inc., SA, Finox Biotech, Laboratories Genevrier, Teva Pharmaceutical Industries Ltd., Allergan plc, Bayer AG, Endo International plc, IBSA Institut Biochimque, and Ferring.

Key players are focused on product approval for growth considerations and to cater to the changing demand of the industry. The introduction of innovative and technologically advanced products is also the focus of key players to increase their market share and for serving patients in a better manner.

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Male Hypogonadism Market Analysis On Trends and Need 2025 - Latest Herald

The impact of the coronavirus on the Male Hypogonadism Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 20682019-2019 – Jewish Life News

The Male Hypogonadism Market globally is a standout amongst the most emergent and astoundingly approved sectors. This worldwide market has been developing at a higher pace with the development of imaginative frameworks and a developing end-client tendency.

Given the debilitating impact of COVID-19 (Coronavirus) on the Male Hypogonadism market, companies are vying opportunities to stay afloat in the market landscape. Gain access to our latest research analysis on COVID-19 associated with the Male Hypogonadism market and understand how market players are adopting new strategies to mitigate the impact of the pandemic.

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The worldwide Male Hypogonadism market is an enlarging field for top market players,

Company Profiles

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This Male Hypogonadism report begins with a basic overview of the market. The analysis highlights the opportunity and Male Hypogonadism industry trends that are impacted the market that is global. Players around various regions and analysis of each industry dimensions are covered under this report. The analysis also contains a crucial Male Hypogonadism insight regarding the things which are driving and affecting the earnings of the market. The Male Hypogonadism report comprises sections together side landscape which clarifies actions such as venture and acquisitions and mergers.

The Report offers SWOT examination and venture return investigation, and other aspects such as the principle locale, economic situations with benefit, generation, request, limit, supply, and market development rate and figure.

Quantifiable data:-

Geographically, this report studies the top producers and consumers, focuses on product capacity, production, value, consumption, market share and growth opportunity in these key regions, covering North America, Europe, China, Japan, Southeast Asia, India

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Research objectives and Reason to procure this report:-

Finally, the global Male Hypogonadism market provides a total research decision and also sector feasibility of investment in new projects will be assessed. Male Hypogonadism industry is a source of means and guidance for organizations and individuals interested in their market earnings.

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The impact of the coronavirus on the Male Hypogonadism Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 20682019-2019 - Jewish Life News

Male Hypogonadism Therapy Market Analysis by Size, Share, Top Key Manufacturers, Demand Overview, Regional Outlook And Growth Forecast to 2026 Cole…

Therapeuticsmd

Global Male Hypogonadism Therapy Market Segmentation

This market was divided into types, applications and regions. The growth of each segment provides an accurate calculation and forecast of sales by type and application in terms of volume and value for the period between 2020 and 2026. This analysis can help you develop your business by targeting niche markets. Market share data are available at global and regional levels. The regions covered by the report are North America, Europe, the Asia-Pacific region, the Middle East, and Africa and Latin America. Research analysts understand the competitive forces and provide competitive analysis for each competitor separately.

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Global Male Hypogonadism Therapy Market Regions and Countries Level Analysis

The regional analysis is a very complete part of this report. This segmentation highlights Male Hypogonadism Therapy sales at regional and national levels. This data provides a detailed and accurate analysis of volume by country and an analysis of market size by region of the world market.

The report provides an in-depth assessment of growth and other aspects of the market in key countries such as the United States, Canada, Mexico, Germany, France, the United Kingdom, Russia and the United States Italy, China, Japan, South Korea, India, Australia, Brazil and Saudi Arabia. The chapter on the competitive landscape of the global market report contains important information on market participants such as business overview, total sales (financial data), market potential, global presence, Male Hypogonadism Therapy sales and earnings, market share, prices, production locations and facilities, products offered and applied strategies. This study provides Male Hypogonadism Therapy sales, revenue, and market share for each player covered in this report for a period between 2016 and 2020.

Why choose us:

We offer state of the art critical reports with accurate information about the future of the market.

Our reports have been evaluated by some industry experts in the market, which makes them beneficial for the company to maximize their return on investment.

We provide a full graphical representation of information, strategic recommendations and analysis tool results to provide a sophisticated landscape and highlight key market players. This detailed market assessment will help the company increase its efficiency.

The dynamics of supply and demand shown in the report offer a 360-degree view of the market.

Our report helps readers decipher the current and future constraints of the Male Hypogonadism Therapy market and formulate optimal business strategies to maximize market growth.

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Table of Contents:

Study Coverage: It includes study objectives, years considered for the research study, growth rate and Male Hypogonadism Therapy market size of type and application segments, key manufacturers covered, product scope, and highlights of segmental analysis.

Executive Summary: In this section, the report focuses on analysis of macroscopic indicators, market issues, drivers, and trends, competitive landscape, CAGR of the global Male Hypogonadism Therapy market, and global production. Under the global production chapter, the authors of the report have included market pricing and trends, global capacity, global production, and global revenue forecasts.

Male Hypogonadism Therapy Market Size by Manufacturer: Here, the report concentrates on revenue and production shares of manufacturers for all the years of the forecast period. It also focuses on price by manufacturer and expansion plans and mergers and acquisitions of companies.

Production by Region: It shows how the revenue and production in the global market are distributed among different regions. Each regional market is extensively studied here on the basis of import and export, key players, revenue, and production.

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Tags: Male Hypogonadism Therapy Market Size, Male Hypogonadism Therapy Market Growth, Male Hypogonadism Therapy Market Forecast, Male Hypogonadism Therapy Market Analysis

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Male Hypogonadism Therapy Market Analysis by Size, Share, Top Key Manufacturers, Demand Overview, Regional Outlook And Growth Forecast to 2026 Cole...

Global Human Immunoglobulin (pH4) for Intravenous Injection (COVID-19) Market to Surpass US$ 99,772.2 Million by 2027 – CMI – Yahoo Finance

SEATTLE, April 23, 2020 (GLOBE NEWSWIRE) -- According to Coherent Market Insights, the global human immunoglobulin (pH4) for intravenous injection (COVID-19) market is estimated to be valued at US$ 43,205.8 million in 2020, and is expected to exhibit a CAGR of 12.7% during the forecast period (2020-2027).

Key Trends:

Key trends in the market include viral disease outbreaks, the increasing prevalence of chronic lymphocytic leukemia, and demand for immune globulin products in the market.

According to the American Cancer Society around 60,530 new cases of leukemia will be diagnosed in the U.S in 2020 out of which 21,040 new cases will be of chronic lymphocytic leukemia (CLL).

Similarly, according to the Cancer Research UK, around 3,500 new cases of chronic lymphocytic leukemia (CLL) were diagnosed in the U.K in 2017.

Request for Sample PDF copy @ https://www.coherentmarketinsights.com/insight/request-sample/3790

Moreover, the growing demand for immune globulin (IG) products is expected to drive the human immunoglobulin (ph4) for intravenous injection (COVID-19) market growth. For instance, on August 12, 2019, the U.S. Food and Drug Administration (FDA) confirmed that demand for immune globulin products has increased in recent years and there is a shortage of Immune Globulin (Subcutaneous) (IGSC) and Immune Globulin (Intravenous) (IGIV) products in the U.S. The U.S. Food and Drug Administration is working closely with manufacturers such as Asceniv, Bivigam, Octagam, Panzyga, Privigen and others of various immune globulin (intravenous) (IGIV) products to help mitigate the supply situation for IG products.

Key Market Takeaways:

Key players operating in market are

Takeda Pharmaceutical Company Limited, Baxter International Inc., CSL Behring, Bayer AG, Grifols, S.A., Octapharma AG, Shanghai RAAS Blood Products Co., Ltd., Hualan Biological Engineering Inc., China Biologic Products, Inc., Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd., Boya Bio-Pharmaceutical Group Co., Ltd., ADMA Biologics, Inc., and Sinopharm Group Co., Ltd.

Buy this Research Report @ https://www.coherentmarketinsights.com/insight/buy-now/3790

Market Segmentation:

Related Topics:

HEALTHCARE CONTRACT RESEARCH OUTSOURCING MARKET

Healthcare Contract Research Outsourcing is conducted by pharmaceutical and medical device sectors for development of new drugs and medical devices. Clinical trials form the key part of pharmaceutical drug and medical device development and in the current scenario clinical trials are conducted across multiple locations in various geographies. Increasing cost and time required for drug development is expected to propel growth of the global healthcare contract research outsourcing market over the forecast period.

Read more @ https://www.coherentmarketinsights.com/market-insight/healthcare-contract-research-outsourcing-market-3788

ANDROGEN REPLACEMENT THERAPY MARKET

Androgen replacement therapy (ART), often referred to as testosterone replacement therapy (TRT), is a form of hormone therapy, in which androgens, often testosterone, are replaced. ART is often prescribed to counter the effects of male hypogonadism. It typically involves the administration of testosterone through injections, skin creams, patches, gels, or subcutaneous pellets. Testosterone replacement therapy is a promising technology for improving symptoms of hypogonadism and to raise the testosterone level.

Read more @ https://www.coherentmarketinsights.com/market-insight/androgen-replacement-therapy-market-3787

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Global Human Immunoglobulin (pH4) for Intravenous Injection (COVID-19) Market to Surpass US$ 99,772.2 Million by 2027 - CMI - Yahoo Finance

Aytu BioScience Announces Exclusive Distribution Agreement for COVID-19 IgG/IgM Rapid Test with Singapore-Based Biolidics Limited – Yahoo Finance

ENGLEWOOD, CO / ACCESSWIRE / April 23, 2020 / Aytu BioScience, Inc. (AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced the signing of a definitive agreement (the "Agreement") with Singapore-based Biolidics, Limited (SGX: 8YY; "Biolidics") to exclusively distribute Biolidics' COVID-19 IgG/IgM Rapid Test in the United States.

Under the terms of the Agreement, Aytu will exclusively distribute Biolidics' COVID-19 IgG/IgM rapid antibody test in the United States. Aytu has committed to purchase 500,000 tests within one business day from the date of signing of the Agreement. As an additional component of Aytu's exclusivity, the Company has committed to purchase a minimum of 1,250,000 tests within the first three months of the Agreement.

Biolidics' COVID-19 IgG/IgM Rapid Test has been issued Provisional Authorization for distribution by Singapore's Health Science's Authority (HSA), and the product has been authorized for export from Singapore. Biolidics' COVID-19 IgG/IgM Rapid Test will be supplied from Biolidics' facility in Singapore.

Aytu will collaborate with Biolidics and lead the U.S. clinical trials processes and plans to complete and obtain U.S. Food and Drug Administration ("FDA") 510k regulatory filing clearance of the COVID-19 IgG/IgM rapid test kits.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We are pleased to be partnering with Biolidics in distributing this COVID-19 rapid test in the U.S. With the continued call in the United States for increased COVID-19 testing, we are entering this distribution Agreement at an excellent time. We have experienced significant demand for our current COVID-19 rapid test, so adding this test to our product offering will enable us to better meet the high demand in the U.S. We look forward to a productive working relationship with Biolidics and thank them for their confidence in allowing Aytu to take this product to market in the United States."

Incorporated in 2009 and listed on the Singapore Stock Exchange, Biolidics Limited is a Singapore-based precision medicine medical technology company with a focus in developing a portfolio of innovative diagnostic solutions to lower healthcare costs and improve clinical outcomes.

About Aytu BioScience, Inc.

Aytu BioScience, Inc. is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired U.S. distribution rights to two COVID-19 IgG/IgM rapid tests. These coronavirus tests are solid phase immunochromatographic assays used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human marketing and sales platform.

Story continues

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the Company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: our ability to successfully commercialize Healight Platform Technology, our ability to obtain FDA approval for the Healight Platform Technology, the effectiveness of the Healight Platform Technology in treating patients with COVID-19 or other illnesses, our ability to adequately protect the intellectual property associated with the Healight Platform Technology, regulatory delays, the reliability of the Healight Platform Technology in killing viruses and bacteria, market acceptance of UV based medical devices, risks associated with the our COVID-19 rapid tests including our ability to enforce the exclusivity provisions of the distribution agreements, the reliability of serological testing in detecting COVID-19, shipping delays and their impact on our ability to introduce the COVID-19 rapid tests, the ability of the COVID-19 rapid tests to accurately and reliably test for COVID-19, the manufacturers of the COVID-19 rapid tests' ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 rapid test kits, the demand or lack thereof for the COVID-19 rapid test kits, our ability to obtain additional COVID-19 rapid tests to meet demand, our ability to secure additional tests if the manufactures of the COVID-19 rapid tests are unable to meet demand, the effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the Company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

Contact for COVID-19 IgG/IgM Rapid Test and Healight-Related Inquiries:

COVID-19@aytubio.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/586556/Aytu-BioScience-Announces-Exclusive-Distribution-Agreement-for-COVID-19-IgGIgM-Rapid-Test-with-Singapore-Based-Biolidics-Limited

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Aytu BioScience Announces Exclusive Distribution Agreement for COVID-19 IgG/IgM Rapid Test with Singapore-Based Biolidics Limited - Yahoo Finance

Aytu BioScience Confirms Export and Incoming Delivery of COVID-19 IgG/IgM Rapid Tests – Yahoo Finance

Chinese Officials Confirm China Won't Restrict Exports of Medical Products Needed to Fight Coronavirus

Company in Late-Stage Negotiations to Secure Distribution Agreement for Additional COVID-19 IgG/IgM Rapid Test Which is Approved by China's National Medical Products Administration (NMPA)

ENGLEWOOD, CO / ACCESSWIRE / April 17, 2020 / Aytu BioScience, Inc. (AYTU), (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that export and delivery of the Company's incoming COVID-19 rapid tests remains on track as previously announced.

Additionally, the Company is in late-stage negotiations to secure rights to distribute a second COVID-19 IgG/IgM rapid test, which is approved by China's National Medical Products Administration (NMPA).

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "Since the Company began taking the fight to COVID-19, we have continued to aggressively search for and evaluate diagnostic tests and other novel technologies that may complement our current product offering and benefit COVID-19 patients. Also, given the nationwide shortage of tests, we believe we are obligated to secure as many additional tests as we can to help with this shortage. To that end, I am excited to say we're in the final stages of securing yet another IgG/IgM antibody rapid test for U.S. distribution. This test is already approved by China's NMPA, is being regularly exported from China, and has strong clinical performance. By securing this additional antibody test, we expect to have an even greater supply to fulfill the substantial demand we're experiencing. We all need to continue to do the very best we can to help COVID-19 patients and those medical professionals for whom they care."

Mr. Disbrow continued, "On March 31, an announcement was made by China's Ministry of Commerce restricting the export of medical materials that have not obtained approval from the NMPA. It is important to note that just yesterday the Associated Press released an article titled, China says no plans to limit export of anti-virus supplies.' The article states: Commerce Ministry spokesman Gao Feng said Beijing has taken steps to speed up customs clearance while ensuring the quality of exported epidemic-prevention goods. Gao said Thursday, China has not and will not restrict the export of epidemic prevention materials.' These statements provide us with confidence and are consistent with the information we continue to receive from our test kit licensor. We remain confident about the timely delivery of the Company's incoming order of COVID-19 IgG/IgM tests," commented Mr. Disbrow.

Mr. Disbrow concluded, "We have received further confirmation that the COVID-19 IgG/IgM Rapid Test manufactured by Zhejiang Orient Gene is in the approval process with NMPA. We remain highly confident in the test's clinical performance as recently demonstrated in a published, third-party peer-reviewed study and believe that the Zhejiang Orient Gene COVID-19 IgG/IgM Rapid Test is a reliable test in detecting COVID-19 antibodies. The independent study demonstrates test accuracy of 98.0% and 94.1% for IgG and IgM, respectively, when using PCR-positive cases as true positives, which we believe establishes strong clinical utility of the test."

The Company will continue to inform our stakeholders about our continuing developments relating to our COVID-19 fight and the progress of the Aytu BioScience business.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Story continues

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing Zhejiang Orient Gene's COVID-19 Rapid Test (the "COVID-19 Rapid Test"), shipping delays or regulatory processes and their impact on our ability to introduce the COVID-19 Rapid Test, the ability of the COVID-19 Rapid Test to accurately and reliably test for COVID-19, Zhejiang Orient Gene's ability to manufacture the COVID-19 Rapid Test on a high volume scale, manufacturing problems, customs problems or delays related to the COVID-19 Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 Rapid Test Kit, the demand or lack thereof for the COVID-19 Rapid Test Kit, Zhejiang Orient Gene's ability to obtain approval from China's National Medical Product Administration ("NMPA") to continue to manufacture and export the COVID-19 Rapid Test, the impact the ongoing disputes surrounding COVID-19 between the People's Republic of China and the United States of America may have on our ability to import additional COVID-19 Rapid Tests from Zhejiang Orient Gene, our ability to successfully identify and enter into an agreement with an alternative manufacture of a COVID-19 rapid test that is approved by the NMPA, the timing of any agreement with an alternative manufacture of a COVID-19 rapid test, any reputational or business harm that we may incur in the event the COVID-19 Rapid Test is not reliable or accurate in testing for COVID-19, any reputational or business harm that we may incur for selling the COVID-19 Rapid Test from a manufacture that is not currently approved by the NMPA, whether the testing standards of the NMPA are comparable to the FDA's standards and any market inference whether positive or negative that may be derived from selling rapid tests that are or are not manufactured by companies approved by the NMPA, scientific and market acceptance of antibody tests as acceptable tests for the detection of COVID-19, the reliability of independent third-party study as it relates to the measure of effectiveness of the COVID-19 Rapid Test, our ability to obtain COVID-19 rapid tests from NMPA approved manufactures on acceptable terms, our ability to meet the demand for COVID-19 rapid tests, unfavorable media coverage related to the COVID-19 Rapid Test, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

CONTACT:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/585517/Aytu-BioScience-Confirms-Export-and-Incoming-Delivery-of-COVID-19-IgGIgM-Rapid-Tests

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Aytu BioScience Confirms Export and Incoming Delivery of COVID-19 IgG/IgM Rapid Tests - Yahoo Finance

Aytu BioScience Announces Positive Results from an Independently Conducted Clinical Study of the Company’s Licensed COVID-19 IgG/IgM Point-of-Care…

Independent clinical study demonstrates test accuracy of 98.0% and 94.1% for IgG and IgM, respectively, when using PCR-positive cases as true positives

ENGLEWOOD, CO / ACCESSWIRE / April 16, 2020 / Aytu BioScience, Inc. (AYTU), (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that results from an independent clinical study using the Company's licensed Coronavirus Disease 2019 ("COVID-19") IgG/IgM Rapid Test were published in the journal Infection Ecology & Epidemiology, further validating the accuracy, specificity and performance of the antibody rapid test.

In this recently published clinical study which included 29 COVID-19 positive cases confirmed by PCR and 124 healthy donors, the rapid test showed an overall specificity of 100% and 99.2% for IgM and IgG, respectively. The authors note, "The high negative predictive value indicates that the rapid test will be useful for detecting past infections and possible immunity, which may be crucial for restoring social functions after lockdown."

Capillary blood samples or serum from PCR-confirmed COVID-19 patients were analyzed with results from the COVID-19 IgG/IgM Rapid Test. Sixty-nine percent of samples from PCR-confirmed COVID-19 patients tested IgM positive, and 93.1% tested IgG positive. These results are well in line with the previously reported specificity of 91.9% for IgG and IgM. The authors note that variability in samples obtained during COVID-19 disease or convalescence period means that in the PCR-confirmed cases, antibodies may not yet have had time to develop. If this were the case, sensitivities of the test could actually be higher.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented "This independently conducted study, which was peer-reviewed and published earlier this week, demonstrates the clinical performance of this COVID-19 IgG/IgM rapid test and establishes the test's utility in understanding a patient's past exposure to COVID-19 and its potential to assess patient immunity as we move past this pandemic and get our society back to work. We are happy to see a leading clinical institution further establish the clinical utility of this important serological test."

The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has now been validated in multiple independent trials and is CE marked.

https://www.tandfonline.com/doi/full/10.1080/20008686.2020.1754538

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Story continues

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

CONTACT:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/585321/Aytu-BioScience-Announces-Positive-Results-from-an-Independently-Conducted-Clinical-Study-of-the-Companys-Licensed-COVID-19-IgGIgM-Point-of-Care-Rapid-Test

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Aytu BioScience Announces Positive Results from an Independently Conducted Clinical Study of the Company's Licensed COVID-19 IgG/IgM Point-of-Care...

Aytu BioScience Provides Update on its Licensed COVID-19 IgG/IgM Rapid Test Supply and Ongoing U.S. Distribution – Yahoo Finance

Company Places Third Purchase Order for One Million Tests

ENGLEWOOD, CO / ACCESSWIRE / April 15, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs today provided an update on the supply and distribution of the company's licensed COVID-19 IgG/IgM Rapid Test. The company has sold or allocated the initial 100,000 tests to U.S. customers and is awaiting delivery of the next 500,000 tests.

Additionally, the company has increased the size of its third purchase order to one million tests. The company has been informed the order has been accepted by the manufacturer.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "The company has been working on multiple fronts to distribute the initial shipment of COVID-19 IgG/IgM Rapid Tests while coordinating the incoming supply of our next shipment of 500,000 tests. We are pleased that the manufacturer has completed this second order, which is now awaiting customs clearance. Further, we have been informed the manufacturer has accepted another purchase order, which was increased to one million tests. We are proud to be helping the medical community in delivering our initial shipment of tests to those professionals in need. We look forward to having additional supply to further fulfill the significant demand we have for COVID-19 tests. With the 500,000 tests now awaiting clearance, we'll be in a position to fulfill the pending orders very soon."

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the Company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 IgG/IgM Rapid Test, shipping delays and their impact on our ability to introduce the COVID-19 IgG/IgM Rapid Test, our ability to enforce our exclusive rights to distribute the COVID-19 IgG/IgM Rapid Test in the jurisdictions set forth in the distribution agreement, the ability of the COVID-19 IgG/IgM Rapid Test to accurately and reliably test for COVID-19, the manufacture of the COVID-19 IgG/IgM Rapid Test's ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 IgG/IgM Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 IgG/IgM Rapid Test Kit, the ability to obtain a sufficient number of COVID-19 IgG/IgM Rapid Test kits to meet demand if any, the demand or lack thereof for the COVID-19 IgG/IgM Rapid Test Kit, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Story continues

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Aytu BioScience Provides Update on its Licensed COVID-19 IgG/IgM Rapid Test Supply and Ongoing U.S. Distribution - Yahoo Finance

Progressive Report On Male Hypogonadism Market By Growth, Demand & Opportunities & Forecast To 2025 | Astrazeneca Plc., Eli Lilly and Company…

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Progressive Report On Male Hypogonadism Market By Growth, Demand & Opportunities & Forecast To 2025 | Astrazeneca Plc., Eli Lilly and Company...

Male Hypogonadism Market 2020: Insights and Regional Forecast to 2026 TRUX Route Management Systems, Soft-Pak, Cairn Applications, 21st Century…

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Male Hypogonadism Market 2020: Insights and Regional Forecast to 2026 TRUX Route Management Systems, Soft-Pak, Cairn Applications, 21st Century...

Testosterone Cypionate Market Size, Key Trends, Challenges and Standardization, Research, Key Players, Economic Impact and Forecast to 2026|Pfizer,…

Complete study of the global Testosterone Cypionate market is carried out by the analysts in this report, taking into consideration key factors like drivers, challenges, recent trends, opportunities, advancements, and competitive landscape. This report offers a clear understanding of the present as well as future scenario of the global Testosterone Cypionate industry. Research techniques like PESTLE and Porters Five Forces analysis have been deployed by the researchers. They have also provided accurate data on Testosterone Cypionate production, capacity, price, cost, margin, and revenue to help the players gain a clear understanding into the overall existing and future market situation.

Key companies operating in the global Testosterone Cypionate market include _Pfizer, Cipla, Sun Pharmaceutical, Teva, Perrigo, Hikma Pharmaceuticals

Get PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :

https://www.qyresearch.com/index/detail/1542957/global-testosterone-cypionate-market

Segmental Analysis

The report has classified the global Testosterone Cypionate industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Testosterone Cypionate manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Testosterone Cypionate industry.

Global Testosterone Cypionate Market Segment By Type:

, 200 mg/mL, 100 mg/mL

Global Testosterone Cypionate Market Segment By Application:

Primary hypogonadism, Hypogonadotropic hypogonadism, Late-onset hypogonadism Global Testosterone Cypionate

Competitive Landscape

It is important for every market participant to be familiar with the competitive scenario in the global Testosterone Cypionate industry. In order to fulfil the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key companies operating in the global Testosterone Cypionate market include _Pfizer, Cipla, Sun Pharmaceutical, Teva, Perrigo, Hikma Pharmaceuticals

Key questions answered in the report:

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TOC

Table of Contents 1 Testosterone Cypionate Market Overview1.1 Product Overview and Scope of Testosterone Cypionate1.2 Testosterone Cypionate Segment by Type1.2.1 Global Testosterone Cypionate Sales Growth Rate Comparison by Type (2021-2026)1.2.2 200 mg/mL1.2.3 100 mg/mL1.3 Testosterone Cypionate Segment by Application1.3.1 Testosterone Cypionate Sales Comparison by Application: 2020 VS 20261.3.2 Primary hypogonadism1.3.3 Hypogonadotropic hypogonadism1.3.4 Late-onset hypogonadism1.4 Global Testosterone Cypionate Market Size Estimates and Forecasts1.4.1 Global Testosterone Cypionate Revenue 2015-20261.4.2 Global Testosterone Cypionate Sales 2015-20261.4.3 Testosterone Cypionate Market Size by Region: 2020 Versus 2026 2 Global Testosterone Cypionate Market Competition by Manufacturers2.1 Global Testosterone Cypionate Sales Market Share by Manufacturers (2015-2020)2.2 Global Testosterone Cypionate Revenue Share by Manufacturers (2015-2020)2.3 Global Testosterone Cypionate Average Price by Manufacturers (2015-2020)2.4 Manufacturers Testosterone Cypionate Manufacturing Sites, Area Served, Product Type2.5 Testosterone Cypionate Market Competitive Situation and Trends2.5.1 Testosterone Cypionate Market Concentration Rate2.5.2 Global Top 5 and Top 10 Players Market Share by Revenue2.5.3 Market Share by Company Type (Tier 1, Tier 2 and Tier 3)2.6 Manufacturers Mergers & Acquisitions, Expansion Plans2.7 Primary Interviews with Key Testosterone Cypionate Players (Opinion Leaders) 3 Testosterone Cypionate Retrospective Market Scenario by Region3.1 Global Testosterone Cypionate Retrospective Market Scenario in Sales by Region: 2015-20203.2 Global Testosterone Cypionate Retrospective Market Scenario in Revenue by Region: 2015-20203.3 North America Testosterone Cypionate Market Facts & Figures by Country3.3.1 North America Testosterone Cypionate Sales by Country3.3.2 North America Testosterone Cypionate Sales by Country3.3.3 U.S.3.3.4 Canada3.4 Europe Testosterone Cypionate Market Facts & Figures by Country3.4.1 Europe Testosterone Cypionate Sales by Country3.4.2 Europe Testosterone Cypionate Sales by Country3.4.3 Germany3.4.4 France3.4.5 U.K.3.4.6 Italy3.4.7 Russia3.5 Asia Pacific Testosterone Cypionate Market Facts & Figures by Region3.5.1 Asia Pacific Testosterone Cypionate Sales by Region3.5.2 Asia Pacific Testosterone Cypionate Sales by Region3.5.3 China3.5.4 Japan3.5.5 South Korea3.5.6 India3.5.7 Australia3.5.8 Taiwan3.5.9 Indonesia3.5.10 Thailand3.5.11 Malaysia3.5.12 Philippines3.5.13 Vietnam3.6 Latin America Testosterone Cypionate Market Facts & Figures by Country3.6.1 Latin America Testosterone Cypionate Sales by Country3.6.2 Latin America Testosterone Cypionate Sales by Country3.6.3 Mexico3.6.3 Brazil3.6.3 Argentina3.7 Middle East and Africa Testosterone Cypionate Market Facts & Figures by Country3.7.1 Middle East and Africa Testosterone Cypionate Sales by Country3.7.2 Middle East and Africa Testosterone Cypionate Sales by Country3.7.3 Turkey3.7.4 Saudi Arabia3.7.5 U.A.E 4 Global Testosterone Cypionate Historic Market Analysis by Type4.1 Global Testosterone Cypionate Sales Market Share by Type (2015-2020)4.2 Global Testosterone Cypionate Revenue Market Share by Type (2015-2020)4.3 Global Testosterone Cypionate Price Market Share by Type (2015-2020)4.4 Global Testosterone Cypionate Market Share by Price Tier (2015-2020): Low-End, Mid-Range and High-End 5 Global Testosterone Cypionate Historic Market Analysis by Application5.1 Global Testosterone Cypionate Sales Market Share by Application (2015-2020)5.2 Global Testosterone Cypionate Revenue Market Share by Application (2015-2020)5.3 Global Testosterone Cypionate Price by Application (2015-2020) 6 Company Profiles and Key Figures in Testosterone Cypionate Business6.1 Pfizer6.1.1 Corporation Information6.1.2 Pfizer Description, Business Overview and Total Revenue6.1.3 Pfizer Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.1.4 Pfizer Products Offered6.1.5 Pfizer Recent Development6.2 Cipla6.2.1 Cipla Testosterone Cypionate Production Sites and Area Served6.2.2 Cipla Description, Business Overview and Total Revenue6.2.3 Cipla Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.2.4 Cipla Products Offered6.2.5 Cipla Recent Development6.3 Sun Pharmaceutical6.3.1 Sun Pharmaceutical Testosterone Cypionate Production Sites and Area Served6.3.2 Sun Pharmaceutical Description, Business Overview and Total Revenue6.3.3 Sun Pharmaceutical Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.3.4 Sun Pharmaceutical Products Offered6.3.5 Sun Pharmaceutical Recent Development6.4 Teva6.4.1 Teva Testosterone Cypionate Production Sites and Area Served6.4.2 Teva Description, Business Overview and Total Revenue6.4.3 Teva Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.4.4 Teva Products Offered6.4.5 Teva Recent Development6.5 Perrigo6.5.1 Perrigo Testosterone Cypionate Production Sites and Area Served6.5.2 Perrigo Description, Business Overview and Total Revenue6.5.3 Perrigo Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.5.4 Perrigo Products Offered6.5.5 Perrigo Recent Development6.6 Hikma Pharmaceuticals6.6.1 Hikma Pharmaceuticals Testosterone Cypionate Production Sites and Area Served6.6.2 Hikma Pharmaceuticals Description, Business Overview and Total Revenue6.6.3 Hikma Pharmaceuticals Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.6.4 Hikma Pharmaceuticals Products Offered6.6.5 Hikma Pharmaceuticals Recent Development 7 Testosterone Cypionate Manufacturing Cost Analysis7.1 Testosterone Cypionate Key Raw Materials Analysis7.1.1 Key Raw Materials7.1.2 Key Raw Materials Price Trend7.1.3 Key Suppliers of Raw Materials7.2 Proportion of Manufacturing Cost Structure7.3 Manufacturing Process Analysis of Testosterone Cypionate7.4 Testosterone Cypionate Industrial Chain Analysis 8 Marketing Channel, Distributors and Customers8.1 Marketing Channel8.2 Testosterone Cypionate Distributors List8.3 Testosterone Cypionate Customers 9 Market Dynamics9.1 Market Trends9.2 Opportunities and Drivers9.3 Challenges9.4 Porters Five Forces Analysis 10 Global Market Forecast10.1 Global Testosterone Cypionate Market Estimates and Projections by Type10.1.1 Global Forecasted Sales of Testosterone Cypionate by Type (2021-2026)10.1.2 Global Forecasted Revenue of Testosterone Cypionate by Type (2021-2026)10.2 Testosterone Cypionate Market Estimates and Projections by Application10.2.1 Global Forecasted Sales of Testosterone Cypionate by Application (2021-2026)10.2.2 Global Forecasted Revenue of Testosterone Cypionate by Application (2021-2026)10.3 Testosterone Cypionate Market Estimates and Projections by Region10.3.1 Global Forecasted Sales of Testosterone Cypionate by Region (2021-2026)10.3.2 Global Forecasted Revenue of Testosterone Cypionate by Region (2021-2026)10.4 North America Testosterone Cypionate Estimates and Projections (2021-2026)10.5 Europe Testosterone Cypionate Estimates and Projections (2021-2026)10.6 Asia Pacific Testosterone Cypionate Estimates and Projections (2021-2026)10.7 Latin America Testosterone Cypionate Estimates and Projections (2021-2026)10.8 Middle East and Africa Testosterone Cypionate Estimates and Projections (2021-2026) 11 Research Finding and Conclusion 12 Methodology and Data Source12.1 Methodology/Research Approach12.1.1 Research Programs/Design12.1.2 Market Size Estimation12.1.3 Market Breakdown and Data Triangulation12.2 Data Source12.2.1 Secondary Sources12.2.2 Primary Sources12.3 Author List12.4 Disclaimer*

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Aytu BioScience Consumer Health Subsidiary Launches Regoxidine(R), an FDA Approved Hair Regrowth Treatment Foam that Contains 5% Minoxidil and Targets…

ENGLEWOOD, CO / ACCESSWIRE / April 13, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today the launch of Regoxidine, an over-the-counter foam formulation of minoxidil available for use by both men and women. Regoxidine is indicated for hair treatment and regrowth and is available through the company's recently acquired, wholly-owned subsidiary Innovus Pharmaceuticals. Regoxidine is a branded alternative to hair regrowth treatment Rogaine.

Regoxidine is available for purchase through the product's website regoxidine.com. The product is also available through its Beyond Human marketing and sales platform and through Amazon. Over 11 million Americans purchased and used hair regrowth products in 2019.

Regoxidine for Men and Regoxidine for Women are the second and third FDA-approved, over-the-counter drugs Innovus Pharmaceuticals has launched to date following the launch of FlutiCare (fluticasone propionate 50 mcg nasal spray) in 2017. FlutiCare is indicated to treat nasal and allergy-related symptoms.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We are excited about the launch of Regoxidine OTC and the expansion of our consumer health product portfolio. Regoxidine represents the first consumer product launch since completing the merger between Aytu and Innovus, and the consumer health team will continue its focus on developing and launching new products that address large segments of consumers. Through the expansion of the over-the-counter product portfolio, and the growth of our existing prescription and consumer healthcare products, we anticipate continued revenue growth with strong contribution from both of Aytu's business segments, expected to accelerate our path to profitability."

About Regoxidine 5% Minoxidil Foam for Men and Women

Regoxidine is a topical foam containing 5% minoxidil that is approved by the FDA as a hair regrowth treatment and is used to grow hair on the top of the scalp. The active ingredient is 5% minoxidil and is comparable to the Rogaine* line of similar products from Johnson & Johnson. The product comes in a 60g canister and will be sold as a 90-day supply for men and as a 120-day supply for women. Regoxidine is available as a foam for men and women.

The American Hair Loss Association (AHLA) reported that more than 95% of hair loss is caused by androgenetic alopecia. Also, approximately 35 million men and 21 million women 35 years of age and older experience hair loss. The 5% minoxidil market segment of the hair regrowth treatment market is projected to grow more than 4.5% annually through 2024. According to Global Market Insights the US market is valued at $0.5 billion with approximately 50 million retail units sold. The 5% foam products are the newest means of minoxidil delivery and are proven to be more effective against androgenic alopecia among men than other minoxidil formulations.

For more information visit http://www.regoxidine.com

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Story continues

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the Company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 IgG/IgM Rapid Test, shipping delays and their impact on our ability to introduce the COVID-19 IgG/IgM Rapid Test, our ability to enforce our exclusive rights to distribute the COVID-19 IgG/IgM Rapid Test in the jurisdictions set forth in the distribution agreement, the ability of the COVID-19 IgG/IgM Rapid Test to accurately and reliably test for COVID-19, the manufacture of the COVID-19 IgG/IgM Rapid Test's ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 IgG/IgM Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 IgG/IgM Rapid Test Kit, the ability to obtain a sufficient number of COVID-19 IgG/IgM Rapid Test kits to meet demand if any, the demand or lack thereof for the COVID-19 IgG/IgM Rapid Test Kit, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

*Rogaine is a trademark of Johnson & Johnson.

CONTACT:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

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Aytu BioScience Consumer Health Subsidiary Launches Regoxidine(R), an FDA Approved Hair Regrowth Treatment Foam that Contains 5% Minoxidil and Targets...

Hypergonadism: Symptoms, Causes, Treatment, and More

Hypergonadism is a condition in which your gonads overproduce hormones. Gonads are your reproductive glands. In men, gonads are the testes. In women, theyre the ovaries. As a result of hypergonadism, you can end up with higher-than-normal levels of testosterone and estrogen.

Hypergonadism is less common than hypogonadism. Hypogonadism is another term for abnormally low hormone production in the gonads.

Hypergonadism and hypogonadism are both treatable. However, depending on when they appear, they can affect puberty, fertility, and other issues related to development and reproductive health.

Hypergonadism that develops prior to puberty can lead to precocious puberty. Precocious puberty is the early and rapid onset of changes related to sexual maturity. Hypergonadism is one of several possible causes of precocious puberty.

In boys and girls, hypergonadism can bring on:

Some symptoms of hypergonadism and precocious puberty are unique to each sex.

In girls, hypergonadism can cause:

In boys, hypergonadism can cause:

Hormonal treatments aimed at slowing the onset of puberty can be effective, and may help to make for a more normal adolescence.

Doctors cant always diagnose the cause of precocious puberty. Some conditions that are associated with it include:

In mild cases of hypergonadism prior to puberty, the onset of physical and mood changes may not be abnormally early or significant enough to cause any psychological or long-term physical complications.

If hypergonadism develops after puberty, men may face early hair loss and women may have some facial hair growth.

The underlying cause of hypergonadism is often never identified. When the cause of is unknown, its known as idiopathic hypergonadism.

There are several health conditions that are known to cause hypergonadism. Some of them include:

Youre at a higher risk of hypergonadism if you use anabolic steroids. Thats because those supplements can lead to abnormally high levels of testosterone and other androgens (male sex hormones) as well as estrogen, a female sex hormone.

Aside from acne and other physical changes, such as facial hair on women and more breast tissue in men, hypergonadism can cause some more serious complications.

Hypergonadism can interfere with regular menstrual cycles. That can make it difficult for women to become pregnant.

Men may also have fertility challenges, especially if their hypogonadism was caused by anabolic steroid use. Anabolic steroids can affect testicular health, including reducing the production of sperm.

Generally, the complications associated with hypergonadism are related to the underlying cause. Treating the cause may help reduce symptoms and complications brought on by hypergonadism.

If you notice precocious puberty in your child or physical changes in yourself that may be related to hormonal abnormalities, discuss your concerns with a doctor.

If hypergonadism is suspected, your doctor may order a blood test to see if hormone levels are unusually elevated. Additional tests might include a pelvic ultrasound to get a more detailed view of the adrenal glands and other parts, such as the ovaries (for women). Brain imaging may be done to look for tumors of the pituitary gland.

Treating hypergonadism is difficult. The goal is to reduce hormone levels, which is more difficult than trying to increase hormone levels.

The hormonal treatments that are administered for hypergonadism include a combination of hormones tailored to your particular levels. This can be a slow process. It may take some time to find the right mix of hormones at the right dosages.

If a specific cause can be diagnosed, then treatment will also focus on caring for that condition. If a gland has a tumor, for instance, it may be necessary to surgically remove the tumor. If the cause is severe underactive thyroid, you may be prescribed strong doses of thyroid medication to help restore healthier body chemistry.

Hypergonadism, unlike hypogonadism, is a rare condition, often triggered by a more serious health problem. Treating that underlying cause and working with your doctor to help balance out your hormone levels may help you avoid or at least reduce hypergonadism complications.

One important key is to see a doctor as soon as you suspect that there may be hormone-related problems. An earlier start to hormone treatment may mean a faster resolution.

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Hypergonadism: Symptoms, Causes, Treatment, and More

What is testosterone replacement therapy, and do you need it – KTAR.com

Talk to anyone whose been around for a few decades, and youll usually hear that life gets sweeter with age. Even with the inevitable slowdown that starts in your 30s, your best years can still be ahead.

Perhaps youve noticed that slowdown: If you become fatigued more easily than you used to, your mind isnt as sharp, or your libido is on the decline, it could be because of low testosterone.

As you grow, your brain periodically produces signal hormones responsible for stimulating testosterone production, according to Vital4Men. Testosterone is the main hormone responsible for the growth and development of male sex organs, muscle mass, and bone density. It also gives you energy and affects your mood.

When testosterone reaches an acceptable range, brain signals slow down, which allows your testosterone to lower. However, that decrease could lead to testicular problems at this stage. This low level of testosterone production is called hypogonadism.

Signs you may have low testosterone

The symptoms of low testosterone or hypogonadism include the following:

You may not think that you have low testosterone if you ignore symptoms or simply attribute them to aging. Unfortunately, hoping these issues will go away on their own wont work and, in fact, you may notice they just get worse.

Your testosterone levels will likely continue to decline over time and the severity of your symptoms will most likely continue to increase, Vital4Men says.

However, if you pay attention, the good news is that low testosterone is treatable, so you can feel like yourself again and look forward to the years ahead.

One of the best treatments is testosterone replacement therapy.

What is testosterone replacement therapy?

Testosterone replacement therapy can improve the symptoms of low testosterone. Doctors may prescribe testosterone through injections, gels, patches, surgically implanted pellets, or oral options to improve hormone levels.

The treatment process is simple. For example, when you visit Vital4men, the medical professionals will perform a blood test to determine if you are an eligible candidate for testosterone replacement therapy, and youll receive your results within a few days.

If your testosterone levels fall outside the normal range, you may be a candidate for treatment. Your doctor will go over potential side effects to determine if testosterone replacement therapy is the right option.

At the viTal4men clinic, we treat low testosterone levels with testosterone replacement therapy to get you back to your optimum level, the company says. We are a complete mens wellness center.

The clinic will support you through the entire process. The best part, though, is the results. While your outcome will be individual, there are many potential benefits to testosterone replacement therapy:

If youre experiencing any of the symptoms of low testosterone, dont give up hope. Visit Vital4Men for more information and to schedule a free testosterone level test.

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Alcohol Consumption Linked to Lower Bone Formation Markers in Patients With HIV – Infectious Disease Advisor

Greater alcohol consumption is associated with lower serum bone formation markers in patients living with HIV (PLWHIV) with substance use disorder, according to study results published in Alcoholism: Clinical and Experimental Research.

Previous studies have established that low bone mass is common and fracture risk is increased for PLWHIV. Several factors may contribute to the low bone density, including the effect of HIV itself, low body mass index, hypogonadism, liver disease, and smoking and alcohol consumption.

As limited data are available on alcohol consumption and bone turnover markers, the goal of the current study was to investigate the association between alcohol consumption and bone turnover markers, specifically serum C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1 N-terminal propeptide (P1NP), in PLWHIV with substance use disorder.

The study cohort included 233 patients, and after exclusion of 35 due to fracture in the preceding year or missing data, the final sample was 198 individuals (median age, 50 years; 38% women). Almost all patients (93%) were prescribed antiretroviral medication, and most (72%) had HIV viral load suppression.

Approximately half (48%) of the study cohort met criteria for both current alcohol and drug dependence. At baseline and 12-month follow-up, the mean daily number of drinks was 1.93 and 1.51, respectively; mean number of heavy drinking days was 4.65 and 3.25, respectively.

Higher average number of drinks/day was significantly associated with lower P1NP (=-1.09; 95% CI, -1.94 to -0.23 per each additional drink). Bone formation was lower in patients who drank on 20 days in the past month (P1NP, -15.45 ng/mL; 95% CI, -26.23 to -4.67) compared with those who did not. Furthermore, a higher number of heavy drinking days was associated with lower bone formation (=-0.58, 95% CI, -1.05 to -0.12 per additional heavy drinking day).

There was a significant association between a phosphatidylethanol level 8 ng/mL and lower P1NP. In addition, an increase in mean drinks per day over 12 months was associated with a nonsignificant decrease in bone formation (=-1.14; 95% CI, -2.40 to 0.12; P =.08 per each additional drink).

As for the effect of change in alcohol consumption over time, the researchers reported that neither change in the number of heavy drinking days nor change in whether a participant had alcohol use on 20 days in a month was significantly associated with bone formation.

There were no significant associations between alcohol consumption and bone resorption.

The researchers acknowledged several study limitations, including that alcohol use was measured only during the 30 days before each study interview and not throughout the follow-up. Data were also missing on nadir CD4 levels and other markers to assess bone formation, and there was no HIV-uninfected comparator group.

Information about low [bone turnover markers] may provide motivation for [PLWHIV] to reduce alcohol use and mitigate risks related to abnormal bone metabolism, concluded the researchers.

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Reference

Kim TW, Ventura AS, Winter MR, et al. Alcohol and bone turnover markers among people living with HIV and substance use disorder [published online March 2, 2020]. Alcohol Clin Exp Res. doi:10.1111/acer.14303

This article originally appeared on Endocrinology Advisor

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Alcohol Consumption Linked to Lower Bone Formation Markers in Patients With HIV - Infectious Disease Advisor

Aytu BioScience Submits Notice of Commercialization to the FDA, Allowing for Company’s Distribution of its 2-10 Minute COVID-19 IgG/IgM Point-of-Care…

Commercial Distribution of First 100,000 Tests to Commence Upon Receipt of Inbound Product Shipment

ENGLEWOOD, CO / ACCESSWIRE / March 23, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it has received confirmation from the U.S. Food and Drug Administration (FDA) that the company may begin distribution of its Coronavirus Disease 2019 ("COVID-2019") IgG/IgM Rapid Test throughout the United States. The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers results between 2 and 10 minutes at the point-of-care.

Aytu expects delivery of its first shipment of 100,000 tests this week. The Company has been in discussions with healthcare distributors, healthcare institutions, medical practices, and government agencies and is working quickly to begin distribution into the U.S. healthcare supply chain.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We are moving as quickly as we can to bring the COVID-19 IgG/IgM Rapid Test to the U.S. professional medical community. With product now in transit to our warehouse in Colorado we're optimistic that we can have test kits ready for sale in the very near term. In the two short weeks since signing our distribution agreement, we have ordered our first 100,000 tests and have received confirmation from FDA that we may begin distribution. We are optimistic that we're now just days away from placing these COVID-19 test kits into the hands of healthcare professionals."

The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 126 patient clinical trial and is CE marked.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 113 patient clinical trial and has received CE marking.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

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Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

Contact for COVID-19 IgG/IgM Rapid Test-Related Inquiries:COVID-19@aytubio.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/582030/Aytu-BioScience-Submits-Notice-of-Commercialization-to-the-FDA-Allowing-for-Companys-Distribution-of-its-2-10-Minute-COVID-19-IgGIgM-Point-of-Care-Rapid-Test

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Aytu BioScience Submits Notice of Commercialization to the FDA, Allowing for Company's Distribution of its 2-10 Minute COVID-19 IgG/IgM Point-of-Care...

Aytu BioScience Expands Its Distribution Rights for Coronavirus 2019 (COVID-19) Point-of-Care Rapid Test to Canada and Mexico – Yahoo Finance

Company Expects to Seek Regulatory Clearance Under Health Canada and COFEPRIS Expedited Clearance Procedures

ENGLEWOOD, CO / ACCESSWIRE / March 19, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it extended its distribution right to commercialize the clinically validated and commercially used coronavirus 2019 (COVID-19) IgG/IgM Rapid Test. The test has been licensed from L.B. Resources, Limited (a Hong Kong Corporation). The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers clinical results between 2 and 10 minutes at the point-of-care. This amendment expands Aytu's commercial rights and grants Aytu the right to distribute and commercialize the COVID-19 test in North America, specifically including the United States, Canada and Mexico.

The Company expects to pursue expedited regulatory clearance of the product with Health Canada and COFEPRIS (Comisin Federal para la Proteccin contra Riesgos Sanitarios), the regulatory agencies in Canada and Mexico, respectively.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We have to be progressive in doing our part in combatting the spread of the COVID-19 virus. We need to ensure that screening is available across North America and providing broad access to screening tests has to be among our highest priorities as we collectively fight the coronavirus outbreak. With COVID-19 now designated as a global pandemic, we believe we should expand our efforts to assist healthcare providers with faster point-of-care detection."

The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 113 patient clinical trial and is CE marked.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 113 patient clinical trial and has received CE marking.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Story continues

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/581543/Aytu-BioScience-Expands-Its-Distribution-Rights-for-Coronavirus-2019-COVID-19-Point-of-Care-Rapid-Test-to-Canada-and-Mexico

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Aytu BioScience Expands Its Distribution Rights for Coronavirus 2019 (COVID-19) Point-of-Care Rapid Test to Canada and Mexico - Yahoo Finance

CLARUS THERAPEUTICS ANNOUNCES FINANCING TO SUPPORT THE COMMERCIAL LAUNCH AND AVAILABILITY OF JATENZO (TESTOSTERONE UNDECANOATE) CAPSULES, CIII FOR THE…

Financing to speed commercialization of the only FDA-approved oral treatment of its kind for testosterone deficiency1,2

NORTHBROOK, Ill., March 16, 2020 (GLOBE NEWSWIRE) -- Clarus Therapeutics, Inc., a commercial mens health specialty pharmaceutical company, announced today that it has completed a senior debt financing of up to $75M. Morgan Stanley & Co. LLC acted as sole placement agent for the transaction.

Clarus will use the proceeds from this financing to accelerate the commercialization strategy and launch for JATENZO (testosterone undecanoate) capsules, CIII, the first and only FDA-approved oral softgel testosterone replacement therapy for the treatment of men with hypogonadism due to certain medical conditions. This additional investment builds on an exceptional year for the company, which includes hiring multiple key executives and making JATENZO available for patients.

We are thrilled to have this investment as we bring JATENZO to market, said Dr. Robert Dudley, Chief Executive Officer of Clarus Therapeutics, Inc. We can now fully implement JATENZOs commercialization strategy and move Clarus closer to profitability.

About HypogonadismHypogonadism, also known as testosterone deficiency, is a condition in men in which the body does not produce enough testosterone.3 Only those men who are symptomatic and have consistently low results on a reliable testosterone assay should be offered testosterone replacement therapy, according to current treatment guidelines from both the Endocrine Society and the American Urological Association.3,4 Treatment is meant to induce and maintain secondary sex characteristics and improve clinical symptoms associated with testosterone deficiency.4About Clarus Therapeutics, Inc.Clarus is a men's specialty pharmaceutical company developing and commercializing JATENZO, a product protected by patents issued in the United States and in other major pharmaceutical markets around the world. Clarus owns the worldwide, royalty-free commercialization rights for JATENZO.For more information, please visit:www.clarustherapeutics.com.

About JATENZO JATENZO is the first and only FDA-approved oral testosterone undecanoate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).1,2

JATENZOs proprietary formulation is built around testosterone undecanoatea testosterone prodrug that the body converts to testosterone. In the JATENZO pivotal inTUne (investigational testosterone undecanoate) clinical trial, 87 percent of hypogonadal men treated with JATENZO achieved a mean total testosterone concentration in the eugonadal range at the end of treatment.1 The efficacy and safety of JATENZO was evaluated in 166 adult, hypogonadal males in a 4-month, open-label study. The primary endpoint was the percentage of patients with mean plasma total testosterone concentration (Cavg) over 24 hours within the normal eugonadal range on the final pharmacokinetic visit of the study.

INDICATIONJATENZO (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Limitation of use

Safety and efficacy of JATENZO in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASES IN BLOOD PRESSURE

CONTRAINDICATIONS

JATENZO is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate, in women who are pregnant, in men with a known hypersensitivity to JATENZO or its ingredients, or in men with hypogonadal conditions that are not associated with structural or genetic etiologies as JATENZO has not been established for these conditions and there is a risk of increased blood pressure with JATENZO that can increase the risk of MACE.

WARNINGS AND PRECAUTIONS

ADVERSE EVENTS

The most common adverse events of JATENZO (incidence 2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

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The safety and efficacy of JATENZO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.

There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing JATENZO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. There is insufficient long-term safety data in geriatric patients utilizing JATENZO to assess the potentially increased risk of cardiovascular disease and prostate cancer.

Please click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure.

Media ContactAmir KhanPhone: (212) 462-8767Email: Amir.Khan@Syneoshealth.com

1JATENZO (testosterone undecanoate) [prescribing information]. Clarus Therapeutics, Inc.

2US Food & Drug Administration. FDA Approved Drug Products. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206089. Accessed October 1, 2019.

3Bhasin S, et al. J Clin Endocrinol Metab. 2018;103(5):1715-1744.

4Mulhall JP, et al. J Urol. 2018;200(2):423-432.

2020 Clarus Therapeutics, Inc. All rights reserved.

JATENZO is a registered trademark of Clarus Therapeutics, Inc.

COR-US-0038 03/2020

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CLARUS THERAPEUTICS ANNOUNCES FINANCING TO SUPPORT THE COMMERCIAL LAUNCH AND AVAILABILITY OF JATENZO (TESTOSTERONE UNDECANOATE) CAPSULES, CIII FOR THE...

Alcohol Consumption Linked to Lower Bone Formation Markers in Patients With HIV – Endocrinology Advisor

Greater alcohol consumption is associated with lower serum bone formation markers in patients living with HIV (PLWHIV) with substance use disorder, according to study results published in Alcoholism: Clinical and Experimental Research.

Previous studies have established that low bone mass is common and fracture risk is increased for PLWHIV. Several factors may contribute to the low bone density, including the effect of HIV itself, low body mass index, hypogonadism, liver disease, and smoking and alcohol consumption.

As limited data are available on alcohol consumption and bone turnover markers, the goal of the current study was to investigate the association between alcohol consumption and bone turnover markers, specifically serum C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1 N-terminal propeptide (P1NP), in PLWHIV with substance use disorder.

The study cohort included 233 patients, and after exclusion of 35 due to fracture in the preceding year or missing data, the final sample was 198 individuals (median age, 50 years; 38% women). Almost all patients (93%) were prescribed antiretroviral medication, and most (72%) had HIV viral load suppression.

Approximately half (48%) of the study cohort met criteria for both current alcohol and drug dependence. At baseline and 12-month follow-up, the mean daily number of drinks was 1.93 and 1.51, respectively; mean number of heavy drinking days was 4.65 and 3.25, respectively.

Higher average number of drinks/day was significantly associated with lower P1NP (=-1.09; 95% CI, -1.94 to -0.23 per each additional drink). Bone formation was lower in patients who drank on 20 days in the past month (P1NP, -15.45 ng/mL; 95% CI, -26.23 to -4.67) compared with those who did not. Furthermore, a higher number of heavy drinking days was associated with lower bone formation (=-0.58, 95% CI, -1.05 to -0.12 per additional heavy drinking day).

There was a significant association between a phosphatidylethanol level 8 ng/mL and lower P1NP. In addition, an increase in mean drinks per day over 12 months was associated with a nonsignificant decrease in bone formation (=-1.14; 95% CI, -2.40 to 0.12; P =.08 per each additional drink).

As for the effect of change in alcohol consumption over time, the researchers reported that neither change in the number of heavy drinking days nor change in whether a participant had alcohol use on 20 days in a month was significantly associated with bone formation.

There were no significant associations between alcohol consumption and bone resorption.

The researchers acknowledged several study limitations, including that alcohol use was measured only during the 30 days before each study interview and not throughout the follow-up. Data were also missing on nadir CD4 levels and other markers to assess bone formation, and there was no HIV-uninfected comparator group.

Information about low [bone turnover markers] may provide motivation for [PLWHIV] to reduce alcohol use and mitigate risks related to abnormal bone metabolism, concluded the researchers.

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Reference

Kim TW, Ventura AS, Winter MR, et al. Alcohol and bone turnover markers among people living with HIV and substance use disorder [published online March 2, 2020]. Alcohol Clin Exp Res. doi:10.1111/acer.14303

Originally posted here:
Alcohol Consumption Linked to Lower Bone Formation Markers in Patients With HIV - Endocrinology Advisor

Aytu BioScience Announces Acceleration of U.S. Availability of COVID-19 IgG/IgM Rapid Test Based on Updated FDA Policy – Yahoo Finance

Updated FDA Policy Likely Enables Near-Term Availability of COVID-19 Test in the U.S.

ENGLEWOOD, CO / ACCESSWIRE / March 17, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that the company intends to expedite the U.S. launch of its recently licensed COVID-19 IgG/IgM Point-of-Care Rapid Test in light of yesterday's updated FDA policy on coronavirus diagnostic testing.

On March 16, 2020 the FDA announced, "as part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S. We believe the unprecedented policy set forth in today's updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests..." Further, the agency made recommendations specifically for test developers stating that "the FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated" and other labeling conditions are satisfied.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "While we are still working with FDA on making the COVID-19 Rapid Test available, we believe that this updated policy may enable near-term availability of our recently-licensed point-of-care test. During this public health emergency, we are working tirelessly to satisfy all requirements in order to make the test available to the professional medical community as soon as possible." Disbrow also commented that, "We have already gotten confirmation from the manufacturer that our initial supply is being shipped and is expected to arrive in the U.S. very soon."

The company will continue to provide updates about the near-term availability of the COVID-19 test.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the previously announced, but not yet consummated, merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, the failure to obtain the required votes of Innovus' shareholders or Aytu's shareholders to approve the Merger and related matters, the risk that a condition to closing of the Merger may not be satisfied, that either party may terminate the merger agreement or that the closing of the Merger might be delayed or not occur at all, the price per share utilized in the formula for the initial $8 million merger consideration in the Merger may not be reflective of the current market price of Aytu's common stock on the closing date, potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the Merger, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

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Aytu BioScience Announces Acceleration of U.S. Availability of COVID-19 IgG/IgM Rapid Test Based on Updated FDA Policy - Yahoo Finance

Long-term Opioid Use in Men Linked to Hypogonadism – Medscape

NATIONAL HARBOR, Maryland Long-term opioid use in men is linked to a significantly increased risk for hypogonadism, new research suggests.

Findings from a retrospective case-control study show that men who used long-acting opioids on a long-term basis had close to a 1.5-fold increased risk of developing the condition. Moreover, for every increase in 100 maximum morphine equivalent daily dose (MEDD), there was a 44% increase in risk.

Dr Natalie Hanks

Hypogonadism, a condition in which little or no testosterone is produced by the testes, puts men at risk for infertility and osteoporosis, but such adverse endocrine effects of long-term opioid use are frequently unrecognized, study investigator Natalie Hanks, MD, Ochsner Clinical School, University of Queensland University Medical Center, New Orleans, Louisiana, told Medscape Medical News.

The findings were presented here at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.

The investigators note that opioid-induced androgen deficiency (OPIAD) can be detrimental to patients' quality of life as well as to the healthcare system.

The investigators examined the dose-response relationship between opioids and hypogonadism to shed more light on future diagnosis and management of OPIAD.

The researchers analyzed data from 357 men aged 1880 years with long-term opioid use, defined as using opioids continuously for longer than 3 months.

Exclusion criteria included the following: a diagnosis of hypogonadism prior to initiation of long-term opioid use; a history of Klinefelter syndrome, a rare genetic condition in which a male is born with an extra copy of the X chromosome; other chromosomal abnormalities; cryptorchidism; varicocele; myotonic dystrophy; mumps; radiotherapy to the testes; testicular torsion; long-term corticosteroid use; prostate cancer; or an endocrine disorder.

In total, 95 long-term opioid users had hypogonadism and served as case patients; 263 long-term opioid users did not have hypogonadism and served as control patients.

Case patients were matched to control patients by age, race, and body mass index in a 1:4 ratio. MEDD data were collected from electronic health records.

The prevalence of hypogonadism varied with MEDD dose. It was 15.6% for MEDD <100; 27.1% for MEDD 100199; 41.5% for MEDD 200299, 35.7% for MEDD 300499; and 50% for MEDD 500800.

Interestingly, for 14 patients, the estimated probability of hypogonadism plateaued in the MEDD 500800 range.

The results also showed a significant linear association between maximum MEDD and the odds of developing hypogonadism with long-term use of long-acting opioids (odds ratio, 1.44; 95% confidence interval, 1.16 1.78) by 100 units' difference in maximum MEDD.

"I feel as if hypogonadism is often overlooked or forgotten among all of the other side effects that go along with opioid use," Hanks said. "Our findings require replication in other clinical settings, but our results do suggest that we should start to look for signs of hypogonadism and opioid-induced androgen deficiency in this population and try to diagnose and treat it promptly."

Commenting on the findings for Medscape Medical News, Robert Bolash, MD, Cleveland Clinic, in Ohio, said the study provides important information about an often ignored side effect of long-term opioid use.

Dr Robert Bolash

This "well-matched control trial was conducted in a sizeable cohort and shows a thought-provoking dose-response curve," said Bolash.

"The relationship appears to be nonlinear, with particular hazard at low and moderate doses, then a plateau at high-dose therapy ranges. It would be interesting to see if duration of therapy was similarly hazardous or if dose was the primary driver of this endocrine dysfunction," he added.

Bolash also said the study is an important reminder about this important side effect of long-term opioid used.

"Contemporary pain physicians often consider the respiratory depressant and gastrointestinal side effects of this class of therapy, and may need to revisit the notable challenges that opioids can impart on the endocrine side effects as well," he noted.

Hanks and Bolash report no relevant financial relationships.

American Academy of Pain Medicine (AAPM) 2020 Annual Meeting: Abstract LB015. Presented February 27, 2020.

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Long-term Opioid Use in Men Linked to Hypogonadism - Medscape

Hormone Replacement Therapeutics Market Share, By Product Analysis, Application, End-Use, Regional Outlook, Competitive Strategies & Forecast up…

Latest Report on Hormone Replacement Therapeutics Market size | Segment by Applications (Menopause, Hypothyroidism, Growth Hormone Deficiency, Male Hypogonadism and Other Diseases), by Type (Estrogen Hormone, Growth Hormone, Thyroid Hormone and Testosterone Hormone), Regional Outlook Opportunity, Market Demand, New Latest Trends, Hormone Replacement Therapeutics Market Share & Revenue by Manufacturers, Leading Companies Profiles, 2026. Analyzes current market size and upcoming Few years growth of this industry.

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Hormone Replacement Therapeutics Market Share, By Product Analysis, Application, End-Use, Regional Outlook, Competitive Strategies & Forecast up...

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