Archive for the ‘Hypogonadism’ Category

TORONTO Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF) today announced that the revised commercial partnership agreement with Aytu Bioscience (Aytu) to accelerate the growth of NATESTO in the United States is now closed and fully effective as of December 1, 2019. Both parties have mutually waived the closing conditions of the revised partnership agreement, including the requirement that Acerus complete a raise of a minimum of USD 10 million on or before the end of January 2020, enabling Acerus to launch a U.S.-based specialty sales force, which will promote NATESTO to urologists and endocrinologists. Aytu will continue to book all NATESTO revenue in the United States and they will promote NATESTO to all other specialties including internal medicine and family practice.

To accelerate the launch of Acerus U.S. commercial team, Aytu has agreed to transfer 5 current sales personnel to Acerus as of December 2, 2019. These staff will operate as Acerus employees but they will remain on Aytus payroll until the earlier of the date on which Acerus is ready to fully assume the personnel or June 30, 2020. Aytu will deduct the costs of these sales personnel from quarterly payments otherwise owed to Acerus under the revised agreement, with a final accounting to be done once per year. Throughout 2020, Acerus will be building out a complete US-based specialty care sales force and other commercial functions, significantly increasing the number of employees working directly on NATESTO in the United States.

This co-promotion is expected to significantly increase sales force coverage of targeted U.S. prescribers, putting a higher promotional focus on urologists and endocrinologists, while enabling Aytu to focus its promotional efforts in primary care and other specialties.

Acerus is extremely pleased to see our revised partnership with Aytu moving to execution mode as we strongly believe that the performance of NATESTO in the U.S. will benefit from an enhanced commercial focus on urology and endocrinology, said Ed Gudaitis, President and Chief Executive Officer of Acerus. We are happy to welcome the former Aytu staff to the Acerus team. With this revised partnership, Acerus is effectively pivoting its focus of effort to the U.S. NATESTO opportunity. As such, we have implemented a resource reallocation program within our Canadian office that has led to a greater than 50% reduction in headcount so that we can align our SG&A spend appropriately.

On July 29, 2019 the companies agreed to expand their commercial partnership and amend and restate the original 2016 NATESTO exclusive U.S. license agreement. Under the terms of the new agreement, Aytu returns the NDA for NATESTO in the U.S. back to Acerus. Going forward Acerus will assume all regulatory and clinical responsibilities and costs for the product in the U.S. Acerus will take on a more expansive role in matters such as U.S. marketing, reimbursement and medical strategy as part of the companies joint commercialization committee, and will launch a specialist sales force focused on urologists and endocrinologists (Acerus Sales Channel). Aytu will retain its primary care sales force (Aytu Sales Channel) and will continue to book all product net revenue while serving as the exclusive U.S. supplier of NATESTO to wholesalers, pharmacies and other customers that receive a direct shipment. Financial payments will be based upon a tiered level of net revenue, post cost of goods sold (COGS), based on annual sales performance in the respective Acerus and Aytu Sales Channels.

To establish a high performing commercial footprint in the U.S., Acerus has engaged Syneos Health (NASDAQ: SYNH), a leading integrated biopharmaceutical solutions organization including the industrys largest Contract Commercial Organization (CCO), to be its commercialization partner. Syneos Health has extensive experience in Mens Health and with NATESTO, and offers an end-to-end model that will enable Acerus to rapidly stand up a U.S. commercial team; to scale across all aspects of commercialization, including medical and regulatory affairs, managed markets, marketing and sales; and will provide greater flexibility and effectiveness in resource deployment.

Low testosterone is estimated to affect approximately 39% of men over 45 years old in the U.S.; however, because the condition is underdiagnosed the overall prevalence is uncertain1. While patients have access to other treatment options, NATESTO is unique in that it is administered in seconds via a convenient and simple nasal gel applicator, addressing the risk of testosterone transference associated with other topical products, which carry black box warnings on their product labels.

About NATESTO (Testosterone) Nasal Gel

NATESTO is a nasal gel formulation of testosterone developed by Acerus Pharmaceutical Corporation and indicated as a replacement therapy for men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). It is the first and only nasally-administered testosterone product approved by the U.S. Food and Drug Administration, Health Canada and South Korea Ministry of Food and Drug Safety (MFDS), available in a no-touch dispenser with a metered dose pump. A copy of the NATESTO Canadian product monograph can be found at: http://www.aceruspharma.com/English/products-and-pipeline/NATESTO /default.aspx. For further information, specific to the U.S. product dosing and administration, please visit: http://www.NATESTO .com.

About Acerus

Acerus Pharmaceuticals Corporation is a Canadian-based specialty pharmaceutical company focused on the commercialization and development of innovative prescription products that improve patient experience, with a primary focus in the field of mens health. The Company commercializes its products via its own salesforce in Canada, and through a global network of licensed distributors in the U.S. and other territories.

Acerus shares trade on TSX under the symbol ASP and on OTCQB under the symbol ASPCF. For more information, visit http://www.aceruspharma.com and follow us on Twitter and LinkedIn.

Notice Regarding Forward-Looking Statements

Information in this press release that is not current or historical factual information may constitute forward looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties, including with respect to the commercial performance of NATESTO in the United States, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 4, 2019 which is available at http://www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.

1 Mulligan T, Frick MF, et al. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006 Jul 1; 60(7): 762769

View source version on businesswire.com: https://www.businesswire.com/news/home/20191202005215/en/

Contacts

Media: Edward Gudaitis President and Chief Executive Officer egudaitis@aceruspharma.com (905) 817-8194

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Expanded U.S. NATETSO Partnership Between Acerus Pharmaceuticals and Aytu BioScience Is Now Fully Operational - Financial Post

In a recent report by Transparency Market Research, it is shown that the global testosterone replacement therapy market is expected to grow negatively in the forecast period of 2016 to 2024. This adverse growth of the market is the result of various bans on the use of testosterones by various governments across the globe. Moreover, stringent regulations are also forcing company back-outs from the global testosterone replacement therapy market. This is also adding to the negative growth of the market.

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The Market to Experience -4.2%CAGR During the Forecast

According to the report, the global testosterone replacement therapy market is expected to generate substantially less revenue than previous forecast period. In terms of revenue, the global testosterone replacement therapy market is expected to reach to the value of US$1.3 bn during the forecast of 2016 to 2024.

The global testosterone replacement therapy market is expected to experience 4.2% CAGR. This sluggish growth of the market is the result of various bans on the drugs that are used in the therapy.

Moreover, considering the adverse effects of the testosterone replacement therapy, governments of various countries have posed stringent regulations on their application. This is yet another factor that is compelling the global testosterone replacement therapy market to grow negatively during the forecast.

Historical analysis of the global testosterone replacement therapy market by experts at Transparency Market Research shows that the market stood US$ 2.0bn at the end of 2015.

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AbbVie, INC. to Account for Majority of Market Share

According to the report, the global testosterone replacement therapy market is predominantly consolidated. This is because majority of the dynamics of the market is dominated by AbbVie, INC. a U.S. based pharmaceutical company that specializes in testosterone replacement therapy drugs. This dominance by the company and overall sluggish growth is making the new players entry quite difficult in testosterone replacement therapy market.

These players are looking forward to adopt various strategies such as mergers, collaborations, and partnerships in order to have a stable future in the global crop maintenance robots market. These strategies are providing the businesses with required resources to compete against the well established players of the market.

Whereas, AbbVie, INC. is launching new products in order to maintain its dominance in the global testosterone replacement therapy drugs market. Recently, the company had applied for approval of its cream product that can be used externally for testosterone replacement therapy.

Rising Cases Hypogonadism to Show Some Sign of Growth for the Markets

According to various research and studies, the number of hypogonadism has risen substantially over couple of decades. This growth of the condition is showing some signs of growth in global testosterone replacement therapy market. Rising geriatric population is another minor factor that is expected to show growth possibilities in global testosterone replacement therapy market. Furthermore, various campaigns to educate people about the benefits of testosterone is also helping the global testosterone replacement therapy market to grow slowly in recent times.

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North America is Expected to Exhibit Maximum Growth in the Market

Geriatric population in countries such as U.S. and Canada is one of the major reasons that are supporting North America to dominate the regions of global testosterone replacement therapy market. The growth of the region is also attributed to the presence of various key players of global testosterone replacement therapy market.

The article is listed by Transparency Market Research titled Testosterone Replacement Therapy Market (Product Creams/Gels, Patches, Injections, Gums/Buccal Adhesives, Implants; Active Ingredient Testosterone, Methyl Testosterone, Testosterone Undecanoate, Testosterone Enanthate, Testosterone Cypionate) Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2016 2024.

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Testosterone Replacement Therapy Market to Expand at a Robust 4.20% CAGR Between 2016 and 2024 - Montana Ledger

Human Chorionic Gonadotropin (HCG) Marketreport provides comprehensive insights, revenue generation information, and other significant information related to the global Human Chorionic Gonadotropin (HCG) market, as well as the different trends, drivers and restraints, opportunities, and threats in the parent market till 2024.

Rise in the incidence of male hypogonadism among the geriatric population is the key factor driving the market growth. In addition, increase in traction gained by hCG among healthcare professionals and patients would supplement the market growth. However, cautions and warnings issued by the FDA pertaining to the side effects of hCG therapy is expected to hamper the market growth. Moreover, untapped economies are set to offer lucrative opportunities for the expansion of the hCG market.

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Key Players covered in this report:

Scrippslabs

Leebio

Kamiya Biomedical Company

Human chorionic gonadotropin (hCG) belongs to the family of gonadotropin hormones and is naturally produced by the placenta. hCG hormone plays a pivotal role after the formation of the embryo, and hence has gained significant traction over the years for the treatment of infertility in women and men. hCG triggers ovulation in women and assists in increasing the sperm count in men

Market by Type

-Subunit (-hCG)

-Subunit (-hCG)

Others

Market by Application

Research institutions

Pharmaceutical

Others

Reasons for Buying this Report

This report provides pin-point analysis for changing competitive dynamics

It provides a forward looking perspective on different factors driving or restraining market growth

It provides a 5-year forecast assessed on the basis of how the market is predicted to grow

It helps in understanding the key product segments and their future

It provides pin point analysis of changing competition dynamics and keeps you ahead of competitors

It helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments

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Table of Contents

1 Executive Summary Market Attractiveness Analysis

1.1 Global Human Chorionic Gonadotropin (HCG) Market, by Product Type

1.2 Global Human Chorionic Gonadotropin (HCG) Market, by End User

1.3 Global Human Chorionic Gonadotropin (HCG) Market, by Region

2 Market Introduction

2.1 Definition

2.2 Scope of the Study

2.3 Market Structure

2.4 Key Buying Criteria

3 Research Methodology

3.1 Research Process

3.2 Primary Research

3.3 Secondary Research

3.4 Market Size Estimation

3.5 List of Assumptions

4 Market Dynamics

4.1 Introduction

4.1 Drivers

4.2. Integration of Advanced Technologies

4.3 Restraint

4.4 Opportunities

5 Market Factor Analysis

5.1 Supply Chain Analysis

5.2 Porters Five Forces Analysis

5.2.1 Threat of New Entrants

5.2.2 Bargaining Power of Suppliers

5.2.3 Threat of Substitutes

5.2.4 Bargaining Power of Buyers

5.2.5 Intensity of Rivalry

6 Market Channel

6.1 Overview

6.2 Store-Based

6.3 Non-Store-Based

7 Global Human Chorionic Gonadotropin (HCG) Market, by Product Type

8 Global Human Chorionic Gonadotropin (HCG) Market, by End User

9 Global Human Chorionic Gonadotropin (HCG) Market, by Region

Continued

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Human Chorionic Gonadotropin (HCG) Market 2019 By Share, Size, industry Trends, Outlook, Revenue, Manufacturers, Demand and Forecast to 2024 - Downey...

Alex Nowbar reviews the latest research from the top medical journals

Annals of Internal Medicine

Coaching for weight maintenance

Conroy et al examine the role of coaching in weight management in a randomised controlled trial of 194 participants who had intentionally lost at least 5% of their body weight in the last two years. They also threw in a bit of electronic health records for good measure. The study arms were: tracking via electronic health records versus the same plus coaching. So really its a trial of a two year coaching programme. Good news, at two years weight regain in the coaching group was lower (2.1kg vs 4.9kg in the tracking only group). Those in the coaching group were more likely to maintain weight loss of at least 5%. The coaching was in the form of personalised health coaching through the electronic health record patient portal, with intensive initial contact (weekly for a month) that tapered off over the two years. The electronic health record served as an important part of the control for those in the tracking group because it was used to send the tracking participants questionnaires on general health. This was a well designed study of an interesting intervention format i.e. an electronic health record-based lifestyle intervention.

JAMA

Bempedoic acid for reducing LDL Cholesterol

If you name a trial CLEAR Wisdom, you should be prepared to be accused of being smug. But perhaps Esperion Therapeutics should be. Bempedoic acid was tested in a double-blind randomised controlled trial of 779 people with high cardiovascular risk and raised LDL-C despite maximally tolerated lipid-lowering therapy. At 12 weeks, it reduced LDL-C levels dramatically compared to placebo and was reasonably well-tolerated and safe. Its now ready for the next stage of clinical trials to establish the impact on cardiovascular outcomes. There are a number of players on this stage though, PCSK-9 inhibitors in particular. In fact there are a spate of new cardiovascular drugs making an appearance and each ones glory is being somewhat diluted by the others. It is therefore unclear which will become commonly prescribed and which will fall by the wayside. Unfortunately I suspect it will be marketing and trendiness that determines how this plays out because the head-to-head data is unlikely to come soon.

Lancet

Hope for NASH

Thyroid hormone analogue, resmetirom, is an oral drug for treatment of NASH fibrosis. Harrison et al tested it in a double-blind Phase 2 randomised controlled trial of 125 patients in the US. Naturally, drug-makers, Madrigal, were closely involved in this studys design and analysis. They found it reduced hepatic fat at 12 weeks as measured by MRI proton-density fat fraction. As well as singing the praises of this new drug, this study highlights the utility of this non-invasive measure of hepatic fat as opposed to biopsy which is not practical for serial monitoring. There were also significant lipid profile improvements with resmetirom compared to placebo. However all the efficacy outcomes assessed in this study were biomarkers not actual outcomes so the clinical benefits are not yet known. But these data are promising and certainly confirm that the thyroid hormone pathway has an important role in NASH fibrosis.

Steroids for the DIPs and PIPs

I hate to stereotype, but Dutch trials are often particularly robustly designed, like this double-blind randomised controlled trial of 6 weeks of prednisolone 10mg once daily versus placebo. The inclusion criteria are important here. Participants had to have symptomatic hand osteoarthritis with signs of inflammation in their distal and proximal interphalangeal joints. Objective evidence was required, including osteoarthritis nodes, swelling, or erythema and synovial thickening on ultrasound. And the inclusion criteria even went one step further to require finger pain of at least 30 mm on a 100-mm visual analogue scale (VAS) that flared up during a 48-h non-steroidal anti-inflammatory drug washout (defined as worsening of finger pain by at least 20 mm on the VAS). The primary endpoint of finger pain improvement on the VAS at 6 weeks was positive with a large effect size with no adverse safety signal. These data are extremely useful for those with this condition, but it sounds like itll be in the rheumatologists domain for now. The inclusion assessment appears too strict to be feasible in primary care.

JAMA Internal Medicine

Testosterone and thromboembolic risk

It seems obvious that testosterone therapy should be used only to treat hypogonadism and even then it should not be taken lightly. It has previously been linked to higher risk of heart attack or stroke. This large US observational study of men with deep vein thrombosis or pulmonary embolism (but without a cancer diagnosis) found an association between short-term testosterone therapy and increased risk of a thromboembolic event. The study design was interesting as each individual acted as their own control by examining them 6-12 months before the thromboembolic event while the 6 month period before the event was considered the case period. Other key findings were that thromboembolic risk was highest in the first 3 months after starting testosterone therapy, that route of testosterone made no difference to the risk and that the risk was present in men with or without hypogonadism.

NEJM

Apple watch rhythm notifications

Can an Apple watch detect atrial fibrillation? Probably. 419,297 young people participated in this study. They were monitored for a median of 117 days. An irregular rhythm was flagged in 0.52% of them (3% in the over 65s). These people got sent an ECG patch to wear for 7 days. Of those, only 21% returned the patch to the researchers. Of those who returned the patch, a third had documented atrial fibrillation. There is no comparator group to know whether the incidence of detected atrial fibrillation would have been similar without using the watch. And there was huge potential for selection bias, for example people who felt symptomatic might have been more likely to participate (so these data represent a skewed population) and people with more irregular rhythm periods and/or more symptoms might have been more likely to return the patch (again skewing the data). These bias issues are the reason studies arent conducted in this manner. This study design neither answers the question it says it set out to answer, nor provides clinically relevant evidence.

The new and improved smallpox vaccine

Pittman et al compared two doses of a new smallpox vaccine called modified vaccinia Ankara (MVA) to an existing vaccine (only requiring one dose) in an open-label randomised controlled trial of 440 people. They were looking for non-inferiority in peak antibody titres and the so-called take reaction which were both assessed in a blinded fashion. It is prudent but alarming that we are preparing our defences against a disease that has supposedly been eradicated. But there could be another outbreak one day. The existing vaccine is effective but carries fairly significant risks and hence the need for something better. MVA won the day with respect to equivalent efficacy and fewer serious adverse events. But do these efficacy endpoints (antibodies and the take) really reflect the protection this vaccine provides? And how long would the protection last? Who knows.

Colchicine after myocardial infarction

The inflammatory hypothesis in atherosclerosis has been bubbling away for many years. COLCOT is the first study that practically applies this with a degree of success. COLCOT was a double-blind randomised controlled trial of colchicine 500mcg once daily versus placebo for cardiovascular risk reduction after an MI. Colchicine started within 30 days of the MI was found to reduce cardiovascular events at 2 years, and surprisingly without substantially increasing diarrhoea rates. The cardiovascular event reduction was mainly driven by fewer strokes and fewer revascularisations for angina though which is a bit disappointing since MI and death prevention is what we were really hoping for. Colchicine for prevention of need for revascularisation doesnt even really make sense because there are plenty of other anti-anginal therapies. Arguably this event shouldnt have been part of the primary endpoint. Overall, there are benefits of colchicine that can justify its use but will patients really find it worth the hassle given all the other medications they get given (and often dont adhere to) after an MI?

Alex Nowbar is a clinical research fellow at Imperial College London

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Alex Nowbar's weekly review22 November 2019 - The BMJ - The BMJ

The globalmarket for testosterone replacement therapyis characterized by the presence of a large number of small and large scale manufacturers. All of the manufacturers have been steadfast in filling the meagre market gap in order to enhance their prospects of growth. Furthermore, research and development has been the central characteristic of al the market players operating in the global market.

In 2015, it was found that 80% of the total market share was held by the top five market vendors with AbbVie Inc. taking the lead. The large scale vendors are focusing on establishing an iconic brand for their product by resorting to rigorous marketing and advertising tactics. The smaller companies are expected to concentrate on capturing the local and regional markets to sustain themselves in the current scenario of stiff competition. A negative implication for the leading market players in recent times has been the loss of patents for their products. This has not only plundered them of revenues but has also affected the workflow of these companies.

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The market players are expected to launch awareness campaigns about testosterone replacement therapies in order to educate and inform the consumers. Hence, the market for testosterone replacement therapies is expected to witness the emergence of several new trends and opportunities over the forthcoming years. Some of the key players in the global testosterone replacement therapy market include Bayer AG, Endo Pharmaceuticals, Inc., Novartis AG, and Allergen plc.

The CAGR for theglobal testosterone replacement therapy marketis estimated to be -4.20% over the period between 2016 and 2024. The negative growth rate of the global market is expected to take the market value from US2.0 bn in 2015 to a decreased value of US$1.3 bn by 2024-end.

High Incidence of Hypogonadism to Drive Market Demand

Research studies suggest that around 30% of all men suffer from testosterone deficiency, which has driven demand within the global market for testosterone replacement therapy. Furthermore, the population demographic of men in the age range of 40-79 years is more likely to suffer from testosterone deficiency. The need for mutation or having an offspring amongst men in the aforementioned age range has driven demand within the global market.

Enquiry for Discount onTestosterone Replacement Therapy Market Report

Moreover, the geriatric population has been on a rise, which underhandedly contributes to market growth. Several campaigns aimed at educating people about the benefits of testosterone replacement therapy have been an important propeller of demand within the global market. It is anticipated that more people suffering from testosterone deficiency would resort to these therapies over the coming years.

Side Effects of Testosterone Replacement Therapy Could Obstruct Market Growth

Despite the rising awareness amongst the masses about the advantages of testosterone replacement therapies, the market growth is hindered by the apprehension of the people. The chances of developing metabolic disorders are higher in men who undergo testosterone replacement therapies. Furthermore, the risk of developing cardiovascular diseases also discourages people from resorting to testosterone replacement therapies. The FDA has also cautioned people about the use of such therapies by issuing strict warnings, which has further obstructed the growth of the global market.

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Testosterone Replacement Therapy Market To Witness Huge Growth in 2024 - Downey Magazine

Male hypogonadism is a condition where the body doesnt create enough of the testosterone hormone; the hormone that assumes a key job in manly development and advancement during adolescence. There is an unmistakable need to expand the attention to hypogonadism all through the medicinal calling, particularly in essential consideration doctors who are typically the main port of require the patient. Hypogonadism can altogether decrease the personal satisfaction and has brought about the loss of employment and division of couples, prompting divorce. It is additionally significant for specialists to perceive that testosterone isnt only a sex hormone. There is a significant research being distributed to exhibit that testosterone may have key activities on digestion, on the vasculature, and on mind work, notwithstanding its notable impacts on bone and body structure. Hence the global male hypogonadism market is gaining momentum these days.

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Trending Treatments of Global Male Hypogonadism Market:

Transdermal Patches: Transdermaltestosterone patches are accessible in India under the brand name Androderm.Transdermal patches convey consistent levels of testosterone over a 24-hourtime frame. Application site responses represent most of unfriendly impactsrelated with transdermal patches, with old men demonstrating especiallyinclined to skin bothering. Neighborhood responses incorporate pruritus,rankling under the fix, erythema, vesicle arrangement, indurations, andunfavorably susceptible contact dermatitis. Roughly 10% of the patients suspendfix treatment because of skin responses.

Buccal Tablets: Buccal testosterone tablets, promoted as Striant, discharge testosterone in a pulsatile way, are like endogenous emission. With this course, the pinnacle testosterone levels are quickly accomplished and an unfaltering state is come to constantly portion following twice-day by day dosing. Like gel and transdermal items, buccal organization maintains a strategic distance from first-pass digestion. Nourishment and drink dont change medicate ingestion. Albeit well-endured, transient gum aggravation and a severe taste are the boss antagonistic impacts related with this course. And hence are one of the most effective treatmemt of male hypogonadism market.

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What's Driving the Growth of Global Male Hypogonadism Market - TMR Research Blog

The researchers conducted the study to evaluate whether the clinical prescription of testosterone therapy was associated with short-term risk of venous thromboembolism in men with and without hypogonadism or not. They found that Testosterone therapy is associated with increased risk for venous thromboembolism (VTE) in men. The case-crossover study has been published in JAMA Internal Medicine.

According to the American Heart Association, Venous thromboembolism (VTE) refers to a blood clot that starts in a vein. It is the third leading vascular diagnosis after a heart attack and stroke and includes Deep vein thrombosis andPulmonary embolism .

The researchers used insurance claims databases, researchers identified roughly 40,000 men without cancer whod experienced a VTE. Out of them, nearly 8% were diagnosed with hypogonadism. Each patient served as his own control. The immediate 6 months before the VTE was the case period, and the 6 months before that was the control period.

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A claim for testosterone therapy was more common in the 6 months before VTE, compared with the control period, both for men without hypogonadism (0.8% for case period vs. 0.5% for control period) and for those with (34% vs. 22%).

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It was found that the use of testosterone therapy in the 6-month case period was associated with an increased risk of venous thromboembolism among men with and without hypogonadism. The testosterone prescription during the case period was associated with roughly double the risk for VTE. The risk was highest in the first 3 months of starting testosterone.

The authors concluded that testosterone therapy was associated with an increase in short-term risk for VTE among men with and without hypogonadism, with some evidence that the association was more pronounced among younger men. These findings suggest that caution should be used when prescribing testosterone therapy.

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JAMA Intern Med.Published online November 11, 2019. doi:https://doi.org/10.1001/jamainternmed.2019.5135

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Testosterone therapy prescription linked to increased VTE risk in JAMA study - Specialty Medical Dialogues

Aytu Bioscience (NASDAQ:AYTU) will be announcing its earnings results after the market closes on Thursday, November 14th. Analysts expect the company to announce earnings of ($0.30) per share for the quarter.

Aytu Bioscience (NASDAQ:AYTU) last announced its earnings results on Thursday, September 26th. The company reported ($0.32) earnings per share (EPS) for the quarter, beating the consensus estimate of ($0.33) by $0.01. Aytu Bioscience had a negative net margin of 370.62% and a negative return on equity of 204.18%. On average, analysts expect Aytu Bioscience to post $-1 EPS for the current fiscal year and $0 EPS for the next fiscal year.

Shares of Aytu Bioscience stock opened at $1.01 on Tuesday. Aytu Bioscience has a 1 year low of $0.68 and a 1 year high of $2.61. The firm has a market cap of $21.77 million, a PE ratio of -0.29 and a beta of 4.63. The company has a 50 day simple moving average of $1.14 and a two-hundred day simple moving average of $1.56.

Several equities research analysts have issued reports on AYTU shares. Zacks Investment Research lowered shares of Aytu Bioscience from a buy rating to a hold rating in a research report on Thursday, October 3rd. LADENBURG THALM/SH SH lifted their target price on shares of Aytu Bioscience from $4.00 to $4.75 in a research report on Wednesday, September 18th. ValuEngine lowered shares of Aytu Bioscience from a buy rating to a hold rating in a research report on Monday. Finally, Northland Securities set a $10.00 target price on shares of Aytu Bioscience and gave the company a buy rating in a research report on Friday, September 27th.

Aytu Bioscience Company Profile

Aytu BioScience, Inc, a specialty healthcare company, focuses on developing and commercializing novel products in the field of hypogonadism (low testosterone), insomnia, and male infertility in the United States and internationally. The company markets Natesto, a nasal gel for the treatment of hypogonadism (low testosterone) in men; and ZolpiMist, an oral spray for the treatment of insomnia.

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Aytu Bioscience (AYTU) Scheduled to Post Quarterly Earnings on Thursday - Polson News

AMA recently published a detailed study of over 180+ pages in its repository on Testosterone Replacement Therapy market covering interesting aspects of market with supporting development scenario till 2025. The study provides market size break-up by revenue and volume* for emerging countries and important business segments along with commentary on trending factors, growth drivers. Profiled players in study from the coverage used under bottom-up approach are AbbVie Inc. (United States), Endo International (Ireland), Eli Lilly and Company (United States), Pfizer (United States), Bayer (Germany), Actavis (Allergan) (United States), Novartis (Switzerland), Teva (Israel), Ferring Pharmaceuticals (Switzerland), Kyowa Kirin (Japan), Mylan (United States)

Next step one should take to boost sales? Track latest strategic steps and current scenario analysis of the market @ https://www.advancemarketanalytics.com/sample-report/46424-global-testosterone-replacement-therapy-market

Testosterone is responsible for the development of male sexual characteristics and this hormone formed by the testicles. Insufficient production of testosterone causes erectile dysfunction. Testosterone Replacement Therapy (TRT) is generally termed as hormone therapy for men, designed to counteract the effects of reduced activity in the gonads or hypogonadism. Hypogonadism in men is clinical syndrome, which results in the failure of the testes to produce physiological levels of testosterone. Erectile dysfunction arises due to reduce testosterone production to overcome this testosterone replacement therapy is used to improve the problem.

Market Segmentationby Type (Creams or Gels, Patches, Injections, Buccal Adhesives, Implants, Oral), Application (Hospitals, Clinics)

Make an enquiry before buying this Report @ https://www.advancemarketanalytics.com/enquiry-before-buy/46424-global-testosterone-replacement-therapy-market

Whats Trending in Market: Increasing awareness about testosterone substitute therapy

Growth Drivers: Increasing prevalence of hypogonadism in adult men

The need for having an offspring amongst men

Restraints: High possibility of side effects related to testosterone replacement therapy

View Detailed Table of Content @ https://www.advancemarketanalytics.com/reports/46424-global-testosterone-replacement-therapy-market

Country level Break-up includes:North America (United States, Canada and Mexico)Europe (Germany, France, United Kingdom, Spain, Italy, Netherlands, Switzerland, Nordic, Others)Asia-Pacific (Japan, China, Australia, India, Taiwan, South Korea, Middle East & Africa, Others)

Try a limited scope research document specific to Country or Regional matching your objective.

GET FULL COPY OF United States Testosterone Replacement Therapy market study @ USD 2000

And, Europe Testosterone Replacement Therapy market study @ USD 2500 Major Highlights of TOC:

Chapter One: Market Overview

Scope/Objective of the Study

Chapter Two: Executive Summary - Free of Cost

Chapter Three: Market Dynamics USD400

Market Drivers, Market Challenges, Market Trends

Chapter Four: Market Factor Analysis USD400

Supply/Value Chain Analysis, Porters Five Forces, PESTEL analysis, Market Entropy, Patent & Trademark Analysis, Market Development Scenario

Chapter Five and Seven: Global Testosterone Replacement Therapy, by Market Segmentation and Region (value, volume**) (2013-2024) USD2400

Global Testosterone Replacement Therapy

By Type (Creams or Gels, Patches, Injections, Buccal Adhesives, Implants, Oral)

By Application (Hospitals, Clinics)

Global Testosterone Replacement Therapy Region

North America (United States, Canada and Mexico)

Europe (Germany, France, United Kingdom, Spain, Italy, Netherlands, Switzerland, Nordic, Others)

Asia-Pacific (Japan, China, Australia, India, Taiwan, South Korea, Middle East & Africa, Others)

Chapter Six: Global Testosterone Replacement Therapy Manufacturers/Players Analysis USD1200

Competitive Landscape (Direct & Indirect Competitors), Market Share Analysis, Peer Group Analysis (2018), BCG Matrix, Company Profile, Downstream Buyers & Upstream Suppliers

..

Chapter Nine: Methodology/Research Approach, Data Source, Disclaimer

** If applicable

* Customized Section/Chapter wise Reports or Regional or Country wise Chapters are also available.

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Thanks for reading this article, you can also get individual chapter wise section or region wise report version like North America, Europe or Asia.

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Testosterone Replacement Therapy Industry: Time to Invest in emerging Markets | Endo International, Pfizer, Novartis - News Description

Acerus Pharmaceuticals (TSE:ASP) will be announcing its earnings results before the market opens on Thursday, November 14th.

TSE ASP opened at C$0.08 on Tuesday. The stocks fifty day moving average is C$0.10 and its two-hundred day moving average is C$0.12. The firm has a market capitalization of $20.90 million and a P/E ratio of -1.25. The company has a debt-to-equity ratio of 105.08, a quick ratio of 0.40 and a current ratio of 0.74. Acerus Pharmaceuticals has a fifty-two week low of C$0.07 and a fifty-two week high of C$0.21.

About Acerus Pharmaceuticals

Acerus Pharmaceuticals Corporation, a specialty pharmaceutical company, focuses on the development, manufacture, marketing, and distribution of pharmaceutical products for men's and women's health. The company offers Natesto, a nasal gel for testosterone replacement therapy in adult males diagnosed with hypogonadism; Estrace, an oral tablet for the symptomatic relief of menopausal symptoms; and UriVarx, a natural health product that helps reduce symptoms of hyperactive bladder, such as daytime urinary frequency, urgency, and nocturia.

Recommended Story: Market Capitalization and Individual Investors

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Acerus Pharmaceuticals (ASP) Set to Announce Earnings on Thursday - Polson News

Inovio Pharmaceuticals breached a contract to supply needle-free injectors after learning they would be used to inject testosterone by transgender men, according to a lawsuit filed Nov. 1 in San Diego Superior Court.

BLS Pharma says Inovio was cooperative until it learned the biomedical companys ZetaJet injectors would be used by the transgender men, instead of just men with insufficient testosterone, a condition called male hypogonadism. BLS asked Inovio for its reasons, and the company failed to give a valid reply, according to the lawsuit.

Inovio rejects the claim. The lawsuit has absolutely no merit, said Jeff Richardson, an Inovio spokesman.

San Diego is where Inovio performs research, development, engineering and manufacturing. Company headquarters is in Plymouth Meeting, Pennsylvania. BLS Pharma is headquartered in Lake Forest, Calif.

The civil lawsuit says the monetary loss totals $72.9 million under a conservative estimate. Besides breach of contract, the lawsuit also alleges fraud and negligent misrepresentation.

Inovio acquired ZetaJet in 2016 when it paid $4.3 million in stock and $1.2 million cash for BioJect, its maker. The device uses high pressure supplied by a spring to force liquid medicine through the skin.

The lawsuit says that sale included a provision to sell ZetaJets to the sellers upon request, negotiating in good faith to supply the devices at a 15 percent premium to production cost.

The sellers formed BLS to continue work already planned to enter the needle-free injection market, including testosterone, the lawsuit said. The combination of device and needle-free testosterone syringe would allow patients to inject themselves with greater ease and comfort than by using a needle.

Both men with hypogonadism and biological women becoming transgender men require continual testosterone supplementation to maintain normal male levels of the hormone. That market is valued at $1.3 and $1.8 billion annually, the lawsuit said.

In early 2017, BLS told Inovio it planned to buy the ZetaJets under the contract, for use in a planned clinical trial. It asked for 25,000 of them in April, and negotiations proceeded over the summer while BLS discussed its plans with the FDA, which regulates clinical trials.

On Sept. 7, BLS told Inovio that it had received favorable news about testing the system for transgender men in addition to men with insufficient testosterone.

The following Monday, September 11, 2017, Defendants requested a call with Plaintiff, the lawsuit stated.

At that time Defendants advised Plaintiff that they were rejecting the syringe order, would not authorize BLS to take over manufacturing of the syringes, that their legal department would be sending a letter terminating the relationship, and that they would return the check previously issued by BLS for payment.

According to the lawsuit, Inovio gave as its reason, We dont need transgender, we have Gates.

BLS said it interpreted that reply as meaning that Inovio was already supporting a different publicizable public interest effort through a separate project with the Gates Foundation.

In the following months, BLS said, it tried and failed to find an alternative supplier of the injectors, leaving it without any way to test its product.

The lawsuit also names as defendant Genetronics, a San Diego-based Inovio predecessor. Genetronics purchased Norway-based Inovio in 2005, and shortly thereafter changed the combined companys name to Inovio. The lawsuit says Genetronics is now an Inovio subsidiary.

A civil case management conference has been set for June 19, 2020, according to a Superior Court filing for the case. The case number is 37-2019-00058344-CU-BC-CTL.

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Lawsuit claims contract breached over transgender testosterone therapy - The San Diego Union-Tribune

Abstract and Introduction Abstract

In recent years, testosterone replacement therapy (TRT) has received significant media attention, and the rate of testosterone use has increased notably. A reported association between testosterone use and increased occurrence of myocardial infarction and stroke prompted the FDA to issue a safety bulletin in 2014. Clinical hypogonadism is the only FDA-approved indication for TRT in men; it is not approved to treat age-related low testosterone. Although it is not indicated, TRT is often recommended to improve sexual function, bone density, body composition, muscle strength, mood, behavior, and cognition. The literature on the effectiveness of TRT for various conditions is largely mixed; therefore, current data on appropriate and potentially inappropriate use are important for pharmacists to keep abreast of and discuss with patients.

Recently, the use of testosterone replacement therapy (TRT) has received a lot of media attention. Although its use is growing, there is much debate regarding TRT's risks and benefits.[1] From 2008 to 2012 in the United States, spending on TRT increased from $1 billion to $2 billion, and from 2003 to 2013 there was a fourfold increase in the rate of TRT in men aged 18 to 45 years.[2] In 2013 and early 2014, two studies reported an association between TRT and increased occurrence of myocardial infarction and stroke, prompting the FDA to issue a safety bulletin on January 31, 2014.[3] This article will discuss appropriate TRT use, available formulations and cost, side effects, trends, and the pharmacist's role in patient education, including counseling points.

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Testosterone Replacement Therapy: Controversy and Trends - Medscape

Biotech stocks extended their gains last week amid earnings news flow and the broader market strength. Large-cap pharma stocks saw particular strength.

Here are the key catalytic event a biotech investor should keep a tab on in the unfolding week.

The FDA is set to rule on Lipocine Inc (NASDAQ: LPCN)'s NDA for Tlando, or LPCN 1021 to treat hypogonadism in adult males. The PDUFA date is set for Saturday, Nov. 9.

Alkermes Plc (NASDAQ: ALKS) Phase 1/2 data for ALKS 4230 in solid tumors and ALKS 4230 in combination with Merck & Co., Inc. (NYSE: MRK)'s Keytruda in solid tumors.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) Phase 1 data for CDX-1140 in solid tumors (Friday, Nov. 8).

Pieris Pharmaceuticals Inc (NASDAQ: PIRS) Phase 1/2 data for PRS-343 in HER2-positive solid tumors.

CELYAD SA/ADR (NASDAQ: CYAD) Phase 1 data for CYAD-01 and FOLFOX in colorectal cancer (Friday, Nov. 8) and Phase 1 data for CYAD-101 in colorectal cancer (Saturday, Nov. 9).

Heat Biologics Inc (NASDAQ: HTBX) Phase 2 data for HS-110 and Bristol-Myers Squibb Co (NYSE: BMY)'s Opdivo in non-small cell lung cancer (Friday).

Oncolytics Biotech, Inc. (NASDAQ: ONCY) - interim Phase 1b data for Pelareorep and Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY)'s Tecentriq in breast cancer (Friday).

Nektar Therapeutics (NASDAQ: NKTR) updated Phase 1/2 data for NKTR-214 + Opdivo in multiple cancers (urothelial carcinoma, melanoma, renal cell carcinoma, and non-small cell lung cancer) (Saturday).

Mirati Therapeutics Inc (NASDAQ: MRTX) initial Phase 2 data for sitravatinib in urothelial carcinoma (Saturday).

Allena Pharmaceuticals Inc (NASDAQ: ALNA) Phase 2 data for reloxaliase, or ALLN-177, in primary hyperoxaluria and Phase 3 data for reloxaliase in enteric hyperoxaluria (Friday).

See Also: BTIG: Crispr Could Be A Takeover Target For Vertex

The earnings list is not comprehensive

Monday

Tuesday

Wednesday

Thursday

Friday

Galera Therapeutics has filed to offer 5 million shares in an IPO, with an estimated price range of $14-$16. The company has applied for listing its shares on the Nasdaq under the ticker symbol "GRTX."

89bio, a biotech company focusing on therapies for NASH and other metabolic disorders, is planning a 4.375-million IPO at an estimated price range of $15-17. The company has applied for listing its shares on the Nasdaq under the ticker symbol "ETNB."

Gene testing company Centogene is proposing to offer 4 million shares in an IPO, which are to be priced between $14 and $16. The company has applied to list the shares on the Nasdaq under the ticker symbol "CNTG."

CNS Pharmaceuticals, which develops therapies for brain cancer and other CNS tumors, has filed for a 2.125-million share IPO. The shares, which are likely to be priced in the range of $4-$5, are to be listed on the Nasdaq under the ticker symbol "CNSP."

Tela Bio, which sells soft tissue implants used in hernia repair and reconstructive surgery, is set to offer 4 million shares in an IPO, with each share to be priced between $14 and $16. The company seeks to list the shares on the Nasdaq under the ticker symbol "TELA."

BioNTech SE ADR (NASDAQ: BNTX)Vir Biotechnology Inc (NASDAQ: VIR)

2019 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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The Week Ahead In Biotech: Smid-Cap Earnings Deluge, SITC Conference In The Spotlight - Benzinga

ENGLEWOOD, CO / ACCESSWIRE / November 7, 2019 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs, today announced that the company will present its operational results for the quarter ended September 30, 2019 on November 14, 2019, at 4:30 p.m. ET. The company will review accomplishments from the quarter and provide an overview of its business and growth strategy.

Conference Call Information:

Interested participants and investors may access the conference call by dialing either:

1- 844-602-0380 (toll-free)

1- 862-298-0970 (international)

The webcast will be accessible live and archived on Aytu BioScience's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.

A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) and using the replay access code 56773.

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 Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"). Aytu also has exclusive U.S. and Canadian rights to ZolpiMist, an FDA-approved, commercial-stage prescription sleep aid indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Aytu is the exclusive U.S. licensee with commercial rights to Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. Tuzistra XR is a prescription antitussive consisting of codeine polistirex and chlorpheniramine polistirex in an extended-release oral suspension. Additionally, Aytu is developing MiOXSYS, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS is commercialized outside of the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved, Mexican COFEPRAS approved product, and Aytu is planning U.S.-based clinical trials in pursuit of 510k de novo medical device clearance by the FDA. 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.

Forward-Looking Statements

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 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 to Report Fiscal Q1 FY 2020 Results and Business Update - Yahoo Finance

According to Persistence Market Researchs new report, globalmale hypogonadism marketis slated to exhibit a steady expansion throughout the forecast period (2017-2026). Revenues from the global market for male hypogonadism are estimated to exceed US$ 3,300 Mn by 2026-end.

Governments Taking Initiatives to Spread Awareness about Male Hypogonadism Therapeutics

Lack of sex hormones, usually referred to as male hypogonadism has resulted into many health risks that include osteoporosis, heart disease, and cardiovascular diseases on the back of thinning of bones. Global male hypogonadism market comprises several patented brands that currently have high market penetration. Proliferation in geriatric population in tandem with rising incidences related to rheumatoid arthritis and obesity have been primary factors affecting prevalence of male hypogonadism globally. Mounting incidences of testosterone deficiency in male population is a key factor that prevalence of male hypogonadism has surged worldwide. Several governments around the world have been taking initiatives to spread the awareness on hypogonadism treatment procedures, for example testosterone replacement therapy (TST), in order to relieve the painful burden on patients and their families.

As low testosterone levels are increasingly associated with exacerbation of chronic conditions, it further results into disorders apropos to hypothalamic-pituitary-gonadal axis. Advent of TST has however enabled reduction in cases of male hypogonadism considerably. With growing awareness related to its treatment among patients, the market is likely to gain an uptick during the forecast period. Rising availability of the selective androgen receptor modulators (SARMs) has further sustained the market expansion. The development and high availability of SARMs has led toward the provision of improved treatment procedure to patients having androgen deficiencies, thereby influencing the market growth.

North America will continue to Dominate Global Male Hypogonadism Market

North America will continue to dominate the global male hypogonadism market, with more than one-third revenue share during the forecast period. In addition, revenues from the male hypogonadism market in North America will exhibit the fastest expansion through 2026, as compared to those from all the other regional segments comprised in the report. Europe and Asia-Pacific excluding Japan (APEJ) are also expected to remain lucrative for the male hypogonadism market. The market in APEJ will ride on a slightly higher CAGR than that in Europe through 2026.

Topical gels are expected to remain the most lucrative among drugs available for treatment of male hypogonadism globally, with sales projected to register the fastest expansion through 2026. Injectables will also remain a major revenue contributor to the market. Sales of injectable and transdermal patches are poised to reflect an equal CAGR through 2026.

Testosterone Replacement Therapy to Remain Preferred among Patients

Based on therapy, testosterone replacement therapy is expected to remain preferred among patients with male hypogonadism worldwide. Roughly 66% revenue share of the market is expected to be held by revenues from testosterone replacement therapy by 2026-end. Revenues from gonadotropin replacement therapy will remain slightly more than half revenues gained from testosterone replacement therapy throughout the forecast period.

Klinefelters syndrome is expected to remain the most prevalent disease type observed in the male hypogonadism market, and revenues from treatment of this disease will exceed US$ 1,800 Mn by 2026-end. Kallmann Syndrome and Pituitary Adenomas among disease types will also account for major revenue shares of the market by 2026-end.

Nature of global male hypogonadism market has been observed to be highly competitive. This can be mainly attributed to occupancy of many small as well as large suppliers. New companies entering the male hypogonadism market are leveraging opportunities related to treatment developments and innovations. Strategic alliances are likely to remain strong among vendors for producing and marketing drugs worldwide, thereby increasing their market reach. Active market players listed by PMRs report include Astrazeneca Plc., Merck & Co. Inc., Laboratories Genevrier, Bayer AG, Endo International Plc., Allergan Plc., Ferring, Finox Biotech, AbbVie Inc., Eli Lilly and Company Ltd., Teva Pharmaceutical Industries Ltd., and IBSA Institut Biochimque.

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Male Hypogonadism Market Expand at the Fastest CAGR of 3.7% Throughout the Forecast Quantity 2017-2026 - Zebvo

Biotech stocks extended their gains last week amid earnings news flow and the broader market strength. Large-cap pharma stocks saw particular strength.

Here are the key catalytic event a biotech investor should keep a tab on in the unfolding week.

Conferences

PDUFA Dates

The FDA is set to rule on Lipocine Inc (NASDAQ: LPCN)'s NDA for Tlando, or LPCN 1021 to treat hypogonadism in adult males. The PDUFA date is set for Saturday, Nov. 9.

Clinical Trial Readouts SITC Presentations

Alkermes Plc (NASDAQ: ALKS) Phase 1/2 data for ALKS 4230 in solid tumors and ALKS 4230 in combination with Merck & Co., Inc. (NYSE: MRK)'s Keytruda in solid tumors.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) Phase 1 data for CDX-1140 in solid tumors (Friday, Nov. 8).

Pieris Pharmaceuticals Inc (NASDAQ: PIRS) Phase 1/2 data for PRS-343 in HER2-positive solid tumors.

CELYAD SA/ADR (NASDAQ: CYAD) Phase 1 data for CYAD-01 and FOLFOX in colorectal cancer (Friday, Nov. 8) and Phase 1 data for CYAD-101 in colorectal cancer (Saturday, Nov. 9).

Heat Biologics Inc (NASDAQ: HTBX) Phase 2 data for HS-110 and Bristol-Myers Squibb Co (NYSE: BMY)'s Opdivo in non-small cell lung cancer (Friday).

Oncolytics Biotech, Inc. (NASDAQ: ONCY) - interim Phase 1b data for Pelareorep and Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY)'s Tecentriq in breast cancer (Friday).

View more earnings on IBB

Nektar Therapeutics (NASDAQ: NKTR) updated Phase 1/2 data for NKTR-214 + Opdivo in multiple cancers (urothelial carcinoma, melanoma, renal cell carcinoma, and non-small cell lung cancer) (Saturday).

Mirati Therapeutics Inc (NASDAQ: MRTX) initial Phase 2 data for sitravatinib in urothelial carcinoma (Saturday).

ASN Kidney Week Presentations

Allena Pharmaceuticals Inc (NASDAQ: ALNA) Phase 2 data for reloxaliase, or ALLN-177, in primary hyperoxaluria and Phase 3 data for reloxaliase in enteric hyperoxaluria (Friday).

See Also: BTIG: Crispr Could Be A Takeover Target For Vertex

Earnings

The earnings list is not comprehensive

Monday

Tuesday

Wednesday

Thursday

Friday

IPOs

Galera Therapeutics has filed to offer 5 million shares in an IPO, with an estimated price range of $14-$16. The company has applied for listing its shares on the Nasdaq under the ticker symbol "GRTX."

89bio, a biotech company focusing on therapies for NASH and other metabolic disorders, is planning a 4.375-million IPO at an estimated price range of $15-17. The company has applied for listing its shares on the Nasdaq under the ticker symbol "ETNB."

Gene testing company Centogene is proposing to offer 4 million shares in an IPO, which are to be priced between $14 and $16. The company has applied to list the shares on the Nasdaq under the ticker symbol "CNTG."

CNS Pharmaceuticals, which develops therapies for brain cancer and other CNS tumors, has filed for a 2.125-million share IPO. The shares, which are likely to be priced in the range of $4-$5, are to be listed on the Nasdaq under the ticker symbol "CNSP."

Tela Bio, which sells soft tissue implants used in hernia repair and reconstructive surgery, is set to offer 4 million shares in an IPO, with each share to be priced between $14 and $16. The company seeks to list the shares on the Nasdaq under the ticker symbol "TELA."

IPO Quiet Period Expiry

BioNTech SE ADR (NASDAQ: BNTX)Vir Biotechnology Inc (NASDAQ: VIR)

See more from Benzinga

2019 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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The Week Ahead In Biotech: Smid-Cap Earnings Deluge, SITC Conference In The Spotlight - Yahoo Finance

The Testosterone Replacement Therapy Market Report provides Growth history, Sales channel, Manufacturers profiled in Testosterone Replacement Therapy industry, Market share of product and scope of a region in detail. The Market report also consists of key drivers and limiting factors affect the Testosterone Replacement Therapy Market Growth, Change in industry Trends or challenges faced by Testosterone Replacement Therapy Manufacturers in forecast years.Testosterone Replacement Therapy Market report will help you take well-versed decisions, understand opportunities, plan effective business strategies, plan new projects, analyze drivers and give you a vision on the industry forecast.

GetA Sample PDF Of Report

About this marketIncreased awareness about hypogonadism among the public and primary care physicians will drive the market. Globally, different organizations are working on initiatives to increase patient awareness of hypogonadism and available treatment options. The vendors are actively taking part in the awareness campaign to educate the population about the diagnoses and treatment for hypogonadism. Also, organizations are increase awareness about hypogonadism among medical professionals. They release clinical practice guidelines on testosterone therapy. The testosterone replacement therapy market growth at a CAGR of more than (2%) during the forecast period.

The report splits the global Testosterone Replacement Therapy market into theAmericas, Asia-Pacific, Europe, the Middle East, and Africa Region. The Testosterone Replacement Therapy Market report useful for forecasters, marketers, industry specialists & consultants, sales, product managers, Business Development Advisors, Strategy Advisors, manufactures, potential investors, key executive (CEO and COO) to provides a detailed analysis of the key players in the market which provides a company overview, financial overview, service offering, different strategies used by them, and comprehensive SWOT analysis of

Researcher project Testosterone Replacement Therapy market to grow at a CAGR of -2.46% during the period 2019-2023.

Feel Free to Ask Question Before Purchasing the Report

The worldwide and regional Testosterone Replacement Therapy market elements are precisely explained which helps to understand advancing of business trends, drivers, opportunities, and difficulties for the worldwide Testosterone Replacement Therapy market.

Market Overview

Competitive Landscape

The Porters five forces analysis included in the report educates buyer on the current situations along with anticipated future Testosterone Replacement Therapy market size.

Some of the key topics covered in the report include:

Purchase This Report (Price 2500 USD for a Single-User License)

The CAGR of each segment in the Testosterone Replacement Therapy market along with global market (as a whole) is explained with great ease. Also, global and regional Testosterone Replacement Therapy market supply chain analysis provides vital info about producers, distributers and key end-users in the market. It also explains import-export situations, affecting factors, etc. to fully and deeply reveal market situations.

Table of Contents included in Testosterone Replacement Therapy Market Report PART 01: Executive summary

PART 02: Scope of the report

PART 03: Research Methodology

PART 04: Introduction- Market outline

PART 05: Market landscape Market overview, Market size, and forecast, Five forces analysis

PART 06: Market segmentation by end-user industry

PART 07: Market segmentation by application

PART 08: Geographical segmentation Testosterone Replacement Therapy market in APAC, Europe, North America & ROW

PART 09: A Decision framework

For More Chapters Click Here

Contact Us:

Be sure to follow us on Linkedin at @ 360 Market Updates for more on growth research of the market.

Name: Mr. Ajay More

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Testosterone Replacement Therapy Market Research Study by Porters Five Forces Analysis with CAGR of -2.46% & Forecast to 2023 - Joliet Observer

T-levels boosters and sexual performance enhancers usually come at a steep price and you dont even have the guarantee that theyll render good results. The Krygen XL proves that you can have both potent ingredients, and a fair price for reaching your athletic and personal objectives.

This highly anticipated product is formulated with pharmaceutical-grade pro-sexual ingredients, that will boost your sex life into top gear.

The Krygen XLs new and improved formula helps rev your sexual system into its top shape, by helping you achieve harder erections, ramping up your stamina and power in bed, and helping you perform at your peak.

Men with higher levels of the male hormone usually have greater sexual activity. Older men need to secrete more of it for their libido and erectile function to work properly.

Visit the official website and get your hands on the first bottle of the Krygen XL sent out to you for FREE anywhere in the UK!

But its important to note that erectile dysfunction is often due to other conditions or medications rather than low testosterone levels.

Studies show that testosterone therapy can benefit your sexual health and performance. It also shows that there is a maximum level of testosterone before theres no increased response. For men who dont have hypogonadism, increasing your testosterone may not benefit your libido.

So, boiling it down to the basic benefits, The Krygen XL will:

So a formula that makes all of those things possible has become the core interest of the scientific world. This is where the Krygen XL came into play and due to its rapid absorption technology and fast-acting, all-natural formula, it delivers a blend of ingredients that help boost the flow of blood to the penis chambers and expands its holding capacity.

Regular use of the supplement has a positive effect on the size of your male parts, helping you amp up your manhood, both in terms of length and girth.

Krygen XLs extra strength blend helps maximize the attributes mentioned earlier to help you experience a complete transformation of your sexual health, performance, & confidence.

Why choose the Krygen XL and not another testo enhancer?

Disclaimer:

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Krygen XL has now become the best priced and best reviewed male enhancement supplement in the UK - I'm Herald

HTF MI recently introduced study Global Testosterone Replacement Therapy Market Research Report 2019 with in-depth focused approach on qualitative research, describing product Scope and elaborating industry insights and outlook to 2022. The market Study is putting a lot of emphasis on macro-economic issues, influencing factors and key market trends and drivers gearing up and are changing the dynamics of Global Testosterone Replacement Therapy market.

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TheGlobal Testosterone Replacement Therapy Market research studyis designed especially for business strategists, industry executives, marketing, sales and product managers & consultants highlighting the value drivers that may provides a competitive advantage to a business, giving an upper hand in the industry. What differentiation strategist should bring in its product or services understanding the competitors move and consumer behavior to make it more appealing? The report offers a measurable and verifiable method with in-depth analysis of market concentration, new entrants and the technological advancement and market trends in future. Some of the key vendors driving the market are AbbVie, Endo International, Eli lilly, Pfizer, Actavis (Allergan), Bayer, Novartis, Teva, Mylan, Upsher-Smith, Ferring Pharmaceuticals, Kyowa Kirin & Acerus Pharmaceuticals.

Testosterone deficiency, also referred to as hypogonadism, is a common problem among men aged between 40 and 79 years, with some studies stating that nearly 30% of all men worldwide are affected by hypogonadism. As the incidence of testosterone deficiency increases, it is expected that the demand for TRT will also show a simultaneous increase.The global average price of testosterone replacement therapy is in the decreasing trend, from 45.4 USD/Unit in 2012 to 34.9 USD/Unit in 2016. With the situation of global economy, prices will be in decreasing trend in the following five years.The classification of testosterone replacement therapy includes gels, injections, patches and other types, and the proportion of gels in 2016 is about 72%.Testosterone replacement therapy is widely sold in hospitals, clinics and other field. The most proportion of testosterone replacement therapy is sold in clinics, and the consumption proportion is about 43%.North America region is the largest supplier of testosterone replacement therapy, with a production market share nearly 86% in 2016. Europe is the second largest supplier of Testosterone Replacement Therapy, enjoying production market share nearly 9.9% in 2016.North America is the largest consumption place, with a consumption market share nearly 83% in 2016. Following North America, Europe is the second largest consumption place with the consumption market share of 12%. Market competition is intense. AbbVie, Endo International, Eli Lilly, Pfizer, Actavis (Allergan)Bayer, etc. are the leaders of the industry. The top five players together held about 80% of the market in the same year and they hold key technologies and patents, with high-end customers; have been formed in the monopoly position in the industry. The global Testosterone Replacement Therapy market is valued at 1820 million US$ in 2018 is expected to reach 1300 million US$ by the end of 2025, growing at a CAGR of -4.1% during 2019-2025. This report focuses on Testosterone Replacement Therapy volume and value at global level, regional level and company level. From a global perspective, this report represents overall Testosterone Replacement Therapy market size by analyzing historical data and future prospect. Regionally, this report focuses on several key regions: North America, Europe, China and Japan. At company level, this report focuses on the production capacity, ex-factory price, revenue and market share for each manufacturer

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Further to get in-depth view of Market competitive landscape and Size, The Global Testosterone Replacement Therapy market study is segmented by Application/ end users [Hospitals, Clinics & Others], products type [, Gels, Injections, Patches & Other]. Geographically, this report study is segmented into several key Regions such as North America, Europe, China & Japan with revenue, value drivers and growth rate of Testosterone Replacement Therapy to achieve a competitive edge, value proposition and market dominance in lucrative regions across the globe.

Some of the key questions answered in this report: Detailed Overview of Testosterone Replacement Therapy market will help deliver clients and businesses making strategies. Influencing factors that thriving demand and latest trend running in the market What is the market concentration? Is it fragmented or highly concentrated? What trends, challenges and barriers will impact the development and sizing of Global Testosterone Replacement Therapy market SWOT Analysis of each defined key players along with its profile and Porters five forces tool mechanism to compliment the same. What growth momentum or acceleration market carries during the forecast period? Which region may tap highest market share in coming era? Which application/end-user category or Product Type may seek incremental growth prospects? What would be the market share of key countries likeUnited States, France, Germany, UK, China, and Australia & Japan etc.? What focused approach and constraints are holding the Testosterone Replacement Therapy market tight?

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Chapter 1 is related to Executive summary to describe Definition, Specifications and Classification of Global Testosterone Replacement Therapy market, Applications such as Hospitals, Clinics & Others, Market Segment by Regions;Chapter 2, about objective of the report.Chapter 3, to display Research Methodology used for the report, Comprehensive analysis, using market research tools such as Porters and SWOT analysisChapter 4 , to show the Overall Market Analysis, segmentation analysis, characteristics;Chapter 5, 6 and 7, to show the Market size, share and forecast; Five forces analysis (bargaining Power of buyers/suppliers), Threats to new entrants and market condition;Chapter 8 and 9, to show analysis by regional segmentation North America, Europe, China & Japan, comparison, leading countries and opportunities; Regional Marketing Type Analysis, Supply Chain Analysis.Chapter 10, focus on identifying the key industry influencers, consumer behavior, marketing channels, Industry experts and strategic decision makers overview;Chapter 11 and 12, Market Trend Analysis, Drivers, Challenges by consumer behavior and demand.Chapter 13 and 14, describe about the vendor landscape (classification and Market Positioning)Chapter 15, deals with Testosterone Replacement Therapy Market sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix and data source.

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Thanks for reading this article; you can also get individual chapter wise section or region wise report version like North America, Europe or Asia.

About Author:HTF Market Report is a wholly owned brand of HTF market Intelligence Consulting Private Limited. HTF Market Report global research and market intelligence consulting organization is uniquely positioned to not only identify growth opportunities but to also empower and inspire you to create visionary growth strategies for futures, enabled by our extraordinary depth and breadth of thought leadership, research, tools, events and experience that assist you for making goals into a reality. Our understanding of the interplay between industry convergence, Mega Trends, technologies and market trends provides our clients with new business models and expansion opportunities. We are focused on identifying the Accurate Forecast in every industry we cover so our clients can reap the benefits of being early market entrants and can accomplish their Goals & Objectives.Contact US :Craig Francis (PR & Marketing Manager)HTF Market Intelligence Consulting Private LimitedUnit No. 429, Parsonage Road Edison, NJNew Jersey USA 08837Phone: +1 (206) 317 1218sales@htfmarketreport.comConnect with us atLinkedIn|Facebook|Twitter

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Testosterone Replacement Therapy Market Growing Demand, Analysis by Key Players-Bayer, Novartis - The Market Journal

The Testosterone Replacement Therapy Market report provides an unbiased and detailed analysis of the on-going trends, opportunities/ high growth areas, market drivers, which would help stakeholders to device and align Testosterone Replacement Therapy market strategies according to the current and future marketThe Testosterone Replacement Therapy Market report covers the Global market and regional market analysis. The Testosterone Replacement Therapy industry report examines, keep records and presents the worldwide market size of the important players in each region around the globe. Also, the report offers information of the leading market players in the Testosterone Replacement Therapy market.

AccessGlobal Testosterone Replacement Therapy Market Research ReportDetails at: athttps://www.pioneerreports.com/report/301292

About Testosterone Replacement Therapy Industry

Testosterone deficiency, also referred to as hypogonadism, is a common problem among men aged between 40 and 79 years, with some studies stating that nearly 30% of all men worldwide are affected by hypogonadism. As the incidence of testosterone deficiency increases, it is expected that the demand for TRT will also show a simultaneous increase.

The global average price of testosterone replacement therapy is in the decreasing trend, from 45.4 USD/Unit in 2012 to 34.9 USD/Unit in 2016. With the situation of global economy, prices will be in decreasing trend in the following five years.

The classification of testosterone replacement therapy includes gels, injections, patches and other types, and the proportion of gels in 2016 is about 72%.

Testosterone replacement therapy is widely sold in hospitals, clinics and other field. The most proportion of testosterone replacement therapy is sold in clinics, and the consumption proportion is about 43%.

North America region is the largest supplier of testosterone replacement therapy, with a production market share nearly 86% in 2016. Europe is the second largest supplier of Testosterone Replacement Therapy, enjoying production market share nearly 9.9% in 2016.

North America is the largest consumption place, with a consumption market share nearly 83% in 2016. Following North America, Europe is the second largest consumption place with the consumption market share of 12%.

Market competition is intense. AbbVie, Endo International, Eli Lilly, Pfizer, Actavis (Allergan)Bayer, etc. are the leaders of the industry. The top five players together held about 80% of the market in the same year and they hold key technologies and patents, with high-end customers; have been formed in the monopoly position in the industry.

The worldwide market for Testosterone Replacement Therapy is expected to grow at a CAGR of roughly -4.2% over the next five years, will reach 1410 million US$ in 2024, from 1820 million US$ in 2019, according to a new GIR (Global Info Research) study.This report focuses on the Testosterone Replacement Therapy in global market, especially in North America, Europe and Asia-Pacific, South America, Middle East and Africa. This report categorizes the market based on manufacturers, regions, type and application.

The overviews, SWOT analysis and strategies of each vendor in the Testosterone Replacement Therapy market provide understanding about the market forces and how those can be exploited to create future opportunities.

Key Players in this Testosterone Replacement Therapy market are:

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Important application areas of Testosterone Replacement Therapy are also assessed on the basis of their performance. Market predictions along with the statistical nuances presented in the report render an insightful view of the Testosterone Replacement Therapy market. The market study on Global Testosterone Replacement Therapy Market 2018 report studies present as well as future aspects of the Testosterone Replacement Therapy Market primarily based upon factors on which the companies participate in the market growth, key trends and segmentation analysis.

Application of Testosterone Replacement Therapy Market are:

Product Segment Analysis of the Testosterone Replacement Therapy Market is:

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Regions Covered in Testosterone Replacement Therapy Market are:-

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The Testosterone Replacement Therapy Market Report is Prepared with the Main Agenda to Cover the following points:

Report Price: USD 3480

No of Pages in Testosterone Replacement Therapy Market:120

Analysis & Forecast Time Period: 2015-2024

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Analysis of Testosterone Replacement Therapy Market Based On Market Capacity, Technological Advancement, Production and Growth Rate 2024 - eBurban

Male menopause? The first thing that you wonder when you hear this term is can a man experience menopause? Well, if research studies are to be believed, women are not the only ones who go through hormonal changes during old age. Even men experience low levels of hormones as they age. However, in some men, this decline may lead to low testosterone. This is the reason why many experts prefer to call the condition andropause or late-onset hypogonadism (LOH) or androgen deficiency in aging male (ADAM) instead of male menopause.What is andropause?Andropause is derived from Greek words in which Andras means human male and pause means cessation. Hence, andropause is defined as a condition which causes a decrease in sexual satisfaction or a decline in the generalized feeling of well-being due to testosterone deficiency.

What causes andropause?In every man, the level of testosterone hormone tends to decline after the age of 25 and continues to decrease gradually till the rest of the life. The hormone levels decline at a rate of one percent per year with age.

The production of testosterone decreases as a function of age, however, this decrease is not universal. Moreover, the rate of decline in hormonal levels is different in different individuals. In most men, the gradual decline of the hormonal levels doesnt seem to have any effect on their sexual performance. However, in some, it can lead to a drastic fall in sex drive or libido. The rate of decline is affected by chronic health problems such as obesity, illness, emotional stress, medication and poor lifestyles.

At what age does andropause begin?Andropause can occur between 40-60 years of age. Sometimes, younger men may also experience andropause symptoms due to certain health issues.

What happens during andropause?One of the reasons for a decline in the testosterone level with age is due to a reduction in the mass of Leydig cells present in the testicles. These cells play a key role in the production of androgen (testosterone) when stimulated by the luteinizing hormone (LH). It could also be due to a dysfunction in the pituitary and hypothalamic equilibrium that control the secretion of LH. This lead to abnormally low levels of LH, which in turn causes low testosterone production. Testosterone deficiency can affect the psychological, sexual, emotional, and physical well being.

Here are the common signs and symptoms of male menopauseLow sex drive: Testosterone plays an important role in maintaining your sex drive and function. Hence, low levels of this hormone can lead to loss of libido. Moreover, in the long run, it can also cause difficulty in achieving an erection, increasing the risk of erectile dysfunction. The diagnosis of late-onset hypogonadism is based on the symptoms associated with sexual health such as loss of libido, morning penile erection, and erectile dysfunction.

Depression: Studies have shown that depression can be associated with low concentrations of testosterone in older men. This is because testosterone helps to regulate mood.

Fatigue: It is one of the common symptoms of andropause which may occur due to low levels of testosterone or hypotestosteronemia. Testosterone is needed by the body to maintain energy levels and lack of energy leads to fatigue.

Abdominal obesity: Aging in men is associated with fat deposition in the central and upper body. This could be due to the decline in the concentration of growth hormones with age. These hormones also play a key role in the maintaining the levels of the sex hormonebinding globulin (SHBG) and testosterone. Hence, a decline in the growth hormones increases SHBG levels and causes testosterone deficiency with age.

As testosterone slows down the buildup of fat in the abdominal region, the deficiency of the hormone causes accumulation of belly fat.

Low bone density: A significant reduction in the testosterone levels in young men can accelerate bone loss and osteoporosis. In older men, normal levels of testosterone are needed to maintain bone mineral density, especially at the spine and hip region. Hence, low levels of testosterone in older men can increase the risk of hip fracture due to low bone mineral density.

Insomnia: Testosterone also helps to regulate sleep patterns. If the testosterone level reduces, it can lead to disturbed sleep and insomnia. And with age, this can further cause irritability, daytime sleepiness, and difficulty in staying asleep.

In addition to these symptoms, testosterone deficiency can lead to impaired cognitive function, reduced muscle mass and strength, and increased risk of cardiovascular complications.

How is andropause treated?If the symtptoms of andropause are not affecting your day to day life and can be alleviated by adopting a healthy lifestyle with a nutritious diet, exercise, and proper sleep, then you may not require any treatment.

However, if you are experiencing any severe symptoms, then you must discuss the same with your doctor.

Studies have reported that testosterone replacement therapy (TRT) can help improve symptoms such as fatigue, decreased libido, and depression. The other benefits of TRT include:

-Improved body composition and muscle strength

-Improved bone mineral density

-Improved cognitive function

References:

1. Nandy PR, Singh DV, Madhusoodanan P, Sandhu AS. Male Andropause : A Myth or reality. Med J Armed Forces India. 2008 Jul;64(3):244-9.

2. Singh P. Andropause: Current concepts. Indian J Endocrinol Metab. 2013 Dec;17(Suppl 3):S621-9.

3. Gould DC, Petty R. The male menopause: does it exist?: for: some men need investigation and testosterone treatment. West J Med. 2000 Aug;173(2):76-8.

Read the rest here:
Andropause or male menopause: Causes and symptoms - Times of India

WHEN Cassie Hylans gave birth to baby Freddie-Philip it was extra special.

Not just because it was the first time she had met her son, but because she knew he wouldn't live much longer.

2

But nothing could have prepared the 27-year-old and her partner Steven Hale, 25, for that heartbreaking moment.

Cassie, from Burton upon Trent, Staffordshire, told DerbyshireLive: "As he took his last breath my partner dropped to his knees and screamed.

"It was the hardest thing you could ever go through.

"It was so surreal just watching it happen and not being able to do anything to help keep him alive."

The couple discovered at their 20-week scan that Cassie has a genetic condition called Kallmann Syndrome there was a 50 per cent chance it would be passed onto her baby.

It meant that he had no fluid around him and his kidneys were covered in cysts.

Cassie, a cleaner, said she was given some options - all of which she refused - and decided to continue with the pregnancy.

She said:"We knew he wouldnt survive but at the end of the day he was still my baby and I was growing him. I wanted to see his face and give him a cuddle. He was ours."

We knew he wouldnt survive but at the end of the day he was still my baby and I was growing him

Freddie-Philip was born breathing on November 29, 2016, and the family were able to spend "four hours of unexpected precious time" with him.

Cassie said:"I gave birth on the normal labour ward and we took tonnes of pictures, had cuddles with him and the vicar came and gave him a blessing. We still talk to her to this day.

"The nurses were amazing and gave us two teddies and a keepsake memory box with his hand and footprints in. It was really special."

The family were supported by staff at the Snowdrop Suite, a special unit for bereaved parents at Burton's Queen's Hospital.

Cassie said: "My mum and partner were there with me the whole way through and I cant remember that much because it was all a blur.

"We could spend as much time with him as we wanted the nurses left us to it and we were at the end of the labour ward so we didnt have to see new mums walking around with their babies."

The pair were able to keep Freddie-Philip with them in a special cuddle cot, but when the time came to return home, the new parents were devastated.

What is Kallmann syndrome?

Kallmann syndrome is a rare geneitc condition, characterised by delayed or absent puberty and an impaired sense of smell.

It is a form ofhypogonadotropic hypogonadism, which is a condition resulting from a lack of production of certain hormones that direct sexual development.

Males often have an unusually small penis and undescended testes and most don't develop secondary sex characteristics at puberty - such as the growth of facial hair, deeping of the voice.

In females the start of monthly periods and breast development is usually delayed or doesn't happen at all.

Without treatment, most affected men and women are unable to have biological children.

Kallmann syndrome can have a wide variety of additional signs and symptoms including a failure of one kidney to develop, abnormalities of bones in the fingers or toes, a cleft lip or palate, abnormal eye movements, hearing loss, and abnormalities of tooth development.

Some affected individuals have a feature called bimanual synkinesis, in which the movements of one hand are mirrored by the other hand.

It's more common in males than females.

Source: Genetic Home Reference

Cassie said: "It was so hard to go home.

"Everything was normal and his bedroom was fully kitted out waiting for him.

"Going there without him in our arms was heartbreaking and it was like our world had stopped."

Cassie said the tragedy did not put the couple off having another child and when they got pregnant with Bobby, who is now aged 23 months, they were "so happy."

2

She said: "The pregnancy was fine, but he only has one kidney.

"I was overwhelmed when Bobby was born.

"I felt heartbroken that he would never get to meet his big brother and he was the spitting image of Freddie-Philip.

"November will always be a very bittersweet month for me as Bobby was born at the start and Freddie was born at the end."

Cassie is full of praise for the midwives who cared for her following Freddie-Philip's death and said they were still welcome to access support at the Snowdrop Suite.

She said: "That time was so precious and without the staff at the hospital and the specialist suite we would not have been able to make such special memories.

LITTLE FIGHTER Mystery bone marrow donor saved our baby's life and gave my family a future

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BGT BABY! Britain's Got Talent judge Alesha Dixon has given birth to her second child

"Baby loss awareness is so important and it should not be a taboo subject. I would rather people talk about it then ignore that it happened.

"Freddie-Philip was still here. He is still a person. He is my son."

The couple have shared their story to mark Baby Loss Awareness Week, which ends today.

Here is the original post:
We screamed as our baby boy took his last breath at four hours old after I gave birth knowing hed die - The Sun

WHEN Cassie Hylans gave birth to baby Freddie-Philip it was extra special.

Not just because it was the first time she had met her son, but because she knew he wouldn't live much longer.

2

But nothing could have prepared the 27-year-old and her partner Steven Hale, 25, for that heartbreaking moment.

Cassie, from Burton upon Trent, Staffordshire, told DerbyshireLive: "As he took his last breath my partner dropped to his knees and screamed.

"It was the hardest thing you could ever go through.

"It was so surreal just watching it happen and not being able to do anything to help keep him alive."

The couple discovered at their 20-week scan that Cassie has a genetic condition called Kallmann Syndrome there was a 50 per cent chance it would be passed onto her baby.

It meant that he had no fluid around him and his kidneys were covered in cysts.

Cassie, a cleaner, said she was given some options - all of which she refused - and decided to continue with the pregnancy.

She said:"We knew he wouldnt survive but at the end of the day he was still my baby and I was growing him. I wanted to see his face and give him a cuddle. He was ours."

We knew he wouldnt survive but at the end of the day he was still my baby and I was growing him

Freddie-Philip was born breathing on November 29, 2016, and the family were able to spend "four hours of unexpected precious time" with him.

Cassie said:"I gave birth on the normal labour ward and we took tonnes of pictures, had cuddles with him and the vicar came and gave him a blessing. We still talk to her to this day.

"The nurses were amazing and gave us two teddies and a keepsake memory box with his hand and footprints in. It was really special."

The family were supported by staff at the Snowdrop Suite, a special unit for bereaved parents at Burton's Queen's Hospital.

Cassie said: "My mum and partner were there with me the whole way through and I cant remember that much because it was all a blur.

"We could spend as much time with him as we wanted the nurses left us to it and we were at the end of the labour ward so we didnt have to see new mums walking around with their babies."

The pair were able to keep Freddie-Philip with them in a special cuddle cot, but when the time came to return home, the new parents were devastated.

What is Kallmann syndrome?

Kallmann syndrome is a rare geneitc condition, characterised by delayed or absent puberty and an impaired sense of smell.

It is a form ofhypogonadotropic hypogonadism, which is a condition resulting from a lack of production of certain hormones that direct sexual development.

Males often have an unusually small penis and undescended testes and most don't develop secondary sex characteristics at puberty - such as the growth of facial hair, deeping of the voice.

In females the start of monthly periods and breast development is usually delayed or doesn't happen at all.

Without treatment, most affected men and women are unable to have biological children.

Kallmann syndrome can have a wide variety of additional signs and symptoms including a failure of one kidney to develop, abnormalities of bones in the fingers or toes, a cleft lip or palate, abnormal eye movements, hearing loss, and abnormalities of tooth development.

Some affected individuals have a feature called bimanual synkinesis, in which the movements of one hand are mirrored by the other hand.

It's more common in males than females.

Source: Genetic Home Reference

Cassie said: "It was so hard to go home.

"Everything was normal and his bedroom was fully kitted out waiting for him.

"Going there without him in our arms was heartbreaking and it was like our world had stopped."

Cassie said the tragedy did not put the couple off having another child and when they got pregnant with Bobby, who is now aged 23 months, they were "so happy."

2

She said: "The pregnancy was fine, but he only has one kidney.

"I was overwhelmed when Bobby was born.

"I felt heartbroken that he would never get to meet his big brother and he was the spitting image of Freddie-Philip.

"November will always be a very bittersweet month for me as Bobby was born at the start and Freddie was born at the end."

Cassie is full of praise for the midwives who cared for her following Freddie-Philip's death and said they were still welcome to access support at the Snowdrop Suite.

She said: "That time was so precious and without the staff at the hospital and the specialist suite we would not have been able to make such special memories.

WORKING MUM I gave birth on the hospital ward I run it was like Carry On Nurse

GIRL TALK Mums who are stressed during pregnancy are more likely to give birth to a girl

OH BABY! Mum-to-be slammed for placing used pregnancy test on cake announcing her baby news

WISE WORDS The 7 things you should NEVER say to parents who've lost a baby & how to help

BGT BABY! Britain's Got Talent judge Alesha Dixon has given birth to her second child

"Baby loss awareness is so important and it should not be a taboo subject. I would rather people talk about it then ignore that it happened.

"Freddie-Philip was still here. He is still a person. He is my son."

The couple have shared their story to mark Baby Loss Awareness Week, which ends today.

Continued here:
We screamed as our baby boy took his last breath at four hours old after I gave birth knowing hed die - The Scottish Sun

The globalmarket for testosterone replacement therapyis characterized by the presence of a large number of small and large scale manufacturers. All of the manufacturers have been steadfast in filling the meagre market gap in order to enhance their prospects of growth. Furthermore, research and development has been the central characteristic of al the market players operating in the global market.

In 2015, it was found that 80% of the total market share was held by the top five market vendors with AbbVie Inc. taking the lead. The large scale vendors are focusing on establishing an iconic brand for their product by resorting to rigorous marketing and advertising tactics. The smaller companies are expected to concentrate on capturing the local and regional markets to sustain themselves in the current scenario of stiff competition.

A negative implication for the leading market players in recent times has been the loss of patents for their products. This has not only plundered them of revenues but has also affected the workflow of these companies. The market players are expected to launch awareness campaigns about testosterone replacement therapies in order to educate and inform the consumers. Hence, the market for testosterone replacement therapies is expected to witness the emergence of several new trends and opportunities over the forthcoming years. Some of the key players in the global testosterone replacement therapy market include Bayer AG, Endo Pharmaceuticals, Inc., Novartis AG, and Allergen plc.

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The CAGR for theglobal testosterone replacement therapy marketis estimated to be -4.20% over the period between 2016 and 2024. The negative growth rate of the global market is expected to take the market value from US2.0 bn in 2015 to a decreased value of US$1.3 bn by 2024-end.

High Incidence of Hypogonadism to Drive Market Demand

Research studies suggest that around 30% of all men suffer from testosterone deficiency, which has driven demand within the global market for testosterone replacement therapy. Furthermore, the population demographic of men in the age range of 40-79 years is more likely to suffer from testosterone deficiency. The need for mutation or having an offspring amongst men in the aforementioned age range has driven demand within the global market. Moreover, the geriatric population has been on a rise, which underhandedly contributes to market growth. Several campaigns aimed at educating people about the benefits of testosterone replacement therapy have been an important propeller of demand within the global market. It is anticipated that more people suffering from testosterone deficiency would resort to these therapies over the coming years.

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Side Effects of Testosterone Replacement Therapy Could Obstruct Market Growth

Despite the rising awareness amongst the masses about the advantages of testosterone replacement therapies, the market growth is hindered by the apprehension of the people. The chances of developing metabolic disorders are higher in men who undergo testosterone replacement therapies. Furthermore, the risk of developing cardiovascular diseases also discourages people from resorting to testosterone replacement therapies. The FDA has also cautioned people about the use of such therapies by issuing strict warnings, which has further obstructed the growth of the global market.

See original here:
Testosterone Replacement Therapy Market: An Insight on the Important Factors and Trends Influencing the Market - Online News Guru

An individuals experiences during early life can influence their risk for disease as an adult. Dr. David Barker first postulated this in the 1980s following his observations that infants born with low birth weight were at significantly increased risk for developing cardiovascular disease as adults. This idea was controversial at the time because it challenged the conventional thinking that unhealthy lifestyle was the primary cause of cardiovascular disease. However, subsequent epidemiologic studies confirmed Barkers findings and the concept that early-life experiences are an important determinant of adult disease risk became known as the Barker hypothesis.

While the Barker hypothesis was derived from evidence linking foetal malnutrition to cardiovascular disease risk in adulthood, the concept has since expanded to include a broader spectrum of risk factors, diverse disease states targeting different organ systems, and developmental periods extending beyond gestation. In recognition of this paradigm shift, the Barker hypothesis was renamed the developmental origins of health and disease (DOHaD) hypothesis. Several decades of DOHaD research have identified at least four categories of early-life risk factors: the nutritional status of the pregnant woman and young child, psychosocial stress, immunological stress, particularly infection during pregnancy, and chemical exposures. It is now also appreciated that the risk of most, if not all, adult-onset diseases are influenced by early-life stress, but only if exposures occur during specific periods of development. These high-risk periods are referred to as critical periods or critical windows of development, and these vary depending on the early-life insult and the target organ. For many organ systems, however, the foetal period is the primary critical window.

The nervous system is particularly vulnerable to early-life stressors, perhaps because human brain development continues after birth, throughout early childhood and into adolescence. To date, research supports an association between early-life environmental insults and increased risk of neuropsychiatric disorders like schizophrenia, demyelinating diseases, such as multiple sclerosis (MS), and neurodegenerative diseases, such as Alzheimers and Parkinsons diseases (AD and PD, respectively). Whether an early-life stressor increases an individuals risk for neuropsychiatric or neurologic disease depends on numerous factors. What is the type and magnitude of the stressor? Is the insult continuous, intermittent, or a single isolated incident? What is the timing of exposure relative to critical windows of development, which vary across different brain regions? Does the affected individual carry genes that confer increased susceptibility or increased resistance to the adverse effects of the stressor? Sex also influences the impacts of early-life stressors, perhaps because gonadal sex hormones influence many of the organisational aspects of neurodevelopment. Examining the sex-specificity of early-life stressors may be important for understanding why many neurological and neuropsychiatric diseases exhibit a sex bias in their incidence and clinical profile.

Maternal infection during pregnancy is strongly linked to increased risk of schizophrenia, though it does not appear that any specific pathogen or class of pathogens is responsible. While there is disagreement as to whether a specific trimester of pregnancy is most vulnerable, the pro-inflammatory environment created by maternal infection is thought to alter the pattern of cellular connections made in the foetal brain, laying the groundwork for altered behavior in adulthood. Emerging evidence also suggests that early-life exposure to the lead (Pb) may increase risk for schizophrenia, particularly in individuals that express a mutation in the disrupted in schizophrenia 1 (DISC-1) gene, a gene that is strongly associated with schizophrenia and related mental disorders. AD is the most common cause of progressive dementia in elderly adults and it is rapidly increasing in global incidence; PD is the second most common neurodegenerative disease after AD. Only a small percentage of cases of either disease can be attributed to solely genetic causes, supporting a role for environmental factors in determining individual risk. Recent studies have identified early-life risk factors for AD and PD, including low birth weight, premature birth, living in a rural area, low socioeconomic status during childhood, and prenatal or early childhood exposures to environmental pollutants, including heavy metals, pesticides, and air pollution. Air pollution has also been linked to an increased risk of MS.

A key question in the field is how do early-life events influence risk of adult-onset disease? It is believed that environmental stressors disrupt the organisational patterning and/or function of the developing brain by altering cell numbers or interfering with the differentiation of neurons or glial cells. So why do these changes not manifest as functional deficits or disease until adulthood? One explanation is that the affected cells are not functional until later in life. For example, exposure of the developing brain to high concentrations of the food additive monosodium glutamate (MSG) causes excessive death of neurons in the hypothalamus by triggering apoptosis, a form of programmed cell death. However, functional deficits associated with the foetal loss of these hypothalamic neurons (hypogonadism and infertility) become evident only in adolescence when the neuroendocrine function of these neurons is normally activated. Alternatively, the adverse impacts of the early-life stressor are masked or initially attenuated due to compensatory mechanisms or plasticity of the brain. However, these developmental perturbations predispose the individual to neural deficits following subsequent insults, such as chemical exposure, disease, or aging due to decreased brain reserve capacity. This phenomenon has been demonstrated in both animal models and humans following developmental exposures to methyl mercury or pesticides.

In summary, the experimental evidence indicates that early-life insults can fundamentally change the trajectory of brain development, thereby diminishing the ability of the brain to protect against subsequent insults, which increases susceptibility to disease in adulthood. A significant challenge in the field is to identify early-life stressors that increase adult-onset disease in humans. Detecting effects in the human population is difficult because the effects do not manifest until well after the developmental exposure. However, the effort to identify these associations merits investment of research dollars because preventing disease by identifying and reducing or eliminating risk factors is more effective than treating disease in terms of both individual and societal costs.

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Environmental exposures during early life influence adult disease risk - Open Access Government