Category Archives: Testosterone

Biotechnology company Halozyme Therapeutics, Inc. (Nasdaq: HALO) is set to acquire pharmaceutical company Antares Pharma, Inc. (Nasdaq: ATRS) in a deal that will create a leading drug delivery and specialty product company and diversify revenue, SEC filings say.

Pursuant to the agreement, Halozyme will acquire Antares for $5.60 per share in cash, for a total valuation of approximately $960 million. This will be funded with existing cash on hand and new sources of debt.

As stated in the filings, the transaction will have financial and strategic benefits. In particular, the deal will have immediate revenue and non-GAAP earnings accretion and it will have long-term financial benefits; new business development will enhance long-term growth consistent with strategic goals and priorities; there will be opportunities for large market expansion in high-revenue sectors; Antares products are high-growth and durable with a proven track record; and the companies have complementary platforms.

According to Antares website, its medicines include Xyosted, the first and only weekly auto-injector testosterone therapy; Tlando, an oral treatment for testosterone replacement therapy; and Nocdurna is the first and only sublingual tablet for the treatment of nocturia due to nocturnal polyuria in adults who wake up at least 2 times per night to urinate.

The addition of Antares, particularly with its best-in-class auto injector platform and specialty commercial business, augments Halozymes strategy, further strengthens our position as a leading drug delivery company and extends our strategy to include specialty products, Dr. Helen Torley, president and chief executive officer of Halozyme, said in a press release.

Accordingly, the deal is expected to accelerate Halozymes top- and bottom-line growth through 2027, with additional drivers of growth past 2027 like new products, therapies and partnerships. As noted in the filings, Antares business consists of a best-in-class, differentiated, royalty revenue generating auto injector platform business that offers broad licensing opportunity, and a commercial business, with three proprietary commercial products. Halozyme will purportedly expand these opportunities via its ENHANZE platform.

Furthermore, Halozyme anticipates expanding Antares core platform and capabilities to drive growth and revenue, as well as adding intellectual property protections. Additionally, Antares auto injector platform is suitable for use with a broad range of medications. As a result, this versatility enables a highly licensable business with significant revenue upside.

We are pleased to have reached this agreement with Halozyme, as this transaction showcases the value of Antares highly complementary business, provides our shareholders with attractive and certain value, and brings together industry-leading expertise and drug delivery platforms to accelerate growth and create new opportunities, Robert F. Apple, president and chief executive officer of Antares, said in a statement.

Upon completion, Halozyme expects a strong balance sheet with less than 3.5x net debt-to-EBITDA ratio at the time of transaction close this ratio is expected to decrease after consummation.

The reverse triangular merger has been unanimously approved by both companies respective board of directors.

The April 13 deal is subject to customary closing conditions and expected to close in the first half of 2022.

Antares is represented by Skadden, Arps, Slate, Meagher & Flom LLP and its financial advisor is Jeffries LLC. Halozyme is represented by Weil, Gotshal & Manges LLP and its financial advisors are BofA Securities and Wells Fargo Securities LLC.

Prior to the announcement, Halozyme and Antares stock was valued at $41.62 and $3.74, respectively on April 12. When it was announced on April 13, Halozyme and Antares stocks were valued at $41.46 and $5.58, respectively. A few days later, on April 18, Halozymes stock closed at $41.74 and Antares stock closed at $5.57.

See the article here:
Halozyme Therapeutics to Acquire Antares Pharma for $960M, Eyeing its Auto Injector Platform - Law Street Media

Member Article

More than 90% of our male clients are entrepreneurs, business leaders and managers of SMEs, who have identified and presented with a number of the core symptoms of the male menopause.

Ross Tomkins Co-Founder Newcastle Upon Tyne Based Alphagenix

Some of the UKs leading male entrepreneurs and small medium enterprise (SME) business leaders are turning to hormonal bio-hacks in order to boost and optimise their performance as part of an increasing trend in maximising performance in the business world.

Entrepreneurs and business leaders are part of a new trend of men now looking to tackle the male menopause also known as the andropause head-on and to improve hormonal well-being in their business and personal lives. Many are educating themselves on the subject, being diagnosed and taking TRT (Testosterone Replacement Therapy) as part of an overall wellness plan of incremental diet, lifestyle, health and well-being changes aimed at enhancing and improving their mental health and physical well-being. The benefits to entrepreneurs and business owners are immense and proven;

Improved clarity of thought and decision makingOptimising physical and mental performanceBoosting energy levelsMaintaining a competitive edgeIncreasing drive and focusIncreased levels of fitnessEnhanced mood and well being

Ross Tomkins, author, healthcare investor and qualified physiotherapist, is one of those successful business owners who 11 years ago was diagnosed as suffering from the male menopause and low testosterone when he was 32 years old. He calls his diagnosis and treatment using testosterone replacement therapy (TRT) life-changing both in his personal and business life and a fundamental component of his business success today.

Ross decided to set up Alphagenix to raise awareness of his own hormonal journey with the andropause. He wanted to educate men on how they could improve their hormonal health and well-being. Alphagenix specialises in the education, diagnosis and treatment of the male menopause and is also one of the leading experts in TRT. Conscious of his own experiences with doctors and treatment, Ross wanted to create a unique, personalised and quality-led service though Alphagenix, which not only provides education, investigation, diagnosis and treatment, but then ensures continual monitoring using periodic blood tests and consultations. As someone with a 20-year career in the healthcare and well-being sector - and who has been on the andropause journey himself - he built the core foundations of Alphagenix on first-hand knowledge and personal experience.

Ross Tomkins said:

We have seen a huge surge of interest in what we do at Alphagenix from entrepreneurs, CEOs and business leaders wanting to learn more about the male menopause and to get diagnosed. More than 90% of our male clients are entrepreneurs, business leaders and managers of SMEs, who have identified and presented with a number of the core symptoms of the male menopause. Many of those clients are looking to optimise their performance and health in their day-to-day business lives. They want to have increased energy levels, better clarity, of focus and concentration in their work and decision-making processes and to ultimately to improve their overall health and well-being.

The male menopause has for far too long been regarded as a myth, but increasingly the issue of mens hormonal health is being taking much more seriously in the workplace and business culture because of the huge impact it can have on men in their day-to-day lives and their personal relationships. The male menopause has also been widely acknowledged to have a huge adverse impact on personal performance in the business world. It can not only affect personal performance, but contribute to a reduced sense of well-being, concentration, mood and energy levels, all of which ultimately impact performance in the business and workplace. Symptoms include

Brain fog, difficulty in rememberingLack of focus and concentration in decision makingLow energy levelsLack of sex driveFatigue and tiredness at workReduced muscle strengthIncreased body fatOsteoporosisDepression

Men are now seeking better knowledge and education on the subject, getting diagnosed, being tested and starting TRT as part of a wider bio-hack tool kit to optimise their performance and health alongside diet, meditation and exercise. At the core of the diagnosis is a low testosterone count, which leads to a wide range of symptoms, including low energy, reduced muscle mass or muscle weakness, poor focus, depression, obesity, insomnia, lack of libido, lack of motivation and lowered self-confidence.

Ross can speak first hand of his experience as someone who was diagnosed with the male menopause at a relatively young age. Since his first diagnosis and treatment, Ross has gone on to become a highly successful investor and businessman in the healthcare, well-being and property sectors. Ross started six businesses, sold four of them, invested and acquired a further six companies. He cites his diagnosis and subsequent treatment as ground-breaking, giving him a new lease of life. Since his diagnosis 11 years ago, Ross has led a full and active life with a beautiful family.

Ross Tomkins added:

Traditionally, we associate low testosterone with men over 55 generally, but alarmingly there are more and more young gentlemen being diagnosed in their thirties, as I was. We have a number of clients at Alphagenix who are in their thirties and our youngest client is 29. It is absolutely vital that men do take this seriously and educate themselves on the issue, get tested and diagnosed.

For any man at the top of his profession either in business or as an entrepreneur its really important to look after your physical and mental health. There are so many wider issues associated with the male menopause that can affect a mans health, well-being and relationship.

Ross was first diagnosed at the age of 32, after having encountered a number of symptoms that included aching joints, a complete lack of focus and brain-fog. His GP at the time suggested that perhaps his symptoms were all in his head, prompting Ross to search for a private physician with an interest in mens health. After a 60-minute consultation, Ross was diagnosed with low testosterone and an iodine deficiency. The diagnosis was confirmed by tests and Ross began taking TRT and an iodine supplement. In a matter of days, Ross felt the huge benefits of his treatment, while the private physician made further lifestyle recommendations and changes, including a specific diet.

We are not claiming that TRT is a magic formula for being successful in business, but many entrepreneurs, business owners and leaders attest to the fact it has made a huge difference in their personal lives and their performance in business and to their day-to-day drive for success. They have more energy, more clarity and focus and feel so much more energised in their everyday lives. This is really critical when your making key decisions in your business. If you are on top of your health, optimising your sleep, diet and exercise and taking TRT, then its only natural to expect a positive mental and physical outlook on life.

Alphagenix has a team of private doctors provided by BMP Medical Ltd., who are all UK-trained and registered with the General Medical Council (GMC). They continue to work in the NHS and private consulting. Alphagenixs services are registered and regulated by the Care Quality Commission in the UK.

Clinical lead for Alphagenix is Dr Usman Sajjad, a GP with a special interest in sports exercise medicine, as well as the andropause. Having qualified as a doctor in 2014 from the University of Leeds and as a GP in 2020, Dr Sajjad has worked in top-level sports such as Premier League football, rugby and professional boxing. He is currently employed as the personal doctor for several high-profile professional boxers, some of whom are current world champions.

Having suffered personally from severe hypogonadism for a lot of 2020, Dr Sajjad understood how a low testosterone impacted physical and mental health. He also competed as a superheavyweight amateur boxer from 2010 to 2014. His personal experience and recovery motivated him to join Alphagenix to help other men who are suffering with similar issues. He is an academic member of the European Academy of Andrology and also runs his own The Doctor Uz Podcast show, in which he touches on a wide variety of subjects and interviews notable guests.

Ross Tomkins concluded:

It is absolutely vital that we have better hormonal education and treatment of the menopause both for men and women. Men need to better understand how the menopause affects their female partners and women need to also understand that their male partners might well be masking their symptoms for fear of embarrassment or feeling emasculated. We also need much better education and understanding within the business worlds and the workplace.

We are making small steps, but we have a long way to go in understanding and treating mens health in general. We have campaigns and awareness for testicular cancer and prostate cancer, yet we dont have any awareness of the male menopause, which is also linked to both prostate and testicular cancer. A huge part of the problem and lack of education around the subject lies in the fact that men do not openly talk about their health to each other or open up to their partners. We tend to have the standard response: Im fine its nothing to worry about. Id like to have the male menopause talked about in the same way we now recognise mental health.

This was posted in Bdaily's Members' News section by i5 Media .

The rest is here:
Losing Your Business Mojo? Business Leaders & Entrepreneurs Using Testosterone Replacement Therapy To Tackle Male Menopause In The Workplace -...

Estosterone undecanoate (Tlando; Antares Pharma, Inc) is indicated as testosterone replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone in adult patients.

The FDA has approved the oral drug estosterone undecanoate (Tlando; Antares Pharma, Inc) for testosterone replacement therapy (TRT) for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult patients.

The FDA approval of Tlando brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients. We have recently expanded our commercial organization to 108 sales representatives and expect to leverage our relationships with urologists and endocrinologists to drive adoption of Tlando, said Robert F. Apple, president and chief executive officer of Antares Pharma, in a press release. This approval also reinforces the opportunity for Antares to continue to drive share gains in the TRT market with both Tlando and Xyosted and support our future growth with an expanded commercial portfolio. We look forward to launching Tlando commercially, which will provide a complementary treatment option to patients and clinicians in the second quarter of this year.

Male hypogonadism is an endocrine disorder in which the body is unable to produce enough testosterone. The condition is estimated to affect approximately 35% of men 45 years of age and older, as well as 30% to 50% of men with obesity or type 2 diabetes.

Tlandois indicated for TRT in adult males with conditions such as primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). The safety and efficacy of Tlandohas not been established in males under 18 years of age.

Antares Pharma said it will seek to launch Tlandoin the second quarter of 2022 to provide a complementary treatment option for patients and clinicians

We believe Tlandos oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options. As we prepare for the commercial launch, we look forward to our sales representatives detailing a differentiated portfolio of products consisting of Xyosted, Tlando and Nocdurna that will continue to deliver solutions for improved patient care, said Joe Renda, senior vice president, Commercial of Antares Pharma, in a press release.

Reference

Antares Pharma Announces FDA Approval Of TLANDO, an Oral Treatment for Testosterone Replacement Therapy Commercial launch expected in 2Q 2022. Antares Pharma. [news release]. March 29, 2022. https://www.biospace.com/article/releases/antares-pharma-announces-fda-approval-of-tlando-an-oral-treatment-for-testosterone-replacement-therapycommercial-launch-expected-in-2q-2022/

Read the original here:
FDA Approves Oral Testosterone Replacement Therapy for Hypogonadism - Pharmacy Times

Medina, OH: The safe and effective hormone therapy at Advanced Age Management targets people with various health issues, including weight gain, tiredness, declining sex drive, and depressed mood. For men over 35 years, these health problems could result from low testosterone levels and other hormonal issues. That is why the trt center is happy to work with all symptomatic patients. The wellness center for men is well-equipped to offer Hypothyroidism Therapy, Hormone Replacement Treatment, Erectile Dysfunction Treatment, and Low T Symptoms. Other treatments offered by Advanced Age Management are Testosterone Replacement Therapy and Growth Hormone Releasing and Medical Peptide Therapy.

For over 15 years, Advanced Age Management has served patients from varied backgrounds, including professional athletes. The advanced treatment facility for men is owned and managed by John Kocka M.D., a board-certified physician and age management specialist. Dr. Kocka is board-certified in Age Management from the American Academy of Anti Aging, Age Management Medical Group and physician-certified by the Cenegenics Medical Institute. He is a member of the International Hormone Society, International Society for the Study of the Aging Male and the American College of Sports Medicine. He is a trusted authority in testosterone replacement therapy.

Hormone Replacement Therapy (HRT) is a process of replenishing naturally produced hormones among men. The process usually happens when men age and may lead to increased pain and aches, insomnia, sleep disturbance, and slower metabolism, which often leads to increased body fat and other health complications. The pros of choosing Advanced Age Management include an opportunity to work with a leading doctor, access to comprehensive and tailored treatment solutions, and ongoing support from in-house physicians.

The HRT treatment for men plays a vital role in revitalizing sex drive, building muscle mass, and promoting the production of red blood cells. For men with low testosterone levels, the treatment can go a long way to promote vitality, health, and enhance the quality of life. Dr. Kocka begins treatment by creating a custom treatment solution. Treatments such as medina testosterone replacement therapy are supplemented by healthier habits, such as exercise, improved diet, and quality sleep.

Another critical treatment offered by Advanced Age Management is Vitamin B12 and other Amino Acid Treatments. The cost of treatment varies depending on the type of treatment and personalized medical treatment plans. Patient reviews posted on the website paint a picture of an advanced treatment facility that is highly recommended for its friendly and knowledgeable staff and excellent treatment facilities.

To get in touch with the treatment experts at Advanced Age Management, call 216.471.8220, or visit them at 1188 Medina Rd R18, Medina, OH, 44256. The clinic is keen to address health concerns and improve quality of life. They operate Monday to Friday at different hours, between 8:00 am to 5:30 pm.

Media Contact

Company NameAdvanced Age ManagementContact NameJohn Kocka, M.D.Phone216.471.8220Address1188 Medina Rd R18CityMedinaStateOHPostal Code44256CountryUnited StatesWebsitehttps://www.lowtohio.com/

Read the original:
About the Advanced Age Management Medina Testosterone Replacement Therapy in Medina, OH - Digital Journal

Among patients with diabetes, women are just as likely as men to suffer from sexual dysfunction, but their issues are overlooked, with the narrative focusing mainly on the impact of this issue on men, say experts.

Women with diabetes can experience reduced sexual desire, painful sex, reduced lubrication, and sexual distress, increasing the risk of depression, and such issues often go unnoticed despite treatments being available, said Kirsty Winkley, PhD, diabetes nurse and health psychologist, King's College London, UK.

There is also the "embarrassment factor" on the side of both the healthcare professional and the patient, she said in a session she chaired at the Diabetes UK Professional Conference 2022 this week. Many women with diabetes "wouldn't necessarily know" that their sexual dysfunction "is related to their diabetes," she told Medscape Medical News.

For women, sexual health conversations are "often about contraception and pregnancy," as well as menstrual disorders, genital infections, and hormone replacement therapy. "As healthcare professionals, you're trained to focus on those things, and you're not really considering there might be sexual dysfunction. If women aren't aware that it's related to diabetes, you've got the perfect situation where it goes under the radar."

However, co-chair Debbie Cooke, PhD, health psychologist at the University of Surrey in Guildford, explained that having psychotherapy embedded within the diabetes team and "integrated throughout the whole service" means that the problem can be identifiedand treatment offered.

The issue is that such integration is "very uncommon" and access needs to be improved, Cooke told Medscape Medical News.

Jacqueline Fosbury, psychotherapy lead at Diabetes Care for You, Sussex Community NHS Foundation Trust, said that "intimate activity is clearly beneficial for emotional and physical health," as it is associated with increased oxytocin release, the burning of calories, better immunity, and improved sleep.

Sexual dysfunction is common in people with diabetes, she noted. Poor glycemic control can "damage" blood vessels and nerves, causing reduced blood flow and loss of sensation in sexual organs.

A recent study led by Belgian researchers found that among more than 750 adults with diabetes 36% of men and 33% of women reported sexual dysfunction.

Sexual dysfunction was more common in women with type 1 diabetes, at 36%, compared with 26% for those with type 2 diabetes. The most commonly reported issues were decreased sexual desire, lubrication problems, orgasmic dysfunction, and pain. Body image problems and fear of hypoglycemia also affectsexuality and intimacy, leading to "sexual distress."

Moreover, Fosbury said female sexual dysfunction has been identified as a "major predictor" of depression, she added, which in turn reduces libido.

Treatments for women can include lubricants, local estrogen, and medications that are prescribed off-label such as sildenafil. The same is true of testosterone therapy, which can be used to boost libido.

Next, Trudy Hannington, a psychosexual therapist with Leger Clinic, Doncaster, UK, talked about how to use an integrated approach to address sexuality overall in people with diabetes.

She said this should be seen in a biopsychosocial context, with emphasis on the couple, on sensation and communication, and sexual growth, as well as changes in daily routines.

There should be a move away from "penetrative sex," Hannington said, with the goal being "enjoyment, not orgasm." Pleasure should be facilitated and the opportunities for "performance pressure and/or anxiety" reduced.

She discussed the case of Marie, a 27-year-old woman with type 1 diabetes who had been referred with painful sex and vaginal dryness. Marie had "never experienced orgasm," despite being in a same-sex relationship with Emily.

Marie's treatment involved a sexual growth program, to which Emily was invited, as well as recommendations to use lubricants, vibrators, and to try sildenafil.

Fosbury reiterated that, in men, sexual dysfunction is "readily identified as a complication of diabetes" and is described as "traumatic" and "crucial to well-being." It is also seen as "easy to treat" with medication, such as that for erectile dysfunction.

It is therefore is crucial to talk to women with diabetes about possible sexual dysfunction, and the scene must be set before the appointment to explain that the subject will be broached. In addition, handouts and leaflets should be available for patients in the clinic so they can read about female sexual health and to lower the stigma around discussing it.

"Cultural stereotypes diminish the importance of female sexuality and prevent us from providing equal consideration to the sexual difficulties of our patients," she concluded.

No funding declared. No relevant financial relationships declared.

Diabetes UK Professional Conference 2022. Session: Sexual healing in the diabetes clinic. Presented March 28, 2022.

For more diabetes and endocrinology news, follow us on Twitter and Facebook.

Read more here:
Below the Belt: Sexual Dysfunction Overlooked in Women With Diabetes - Medscape

Sarah Silbiger/Getty Images

The U.S. Food and Drug Administrationhas a very busy week ending the month of March and moving into April. Heres a look.

Bristol Myers Squibbs Reblozyl for Anemia in Beta Thalassemia Patients

Bristol Myers Squibbhad atarget action dateof March 27, 2022, for its supplemental Biologics License Application (sBLA) for Reblozyl (luspatercept-aamt) for anemia in adults with non-transfusion dependent (NTD) beta thalassemia. The agency requested additional data, which BMS supplied, and the FDA called it a major amendment andaddedthree months to the target action date. The PDUFA date is now June 27.

The drug is a first-in-class erythroid maturation agent. It is being jointly developed by BMS and Merck via Mercks acquisition of Acceleron. It is already approved in the U.S. for anemia in adults with beta thalassemia who require regular RBC transfusions. It is also approved for anemia failing an erythropoiesis-stimulating agent and requires two or more RBC units over eight weeks in adults with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).

Antares Tlando for Testosterone Replacement Therapy

Antares Pharmaand Lipocine have atarget action dateof March 28 for itsresubmissionfor its New Drug Application (NDA) for Tlando (testosterone undecanoate), an oral treatment for testosterone replacement therapy. It was granted tentative approval from the FDA as a twice-daily oral formulation of testosterone for testosterone replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone or hypogonadism in adult males. The agency concluded the drug met all required efficacy, quality and safety standards needed for approval and will be eligible for final approval and marketed in the U.S. when the exclusivity period previously granted to Clarus Therapeutics for Jatenzo expires on March 27.

Mercks Keytruda for Advanced Endometrial Carcinoma

Merckhad atarget action dateof March 28 for its sBLA for Keytruda (pembrolizumab), its anti-PD-1 checkpoint inhibitor, as a monotherapy for patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression after previous systemic treatment in any setting and are not candidates for curative surgery or radiation. Keytruda is already approved for adults and children with unresectable or metastatic MSI-H or dMMR solid tumors that have progressed after previous treatment and have no satisfactory alternative treatment options. It wasapprovedfor this new indication on March 21.

Akebias Vadadustat for Anemia Due to Chronic Kidney Disease

Akebia Therapeutics has atarget action dateof March 29 for its NDA for vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for anemia due to chronic kidney disease in adults on dialysis and not on dialysis. It is being developed with Otsuka Pharmaceutical Co.

In a June 1, 2021statement, John P. Butler, Akebias chief executive officer, stated, The acceptance of our vadadustat NDA filing marks another important milestone for Akebia and Otsuka, as we work to bring a new oral treatment option to patients living with anemia due to CKD.

Amylyxs ALS Drug to Be Reviewed by Advisory Committee

The FDAs Peripheral and Central Nervous System Drugs Advisory Committee isholdinga meeting on March 30 to discussAmylyx Pharmaceuticals NDA for sodium phenylbutyrate/taurursodiol powder for oral suspension for the treatment of amyotrophic lateral sclerosis (ALS). The drug has been granted Priority Review.

There are few treatments approved for ALS, a devastating disease that impacts a persons ability to move, speak, eat and breathe,saidDr. Lahar Mehta, Head of Global Clinical Development of Amylyx, in February 2022. We look forward to a robust scientific discussion with the members of the advisory committee panel regarding the clinical data submitted to support our New Drug Application for AMX0035.

Gilead/Kites Yescarta for Second-Line R/R Large B-Cell Lymphoma

Kite, a Gilead Company, has atarget action dateof April 1 for its sBLA under Priority Review for Yescarta, its CAR T-cell therapy, for second-line relapsed or refractory large B-cell lymphoma (LBCL). The therapy was evaluated against the current standard of care in the Phase III ZUMA-7 study. With a median follow-up of two years, the trial hit the primary endpoint of event-free survival (EFS), demonstrating a 2.5-fold increase in patients who were alive at two years and did not require additional cancer treatment or experienced cancer progression, and a four-fold great median EFS compared to SOC.

Mercks Vaxneuvance Vaccine Against Pneumococcal Disease in Children

Merck has atarget action dateof April 1 for its sBLA for Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the prevention of invasive pneumococcal disease in children six weeks through 17 years of age. It has Priority Review status. The sBLA is supported by Phase II and III trials data in pediatric populations.

Vaxneuvance has the potential to provide meaningful protection against invasive pneumococcal disease for children and infants by targeting pneumococcal strains, or serotypes, that contribute to substantial disease burden, including serotype 3, and broadening coverage to additional disease-causing serotypes, 22F and 33F, which are not included in the pneumococcal conjugate vaccine (PCV) currently available for this population, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Read more here:
FDA Action Alert: A Very Busy Week for Drug Application Decisions - BioSpace

Testosterone replacement therapy is used for the treatment of age-related male hypogonadism, and prostate-specific antigen (PSA) is a primary screening tool for prostate cancer. The systematic review and meta-analysis aimed to determine the effect of testosterone replacement therapy on PSA levels.Medline, Cochrane Library, EMBASE, and Google Scholar databases were searched until February 28, 2014, and inclusion criteria were as follows: randomized controlled trial; intervention group received testosterone/androgen replacement therapy; control group did not receive treatment; and no history of prostate cancer. The primary outcome was change of PSA level between before and after treatment. Secondary outcomes were elevated PSA level after treatment, and the number of patients who developed prostate cancer.After initially identifying 511 articles, 15 studies with a total of 739 patients that received testosterone replacement and 385 controls were included. The duration of treatment ranged from 3 to 12 months. Patients treated with testosterone tended to have higher PSA levels, and thus a greater change than those that received control treatments (difference in means of PSA levels = 0.154, 95% confidence interval [CI] 0.069 to 0.238, P < 0.001). The difference in means of PSA levels were significant higher for patients that received testosterone intramuscularly (IM) than controls (difference in means of PSA levels = 0.271, 95% CI 0.117-0.425, P = 0.001). Elevated PSA levels after treatment were similar between patients that received treatment and controls (odds ratio [OR] = 1.02, 95% CI 0.48-2.20, P = 0.953). Only 3 studies provided data with respect to the development of prostate cancer, and rates were similar between those that received treatment and controls.Testosterone replacement therapy does not increase PSA levels in men being treated for hypogonadism, except when it is given IM and even the increase with IM administration is minimal.

More here:
The effect of testosterone replacement therapy on prostate ...

Its an often-forgotten fact that being strong on the outside requires us to have a healthy, solid frame on the inside. Many gymgoers spend a great deal of time focusing on their aesthetics without paying proper attention to the all-important foundation, but it is essential to realize that big and beautiful muscles require support from solid, healthy bones. Skeletal density is essential for mobility, injury protection and mineral storage but as we age, our bones often need more attention, leading many to question whether its still ok to still lift weights as we hurtle through our 40s.

Maturity also brings the increased risk of a lack of bone density, leading to more fragile or brittle bones (osteoporosis).Linda A. Russell, MD,member of the Hospital for Special Surgery,and a New York City-based expert in rheumatology, perioperative medicine, and metabolic bone, explains how we can keep our bones strong, and whether its still OK tolift weights as we get older.

What happens to our bones as we age?

There are two major bone cell types, Russell says. The osteoclast, and the osteoblast. From the day that we are born, until around age 25 to 30, we make more bone than we lose. So, the bone strength gets better and better. And then somewhere around 25 and 30, we all sadly reach our peak bone density, and thats the strongest that our bones will ever be. Then, as we start the normal aging process, we start to lose more bone than we make and slowly the bone density begins to decline.

Can men just be given testosterone replacement therapy to reverse this process?

Men dont go through a menopause, Russell says. But they do have a slow lowering of their testosterone levels. We dont like to give elderly men TRT because it increases the risk of prostate cancer. I saw a young gentleman in his 30s, who had low testosterone levels and osteoporosis. We would probably supplement him (with testosterone), but with more elderly men we generally dont.

Is weightlifting a good way to maintain healthy bones naturally, even as we age?

You know, it really depends on the individual and how much of their time they devote to fitness, says Dr. Russell. The interesting thing is that weight-bearing exercises are wonderful for bones. So, if you participate in a regular weight-bearing exercise program, your bone health will be absolutely better. And we know that, for instance, if you go into space, astronauts lose lots of bone because there is no gravity. If you take someone who is

sick, and you put them in a hospital bed, within about two weeks theyll start losing bone. The more that you can have activities where you are against gravity, the better your bone health is going to be.

How important is the relationship between muscle mass and strong healthy bones?

Muscle is attached to bone. Muscle pulls on bone. The stronger the muscle, the greater the pull on the bone, and the better it is for the bone, says Russell. So, if you have somebody that is really well defined, they have a nice cardio program, and a nice weight-strengthening program, then thats going to be beneficial. If you take a 40-year-old, who is a couch potato, and has some adiposity (fat) around their middle, they are not going to be as healthy as someone whos hitting the gym five days a week. Strong muscle helps bone, age is important, but for me, being a rheumatologist and seeing people of all ages, its really their fitness that speaks more than their age.

Russell points out that a good workout program becomes even more essential as we reach our 40s, because muscle mass is already beginning to decline naturally. You lose about a third of a pound of muscle mass per year, she says. You can work hard so that this doesnt happen. You can exercise and do your weight training, but if youre just a guy that doesnt really exercise you will start losing muscle and if you looked at an MRI of the that muscle, it has more fat interspersed with the muscle. For someone that is very fit, there is very little fat in the muscle shown on an MRI.

What should men avoid to maintain healthy bones?

A risk factor for osteoporosis is having more than three alcoholic beverages per day, says Russell. There are probably a good number of people that drink at least that much alcohol per day. Its not ideal for bone.

In addition, Russell adds that it is important to get checked out by a doctor because problems with bones can often be caused by other medical issues. Rheumatoid arthritis is associated with bone loss, she says. A lot of liver diseases are also associated with bone loss. If you have rheumatoid arthritis and you are treated with medication, you reduce the chances of bone loss. But some medications are associated with bone loss, like prednisone, or medications used to treat prostate cancer because they are trying to lower the testosterone level. Tobacco is also very bad for bone health. Tobacco is directly toxic to the osteoblast, the cell that makes bone.

So, its good to keep lifting in my 40s and beyond?

At any age, studying proper lifting form and not trying to move a force that is too heavy for you is a good idea to prevent injury, bone and joint problems. And in terms of minerals, Dr. Russell points out that vitamin D and calcium are essential for bone health, and these can

often be consumed through a normal diet, so make sure you include proper nutrition within your training resume. But when it comes to lifting weights, you still have plenty of life in those old bones!

Visit link:
Build and Maintain Healthy Bones No Matter Your Age - Muscle & Fitness

Pharmacological body alteration

Transgender hormone therapy, also called Hormone replacement therapy (HRT) or gender-affirming hormone therapy (GAHT), is a form of hormone therapy in which sex hormones and other hormonal medications are administered to transgender or gender nonconforming individuals for the purpose of more closely aligning their secondary sexual characteristics with their gender identity. This form of hormone therapy is given as one of two types, based on whether the goal of treatment is feminization or masculinization:

Some intersex people may also undergo hormone therapy, either starting in childhood to confirm the sex they were assigned at birth, or later in order to align their sex with their gender identity. Non-binary people may also engage in hormone therapy in order to achieve a desired balance of sex hormones or to pass as a desired gender. [1]

The formal requirements to begin gender-affirming hormone therapy vary widely depending on geographic location and specific institution. Gender affirming hormones can be prescribed by a wide range of medical providers including, but not limited to, primary care physicians, endocrinologists, and obstetrician-gynecologists.[2]

Historically, many health centers required a psychiatric evaluation and/or a letter from a therapist before beginning therapy. Many centers now use an informed consent model that does not require any routine formal psychiatric evaluation but instead focuses on reducing barriers to care by ensuring a person can understand the risks, benefits, alternatives, unknowns, limitations, and risks of no treatment.[3] Some LGBT health organizations (notably Chicago's Howard Brown Health Center[4] and Planned Parenthood[5]) advocate for this type of informed consent model.

The Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People (SOC) require that patients seeking gender-affirmation hormone therapy be evaluated for gender dysphoria by either a mental health professional or hormone provider who is qualified in the area of transgender care. The Standards also require that the patient give informed consent, in other words, that they consent to the treatment after being fully informed of the risks involved.[6] Before beginning gender-affirming hormone therapy, the patient must be evaluated for significant medical and mental health concerns. If present, these must be addressed and reasonably well-controlled.[6]

The World Professional Association for Transgender Health (WPATH) Standards of Care, 7th edition, note that both of these approaches to care are appropriate.[2]

Many international guidelines and institutions require persistent, well-documented gender dysphoria as a pre-requisite to starting gender-affirmation therapy. Gender dysphoria refers to the psychological discomfort or distress that an individual can experience if their sex assigned at birth is incongruent with that person's gender identity.[6] Signs of gender dysphoria can include comorbid mental health stressors such as depression, anxiety, low self-esteem, and social isolation.[7] It is important to note that not all gender nonconforming individuals experience gender dysphoria.

The World Professional Association for Transgender Health (WPATH) and the Endocrine Society formulated guidelines that created a foundation for health care providers to care for transgender patients.[8] UCSF guidelines are also used.[9][citation needed] There is no generally agreed-upon set of guidelines, however.[citation needed]

Adolescents experiencing gender dysphoria may opt to undergo puberty-suppressing hormone therapy at the onset of puberty. The Standards of Care set forth by WPATH recommend individuals pursuing puberty-suppressing hormone therapy wait until at least experiencing Tanner Stage 2 pubertal development.[6] Tanner Stage 2 is defined by the appearance of scant pubic hair, breast bud development, and/or slight testicular growth.[10] WPATH classifies puberty-suppressing hormone therapy as a "fully reversible" intervention. Delaying puberty allows individuals more time to explore their gender identity before deciding on more permanent interventions and prevents the physical changes associated with puberty.[6]

The preferred puberty-suppressing agent for both individuals assigned male at birth and individuals assigned female at birth is a GnRH Analogue.[6] This approach temporarily shuts down the Hypothalamic-Pituitary-Gonadal (HPG) Axis, which is responsible for the production of hormones (estrogen, testosterone) that cause the development of secondary sexual characteristics in puberty.[11] It is important for adolescents undergoing puberty-suppressing hormone therapy to be monitored by a medical professional.

Feminizing hormone therapy is typically used by gender-nonconforming persons, such as transgender women, who desire the development of feminine secondary sex characteristics. Individuals who identify as non-binary may also opt-in for feminizing hormone treatment to better align their body with their desired gender expression. [12] Feminizing hormone therapy usually includes medication to suppress testosterone production and induce feminization. Types of medications include estrogens, antiandrogens (testosterone blockers), and progestogens.[13] Most commonly, an estrogen is combined with an antiandrogen to suppress and block testosterone.[14] This allows for demasculinization and promotion of feminization and breast development. Estrogens are administered in various modalities including injection, transdermal patch, and oral tablets.[15]

The desired effects of feminizing hormone therapy focus on the development of feminine secondary sex characteristics. These desired effects include: breast tissue development, redistribution of body fat, decreased body hair, reduction of muscle mass, and more.[14] The table below summarizes some of the effects of feminizing hormone therapy in transgender women:

Footnotes and sources

Masculinizing hormone therapy is typically used by gender-nonconforming persons, such as transgender men, who desire the development of masculine secondary sex characteristics. Masculinizing hormone therapy usually includes testosterone to produce masculinization and suppress the production of estrogen.[29] Treatment options include oral, parenteral, subcutaneous implant, and transdermal (patches, gels). Dosing is patient-specific and is discussed with the physician.[30] The most commonly prescribed methods are intramuscular and subcutaneous injections. This dosing can be weekly or biweekly depending on the individual patient.[citation needed]

Unlike feminizing hormone therapy, individuals undergoing masculinizing hormone therapy do not usually require additional hormone suppression such as estrogen suppression. Therapeutic doses of testosterone are usually sufficient to inhibit the production of estrogen to desired physiologic levels.[11]

The desired effects of masculinizing hormone therapy focus on the development of masculine secondary sex characteristics. These desired effects include: increased muscle mass, development of facial hair, voice deepening, increase and thickening of body hair, and more.[31]

Hormone therapy for transgender individuals has been shown in medical literature to be generally safe, when supervised by a qualified medical professional.[32] There are potential risks with hormone treatment that will be monitored through screenings and lab tests such as blood count (hemoglobin), kidney and liver function, blood sugar, potassium, and cholesterol.[30][13] Taking more medication than directed may lead to health problems such as increased risk of cancer, heart attack from thickening of the blood, blood clots, and elevated cholesterol.[30][33]

The Standards of Care published by the World Professional Association for Transgender Health (WPATH) summarize many of the risks associated with feminizing hormone therapy (outlined below).[6] For more in-depth information on the safety profile of estrogen-based feminizing hormone therapy visit the feminizing hormone therapy page.

The Standards of Care published by the World Professional Association for Transgender Health (WPATH) summarize many of the risks associated with masculinizing hormone therapy (outlined below).[6] For more in-depth information on the safety profile of testosterone-based masculinizing hormone therapy visit the masculinizing hormone therapy page.

Transgender hormone therapy may limit fertility potential.[34] Should a transgender individual choose to undergo sex reassignment surgery, their fertility potential is lost completely.[35] Before starting any treatment, individuals may consider fertility issues and fertility preservation. Options include semen cryopreservation, oocyte cryopreservation, and ovarian tissue cryopreservation.[34][35]

A study due to be presented at ENDO 2019 (the Endocrine Society's conference) reportedly shows that even after one year of treatment with testosterone, a transgender man can preserve his fertility potential.[36]

Many providers use informed consent, whereby someone seeking hormone therapy can sign a statement of informed consent and begin treatment without much gatekeeping. For other providers, eligibility is determined using major diagnostic tools such as ICD-10 or the Diagnostic and Statistical Manual of Mental Disorders (DSM). Psychiatric conditions can commonly accompany or present similar to gender incongruence and gender dysphoria. For this reason, patients are assessed using DSM-5 criteria or ICD-10 criteria in addition to screening for psychiatric disorders. The Endocrine Society requires physicians that diagnose gender dysphoria and gender incongruence to be trained in psychiatric disorders with competency in ICD-10 and DSM-5. The healthcare provider should also obtain a thorough assessment of the patient's mental health and identify potential psychosocial factors that can affect therapy.[37]

The ICD-10 system requires that patients have a diagnosis of either transsexualism or gender identity disorder of childhood. The criteria for transsexualism include:[38]

Individuals cannot be diagnosed with transsexualism if their symptoms are believed to be a result of another mental disorder, or of a genetic or chromosomal abnormality.[citation needed]

For a child to be diagnosed with gender identity disorder of childhood under ICD-10 criteria, they must be pre-pubescent and have intense and persistent distress about being the opposite sex. The distress must be present for at least six months. The child must either:

The DSM-5 states that at least two of the following criteria must be experienced for at least six months' duration for a diagnosis of gender dysphoria:[39]

In addition, the condition must be associated with clinically significant distress or impairment.[39]

Some organizations but fewer than in the past require that patients spend a certain period of time living in their desired gender role before starting hormone therapy. This period is sometimes called real-life experience (RLE). The Endocrine Society stated in 2009 that individuals should either have a documented three months of RLE or undergo psychotherapy for a period of time specified by their mental health provider, usually a minimum of three months.[40]

Transgender and gender non-conforming activists, such as Kate Bornstein, have asserted that RLE is psychologically harmful and is a form of "gatekeeping", effectively barring individuals from transitioning for as long as possible, if not permanently.[41]

Gender-affirming care is health care that affirms people to live authentically in their genders, no matter the gender they were assigned at birth or the path their gender affirmation (or transition) takes. It allows each person to seek only the changes or medical interventions they desire to affirm their own gender identity, and hormone therapy (HRT or gender-affirming hormone therapy) may be a part of that. [42]

Some transgender people choose to self-administer hormone replacement medications, often because doctors have too little experience in this area, or because no doctor is available. Others self-administer because their doctor will not prescribe hormones without a letter from a psychotherapist stating that the patient meets the diagnostic criteria and is making an informed decision to transition. Many therapists require at least three months of continuous psychotherapy and/or real-life experience before they will write such a letter. Because many individuals must pay for evaluation and care out-of-pocket, costs can be prohibitive.

Access to medication can be poor even where health care is provided free. In a patient survey conducted by the United Kingdom's National Health Service in 2008, 5% of respondents acknowledged resorting to self-medication, and 46% were dissatisfied with the amount of time it took to receive hormone therapy. The report concluded in part: "The NHS must provide a service that is easy to access so that vulnerable patients do not feel forced to turn to DIY remedies such as buying drugs online with all the risks that entails. Patients must be able to access professional help and advice so that they can make informed decisions about their care, whether they wish to take the NHS or private route without putting their health and indeed their lives in danger."[43] Self-administration of hormone replacement medications may have untoward health effects and risks.[44]

A number of private companies have attempted to increase accessibility for hormone replacement medications and help transgender people navigate the complexities of access to treatment.

Follow this link:
Transgender hormone therapy - Wikipedia

Everything You Need to Know About TRT

Its commonly accepted that as you grow older, Father Time forces you to slow down and lose strength as body fat collects around your midriff, and you begin to morph into the stereotypical male whos past his prime and has seen better days. Worse, your thinking can become cloudy and your memory may develop gaps as you begin the steady slide of cognitive decline.

Adding to this misery, the aches and pains of rising inflammation start to become more common. The dynamism of your physical prime starts to fade. Eventually, old injuries take center stage as the pain begins to grow. The slow creep of time begins to overtake your body as it seems to betray you. As time marches on, you feel as if you are becoming a shell of the man you once were.

RELATED: Nutritionists Share the Foods That Lower Testosterone

This is a terrifying reality as your sense of physical power gives way to a meeker existence. However, medical science has a way to get at the heart of these symptoms and give men a new lease on life.

In its molecular form, testosterone is the hormone that forms the foundation of masculinity.

At your physical peak (between 17 to 19 years of age), your testosterone is at its highest level of as much as 1,200 ng/dl (nanograms per deciliter). At the age of 35, your testosterone levels begin to drop at a rate of 1% a year.

Also, environmental factors such as exposure to plastics, toxins in the environment, and water pollution can interfere with testosterone production. Anyone with levels of around 350 ng/dl or lower can begin to experience symptoms of low testosterone.

Symptoms of low testosterone can include:

Making matters worse, these symptoms can go unnoticed as they develop over time. The slow and steady rise of these symptoms can sneak under your radar causing you to settle for a lower quality of life.

But there is a solution for you to consider.

Testosterone Replacement Therapy (TRT) is the medical treatment of testosterone deficiency to help men recover their physical masculinity and health.

By optimizing testosterone levels, you can reverse the negative effects of testosterone deficiency. This can result in a type of rebirth as TRT fights back the corrosive effects of low testosterone.

TRT has been clinically proven to:

There are a number of TRT therapies to help men normalize their testosterone - some natural and some external. Natural treatments can include supplements such as vitamin D and DHEA, among others, to support testosterone production. Also, getting quality sleep and stress management to lower cortisol levels, both of which are toxic to testosterone production.

External treatments include external testosterone in the form of injections, pills, time-released pellets inserted under the skin, and creams.

All of these different treatments need to be carefully considered in consultation with a medical professional. But, before treatment is prescribed, you need to know your T-levels.

Todays society has a stigma about TRT, labeling men who seek treatment as weak or less of a man. But testosterone deficiency is a real medical problem that can impact your long-term health. Just as women seek hormone treatment for estrogen levels or menopause, hormonal health is a major factor in the quality of life for men.

Other reasons concern the abuse of testosterone, especially among athletes and bodybuilders. Many men have a history of abusing testosterone even starting in adolescence to increase their muscle mass. The levels that they use can be as high as 5 to 10 times the recommended dosage and can have significant negative effects. This is clearly not the model used for medical treatment, reports Michael Werner, M.D, Medical Director and Founder at Maze Sexual & Reproductive Health.

A trained TRT medical professional will order a comprehensive round of lab work to assess the needs of a patient. These tests include:

These tests can take place over a few days or weeks as a medical professional factors in your goals for treatment along with an account of any symptoms before tailoring a treatment plan.

TRT is fairly inexpensive, costing around $40, and is covered by most insurance companies.

Dr. Werner goes on to explain, In my practice, once we achieve a T-level of 600-800 ng/dl, patients report that they experience a significant improvement in energy, libido, and positive mental outlook. While some patients report that they feel an improvement in the first week, it can take 3-4 months to notice an increase in energy levels, increased muscle mass, better workouts, motivation to exercise, increased drive to tackle difficult challenges, better quality sleep, loss of body fat, and stronger erections. However, it can take up to 9 months in some cases, so I recommend to anyone seeking TRT to commit to a full year to set themselves up to succeed. During this time, I would estimate that 90% of them have experienced a significant improvement of their symptoms and lives.

TRT requires regular medical supervision because treatment increases the level of red blood cell production. This can cause a thickening of the blood resulting in cardiovascular issues if allowed to go unnoticed (this is why you need to drink lots of water and your doctor may recommend occasionally donating blood).

You also need to go for regular checkups outside of TRT, particularly for cancer. Testosterone is an anabolic hormone that improves protein synthesis for muscle growth. But, since its an anabolic hormone that promotes growth, it can also accelerate the spread of cancer if present, but undiagnosed, which can have serious life-altering side effects.

The most crucial factor to weigh up is your commitment. TRT is not something that you do for a while, then skip and come back to. If youre receiving external testosterone in the form of weekly injections or pills, your body sensing high T-levels may stop producing testosterone altogether at some point. As a result, continued treatment will be needed to keep your T-levels normalized.

The benefits of TRT can be massive but its important that you consult with a trained physician about all aspects of treatment positive and negative, natural and medical to make an informed decision.

You Might Also Dig:

Go here to read the rest:
Testosterone Therapy Replacement: Is It for You? - AskMen