Menopause is defined as the final menstrual period and is typically confirmed after a woman has missed her period for 12 consecutive months. Most women experience menopause between ages 40 and 58. An estimated 45 million women in the U.S. are approaching or in menopause, which results in a decrease in estrogen and other hormones. Hot flashes, vaginal dryness and loss of bone density are…
Male Contraceptive Initiative (MCI), a non-profit, has partnered with the pharmaceutical company Eppin Pharma to provide a Program Related Investment (PRI) of up to $800K to support clinical trial activities for the company’s novel short-term, non-hormonal oral male contraceptive pill. Eppin Pharma’s lead male contraceptive candidate is a small organic compound that binds to EPPIN, a protein on the surface of human…
About a year ago Celmatix, a New York-based pre-clinical stage biotech company focused on ovarian biology, announced, that a novel PCOS target identified as part of its five-year, multi-target alliance with Evotec, progressed into hit-identification. Today Celmatix announced that another milestone has been achieved in this alliance, as Evotec and Bayer AG are advancing a second drug program, centered around a novel Celmatix-identified drug target,…
Women’s health pharma company TherapeuticsMD has entered into definitive agreements to license its products to an affiliate of Mayne Pharma, an ASX-listed specialty pharmaceutical company focused on commercializing novel and generic pharmaceuticals, for commercialization in the United States. In addition, TXMD has agreed to sell certain assets to Mayne Pharma to allow Mayne Pharma to commercialize the products. TherapeuticsMD’s products are designed…
Sebela Pharmaceuticals is launching a new division of the company named Sebela Women’s Health along with the appointment of Kelly Culwell, MD, as Head of Research and Development for the division. Bringing more than twenty years’ experience in women’s health across public, private and non-profit organizations, Dr. Culwell joins the team when the company is in the final stages of clinical development of two…
Bayer has received approval from the U.S. Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) that extends the duration of use for its intrauterine device (IUD) Mirena (levonorgestrel-releasing intrauterine system) 52 mg by one more year, making it available to prevent pregnancy for up to eight years. The approval is based on results from a Phase 3 extension trial…
Myovant Sciences and Pfizer have announced that the U.S. Food and Drug Administration (FDA) has approved MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months. The approval is supported by one-year efficacy and safety data,…
Organon, the global women’s healthcare pharma company, and Daré Bioscience have entered into an agreement whereby Organon will license global rights to XACIATO (clindamycin phosphate vaginal gel, 2%). XACIATO is an FDA-approved medication for the treatment of bacterial vaginosis (BV) in females 12 years of age and older. XACIATO received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the…
