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…
Global women’s health pharma company Organon has entered into an agreement with Shanghai Henlius Biotech, whereby Organon will license commercialization rights for biosimilar candidates referencing Perjeta (pertuzumab, HLX11) and Prolia/Xgeva (denosumab, HLX14). Organon will acquire exclusive global commercialization rights except for China; including Hong Kong, Macau and Taiwan. Pertuzumab is used for the treatment of certain patients with HER2+ breast cancer in combinations with…
Global investment firms PAI Partners and Carlyle have agreed to acquire Theramex, a global specialty pharmaceuticals company focused on women’s health, from CVC Capital Partners VI. The details Theramex was created following the carve-out of a portfolio of women’s health pharma products in 2018, and has subsequently developed into one of the largest specialty pharma platforms dedicated to women and their health.…
Women’s health pharma company Theramex and ObsEva, a biopharma company developing and commercializing novel therapies for women’s health have entered into a licensing agreement to commercialize and launch Linzagolix, an oral GnRH antagonist. The launch will be for global markets outside of the U.S., Canada, and Asia. Linzagolix is a GnRH receptor antagonist for the treatment of uterine fibroids. Linzagolix is also…
