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…
Pharma giant Ferring has finalized a two-year investment agreement including an acquisition option with Robyn, a community-driven fertility platform, that provides access to a network of integrative parental wellness tools, resources, and specialists. Robyn was founded in 2019 by Allison Kasirer and took part in the 2021 cohort of the UnitedHealthcare Accelerator Powered by Techstars. Prior to Ferring’s investment the company raised $1.2M…
Forensic analysis of stone age human fertility to better understand why modern-day sperm counts are falling, and a project to support safe birth in rural Ethiopia by providing trained midwives and solar power kits, are among 17 winners of a new Ferring Pharmaceuticals grant program. The new program is designed to tackle inequalities and disparities in reproductive medicine and maternal health, reinforcing…
Theramex, a company dedicated women’s health, recently acquired the Femarelle product licence to treat menopause symptoms. Femarelle will be available in different markets starting in late spring 2022. This commercialisation agreement was reached with Se-cure Pharmaceuticals, the company that developed the product. Femarelle offers non-hormonal therapy to balance oestrogen levels in women from peri-menopause through menopause to post-menopause relieving the symptoms and…
