Pharma

Besins Healthcare Opens New State-of-the-Art Hormone Factory in Response to Surge in Demand for HRT and Fertility Support

Women’s and Men’s Reproductive Health Pharma Company Besins Healthcare, has opened a new hormone production facility in Muel, Spain, bolsteing their global hormone production capacity by a 30%. This milestone is a response to the growing worldwide demand for hormones, particularly concerning late pregnancies and menopause. The opening follows Besins Healthcare’s strategic acquisition of a hormone production site in Drogenbos, Belgium, in…

Asieris’ Cevira, the First Non-Vaccine Investigational Product for Cervical HSIL, Has Achieved Its Primary Endpoint

In a stride forward for women’s health and cervical cancer prevention, Asieris Pharmaceuticals has declared the successful completion of its Phase III clinical trial for APL-1702 (Cevira), a non-surgical treatment aimed at cervical high-grade squamous intraepithelial lesions (HSIL). This significant milestone could shift the paradigm in treating this precancerous condition, offering a less invasive alternative to surgery, and may particularly benefit women…

Gedeon Richter and Sumitomo Pharma Receive CHMP Approval for Endometriosis Treatment RYEQO

In an advancement that could change the landscape of endometriosis treatment, pharmaceutical giants Gedeon Richter and Sumitomo Pharma recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for RYEQO. The drug, initially approved for the treatment of uterine fibroids, is on track to receive European Commission (EC) approval for the…

Palatin Technologies Partners with UpScriptHealth to Ease Access to HSDD Treatment Vyleesi

Palatin Technologies has announced a partnership with telehealth service provider UpScriptHealth. The collaboration aims to raise awareness about hypoactive sexual desire disorder (HSDD) and increase the accessibility of Vyleesi through UpScriptHealth’s Women’s Health Platform. According to the company Vyleesi is the only FDA-approved, as-needed treatment for acquired, generalized HSDD in premenopausal women. The partnership will make Vyleesi available to UpScriptHealth’s extensive patient…

Perrigo Receives FDA Approval for Opill Over-the-Counter Oral Contraceptive

Perrigo has achieved a major milestone in women’s healthcare with the FDA approving Opill as an over-the-counter oral contraceptive. Opill is the first birth control pill available without a prescription in the US, revolutionizing access to contraception. Perrigo’s commitment to enhancing lives is evident in this impactful solution for women’s health. Opill has a long history of safe and effective use, supported…

Pharma Company Fresenius Kabi Launches Generic Fertility Treatment

Pharma company Fresenius Kabi has announced the launch of Ganirelix Acetate Injection, a generic fertility drug. The medication is now available for immediate purchase from Fresenius Kabi in the form of 250 mcg/0.5 mL prefilled syringes. Ganirelix Acetate Injection is primarily used to inhibit premature surges in luteinizing hormone (LH), a chemical that triggers reproductive processes like ovulation. It is specifically designed…

FDA Approves Medicines360’s LILETTA for the Treatment of Heavy Menstrual Bleeding

Medicines360, a San Francisco-based nonprofit organization, has achieved a significant milestone with the recent FDA approval of its supplemental New Drug Application (sNDA) for LILETTA. This approval allows LILETTA (levonorgestrel-releasing intrauterine system) 52 mg to be utilized as a treatment option for Heavy Menstrual Bleeding (HMB) for up to five years in women who opt for intrauterine contraception. Extensive research has demonstrated…

Freya Biosciences’ FB101 Shows Promise in Treating Vaginal Dysbiosis

Freya Biosciences, a biotech company specializing in women’s health, has released positive topline results from the Phase 1 clinical trial of FB101, their vaginal microbial immunotherapeutic. The trial focused on addressing asymptomatic vaginal dysbiosis, a common condition in women undergoing infertility treatments. The findings show promise for improving fertility outcomes, particularly in in vitro fertilization (IVF) procedures. Freya Biosciences, headquartered in Copenhagen,…