Global pharmaceutical company Lupin has announced the divestiture of its U.S. Commercial Women’s Health Specialty Business to Evofem Biosciences, a biopharmaceutical company dedicated to women’s health. This strategic move includes the transfer of SOLOSEC (secnidazole) 2g oral granules, an FDA-approved antimicrobial agent for treating bacterial vaginosis (BV) and trichomoniasis. The agreement provides Lupin with the opportunity to receive up to USD 84…
Eli Lilly’s Kisunla (donanemab-azbt) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of early symptomatic Alzheimer’s disease. This includes adults with mild cognitive impairment (MCI) and mild dementia stages of the disease. Alzheimer’s disease affects women disproportionately, with nearly two-thirds of Americans diagnosed being women. The pivotal Phase 3 study, TRAILBLAZER-ALZ 2, showed that Kisunla slowed…
Digital therapeutics company Mika Health has announced a new collaboration with AstraZeneca and Daiichi Sankyo. The initiative, named “UNITE,” aims to enhance the treatment experience for women undergoing breast cancer therapy in Switzerland through the use of Mika Health’s AI-enabled mobile platform. The UNITE initiative was unveiled at the HLTH Europe conference and signifies a significant step towards integrating digital solutions in…
Shanghai Henlius Biotech and women’s health pharma company Organon have announced that the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational biosimilar for Prolia and Xgeva (denosumab). This biosimilar aims to provide an alternative treatment for osteoporosis in postmenopausal women at high risk for fractures and for preventing skeletal-related events in patients with bone metastases.…
Acclinate, a company mobilizing diverse communities for improved healthcare access, has announced the successful closure of its $7 million Series A financing round. Led by Cencora Ventures, with participation from Labcorp and Latimer Ventures, this funding will support Acclinate’s efforts to expand its impact in the realm of clinical trial diversity and health equity. “This investment represents a pivotal moment for Acclinate…
Gilead Sciences has announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for Biktarvy. This approval includes additional data supporting the safety and efficacy of Biktarvy for pregnant individuals living with HIV-1 (PWH) who have suppressed viral loads. Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer…
In a recent webinar titled “The Future of FemTech,” hosted by Reuters Events Pharma, industry leaders got together to explore the ever evolving landscape and intersection of women’s health technology also known as FemTech and the pharma industry. The session, moderated by Femtech Insider’s Kathrin Folkendt, featured an expert panel comprising Elcie Chan from Otsuka, Fatima Perez Sastre from Novartis, Paula Antunes…
Bayer has announced positive topline results from the Phase III OASIS 3 study, shedding light on the potential efficacy and safety of their investigational compound, elinzanetant, in treating moderate to severe vasomotor symptoms (VMS) linked to menopause. These findings bolster the case for elinzanetant’s marketing authorization submissions, which Bayer plans to present to health authorities. In the OASIS 3 study, elinzanetant demonstrated…
