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…
Roche Diagnostics has recently received CE-mark regulatory approval for a novel method of diagnosing Polycystic Ovary Syndrome (PCOS), a common endocrine disorder affecting approximately 1 in 8 women of reproductive age. The newly approved Elecsys Anti-Müllerian Hormone (AMH) Plus immunoassay, previously used in fertility diagnostics, now offers a non-invasive alternative to the traditional transvaginal ultrasound for diagnosing PCOS. PCOS, characterized by a…
Organon, a global healthcare company focusing on women’s health, announced US-wide availability of XACIATO (clindamycin phosphate) vaginal gel 2% by prescription for the treatment of bacterial vaginosis (BV) in females aged 12 and older. BV, a condition resulting from an overgrowth of certain bacteria, disrupts the natural vaginal microbiome, leading to symptoms like odor and discharge. It affects approximately 21 million women…
