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…
Daré Bioscience, a women’s health company, has announced the receipt of a $750K grant from the Bill & Melinda Gates Foundation. This funding is earmarked for the development of bacteria-based live biotherapeutic products, aiming to enhance the health of women and newborns globally. This recent grant follows a previous award of approximately $585K from the foundation, granted to Daré in November 2022…
Asieris Pharmaceuticals has launched a new Women’s Health Business Unit, focusing on advancing treatments in gynecology, particularly for cervical cancer. The initiative centers on APL-1702, a non-surgical treatment for cervical high-grade squamous intraepithelial lesions, positioning the company at the forefront of innovative gynecological care. This move aligns with global health initiatives aimed at combating cervical cancer. The China National Program for Women’s…
Daré Bioscience, a biopharma company specializing in women’s health, has announced the development of DARE-LARC1, a drug delivery platform that can administer therapeutic doses over extended periods. This platform is designed to store and precisely deliver medications for months or years through a single device. The technology behind DARE-LARC1, developed initially at the Massachusetts Institute of Technology by Drs. Robert Langer and…
Pearsanta, a subsidiary of Aditxt, has recently acquired the Mitomic testing platform from MDNA Life Sciences. The transaction, valued at approximately $25 million, is a strategic expansion for Pearsanta, enhancing its capabilities in early disease and cancer detection, particularly in women’s health, focusing on conditions such as endometriosis and ovarian cancer. The Mitomic technology utilizes mitochondrial DNA (mtDNA) to detect diseases at…
Marius Pharmaceuticals, a company dedicated to developing therapies for testosterone deficiency, has launched a pilot study focusing on the effects of its oral testosterone therapy, KYZATREX (testosterone undecanoate), on male fertility, specifically spermatogenesis. KYZATREX, approved for testosterone replacement therapy in adult males with testosterone deficiency, will be the subject of this pioneering study. The study aims to explore how this oral testosterone…
German pharmaceutical company Bayer recently announced positive results from two Phase III trials of its new menopausal relief drug, elinzanetant. The drug aims to reduce vasomotor symptoms, particularly hot flashes, which are common during menopause. The announcement is significant for Bayer’s pharmaceutical division following a series of challenges in drug development. The clinical trials demonstrated that elinzanetant significantly reduces the frequency and…