Organon and Forendo Pharma today announced that the companies have entered into a definitive agreement, under which Organon will acquire Forendo, a clinical-stage drug development company focused on novel treatments in women’s health. Forendo is pioneering the science of intracrinology, addressing disease through a novel, tissue-specific approach. Its lead clinical compound is an investigational, potentially first-in-class oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1)…
Antiva Biosciences, a biopharmaceutical company developing novel, topical therapeutics for the treatment of pre-cancerous lesions caused by human papilloma virus (HPV) infection, has announced the closing of a $31M Series D. The financing was supported by a syndicate of life science investors led by Adjuvant Capital, a leading global and women’s health venture firm, and joined by GV, formerly Google Ventures. Participants in the financing…
Women’s health pharma company Organon has launched a new website, Fertility Journey, with the goal to inform and empower people with resources and information needed to navigate the process of fertility care. The website aims to meet people wherever they are on their fertility journey and equip them with knowledge and questions for consideration to feel prepared and empowered throughout their journey. “Infertility…
Merck spin-off Organon, a global women’s health pharma company that launched earlier this year, is launching its first awareness campaign to raise awareness and ignite a worldwide conversation about the staggering rates of unplanned pregnancy around the world. Worldwide, unplanned pregnancy impacts approximately 121 million women each year. A 2019 study reported that globally, more than 1 billion women have a need for…
By 2030, the world population of menopausal and postmenopausal women is projected to increase to 1.2 billion, with 47 million new entrants each year. Menopause marks the end of a women’s reproductive life, occurring in their late 40s or early 50s. The decline in hormone production by the ovaries can lead to various symptoms, during the menopausal transition, including hot flashes, sleep…
Bayer has announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) that extends the duration of use for its intrauterine device (IUD) Mirena (levonorgestrel-releasing intrauterine system) 52 mg by one year, making it available to prevent pregnancy for up to seven years. The approval is based on results from a Phase 3 extension trial evaluating the…
Roche has decided to withdraw its immunotherapy Tecentriq as a treatment for a type of breast cancer in the United States. The drug received accelerated approval in 2019 to treat inoperable, locally advanced or metastatic triple-negative breast cancer (mTNBC) in people whose tumors express PD-L1, a protein that may help the cancer avoid detection by the immune system. But it failed last year…
Women’s Healthcare company TherapeuticsMD has announced that the Centers for Medicare and Medicaid Services (CMS) confirmed its preliminary recommendation to assign a permanent product-specific Healthcare Common Procedure Coding System (HCPCS) J Code for ANNOVERA. According to TherapeuticsMD, ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) is the first and only FDA-approved long-lasting, reversible contraceptive for women of reproductive age that is patient-controlled…
