BioVaxys has announced that Charles J. Dunton, MD has joined BioVaxys as an Advisor to help provide additional scientific support for BVX-0918A, the Company’s ovarian cancer vaccine candidate, and its planned marketing and sale of Papilocare in the United States. Dr. Dunton, a top global opinion leader, is a gynecologist/oncologist in Indiana. He received his medical degree from Jefferson Medical College and has been in…
Evofem today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EVO100 for the prevention of urogenital gonorrhea in women. Fast Track designation is designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs. According to a new report published by the Centers for Disease…
Only a month after announcing its acquisition of Alydia Health, Merck hosted spin-off Organon‘s management at a meeting with the investor community yesterday. Organon’s leadership shared plans for how the company will deliver sustainable growth and shareholder value as a standalone company. Notable is the strong intended focus on women’s health and plan for more acquisitions in this space. At launch, Organon’s…
Sera Prognostics, “The Pregnancy Company”, focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced the completion of a $100 million Series E financing. Several leading healthcare-focused institutional investors have joined this financing round, including Vivo Capital, aMoon Fund, Parian Global, and others, led by existing investors Anthem, Inc., and Blue Ox Healthcare…
Evofem Biosciences has announced that two new data sets from its Phase 3 AMPOWER trial evaluating Phexxi (lactic acid, citric acid, potassium bitartrate) will be presented at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting (ACSM). The meeting will be conducted virtually from April 30 – May 2, 2021. “These new data sets provide clinical insights into how women used Phexxi…
Roche today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. MMR is a molecular mechanism that functions to correct certain errors that can spontaneously occur during DNA replication. Testing can identify patients eligible for treatment with JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD1 immunotherapy from GlaxoSmithKline (GSK) that was approved by…
Mayne Pharma has announced that the U.S. Food and Drug Administration (FDA) has approved NEXTSTELLIS for the prevention of pregnancy. NEXTSTELLIS is the first and only contraceptive pill containing E4, a naturally occurring estrogen, now produced from a plant source, with a unique mechanism of action that offers potential advantages over other estrogens. “When speaking with patients about their contraceptive options, one…
Women’s health biotech Celmatix focused uniquely on ovarian biology, today announced that Dr. Adrienne Day has joined the company’s advisory board. Dr. Day joins as the company eyes upcoming nonclinical studies for the lead RSTK agonist program, and continued partnering interest in its category-defining multi-omic ovarian health platform. She will play a key role in supporting the strategic and scientific prioritization of…
