Biotech

Dr. Stephen Palmer Joins the Celmatix Executive Team to Lead the Company’s Drug Discovery and Development Efforts in Ovarian Health as Chief Scientific Officer

Women’s Health Biotech Celmatix focused uniquely on ovarian biology has announced the appointment of Dr. Stephen Palmer as Chief Scientific Officer. Dr. Palmer had previously joined the company’s Scientific Advisory Board earlier this year, on the heels of rapid progress with Celmatix’s lead AMHR2 agonist program and the out-licensing of PCOS targets from its multi-omics ovarian health platform. Dr. Palmer is a…

Biovaxys Adds Charles J. Dunton, MD as Scientific Advisor to Support the Company’s Ovarian Cancer Vaccine Clinical Program and Papilocare Marketing

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 Receives Fast Track Designation for EVO100 for Prevention of Gonorrhea in Women

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…

Merck Hosts Organon Investor Day Introducing the New Company’s Vision and Focus on Women’s Health

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…

Pregnancy Company Sera Prognostics Completes a $100 Million Series E Financing to Expand Commercialization of its PreTRM Test

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…

Contraception: Evofem Announces the Presentation of Two New Phexxi Data Sets at the 2021 American College of Obstetricians and Gynecologists Annual Meeting

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 Receives FDA Approval for the First Companion Diagnostic to Identify Endometrial Cancer Patients Eligible for Immunotherapy

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’s Receives FDA Approval for NEXTSTELLIS, a New Oral Contraceptive Containing E4, the First New Estrogen Introduced in the U.S. in 50 Years

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…