Biotech

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…

Dr. Adrienne Day Joins Women’s Health Biotech Celmatix’s Strategic Advisory Board

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…

Merck’s Women’s Health Spinoff Organon Announces the Acquisition of Maternal Health Company Alydia Health

Merck and Alydia Health have announced that they have entered into a definitive agreement pursuant to which, after the intended Merck spinoff of Organon, Organon will acquire Alydia Health. Alydia Health is a commercial-stage medical device company focused on preventing maternal morbidity and mortality caused by postpartum hemorrhage (PPH) or abnormal postpartum uterine bleeding. PPH is one of the most common complications…

Bonafide Brings Innovation to the Menopause Space With New Non-Drug Solutions

Bonafide, the women’s healthcare brand with a unique research-first approach to non-drug products, is at the forefront of modernizing menopause. Since its inception in 2018, the Company has invested millions of dollars on clinical research, conducted at least 3-4 studies per year, and brought one new product to market every 12 months. To date, more than 70,000 women love and trust Bonafide’s…