Biotech

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…

Daré Bioscience Completes Recruitment in Phase 1 Clinical Trial of DARE-HRT1, a Novel Intravaginal Ring for the Treatment of Vasomotor Symptoms and Genitourinary Syndrome Associated with Menopause

Daré, a leader in women’s health innovation has recently announced completion of patient recruitment in its Phase 1 clinical trial of DARE-HRT1 being conducted through its wholly owned subsidiary in Australia. DARE-HRT1 is a novel intravaginal ring (IVR) designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over a 28-day period. It is being developed for the treatment of vasomotor symptoms (VMS)…

Mayne Pharma Launches A Generic Version of ORTH-CEPT, an Oral Contraceptive, in the U.S.

Mayne Pharma has announced the commercial launch of a generic version of ORTHO-CEPT (desogestrel and ethinyl estradiol 0.15 mg / 0.03 mg) tablets to customers in the US. This is the fourth oral contraceptive launched this calendar year after launching generic versions of LOESTRIN 24 FE, ORTHO CYCLEN and ORTHO TRI-CYCLEN. According to IQVIA, the annual US market sales for the four products were…

Ferring, Rebiotix and MyBiotics Collaborate to Develop Live Microbiome-Based Therapeutics in Reproductive Medicine and Maternal Health

Ferring Pharmaceuticals, Rebiotix, a Ferring Company, and MyBiotics Pharma today announced a multi-year strategic collaboration to develop live microbiota-based biotherapeutics to address bacterial vaginosis, a common vaginal infection among women of reproductive age linked to increased risk of miscarriage and complications for pregnancy and fertility. The collaboration is an important step forward in harnessing the power of the human microbiome in this area…