Endometriosis, a condition where endometrial tissue grows outside the uterus, has a strong genetic underpinning. A new study published in the Journal of Molecular Diagnostics sheds light on this connection. Researchers from a team including Genzeva, LumaGene, RYLTI Biopharma, Brigham & Women’s Hospital of Harvard University and QIAGEN Digital Insights used a unique approach in…
The rise of ‘Ozempic babies’ and the uncharted territory of semaglutide in pregnancy
Ozempic, Rybelsus and Wegovy have transformed the diabetes and weight loss treatment landscape, but when it comes to the impact of their active ingredient, semaglutide, on fetal development, “the answer is we do not know,” said Dr. Marijane Hynes, clinical professor of medicine at the George Washington University School of Medicine and Health Sciences. Hynes…
A J&J veteran highlights listening to address overlooked maternal-fetal needs
With nearly 20 years of experience at Johnson & Johnson, Cynthia Accuosti Jones now spearheads the company’s pioneering maternal-fetal medicine group tackling unmet needs in high-risk pregnancies. As vice president of global commercial strategy for autoantibody and maternal fetal health, she spotlights listening as the driver for patient impact. “You can’t have empathy if you…
How a J&J exec found her calling in autoantibody drug development
Dr. Katie Abouzahr’s career, which began in the wards of the UK’s National Health Service (NHS) before extending into management consulting, paved the way for her leadership of autoantibody and maternal fetal medicine programs at Johnson & Johnson. “It’s not a typical pharma executive’s straight line path,” she acknowledged. “Careers can often be jungle gyms…
Organon reinforces commitment to women’s health beyond reproductive health
The fact that women’s health has long been underprioritized is common knowledge. Organon, with roots going back to 1923 and having sharpened its focus on women’s health post its 2021 spinoff from Merck & Co., aims to address significant gaps in treatment and care. “Our commitment to women’s health is not just a part of…
Is the new $15,900 postpartum depression pill worth it?
Sage Therapeutics has pegged the wholesale acquisition price of the oral postpartum depression (PPD) drug Zurzuvae (zuranolone) at $15,900 for a 14-day course of the therapy. The drug, co-developed by Biogen, won the FDA green light in August. The companies plan on launching the drug in December. The DEA has classified zuranolone as Schedule IV,…
Biofourmis and Chugai Pharma partner to develop an objective measure of pain
Chugai Pharma (TYO:4519) and privately-held remote patient monitoring firm Biofourmis are continuing a collaboration to develop digital technologies to objectively measure and manage pain in endometriosis patients. In endometriosis, the lining of a uterus grows outside the womb. The condition can also affect the ovaries and fallopian tubes. The disease affects approximately 10% of women…
Nipocalimab gets positive results in Phase 2 HDFN clinical trial
Johnson & Johnson subsidiary Janssen (NYSE:JNJ) has revealed positive results from the proof-of-concept Phase 2 UNITY clinical trial of nipocalimab for pregnant adults with a high risk of developing severe hemolytic disease of the fetus and newborn (HDFN). HDFN is a rare condition affecting between 3 and 80 out of 100,000 newborns or fetuses each…
GSK stops two Phase 3 studies for novel antibiotic gepotidacin stopped early
GSK (LSE/NYSE:GSK) has announced that it would stop enrolling the pivotal EAGLE-2 and EAGLE-3 studies of the antibiotic gepotidacin based on advice from the independent data monitoring committee. Gepotidacin is a topoisomerase type II inhibitor. The EAGLE-2 and EAGLE-3 trials met the primary efficacy endpoint related to combined clinical and microbiological resolution. The EAGLE-2 and EAGLE-3…
FDA adcom recommends withdrawal of Covis Pharma’s preterm birth drug Makena
FDA’s independent Obstetrics, Reproductive, and Urologic Drugs Advisory Committee has voted almost unanimously that FDA should withdraw its approval of Makena (hydroxyprogesterone caproate injection). A total of 14 of the 15 committee members supported the withdrawal of the drug. In addition, all of the committee concluded that the postmarket study for Makena did not show a benefit.…
Zuranolone could offer rapid relief from postpartum depression
Postpartum depression is one of the most common psychological conditions after childbirth, affecting roughly one in eight new mothers. “Postpartum depression is one of the most common — often underdiagnosed complications of childbirth,” said Dr. Samantha E. Meltzer-Brody, director of the University of North Carolina Center for Women’s Mood Disorders. The pandemic has likely only…
Why Janssen’s nipocalimab could represent a ‘pipeline in a pathway’
At the heart of Johnson & Johnson’s (NYSE:JNJ) $6.5 billion acquisition of Momenta Pharmaceuticals in 2020 is a portfolio of drug candidates for immune-mediated diseases. One of the promising compounds in the acquisition is nipocalimab, which Janssen sees as a potential “pipeline in a pathway.” Nipocalimab holds promise for an array of diseases, ranging from…
FDA approves first drug for chronic yeast infection
The small biopharma Mycovia Pharmaceuticals has notched its first FDA approval with Vivjoa (oteseconazole), a novel drug for treating recurrent vulvovaginal candidiasis (yeast infections). The Durham, North Carolina-based company plans to launch the drug in the U.S. in the second quarter of the year. Vivjoa is an azole antifungal indicated for females with recurrent vulvovaginal…
Is there a better way to treat UTIs? LUCA Biologics says look at the microbiome
In 2019, clinically-studied probiotic specialist Seed Health launched a partner company known as LUCA Biologics focused on women’s health. Based on 15 years of academic vaginal microbiome research, LUCA’s pipeline targets urinary tract infections (UTI), bacterial vaginosis and preterm birth. The company’s first drug candidate targets UTIs and will enter a Phase 1b trial this…