Hologic (NSDQ:HOLX), known in the medtech industry for its mammography and diagnostics devices, is rethinking what it means to be a women’s healthcare company. The 6,000-person company wants to expand its reach to include products that care for women’s well-being, as well as their health – a concept that Dr. Edward Evantash honed when he led […]
Women's Health
Study: Heat-stable drug formulation offers new option to prevent postpartum bleeding
Data from a collaboration between Ferring Pharmaceuticals, Merck (NYSE:MRK) and the World Health Organization showed that a heat-stable formulation of carbetocin is as effective as oxytocin for the prevention of excessive bleeding following vaginal birth. Millions of women are affected by postpartum hemorrhage every year, according to Ferring Pharmaceuticals. Traditionally, women are given oxytocin to prevent […]
Enteris BioPharma touts more Phase II data for oral endometriosis therapy
Enteris BioPharma this week touted positive results from the final treatment arm of a Phase IIa trial of Ovarest, the company’s oral formulation of leuprolide. The drug is designed as an alternative to the injectable therapies available for people with endometriosis. Data from the last treatment arm of Enteris’ Phase IIa trial showed that the optimized […]
On second try, TherapeuticsMD lands FDA nod for vaginal capsule
TherapeuticsMD (NSDQ:TXMD) said today that it won FDA approval for its applicator-free estradiol vaginal capsule, TX-004HR. The soft-gel capsule is designed to treat moderate-to-severe vaginal pain experienced during sex, a symptom of vulvar and vaginal atrophy in women who have undergone menopause. The Boca Raton, Fla.-based company plans to market the product under the name ‘Imvexxy’. This […]
Allergan touts 5-year data for Liletta intrauterine contraceptive
Allergan (NYSE:AGN) and its nonprofit partner, Medicines360, touted five-year data today from an on-going pivotal trial of its intrauterine device, Liletta. The levonorgestrel-releasing contraceptive is approved in the U.S. to be used to prevent pregnancy for up to four years. The companies collected data from women who ranged from 16 – 45 years old. Two women, […]
Qiagen wins FDA nod for point-of-care PartoSure test
Qiagen (NYSE:QGEN) today touted the FDA’s approval of its PartoSure diagnostic test, designed to assess the risk of spontaneous preterm birth in patients with symptoms of preterm labor. The non-invasive strip test detects placental alpha microglobulin-1 and can provide results in less than five minutes, according to Germany-based Qiagen. Beyond the company’s U.S. regulatory win, PartoSure […]
Confer Health raises $9.5m for fertility diagnostic
Confer Health said today that it raised $9.5 million to support its development of affordable, at-home diagnostic devices featuring interchangeable cartridges, a reusable analyzer and a mobile app. The Boston, Mass.-based company’s first urine-based diagnostic test is designed to help couples conceive by tracking three fertility hormones. Confer added that it is also developing an at-home […]
TherapeuticsMD negotiates label for vaginal capsule after NDA resubmission
TherapeuticsMD (NSDQ:TXMD) is negotiating with the FDA over the proposed label for its investigational, applicator-free estradiol vaginal capsule, TX-004HR, the company reported today. The softgel capsule is designed to treat moderate-to-severe vaginal pain experienced during sex, a symptom of vulvar and vaginal atrophy in women who have undergone menopause. The FDA is slated to make a […]
Teva closes $703m sale of global women’s health biz to CVC Capital
Teva Pharmaceuticals (NYSE:TEVA) has finished the $703 million sale of a portfolio of products in its global women’s health business to CVC Capital Partners. The portfolio of divested products includes fertility medicines like Ovaleap, oral contraceptives like Zoely and osteoporosis drugs like Actonel. Now that the sale is closed, the portfolio of medicines will be sold under […]
CDC group tackles access to birth control for women in Puerto Rico
Between May 2016 and August last year, a group organized by the CDC provided services to more than 21,000 women in Puerto Rico in an attempt to boost access to contraception, lower the rate of unintended pregnancy and lessen the number of Zika-related birth defects on the island. Last week, The Lancet Public Health examined the […]