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, […]
Women's Health
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 […]
Enteris touts Ph2 trial data for oral endometriosis therapy
Privately-held biotech Enteris BioPharma touted data today from a Phase IIa trial of its oral leuprolide formulation, Ovarest. The Boonton, N.J.-based company reported that its product triggered significant suppression of estradiol, which is correlated with efficacy in treating endometriosis. “The positive results from the Phase IIa clinical trial of Ovarest are a significant advancement towards Enteris’ […]
TherapeuticsMD submits NDA for hormone therapy to treat vasomotor symptoms
TherapeuticsMD (NSDQ:TXMD) has submitted its bio-identical hormone therapy to the FDA for approval as a treatment for moderate-to-severe vasomotor symptoms due to menopause. The company’s investigational combination of estradiol and progesterone is delivered in a single, oral soft-gel capsule. Shares in TherapeuticsMD fell earlier this month after the company announced that the FDA accepted its resubmitted […]
TherapeuticsMD shares tumble after FDA pushes NDA decision to mid ’18
TherapeuticsMD (NSDQ:TXMD) shares fell 7% yesterday after the company announced that the FDA accepted its resubmitted application for TX-004HR, an investigational, applicator-free estradiol vaginal soft-gel capsule for the treatment of dyspareunia. The company’s shares took a hit presumably because it revealed that its resubmitted application is a Class 2 response – a Class 1 response […]
Governor passes law to keep birth control free in Massachusetts
Massachusetts governor Charlie Baker signed a law on Monday requiring health insurers to cover at least one kind of every type of FDA-approved birth control. The new law protects health care services and rights for women across the state, “irrespective of what goes on in Washington,” the Republican governor said at the bill’s signing, according […]
