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 […]
Women's Health
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 […]
EMD Serono wins FDA nod for redesigned pen injector
Merck KGaA‘s biopharma biz, EMD Serono, said today that it won FDA approval for a redesigned version of its Gonal-f RFF Redi-ject pen injector. The device, which was first approved in 2013, is designed to inject follitropin alfra to induce ovulation and pregnancy in oligo-anovulatory women. The newly-designed pen was evaluated in a simulated-use study involving […]
Teva closes Plan B emergency contraception sale in $2.3B restructuring effort
Teva Pharmaceuticals (NYSE:TEVA) said today that it closed the $675 million cash sale of its Plan B One-Step product and emergency contraception assets to Foundation Consumer Healthcare. The move is part of Teva’s efforts to restructure its business, narrowing its focus on CNS and respiratory conditions. The company also plans to divest of its oncology and […]
Agile Therapeutics touts late-stage trial for once-weekly contraceptive patch
Agile Therapeutics (NSDQ:AGRX) touted data today from a Phase III trial of its once-weekly, low-dose hormonal contraceptive patch, Twirla. The study showed that women experienced mean decreases in length of bleeding and spotting episodes, the Princeton, N.J.-based company reported. Women taking Twirla reported a gradual decrease in the mean total number of bleeding or spotting […]
Teva reintroduces generic Depo-Provera contraceptive in U.S.
Teva Pharmaceuticals (NYSE:TEVA) said today that it is reintroducing the generic equivalent to the Depo-Provera contraceptive in the U.S. The injectable medroxyprogesterone acetate suspension brought in $211 million in sales this year in the U.S., according to the Jerusalem-based pharma giant. “This reintroduction brings an additional product to a market that was previously lacking in options,” Hafrun […]
