Contura announced that it won FDA premarket approval for its Bulkamid hydrogel injection for treating stress urinary incontinence (SUI). Bulkamid is Contura’s proprietary device designed for treating SUI due to intrinsic sphincter deficiency in adult women with SUI or stress predominant mixed incontinence. According to a news release, the product is currently marketed in more […]
Women's Health
Prasco launches generic NuvaRing
Prasco this week said it launched its authorized generic NuvaRing. The generic etonogestrel/ethinyl vaginal ring is a small, flexible vaginal ring that is used by women as a form of birth control. The NuvaRing releases a continuous low dose of hormones for three weeks at a time. “We are proud to launch the authorized generic […]
FDA approves expanded indication for Liletta 6-year IUD
Medicines360 and its partner Allergan (NYSE:AGN) said today that the FDA approved Medicines360’s supplemental new drug application to extend the duration use of the Liletta intrauterine device for up to six years. The Liletta levonorgestrel-releasing intrauterine system now has the longest approved duration of use for a hormonal intrauterine device in the U.S., according to a […]
FDA nixes Evoke Pharma’s gastro nasal spray
The FDA has rejected Evoke Pharma’s (NSDQ:EVOK) application for a metoclopramide nasal spray for diabetic women with gastroparesis. The Solana Beach, Calif. company’s stock price tumbled 40% on the news yesterday that the agency had found dosing inconsistencies in the pivotal pharmacokinetic study for the spray, Gimoti. In an earlier multi-disciplinary letter to the company, […]
Study: Use of long-acting reversible contraception spiked after 2016 election
In a study published this week in JAMA Internal Medicine, researchers reported that use of long-acting reversible contraception increased in the month following the 2016 presidential election. Adjusting for seasonal trends and patient characteristics, the researchers from Brigham & Women’s Hospital found that insertion of contraceptives such as intrauterine devices increased by 21.6% after the […]
Inside Hologic’s evolving definition of women’s healthcare
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 […]
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, […]
