Nuvo Group announced today that it completed the first phase of a collaboration agreement with Sheba Medical Center’s “Sheba BEYOND.” The first phase of the partnership included a pilot program centered around gestational diabetes management. The program shifted necessary non-stress tests (NSTs) to home-based, remote monitoring using Nuvo’s INVU rather than conducting traditional monitoring in […]
Women's Health
NovaXS unveils prototype for smart, needle-free drug delivery device
NovaXS Biotech announced that it unveiled the new prototype for its needle-free injection therapy smart medical device. Formed at the University of California, Berkeley, NovaXS designed its patent-pending Telosis technology to administer a narrow stream of medication without a needle in 0.3 seconds and to analyze injection data to allow for smarter health decisions. The […]
ProMed Pharma begins preclinical testing of resorbable contraceptive implant
After receiving funding from the Bill & Melinda Gates Foundation, ProMed Pharma has begun preclinical evaluation of a novel fully resorbable contraceptive implant. The Plymouth, Minnesota–based company imagines that the contraceptive implants could ultimately find use in low- and middle-income (LMIC) settings. The novel implant potentially could offer women 18 months of contraception through the […]
Theramex wins decentralized procedure approval in EU, UK for hormone drug
Theramex announced today that it received decentralized procedure approval in several EU countries and the UK for its Bijuva capsules. Bijuva possesses an indication for continuous combined hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women with intact uterus and with at least 12 months since last menses, according to a news release. […]
Axonics acquires Contura and its Bulkamid bulking agent for $235M
Axonics (NSDQ: AXNX) announced today that it acquired Contura and its flagship Bulkamid product for up to $235 million. London-based Contura’s Bulkamid is a urethral bulking agent for women with stress urinary incontinence (SUI). It is a next-generation hydrogel injected into the urethral wall in a minimally invasive office or outpatient facility procedure to restore the natural closing pressure […]
Contura wins FDA premarket approval for hydrogel injection
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 […]
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 […]
