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. Get the full story at our sister site, Drug Delivery Business News.
Gynecological
MobileODT raises $7m for portable cervical cancer detection device
MobileODT said today that it raised $6.8 million in a Series B financing round. OrbiMed Advisors led the financing and was joined by a previous investor, Tristel. To date, the Israeli cancer diagnostic company has raised more than $13 million. MobileODT’s device, EVA, is a cheap, portable device that uses an imaging system to detect […]
Allergan, Medicines360 tout 4-year pivotal data for Liletta intrauterine contraceptive
Allergan (NYSE:AGN) and women’s health nonprofit pharma company Medicines360 touted 4-year data today from an ongoing pivotal trial for its Liletta intrauterine contraceptive. The system is approved for the prevention of pregnancy for up to 3 years. More than 1,500 women ranging from 16 to 45 years old were enrolled and studied in the group’s […]
Pfizer collaborates to improve access to injectable contraceptive
Pfizer (NYSE:PFE) said yesterday that it inked a multi-year extension of its collaboration with the Bill & Melinda Gates Foundation and the Children’s Investment Fund Foundation to improve access to the company’s injectable contraceptive, Sayana Press, for women in developing countries. The pharma giant’s product uses Becton Dickinson‘s (NYSE:BDX) Uniject delivery system to administer a long-acting, […]
Actamax seeks FDA nod for sprayable adhesion barrier trial
Actamax Surgical Materials, a DSM-DuPont joint venture, said today that it submitted an Investigational Device Exemption application to the FDA for its adhesion barrier device in gynecological laparoscopic surgery. Adhesions, excessive scar tissue that can form between adjacent internal tissues, are a result of normal wound healing. Adhesions occur post-surgical operations at rates of 50-90%. […]
Femasys Inc. raises $4m
Femasys Inc. said last week that it raised $4 million, according to a regulatory document filed with the SEC. Atlanta-based Femasys wrote that 8 investors contributed to the round and that it paid Los Angeles-based investment bank Salem Partners LLC an estimated $200,000 in sales commissions. The 1st sale in the financing round happened on Jan. 6 […]
FDA accepts Allergan’s new drug application for Liletta contraception device
Allergan (NYSE:AGN) and the global nonprofit women’s health company Medicines360 said today that the FDA accepted its supplemental New Drug Application for the Liletta contraception device. The companies are asking the federal watchdog to extend the system’s duration of use from 3 years to 4 years. Liletta is a levonorgestrel-releasing intrauterine system that is placed […]
Actamax touts clinical data for sprayable adhesion barrier device
Actamax Surgical Materials, a DSM-DuPont joint venture, touted data from a 12-month clinical follow-up study evaluating the effects of its biocompatible, resorbable adhesion barrier device. The results were presented this week at the 45th Global Congress on Minimally Invasive Gynecology in Orlando, Fla. Adhesions, excessive scar tissue that can form between adjacent internal tissues, are […]
Smiths Medical deals Wallace IVF biz to CooperSurgical for $174m
Smiths Group (LON:SMIN) said today it divested its Wallace in-vitro fertilization product line to Cooper Cos. (NYSE:COO) CooperSurgical subsidiary for $174 million (UK £140 million). The divestiture is part of an ongoing program at Smiths to focus its portfolio on “market leading positions of scale in its chosen markets,” the company said. The company said that proceeds from […]
Plaintiff’s lawyers ask FDA to ban Boston Scientific’s pelvic mesh
The law firm that’s bringing a racketeering lawsuit against Boston Scientific (NYSE:BSX) accusing it of smuggling counterfeit resin asked the FDA to ban the medical device maker’s pelvic mesh products made with the allegedly impure resin. Teresa Stevens sued Boston Scientific in January, alleging that the Marlborough, Mass.-based company conspired with subsidiaries in Belgium and Ireland to use counterfeit resin imported from China […]
FDA updates on Boston Scientific surgical mesh implant “counterfeit” material
The FDA today released an update on allegations that Boston Scientific‘s (NYSE:BSX) urogynecologic surgical mesh may contain counterfeit raw material. The agency said it was “examining these allegations” to determine the next steps, but said it is currently not away that the alleged counterfeit raw material is contributing to adverse events with the products. “It […]