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. Get the full story at our sister site, Drug Delivery Business News.
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 would […]
A British health watchdog reportedly plans to recommend that the National Health Service there ban vaginal mesh implants to treat pelvic organ prolapse, citing “serious but well-recognized safety concerns.” In recommending that the implants be limited to research use only, the U.K.’s National Institute for Health & Care Excellence said “evidence of long-term efficacy [for implants […]
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 […]
Teva Pharmaceuticals (NYSE:TEVA) said today that it closed the $1.1 billion cash sale of its Paragard intrauterine copper contraceptive device to Cooper Cos.‘ (NYSE:COO) CooperSurgical unit. The deal included Teva’s manufacturing facility in Buffalo, N.Y., the pharma company reported. The move is part of Teva’s efforts to restructure its business, narrowing its focus on CNS and respiratory […]
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.
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 (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 (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 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. 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 […]