Shares of Agile Therapeutics Inc. (NASDAQ:AGRX) trebled Thursday, rising 223.8% to $1.20 at the market's close following a near-unanimous FDA adcom vote the day before supporting approval for the company's transdermal contraceptive patch, Twirla (levonorgestrel/ethinyl estradiol).
HONG KONG – Indonesian regulators have introduced a medical device risk classification system, as part of a harmonization of regulations across the Association of Southeast Asian Nations (ASEAN) region. The 'Sistem Klasifikasi Risiko Alat Kesehatan' system, known by the acronym Siklara, takes its cues from the ASEAN Medical Device Directive (AMDD).
The U.S. FDA's overhaul of the 510(k) program continues apace with the recent final guidance for the special 510(k) mechanism. However, a member of the FDA staff said clerical errors account for a conspicuous number of conversions of these applications to traditional 510(k)s than any other problem. The agency posted the final guidance for the special 510(k) program in September with features seen in the draft that drew opposition from device makers.
Agile Therapeutics Inc. didn't feel much love Wednesday from FDA reviewers who questioned the efficacy of its Twirla birth control patch, but it got a warm embrace from the Bone, Reproductive and Urologic Drugs Advisory Committee, which voted 14-1, with one abstention, that Twirla's benefits outweigh its risks.
FDA approval of Vumerity (diroximel fumarate), a new therapy for people with multiple sclerosis (MS) offering improved gastrointestinal tolerability over Tecfidera (dimethyl fumarate), marks a win for its co-developers, Biogen Inc. and Alkermes plc, while triggering a $150 million payment from Biogen to its partner to mark the milestone. Biogen will also pay Alkermes a royalty on worldwide sales of the product.
The U.S. Centers for Medicare and Medicaid Services (CMS) has posted a draft rewrite of the coverage memo for next-generation sequencing (NGS), and while the draft rewrite fails to address a number of concerns, the agency eliminated references to advance-stage cancer, opening the door to considerably greater utilization.