Redhill Biopharma Ltd. CEO Dror Ben-Asher told BioWorld that the 2 million patients targeted by just-approved, delayed-release Talicia, previously known as RHB-105, for adult infection by Helicobacter pylori represents "the baseline where we start our promotion," and there's an opportunity to help many more patients. "When you combine the high prevalence of roughly 100 million Americans infected and more than half of the world's population with the association with gastric cancer, it's a major public health concern," he said. About 800,000 people worldwide die every year from gastric cancer, and about 90% of cases are caused by H. pylori.
MELBOURNE, Australia – Although Australia's Therapeutic Goods Administration (TGA) approved its first CAR T therapy in 2018, the country is lacking a system to reimburse those advanced therapies, and industry is calling on government to revalue gene therapies so that patients can access them.
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).
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.
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