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Bookmark or Share- FDA flags additional injury risk for Intercept’s liver drugThe announcement is another setback for Ocaliva, a drug that was once among the most closely watched medicines in the biotechnology industry. Known scientifically as obeticholic acid, Ocaliva was originally developed by biotech company Intercept Pharmaceuticals, which in 2016 secured for the drug the first FDA approval for PBC in two decades ...
- Novo inks Ascendis deal to develop long-acting GLP-1, other metabolic ...In addition, Ascendis could receive up to $77.5 million for each additional drug developed. Ascendis has won Food and Drug Administration approval of two products using its extended release technology, both in rare conditions. In partnering with Novo, Ascendis would gain entry into conditions that have blockbuster sales potential.
- Endometriosis drug research, long underfunded, confronts familiar ...The drug can cause side effects similar to that of menopause and was a “horrific” experience for Schott, who was about 13 years old when it was prescribed to her. Within the past decade, two other products have been approved by the FDA for pain management with endometriosis: AbbVie’s Orilissa in 2018 , and Pfizer and partner Myovant ...
- Sarepta rebuilds drug pipeline with Arrowhead dealThe four clinical-stage medicines Sarepta gains via the deal treat diseases of the muscle, central nervous system and lungs. Two are aimed at muscular dystrophies — long the focus of Sarepta’s drug development. The three preclinical assets, meanwhile, are all designed to treat conditions of the central nervous system.
- Metsera raises $215M to accelerate obesity drug plansThe company’s lead product is a long-acting GLP-1 drug known as MET-097i. In a Phase 1 trial, five weekly injections of the highest dose produced a 7.5% drop in body weight by day 36. At day 57, four weeks after the last dose, the weight loss total rose to 8.1%, suggesting the drug could be given monthly.
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