Jennifer Boggs

1 week ago | bioworld.com | Jennifer Boggs

Pfizer’s loss offers boost to competitors in obesity spacePfizer Inc. is ending work on oral GLP-1 candidate danuglipron for weight loss following the report of a single potentially drug-induced liver injury, a move that appears to open the door for other firms working on oral therapies in the high-dollar obesity space, even as industry watchers seek further details to determine whether similar safety signals could emerge for those competitors.

2 weeks ago | bioworld.com | Jennifer Boggs

CMS rule ditches plan for Medicare coverage of obesity drugsA late 2024 CMS proposal to include obesity drugs like Novo Nordisk A/S’ Wegovy (semaglutide) and Eli Lilly and Co.’s Zepbound (tirzepatide) under Medicaid and Medicare didn’t make it far under the new U.S. administration. A final rule, set to be published in the Federal Register April 15, will not include the provision that would have added obesity drugs to Part D coverage beginning in 2026. BioWorld Regulatory Obesity U.S. CMS Medicare

2 weeks ago | bioworld.com | Jennifer Boggs

Another rebound as Sangamo inks $1.4B capsid deal with LillySangamo Therapeutics Inc. is adding a much-needed $18 million up-front payment in a neurology-focused deal with Eli Lilly and Co. that could bring up to an additional $1.4 billion. In return, Lilly gets access to Sangamo’s neurotropic adeno-associated virus (AAV) capsid, STAC-BBB, which has shown early promise in penetrating the blood-brain barrier penetration, for one initial target with the right to add up to four more.

3 weeks ago | bioworld.com | Jennifer Boggs

Sanofi adds to hemophilia arsenal with FDA nod for QfitliaSanofi SA gained U.S. FDA approval for fitusiran as a first-in-class siRNA therapy for hemophilia. Branded Qfitlia, the antithrombin-lowering therapy is indicated for use as a prophylactic treatment to prevent or reduce bleeding episodes in people with hemophilia A or B, with or without inhibitors. BioWorld MedTech Regulatory Hematologic RNAi U.S. FDA

3 weeks ago | bioworld.com | Jennifer Boggs

Sanofi adds to hemophilia arsenal with FDA nod for QfitliaSanofi SA gained U.S. FDA approval for fitusiran as a first-in-class siRNA therapy for hemophilia. Branded Qfitlia, the antithrombin-lowering therapy is indicated for use as a prophylactic treatment to prevent or reduce bleeding episodes in people with hemophilia A or B, with or without inhibitors, and joins the small but growing group of non-factor therapy options, with the advantage of a broad label and a convenient dosing regimen.