Verve Therapeutics has suspended enrollment in the Phase Ib Heart-1 study evaluating its lead gene editing program VERVE-101 following a serious adverse event, the company announced Tuesday.
The U.S. Food and Drug Administration (FDA) has approved Abbott’s first-of-its-kind TriClip transcatheter edge-to-edge repair (TEER) system that’s specifically designed for the treatment of tricuspid regurgitation (TR), or a leaky tricuspid valve.
The U.S. Court of Appeals for the Federal Circuit on Monday ruled in favor of Teva Pharmaceuticals and Viatris, finding that the final Johnson & Johnson patent over its schizophrenia drug Invega Sustenna is invalid.
AstraZeneca announced Monday that it has secured FDA approval for an add-on to its blockbuster rare disease franchise, providing a potential differentiator as it tries to hold off competition from Novartis, Roche, and biosimilars.
2023 was a banner year for cell and gene therapy, with seven FDA approvals, according to the Alliance for Regenerative Medicine. And the pace doesn’t appear to be slowing at all as the second quarter of this year gets underway. The advocacy group is anticipating an even bigger year for the CGT space in 2024, with a potential 17 approvals in the U.S. and EU combined, according to ARM’s annual Cell & Gene State of the Industry Briefing in January.
Bristol Myers Squibb’s $4.8 billion acquisition of Mirati pays off with strong data from the KRYSTAL-12 study of Krazati, showing that the KRAS inhibitor significantly improves progression-free survival.
Now in Phase III with its small molecule orforglipron, Eli Lilly is leading the oral GLP-1 race against Novo Nordisk, Pfizer, Roche and others.
While disease-modifying therapies largely steal the spotlight in Alzheimer’s drug development, several companies are working to solve this less-discussed but disruptive facet of the illness.
BMS said its experimental drug to treat Crohn’s disease, a chronic inflammatory bowel condition, did not help patients achieve disease remission in a late-stage study.
Moderna has entered into a development and commercialization funding agreement with asset management firm Blackstone Life Sciences to help advance its pipeline of flu vaccine candidates.
