United States
The FDA’s reviewers pointed out that Stealth’s elamipretide missed its primary efficacy endpoints in the main study used to establish its effectiveness.
Eli Lilly CEO David Ricks is confident his company and peer Novo Nordisk are years ahead in the weight loss space, as biotechs press on with compelling data.
WuXi AppTec looks to unload its Philadelphia manufacturing sites and WuXi Biologics slows its rapid expansion in the U.S. as the companies await the Senate’s review of the BIOSECURE Act that threatens to cut them off from U.S. biopharma.
Sage has decided to discontinue the development of dalzanemdor in Alzheimer’s disease. A study of the candidate in Huntington’s is ongoing, with early data expected later this year.
With Monday’s data from SAPPHIRE, Scholar Rock is building toward regulatory submissions for apitegromab in spinal muscular atrophy in the first quarter of 2025.
J&J has recently pulled back from the infectious diseases space, including winding down R&D activity in this area in August 2023.
The clinical hold doesn’t cover its drug’s Investigational New Drug application for autoimmune hepatitis, for which the Phase IIa PORTOLA trial is ongoing.
Relay Therapeutics is cutting its workforce to help streamline its research organization as it looks to complete its first large-scale, pivotal clinical trial.
The company is lowering its previously issued guidance for 2024 adjusted earnings per share by $0.04 per share to account for acquired in-process research and development expenses incurred for acquisitions and collaborations in the third quarter.
Opdivo’s approval for patients with resectable non-small cell lung cancer comes as the regulator recently raised concerns of overtreatment with this type of therapeutic regimen with platinum-doublet chemotherapy.
PRESS RELEASES