FDA

Coherus BioSciences Inc. said on Wednesday the U.S. Food and Drug Administration (FDA) had flagged three observations at its partner’s manufacturing site in China when the agency was conducting inspections related to its experimental cancer drug.

Wednesday, Sanofi released data from a Phase II study showing its investigational anti-CD40L antibody frexalimab met the trial’s primary endpoint and significantly lowered disease activity in patients with relapsing multiple sclerosis. 

FDA

The FDA has placed a clinical hold on PepGen‘s Phase I trial of its neuromuscular candidate, which had been planned for the first half of the year. The Boston biopharma’s stock dropped around 18% post-market Tuesday after the announcement.

pills

Top-line results from a Phase IIa study showed that Glyscend Therapeutics’ lead candidate GLY-200 demonstrated promising safety and efficacy in patients with Type 2 diabetes, the company announced Wednesday.

DNA

Efforts are under way by the FDA to hasten the progress of gene therapies for severe conditions to the market—but reimbursement of these expensive medicines is still at the heart of the challenge. 

FDA

Akebia Therapeutics scored a long-awaited win Tuesday when it announced the FDA has granted a path forward for vadadustat in anemia associated with chronic kidney disease in dialysis-dependent patients, which will not require the company to submit new data. 

Amylyx

Amylyx Pharmaceuticals Inc. said on Tuesday that a European regulatory panel had taken a negative view on its amyotrophic lateral sclerosis (ALS) treatment, stalling the company’s plans on introducing its first commercial drug in the region.

Pfizer

U.S. drugmaker Pfizer Inc. said on Tuesday late-stage study data for its experimental hemophilia therapy showed superiority to the current standard of care treatment in reducing bleeding rates in patients.

Merck

The company will present data at the oncology meeting showing the drug’s significant survival benefit in patients with advanced renal cancer and recurrent, persistent and metastatic cervical cancer.

Novartis

The recommendation follows a review by EMA’s human medicines committee (CHMP) that concluded the benefits of the drug did not outweigh risks, according to the regulator.