Beyfortus

October 4, 2024 9:35 PM

Thermo Fisher’s plant making infant RSV drug breached FDA rules, documents show

One of the largest contract drug manufacturing plants in the U.S. owned by Thermo Fisher Scientific over the past 10 years has repeatedly breached rules meant to ensure drugs are free of contamination, FDA documents show, including twice this year. The most recent U.S. Food and Drug Administration inspection of Thermo Fisher's Greenville plant in May identified manufacturing issues for the respiratory syncytial virus drug Beyfortus, a preventive antibody therapy from AstraZeneca and Sanofi for ...

Sanofi’s mixed fortunes in MS drug trials has market focus on win

Sanofi's most advanced multiple sclerosis drug candidate has missed the main goal of two late-stage trials to treat relapsing forms of the disease, but in a positive surprise succeeded in a study on a less common form of progressive MS. Investors focused on the good news, with analysts saying the trial failure for tolebrutinib in the common relapsing form of the disease, where isolated flare-ups temporarily subside, had been widely expected as a similar compound had fallen short. The shares ju...