Regeneron, whose blood cancer treatment odronextamab was recently turned down by the US regulator but not for reasons relating to efficacy or safety, could soon learn whether its product will be among the drugs to get the thumbs up from the CHMP, the European Medicines Agency’s human medicines committee.

Dollars spent on biopharma M&A so far in 2024 may not be as high as in 2023, but dealmakers say deal volume is robust with many factors influencing the overall value of transactions this year.

New guidance suggests that switching studies will no longer be expected as standard to support determinations of biosimilar interchangeability; instead, analytical and clinical data may suffice.

Vyluma’s eyedrop for treating myopia in children and Vertex’s next-generation triple combination treatment for cystic fibrosis are among the latest drugs that the European Medicines Agency has begun reviewing for potential EU marketing approval.