A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

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.

Sandoz Canada brings a lisdexamfetamine generic to the market, while its US filing still has tentative approval. Meanwhile, off-patent group CGPA launches a social media campaign to tackle misinformation surrounding generics.

From Wyeth/Pfizer to Jiangsu Hengrui to IMab to starting her own biotech, Joan Huaqiong Shen has seen many ups and downs of drug development in China. She sat down with Scrip on the sidelines of the recent DIA China meeting to discuss her latest startup devoted to novel small molecules to treat schizophrenia and epilepsy and a gene therapy for ALS.