Roche will have to wait on its big MS drug ap­pli­ca­tion; Pfiz­er ties up with BioIn­vent on new an­ti­bod­ies for can­cer

Roche’s pi­o­neer­ing MS drug Ocre­vus (ocre­lizum­ab) has hit a snag at the FDA. Billed as one of the biggest po­ten­tial block­busters in the pipeline, which may be used for both re­laps­ing and pro­gres­sive MS, the agency says it needs more time to re­view some new in­fo on the man­u­fac­tur­ing side of the ap­pli­ca­tion. Man­u­fac­tur­ing has re­peat­ed­ly been cit­ed in a slate of CRLs this year, which will mark a decade low in new drug ap­provals.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.