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.

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.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER