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.
Pfizer is stepping up with $10 million in near-term payouts to get a new immuno-oncology collaboration working with Sweden’s BioInvent. They’ll be working on antibodies that target myeloid cells. If they can advance 5 antibodies to the market – a long shot at best – Pfizer is willing to add hundreds of millions of dollars in added milestone payments.
Endo International has appointed Patrick Barry as Senior Vice President, US Branded Pharmaceuticals, effective immediately; and Matthew Davis as Senior Vice President, Research and Development Branded Pharmaceuticals, effective January 3, 2017.
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