Look back at pharma news in the week to April 2, 2021

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Notable regulatory news last week included Bristol Myers Squibb and bluebird bio gaining US clearance for their Abecma, marking the first Food and Drug Administration approval for a CAR-T therapy in the treatment of multiple myeloma. Also, AbbVie had its new drug application for atogepant, a new migraine prevention candidate, accepted for review by the FDA. On the M&A front, Amgen announced last Wednesday that it is buying Rodeo Therapeutics and its 15-PGDH program in regenerative medicine. BioNTech and Pfizer presented more positive news on their COVID-19 vaccine BNT 162b2, this time on its efficacy in children, while Johnson & Johnson hit a production quality snag relating to its COVID-19 Vaccine Janssen.

FDA approves Abecma in r/r multiple myeloma as expected

On Friday, the US FDA approved Abecma (formerly idecabtagene vicleucel [ide-cel] or bb2121) as the first CAR-T cell therapy for relapsed or refractory multiple myeloma (r/r MM). Timing of the approval gives bluebird bio and Bristol Myers Squibb an around nine month lead versus competitors Johnson & Johnson and Legend Biotech, commented SVB Leerink Research analyst Dr Mani Foroohar. The label includes black boxed warnings (mostly as expected). To mitigate safety concerns, Abecma is available through a risk evaluation and mitigation strategy (REMS) that requires administration at a certified healthcare facility. Leerink updates its model to reflect approval (increasing PoS to 100%).

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