The week in pharma: action, reaction and insight – week to August 18, 2023

By Barbara Obstoj-Cardwell. Editor

Among the important regulatory announcements last week, on Monday US biotech Arcellx said that the Food and Drug Administration (FDA) had lifted the partial clinical hold on the trial of its multiple myeloma candidate CART-ddBCMA, which is being developed with Gilead Sciences’ Kite unit. Also, bluebird bio announced that the FDA has decided it would not be necessary to hold an advisory committee meeting ahead of its approval decision for the firm’s sickle cell disease gene therapy lovotibeglogene autotemcel (lovo-cel). In an interview with The Pharma Letter, US biotech Cytokinetics explained its philosophy on R&D and discussed the FDA complete response letter on its heart candidate omecamtiv mercarbil. Also of note, Seagen released new Phase III data showing positive results for its Tukysa in breast cancer, with the latter an important factor for Pfizer, which is in the process of acquiring the US biotech for $43 billion.

Swift FDA clinical hold lift is validating Arcellx and CAR-ddBCMA