News review for the week ending November 15

By Barbara Obstoj-Cardwell. Editor

Regulatory decisions featured heavily in last week’s news, with Celgene and partner Acceleron scoring a first US Food and Drug Administration approval for Reblozyl, a treatment for beta-thalassemia, a rare hematological disorder. On the negative side, Solid Biosciences was hit by a clinical hold on its Duchenne drug candidate, SGT-001. And, on Thursday, China’s BeiGene received its first US regulatory approval, with the FDA clearing its mantle cell lymphoma drug Brukinsa (zanubrutinib) for marketing. Meantime, on the research front, Swiss pharma giant Roche reported positive results with its spinal muscular atrophy candidate risdiplam. Also, following positive data from a Phase III trial of bardoxolone, Reata Pharmaceuticals said it would file for approval of the drug for kidney damage reversal.

FDA approves first drug for anemia tied to rare blood disorder