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2

One-Year Data Will Support NDA for Biogen/Sage MDD Drug

Almost one year after Biogen forged a collaboration with Sage Therapeutics worth $1.52 billion, the development deal for the experimental major depressive disorder treatment zuranolone is bearing fruit that will support an expected rolling New Drug Application during 2022.

4

Janssen and Amgen Combine for Regulatory Win in Multiple Myeloma

Janssen Pharmaceutical and Amgen received another regulatory win for Darzalex Faspro (daratumumab and hyaluronidase-fihj) as the U.S. Food and Drug Administration approved the drug in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

7

Vertex Kidney Disease Drug Proves its Worth in Phase II

Vertex Pharmaceuticals reported the company’s Phase II proof-of-concept trial of VX-147 in patients with APOL1-mediated focal segmental glomerulosclerosis (FSGS), with the drug hitting a statistically significant and clinically meaningful decrease of 47.6% in the urine protein to creatinine ratio (UPCR) at Week 13 compared to baseline.