We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more
8/29/2024
/ Biologics ,
Biosimilars ,
BPCIA ,
Clinical Trials ,
Comment Period ,
Draft Guidance ,
FDA Approval ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Interchangeability ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
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On April 4, 2024, Bristol Myers Squibb (“BMS”) and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after...more
According to PWC, “2023 was a reasonably strong year for the pharmaceutical and life sciences sector with both deal value and volume of M&A close to pre-pandemic levels.” Below is a recap of the top M&A deals in 2023 that...more
On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA)...more
Last week, Pfizer announced that it will acquire Trillium Therapeutics, a clinical stage immune-oncology company based in Cambridge, Massachusetts. Under the agreement, Pfizer reported that it “will acquire all outstanding...more