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The FDA appears to be casting a favorable eye on Biogen’s SOD1-amyotrophic lateral sclerosis drug tofersen, suggesting that reductions in neurofilament light, a protein associated with neuronal damage, could support an Accelerated Approval. Read More
If approved, the candidate could provide the broadest meningococcal serogroup coverage thus far, and could lead to a simplified immunization schedule. Read More
To disrupt the high-cost insulin market, the state of California is teaming up with nonprofit generic drug manufacturer Civica Rx to make insulins that will become available at low cost. Read More
CDER’s Office of Compliance issued 101 warning letters in fiscal 2022 — about two-thirds of them related to COVID-19 products, according to the office’s latest annual report. Read More
BioNTech and OncoC4 have inked a deal that has BioNTech paying $200 million upfront to co-develop and commercialize OncoC4’s anti-CTLA-4 monoclonal antibody candidate as a monotherapy or combination therapy for various cancers. Read More
Johnson and Johnson (J&J) and Janssen Biotech have agreed to pay $25 million to settle a class action lawsuit alleging they violated antitrust laws in marketing their blockbuster drug anti-inflammatory drug Remicade (infliximab). Read More