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GSK is expanding its reach in cancer immunotherapies in a $2.1 billion deal with iTeos Therapeutics to co-develop EOS-448, a monoclonal antibody aimed at getting the body’s immune system to recognize and attack cancer cells. Read More
Emergent BioSolutions’ troubled Bayview, Md., plant, a manufacturing site for Johnson & Johnson’s COVID-19 vaccine, repeatedly failed to seal off a preparation area for vaccine ingredients and allowed production garbage to be carried through the area, leading to contamination, explains Peter Marks, director of FDA’s Center for Biologics Evaluation and Research in a memorandum about the plant’s operations. Read More
The FDA has declined to authorize Bharat Biotech’s COVID-19 vaccine, Covaxin, for emergency use, prompting the Indian drugmaker’s U.S. partner, Ocugen, to instead seek a full approval of the shot through a Biologics License Application (BLA). Read More
Novavax said it plans to file for FDA Emergency Use Authorization (EUA) of its two-dose COVID-19 vaccine in the third quarter, supported by the strong efficacy data from its late-stage trial in which the recombinant DNA-based vaccine proved 100 percent effective in preventing moderate and severe disease, and more than 90 percent effective at preventing symptomatic infections. Read More
The Alzheimer’s Association, the largest nonprofit funder for Alzheimer’s research, has blasted Biogen for its plans to price Aduhelm (aducanumab) — the first drug approved to treat Alzheimer’s in 18 years — at $56,000 a year. Read More
The FDA has cleared the release of two batches of the Johnson & Johnson (J&J) vaccine drug substance manufactured at Emergent BioSolutions’ troubled Bayview, Md., plant, but stopped short of authorizing the facility to restart vaccine production. Read More
In the turbulent week that followed the FDA’s landmark and contested decision to approve Biogen’s Aduhelm (aducanumab), the agency drew strong criticism, including speculation that Acting Commissioner Janet Woodcock’s prospects as permanent agency chief may have been damaged by the approval. Read More
Negotiations have concluded between the FDA and industry on proposed enhancements to be included in the next iteration of the Prescription Drug User Fee Act (PDUFA), with an agreement on a draft letter outlining the agency’s goals. Read More