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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 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 new CHMP recommendations are expected to enable the production of an additional “one to two million vials” of vaccine for the EU market each month, the committee said. 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
In the U.S., the Centers for Disease Control and Prevention (CDC) is reviewing whether messenger RNA-based COVID-19 vaccines are responsible for a recent outbreak of myocarditis and pericarditis in vaccinated individuals, with many cases of the conditions occurring in adolescent males. The CDC said it identified 216 cases of heart inflammation following one shot and 573 cases following a second shot. Read More
A third-party investigation of Eli Lilly’s Branchburg, N.J., facility, the site of internal whistleblower claims alleging that a quality official tampered with findings, has concluded that there is no evidence of wrongdoing at the plant. Read More
The bankruptcy judge overseeing the case, Judge Robert Drain, has argued that a settlement is the best way to quickly obtain financial support for those harmed. Read More
The FDA would need to see safety data from at least 3,000 trial participants to grant Emergency Use Authorization or approval for a COVID-19 vaccine for children under age 12, an agency official told members of its vaccine advisory panel yesterday. Read More
A third member of the FDA’s Peripheral and Central Nervous System Advisory Committee departed from the panel this week after the agency chose to approve Biogen’s Alzheimer’s drug Aduhelm (aducanumab). Read More