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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
FDA Acting Commissioner Janet Woodcock appeared for the first time before a Senate Appropriations subcommittee Thursday to discuss the agency’s fiscal 2022 budget request, and told lawmakers that the FDA urgently needs to revamp its inspection program. Read More
The chairman of the Senate Finance Committee is leading an effort by Senate Democrats to come up with alternative legislation to two House drug pricing bills over concerns that the current House versions will not find their way through Congress. Read More
The FDA is worried that Biogen may take too long to complete a required confirmatory trial for Aduhelm (aducanumab), the high profile Alzheimer’s disease drug that just this week scored a historic FDA approval amidst doubts about its clinical trial data and criticisms of the agency’s close collaboration with Biogen. Read More
The company will now resume the studies and seek regulatory submissions for SCD and beta-thalassemia, said Andrew Obenshain, Bluebird Bio’s president of severe genetic diseases. Read More