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Mississippi’s attorney general has filed a lawsuit against insulin makers Eli Lilly, Sanofi and Novo Nordisk — along with several pharmacy benefit managers (PBMs) — charging them with colluding to artificially hike insulin prices. Read More
The FDA has launched the Generic Drug Cluster, calling it the first forum of its kind focused on increasing scientific alignment among regulatory agencies in countries that focus on generic drug development. Read More
Former FDA Commissioner Stephen Hahn has joined Flagship Pioneering, the science-focused venture capital firm that helped launch Moderna. He starts June 16. 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 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