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The Biden administration is planning to finalize a proposed rule from the waning days of the Trump administration that would restrict federal use of so-called march-in rights to limit prices for drugs developed with the aid of taxpayer-funded research. Read More
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