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The Biden administration yesterday launched a $3 billion program to develop antiviral medicines for treating COVID-19 and confronting future pandemics. Read More
The new forum will offer a confidential platform for discussion of policies in development, including draft guidances for industry, the agency said. Read More
The FDA has approved a third batch of Johnson & Johnson (J&J) COVID-19 vaccine drug substance for release from the embattled Emergent plant in Baltimore, Maryland — but still hasn’t authorized the Bayview facility to resume production. Read More
A proposed regulatory science pilot program and the FDA’s cost estimates under the next iteration of the Biosimilar User Fee Act (BsUFA) program were the focus of discussions in a recent negotiation meeting. Read More
The U.S. and EU reached an agreement to reduce export restrictions for COVID-19 vaccines and therapeutics at a Tuesday summit meeting in Brussels. Read More
As the first infusion of Biogen’s newly approved Alzheimer’s drug Aduhelm was given to a patient in Rhode Island, advocacy group Public Citizen called for the resignations of FDA officials, including Acting FDA Commissioner Janet Woodcock, claiming “the indefensible approval” of the drug showed “a stunning disregard for science.” Read More
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