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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
Regeneron’s antibody cocktail, REGEN-COV, has demonstrated a reduced risk of death for COVID-19 patients in one arm of the UK’s Recovery trial that is investigating multiple potential COVID-19 treatments. Read More
AstraZeneca’s monoclonal antibody cocktail, AZD7442, failed to prevent symptomatic COVID-19 infection in a late-stage study of individuals recently exposed to the SARS-CoV-2 virus. 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