Pink Sheet reporter and editors discuss the CMS coverage decision for Biogen and Eisai’s Alzheimer’s treatment Aduhelm, the FDA conducting fewer advisory committee meetings in 2021 and the Defense Department’s efforts to increase domestic drug production.

Pink Sheet reporters and editors discuss US FDA commissioner nominee Robert Califf’s Senate confirmation hearing, new COVID-19 vaccine recommendations from the US CDC, and issues related to US approval of China-developed cancer drugs.

Pink Sheet reporters and editor review US FDA Acting Commissioner Janet Woodcock’s long career and update Robert Califf’s confirmation process, consider the advisory committee for Merck’s COVID-19 pill, and discuss an under-the-radar case on 340B policy at the US Supreme Court.

Join the Asia Pacific content team for a wide-ranging overview and analysis of recent developments across China, India, South Korea and Japan in the policy, regulatory, commercial and vaccines spaces over the past few months. 

Pink Sheet reporters and editors discuss the authorization of COVID-19 vaccine booster shots for all adults, Aduhelm’s impact on Medicare Part B and rejection by EMA, and the nomination of ex-FDA commissioner Robert Califf for another term.

Pink Sheet reporters and editors discuss the congressional agreement to allow Medicare drug pricing negotiation, the authorization of the Pfizer/BioNTech vaccine for children age 5 to 11, and the departure of the US FDA’s Chief Scientist.

Pink Sheet reporters and editors discuss the issues that could arise when the COVID-19 vaccines are given to children age 5 to 11, Merck’s agreement to share the license for its proposed oral COVID-19 treatment, and problems for a sponsor blocked by an accelerated approval conversion to full approval.

Pink Sheet editor and reporters discuss the impact of Francis Collins’ departure as NIH director, whether FDA and CDC COVID-19 messaging should be harmonized, and the narrowing gap between standard and priority assessment costs.