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.

Pink Sheet reporters and editors look at the search for COVID-19 vaccine correlates of protection, a potential effort to simplify the US FDA’s expedited approval pathways, and new guidance on the use of real-world evidence.

Pink Sheet reporters and editors discuss new developments in US drug pricing reform, FDA considering mandatory opioid prescriber education again, and including China in the agency’s international parallel review initiative, Project Orbis.

Pink Sheet reporters and editors consider the leadership shake-up at the FDA Office of Vaccines Research and Review, the COVID-19 vaccine booster shot debate, and the impact of new safety measures for several JAK inhibitors.

Pink Sheet reporter explains the increased pressure on the FDA now that a coronavirus vaccine booster plan is in place, the surprising results of a survey of agency advisory committee members, and the recalculation of FY 2022 PDUFA fees.