US

Robert Califf’s nomination to return as FDA commissioner will raise protests about a ‘revolving door’ pathway between industry and agency. But, in this case, it may be more apt to talk about how Califf’s time outside FDA led to evolving views on the role of big data in drug regulation.

The request for an interview by the House Select Subcommittee on the Coronavirus Crisis seeks more information on the actions by President Trump and others to influence FDA decisions on HCQ, convalescent plasma, and vaccine decisions.

The most detailed US reporting requirements regarding prescription drug costs and coverage will target medicines reimbursed under the retail pharmacy benefit.

Soon-to-be-released white papers will FRAME how FDA plans assess products manufactured with advanced technologies as part of an initiative to reduce uncertainty for sponsors.

US FDA commissioner-nominee Califf calls for streamlining clinical trial bureaucracy, as well as open access to clinical data.

Harsh assessment of Lilly’s Phase II study by UCL and UCSF professors suggests donanemab may face same hurdles as Biogen’s Aduhelm. Lilly exec says the drug slowed disease progression by six months, but UCL prof says that won’t make a difference.

Complex products are slowly gaining a larger share of ANDA submission and approval totals, which could mean the FDA has to adapt its in-house expertise to compensate.

US FDA says pharmacists may dispense the antipsychotic without a REMS authorization and wholesalers may continue to ship it during temporary suspension of REMS. A high call volume and long wait times have impacted patient access since the modified REMS launched on 15 November.

Citing considerations of simplification, implementation and equity, Advisory Committee on Immunization Practices says everyone ages ≥50 years should get an mRNA vaccine booster dose and recommends all individuals ≥18 years have the option of getting one, without regard to occupational exposure or underlying medical conditions.

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.

Emergency use authorization for Pfizer/BioNTech, Moderna vaccine boosters for everyone ≥18 years was based on the same immune response data that supported previous clearance in certain high-risk groups, although FDA said it also considered additional real-world data on myocarditis risk and the recent increase in COVID-19 cases.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker