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The Evolving Door? What Having A ‘Big Data’ Commissioner Might Mean For US FDA

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.

FDA Leadership

Former FDA Commissioner Hahn Faces Questions From House On Trump Interference, Other COVID Issues

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.

Coronavirus COVID-19 FDA

Medical Benefit, Hospital Drugs Exempt From Detailed Cost, Coverage Reporting In Final Rule

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

Pricing Strategies Reimbursement

US FDA ‘Quietly Working Hard’ To Develop Advanced Manufacturing Framework

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.

Manufacturing Regulation

Califf Outlines Clinical Trial Reform Message, Which Could Travel With Him To Commissioner’s Office

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

Clinical Trials Research & Development

Lilly’s Alzheimer’s Drug Will Get ‘Easier Ride’ Than Aduhelm But Does Not Show Clinical Benefit, Prof Says

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.

Clinical Trials Drug Approval Standards

Growing Complex Generic Application Load May Force US FDA Staffing Changes

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.

Generic Drugs Review Pathway

Clozapine REMS Program Paused After Problems With Re-Certification

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.

Risk Management Drug Review

US CDC Panel Moves To Simplify Pfizer/BioNTech, Moderna COVID-19 Vaccine Booster Recommendations

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.

Coronavirus COVID-19 Vaccines

Pink Sheet Podcast: COVID-19 Boosters For Adults, Aduhelm And Part B, Califf For FDA Commissioner

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.

Vaccines Neurology

Same Data, Broader Use: COVID-19 mRNA Vaccine Booster Authorizations Expanded In US

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.

Coronavirus COVID-19 Vaccines

Keeping Track: A Lawsuit-Driven Complete Response Letter, A Refuse To File Letter, And Some Good News

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

US FDA Performance Tracker Complete Response Letters
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