Agency is pledging to act well ahead of the six-month review deadline in reviewing full applications for COVID 19 vaccines that are already authorized for emergency use. Going too fast may be counterproductive, in more ways than one.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

US FDA seems to want Moderna and Pfizer to study their mRNA vaccines in 3,000 people ages five to 11, suggesting the rate of myocarditis in younger children may be higher than in older teens. Such a finding, and even the hunt for it, could push back any COVID-19 vaccine authorization for this population.

Advisory committee will discuss five types of toxicity risks with adeno-associated virus vector-based gene therapy products at a two-day meeting in September, which follows some recent high-profile instances of adverse events that have delayed development programs.

OOPD’s deputy director has been named the acting head of the office responsible for orphan and rare pediatric disease designations.

US FDA says COVID disruptions may be having an impact; complete response letters have also dropped significantly.

Bavencio, Taltz, Cosentyx, and Opdivo plus Yervoy were this week also the subject of final recommendations from the health technology assessment body, NICE, on whether or not they should be used on the National Health Service for certain indications.

Benefits of the one-shot vaccine outweigh risk, ACIP members agree. One member says he supports its availability but would personally recommend mRNA vaccines instead.

US FDA’s first decision on biosimilars interchangeability might have less meaning for two insulin products, but payer and prescriber responses to interchangeable biosimilars for adalimumab, which are further out on the horizon, may be more instructive regarding the importance of interchangeability status.

Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.

Lilly expects results from donanemab ongoing confirmatory trial in 2023, while Biogen has nine years to finish its postmarket study. CEO David Ricks discusses impact of aducanumab approval backlash, pricing and national coverage decision at STAT summit.

The nation’s top drug regulator vows to adopt ICH’s guidelines on drug safety and efficacy, after dropping the industry a bombshell with the tightening of oncology drug clinical trials a week ago.

Legal experts discuss the intricacies around pharma’s demand for indemnity, a key sticking point for supplies of COVID-19 vaccines from Pfizer and Moderna, and the path forward for countries like India.

US antitrust regulators appear poised to take a broader view of disease areas when reviewing mergers, Lazard Freres financial advisory CEO Peter Orszag cautioned.

Five years after European licensure and launch, and 30 months after FDA approval, Vaxelis enters the US market offering an advantage of fewer shots than current pentavalent vaccines for protection against six diseases in children six weeks to four years old.

Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.

Acting FDA Commissioner Janet Woodcock says stability studies are ongoing and that states shouldn’t get rid of expiring inventory yet.

PIC/S document will help authorities see which manufacturing sites can manage less-significant changes effectively without oversight, as ICH Q12 allows.