Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.

AstraZeneca and the European Commission have both claimed victory in the Vaxzevria supply case brought against the company by the commission. The Moderna coronavirus vaccine is now under review by the European Medicines Agency for use in younger people.

A new evaluation route that the European Medicines Agency launched last year came at the right time for Takeda’s dengue vaccine candidate. 

Foreign facility visits may take longer to reach usual levels because of the ongoing coronavirus outbreaks in other countries.

The sponsor of what could become the EU’s first approved ophthalmic formulation of bevacizumab needs to address outstanding issues raised by the European Medicines Agency about its filing.

Executive Summary: The European pharma industry federation believes the advice provided in the updated draft EU guideline on additional risk minimization measures is far too detailed, resulting in a lack of focus, information overlap and confusion.

Federal district court denies HHS request to dismiss AstraZeneca’s lawsuit, but also suggests Congress needs to clarify the contract pharmacy issue.

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.

Transparency on pricing and cost calculations could improve and inform public policy on medicines access, say EU health ministers.

FDA’s Rick Pazdur notes that while the agency recently allowed Amgen to conduct a key dose comparison study for its landmark KRAS inhibitor post-market it will be less willing to do this in the future, particularly in settings that are less refractory.

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.

News and views from day two of the BIO Digital annual meeting include the increasing number of small companies driving US product approvals, an update on the Reagan-Udall RWE Accelerator project and Merck & Co.'s Julie Gerberding on the need for continued HIV/AIDS research.

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.

BARDA’s suspension of funding for COVID-19 therapeutics risks repeating mistakes of past pandemics as it may cause industry to pull out of the development space, experts say. Industry sources are concerned the Biden administration is focusing on funding NIH at the expense of BARDA.

Investors are trying to wrap their minds around exactly how big Pfizer’s COVID vaccine business will end up being. But they also have questions about Pfizer’s prospects at the opposite end of the patient-population spectrum.

Foreign facility visits may take longer to reach usual levels because of the ongoing coronavirus outbreaks in other countries.

Two batches were authorized because they were made before production waste jammed Emergent BioSolutions' Bayview plant.

Amryt’s birch bark extract oleogel-S10 for Epidermolysis Bullosa patients might become only the third botanical drug to clear the FDA.