Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
The U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine for children ages 5 to 11.
Albert Bourla, chief executive officer of Pfizer, argued this week that politicians were approaching the problem of drug pricing the wrong way — as usual.
Yet another busy week for clinical trial news. Here’s a look.
Paris-based Sanofi reported its third-quarter finances, with most of its categories showing strong growth. However, not everything was rosy
Novartis is the subject of a DOJ inquiry over the company’s marketing and pricing of Entresto over the past five years, receiving a Civil Investigative Demand from the government.
Collaboration is key to faster breakthroughs. The NIH, FDA, and 15 private organizations have announced they are joining forces for the sake of the 30 million Americans suffering from a rare disease.
The osteoarthritis drug tanezumab gets permanent leave from the market. The decision of stopping production was due to negative feedback from the regulators.
This week during the ongoing trial of Elizabeth Holmes, representatives from one wealthy family described the process with which Holmes secured private investments.
In documents prepared for the meeting, the vaccine demonstrated 90.7% effectiveness for the children in this age group.
Scientists are scrambling to find the cause for the sudden spike in human cases of avian influenza A (H5N6) in China to 21 this year, from only five in 2020.