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.
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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.
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Two of the three drugs that were up for review in mid- to late-February received much earlier approval in December 21, the day before the federal government shutdown. The shutdown ended on January 25, 2019.
Following international concern and outrage over a gene editing treatment of human embryos in China, the World Health Organization is taking action.
A rap video extolling the virtues of prescribing a powerful fentanyl-based pain killer to patients beyond what the drug was initially intended, is coming back to haunt Insys founder John Kapoor.
If the new funding bill is signed by the president, the FDA will have some extra funds to support various initiatives.
GeoVax Labs, Inc., a biotechnology company developing human vaccines, today published an open letter to U.S. Department of Health and Human Services Secretary Alex Azar in response to the HHS initiative “Ending the HIV Epidemic: A Plan for America.”
Novartis announced that the FDA approved the company’s Egaten to treat fascioliasis in patients six years of age and older. Novartis also inked a multi-target and multi-year collaboration with AbCellera.
DBV Technologies Provides Update on Regulatory Status of Viaskin Peanut for the Treatment of Peanut-Allergic Children 4 to 11 Years of Age
Eisai Co., Ltd. announced that it has submitted an application to the European Medicines Agency for its in-house discovered antiepileptic drug Fycompa seeking approval for use in pediatric patients with epilepsy.
History shows just how slow public health officials, the federal government, regulators and pharmaceutical companies were to respond to the emergence of HIV in the 1980s. The reasons are numerous—it was a puzzling viral disease, it first appeared in what was then a largely stigmatized patient population, gay men, and there weren’t really any existing treatments for viral diseases.
There’s no doubt that drug prices, particularly sky-high prices for new biologics and companies jacking up the prices of older drugs, is a problem. And it’s definitely a political issue, especially now that candidates are declaring their plans to run for president in 2020.