Government
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.
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.
After the U.S. Food and Drug Administration (FDA) took a hard line on the use of real-world evidence in clinical trials, industry leaders are beginning to back the idea, but with some minor changes.
Lawmakers continue to hear concerns over drug prices, as well as proposals to fix the issue.
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