Policy
Nader Pourhassan, who led CytoDyn for nearly 10 years, was convicted in December 2024 of misleading investors regarding the biotech’s investigational COVID-19 and HIV drug, which artificially inflated its share price.
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An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former U.S. Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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The new designation could speed up the time for approval and could also provide a period of market exclusivity for generics of branded medicines that have no competition.
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.