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.
FEATURED STORIES
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 US 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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Janssen believes the treatment works by restoring synaptic connections in brain cells in individuals with major depressive disorder.
The FY19 Defense Appropriation provides $8 million to the Department of Defense Military Burn Research Program to support a broad research portfolio in the treatment of burns and the trauma associated with burn injuries sustained during combat or combat-related activities.
Scott Gottlieb, the proactive commissioner of the U.S. Food and Drug Administration has resigned, according to reports. Gottlieb will leave the regulatory agency in about a month.
The U.S. Food and Drug Administration (FDA) accepted Celgene’s New Drug Application (NDA) for fedratinib for myelofibrosis. It also granted it a Priority Review, with a target action date of September 3, 2019.
Intrinsic Imaging, a global medical imaging core lab for clinical trials, announces that it recently underwent an extensive 5-day high priority Bioresearch Monitoring Program inspection by the U.S. Food and Drug Administration Center for Drug Evaluation and Research.
On Friday, the FDA raised concerns about losartan potassium tablets sold by India-based Hetero Labs Ltd. and distributed by Camber Pharmaceuticals.
Purdue Pharmaceuticals is seeking to dismiss a Massachusetts lawsuit filed by that state’s attorney general that has been highly critical of the company’s marketing of its opioid pain treatment OxyContin and has also placed blame on the company for 670 opioid-related deaths in the state since 2009.
With concerns over the costs of prescription drugs taking center stage in American politics during a time when there are shortages of insulin and medical devices like EpiPens, it’s no wonder that the general public is frustrated and is calling on the government to take action of some kind.
Esperion announced that the company has successfully completed important and key global marketing applications including the submission of two New Drug Applications for bempedoic acid and the bempedoic acid / ezetimibe combination tablet to the U.S. Food and Drug Administration.