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 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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Noting advances in genetic manipulation and gene editing, the Food and Drug Administration announced a new Plant and Animal Biotechnology Innovation Action Plan.
To suggest that the pharma industry is a reluctant partner in President Donald Trump’s attempts to decrease drug prices is to overstate the fact. But now the industry appears to be pushing back, at least a little bit.
One of the drugs being discussed this week by a U.S. Food and Drug Administration advisory committee is Waltham, Mass.-based Alkermes’ ALKS-5461. The drug itself has some controversy.
Merck’s blockbuster anti-PD-1 therapy Keytruda has snagged another regulatory approval from the U.S. Food and Drug Administration. The checkpoint inhibitor has been approved, in combination with chemotherapy, as a first-line treatment for patients with metastatic squamous non-small cell lung cancer.
Four former Genentech employees have been indicted by a federal grand jury for the alleged theft of company trade secrets in order to help a company set up in Taiwan develop drugs similar to those made by the Roche subsidiary.
In the wake of a significant number of journal articles being retracted due to falsified data, the National Heart, Lung, and Blood Institute, part of the National Institutes of Health, is halting a clinical trial that is testing an experimental stem cell therapy for heart patients.
BeiGene, Ltd. today announced the acceptance by the China National Medical Products Administration (NMPA) of a new drug application (NDA) for zanubrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor
In recognition of this milestone Earth Day Network, the Woodrow Wilson International Center for Scholars, and the U.S. Department of State are launching Earth Challenge 2020 as the world’s largest coordinated citizen science campaign.
Promore Pharma AB, a Swedish biopharmaceutical developer of therapeutic peptides, today announced that that it has had a successful meeting with the US Food and Drug Administration (FDA) regarding the continued development of PXL01.
Eisai Co., Ltd. and Meiji Seika Pharma Co., Ltd. announced that an application seeking manufacturing and marketing approval in Japan was submitted as of today by Meiji for the Parkinson’s disease treatment ME2125 (safinamide mesylate, “safinamide”).