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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With a major lawsuit in Oklahoma targeting Johnson & Johnson and Purdue Pharma’s involvement in the opioid epidemic starting in May, many of the legal documents are being released, with strategies and sometimes incendiary rhetoric coming to light.
The FDA, as part of efforts to update clinical trial eligibility criteria, published four draft guidance documents on cancer clinical trial criteria and one final draft on adolescents in adult oncology trials.
The FDA issues Warning Letters to biopharma, medical device and food companies when they find that a manufacturer has significantly violated FDA regulations. As of March 4, the agency issued 45 Warning Letters this year.
National Cancer Institute Director Norman “Ned” Sharpless will take over the role as acting commissioner of the FDA while the White House seeks a permanent replacement for the outgoing Scott Gottlieb.
The U.S. Food and Drug Administration has been busy approving new treatments for various diseases. Two days into the new week and the regulatory agency has green lit two therapeutics, while other companies are planning to file for potential approval.
The president’s proposed spending plan cuts $4.5 to $5.5 billion from the current budget of the National Institutes of Health, about an 11 percent decrease from 2019.
Shares of CURE Pharmaceutical jumped more than 15 percent Monday ahead of news that the company became the first and only oral thin film company to gain a license from the U.S. Drug Enforcement Agency to manufacture pharmaceuticals using both cannabis plant extracts and synthetic cannabidiol.
Pure Sunfarms’ large-scale facility with 16 grow rooms is optimized for year-round production and expected to yield more than 80 harvests annually
FDA accepts study protocol, providing green light for GENFIT to initiate Phase 2 clinical trial in pediatric NASH
Tecentriq is a monoclonal antibody that binds with the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells. It blocks interactions with both PD-1 and B7.1 receptors.