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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THE LATEST
- FDA PDUFA goal date remains tomorrow, November 28, 2018
Galapagos NV announced today that the FDA has granted GLPG1972/S201086 Fast Track designation for the treatment of patients with osteoarthritis (OA).
Florida-based Catalyst Pharma won regulatory approval for its treatment of a rare autoimmune disorder called Lambert-Eaton myasthenic syndrome (LEMS). The U.S. Food and Drug Administration approval of the new oral drug, Firdapse (amifampridine), is the first ever approved for this disease.
He’s research has not been published in a peer-reviewed scientific journal yet. He made his announcement at the Second International Summit on Human Genome Editing earlier this week. The details of the research were met with widespread condemnation and criticism by researchers globally.
The FDA approved Xospata for adult AML patients who have a FLT3 mutation as detected by an FDA-approved test. Of the 19,000 people in the United States who are estimated to be diagnosed with AML this year, nearly 40 percent will have a FLT3 mutation.
The U.S. Food and Drug Administration (FDA) issued a warning letter to Faro Owiesy, a researcher and physician at the California-based Corona Doctors Medical Clinics, for violating a clinical hold. In addition, the agency warned Owiesy for giving an investigational drug to patients before an investigational new drug (IND) application was approved.
Botanix receives R&D Tax Incentive refund of A$4.6m
MorphoSys AG announced today that its licensee’s affiliate, Janssen Pharmaceutical K.K. (Janssen) reported that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Tremfya(R) (guselkumab) for the treatment of patients with palmoplantar pustulosis who are not responding or are refractory to existing treatments.
MDxHealth SA today announces that the New York State Department of Health has approved its SelectMDx test for Prostate Cancer.
Abu Dhabi Smart Solutions and Services Authority, in collaboration with the Abu Dhabi Health Services Company (SEHA), organized a seasonal influenza vaccination campaign for its employees as a preventive measure to contain the spread of influenza virus at this time of the year.