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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Scott Gottlieb, commissioner of the Food and Drug Administration (FDA) is notoriously outspoken. Let’s take a look at some of Gottlieb’s more recent statements.
As we end October and head into November, the Food and Drug Administration (FDA) continues its work. This upcoming week has several PDUFA action dates for drug applications. Here’s a look.
In the company’s FDA Law Blog, attorneys Deborah L. Livornese, JP Ellison and Josephine M. Torrente outlined problems with the FDA’s complete response letter (CRL) and what should be done about it.
The U.S. Food and Drug Administration (FDA) is eying the spring of 2019 to finalize its biopharmaceutical classification system-based biowaivers guidelines. On Thursday, the regulatory agency released the draft guidance for public consultation.
Growth in Asia continues with ongoing investment in Headquarters site
As part of a plan to lower prescription drug prices for millions of Americans, President Donald Trump is set to announce a sweeping plan to overhaul how Medicare pays for medication.
Xofluza (baloxavir marboxil) was approved for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older. The new medication has a novel mechanism of action that, Roche said, inhibits polymerase acidic endonuclease, an enzyme that is essential for the flu virus to replicate.
Lupin Neurosciences today announces that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization of NaMuscla™ (mexiletine hydrochloride) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders.
Bloomberg Businessweek published a deep-dive into the life of the Shermans and the issues surrounding their death. “No one knows who did it, or why, but everyone has a theory,” the article’s subhead reads.
The Senate passed the bill on October 3 in a 98 to 1 vote. The House passed its version a week earlier in a vote of 393 to 8. The legislation includes provisions to promote research into new pain management drugs and expands access to substance abuse treatment for Medicaid patients.