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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Examples of new syndromes include hypotonia, ataxia, and delayed development syndrome (HADDS) and Sashi-Pena syndrome (SHAPNS).
President Donald Trump signed a bill into law yesterday that requires pharmaceutical companies to provide details of biosimilar deals to the Federal Trade Commission (FTC) for antitrust scrutiny.
In May the FDA placed a hold on the trial and IND for CTX001, an investigational gene editing treatment, citing concerns over questions that had not been addressed in the IND.
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In August, Pfizer filed with the U.S. Food and Drug Administration (FDA) accusing Amgen and Roche of using social media to mislead doctors and patients about biosimilars and their effectiveness.
Today President Donald Trump is expected to sign two bills that will release pharmacists from a so-called “gag order” that prevented them from telling customers when there is a price difference on medicines between paying cash or going through the insurance copay.
Genentech, a Roche company, released data from a long-term clinical trial of Ocrevus in multiple sclerosis. Meanwhile, Novartis isn’t standing still on MS. Earlier this week the company announced that both the FDA and EMA had accepted its NDA and MAA, respectively, for siponimod.
The AP in a recent report notes that drug price increases “slowed somewhat and were not quite as steep as in past years.” But overall, there has been no “massive” drug price cuts.
TFS International is thrilled with the announcement that Lecigon®, a new therapeutic system for symptomatic treatment of Advanced Parkinson’s Disease (APD), has been granted marketing authorization in Sweden.