Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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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.
FDA issued a Complete Response letter to Acacia Pharma on Friday 5 October