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.
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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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The report, which is exaggerated or misinterpreted, appears to have been erroneous and triggered a short stock drop before the company and various analysts responded, calming investors.
The U.S. Food and Drug Administration is warning that some drugs that treat hepatitis C can, in rare cases, actually lead to the worsening of liver function or to live failure in patients with chronic hepatitis C.
Promore Pharma AB today announced that the company was granted a patent in Japan for the usage of LL-37 for treating chronic wounds.
Oncoceutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for ONC206, allowing the first-in-human trial of the compound. ONC206 is the first of the family of drug candidates, which we call “imipridones”, that possess the same core chemical structure as ONC201.
It takes on average five years before the confirmatory trial is even started.
According to “people familiar with the matter,” the company and its owners, the Sackler family, are plotting out a way to end the vast number of lawsuits filed against the company over its marketing practices for OxyContin and other opioid products.
Local Health Departments in Colorado, Kentucky, Maine, Maryland, Massachusetts, Minnesota, Missouri, Nevada, New Hampshire, Ohio, Pennsylvania, Tennessee, and Wisconsin Tell Their Stories
Pharmaceutical manufacturing license and GMP compliance of the Rentschler Fill Solutions plant reconfirmed by the Austrian Agency for Health and Food Safety (AGES)
The Alliance for Regenerative Medicine released a Therapeutic Developers’ Statement of Principles, setting forth a bioethical framework for the use of gene editing in therapeutic applications.
AstraZeneca said the FDA awarded the designation to Farxiga to delay the progression of renal failure and prevent cardiovascular and renal death in patients with chronic kidney disease.