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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While pre-license inspections of manufacturing sites are typically done following the acceptance of a BLA filing, due to the public health emergency of COVID-19, the FDA is instead requiring a quality control unit to be established by each manufacturer with detailed report submissions about their manufacturing processes.
“We are actively working with the FDA to find a way to expedite the plant inspection,” said Joe Turgeon, president and CEO of Spectrum Pharmaceuticals. “The manufacturing facility is ready for inspection and we are eager to assist the FDA in completing their assessment as soon as possible.”
After discovering promising indicators on the path to the development of Branaplam (LMIO70) for spinal muscular atrophy, Novartis now hopes to repurpose the drug for the treatment of Hungtington’s disease.
Shaun Thaxter, the former chief executive officer of Indivior, was sentenced in federal court Thursday, four months after pleading guilty to one misdemeanor count of sharing false information about the addictive properties of Suboxone Film, an opioid-based product.
In the meeting, both the FDA and the U.S. Centers for Disease Control and Prevention presented details about COVID-19 and the requirements for a vaccine.
After reviewing its mid-pandemic performance, it became clear that its greatest challenge is around the handling of data, according to Amy P. Abernethy, M.D., Ph.D., principal deputy commissioner, FDA, speaking at the recent Demy-Colton Virtual Salon, the “Fusion of Technologies.”
Shares of AstraZeneca dropped slightly Wednesday afternoon following reports that a patient participating in the Brazilian arm of the company’s global Phase III study has died.
The settlement stems from multi-year criminal and civil investigations into Purdue’s marketing practices related to its powerful prescription painkiller, OxyContin, which critics have argued facilitated the opioid epidemic.
The U.S. arm of the trial has been paused for more than a month while the U.S. Food and Drug Administration investigates a serious illness that occurred in a patient who received the experimental treatment.
In a challenge trial, people are given a vaccine then intentionally dosed with the virus or bacteria that causes the disease.