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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There is some evidence that COVID-19 infection might be linked to an increase in diabetes, particularly Type 1 diabetes, which is an autoimmune disease most commonly diagnosed in children.
The U.S. Court of Appeals for the Federal Circuit denied Biogen a second look into the patent dispute filed against Mylan for Biogen’s Multiple Sclerosis (MS) drug, Tecfidera.
On Wednesday, the World Health Organization indefinitely postponed the evaluation of Russia’s Sputnik V COVID-19 vaccine due to the ongoing conflict in Ukraine.
In his new book, Warp Speed, Paul Mango said the realization that many healthcare workers didn’t want the vaccine, for instance, was shocking.
After reviewing the trial’s Independent Data Monitoring Committee, the EMPA-KIDNEY trial announced it would stop early as it met prespecified criteria for positive efficacy.
Two former executives of JHL Biotech were sentenced to a year and one day each in prison after being found guilty of conspiracy and fraud.
Several biopharma companies celebrate the U.S. Food and Drug Administration’s approval for clinical trials involving therapeutics for cancer treatment.
More pharmaceutical companies are joining to put economic pressure on Russia by suspending some or all operations within that country following the invasion of Ukraine.
Now that Omicron is becoming less common, its sister variant, BA.2, seems to be surging worldwide and in the U.S. For that and more, continue reading.
BioSpace talked with Paul Mango, one of the key leaders of Operation Warp Speed, about the experience.