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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Pfizer will cease operations within Russia and proceeds from its subsidiary in that country will be donated to provide direct humanitarian support to the people of Ukraine.
The Russian invasion of Ukraine has hampered Ukrainian research to develop new treatments for infection from the SARS-CoV-2 virus and increased the risk of spreading virulent pathogens.
The death toll related to COVID-19 is more than 6 million, according to the Johns Hopkins COVID-19 dashboard, but it has long been suspected that the toll is significantly higher.
The SEC said that Yum China, BeiGene, Zai Lab, HutchMed and ACM Research are all at risk if they do not give U.S. regulators access to their audit records.
Capricor Therapeutics announced less-than-stellar Q4 2021 and full-year 2021 financial results and said the company stopped efforts on its COVID-19 vaccine.
More than two dozen people were given the opportunity to confront members of the Sackler family in a virtual environment and share the impactful pain opioid addiction caused their families.
This target date is the latest development in a long series of setbacks that Acadia - and other pharma companies - have experienced getting Alzheimer’s treatments approved.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Pfizer has launched a Phase II/III study to assess its oral antiviral Paxlovid in non-hospitalized symptomatic pediatric patients who are at risk for progression to serious disease.
AbbVie and Alvotech have settled a case, granting Alvotech a non-exclusive license to all Humira-related patents in the United States beginning on July 1, 2023.