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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AstraZeneca’s Phase III COVID-19 vaccine study in the United States is being further delayed due to the U.S. FDA wanting to take a more thorough look at information related to the trial.
PF-06939926 is currently being evaluated to determine the safety and efficacy of this gene therapy in boys with DMD.
The trial was initially placed on hold in November 2019 due to safety concerns.
Catalyst Pharmaceuticals is reeling this morning after a federal judge dismissed the company’s lawsuit against the U.S. Food and Drug Administration regarding the approval of a rival drug for a rare autoimmune disease from New Jersey-based Jacobus Pharmaceutical.
California Gov. Gavin Newsom signed Senate Bill 852 into law on Monday, paving the way for California to manufacture cheaper versions of insulin and other drugs that have been in short supply in recent years.
More than one month after the government of Russia announced it approved the world’s first vaccine for COVID-19, it announced it will share preliminary data from the first six weeks of the ongoing Phase III study.
The company plans to submit its biologic license application (BLA) to China’s National Medical Products Administration (NMPA) and other regulators worldwide.
One month after the government inked a $750 million contract with Abbott for its new, point-of-care COVID-19 test, President Trump said they will be soon be distributed across the country to double the number of tests being performed in the United States.
The new approval makes it the first FDA-approved therapy in over a decade to treat HES and the third indication for the therapy overall.
A team of more than 60 scientists and bioethicists have signed a letter urging Pfizer to wait until late November before the company seeks FDA authorization of its COVID-19 vaccine candidate in an effort to ensure rigorous safety standards have been met.