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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The U.S. FDA approved Pfizer’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase (ALK)-positive.
The filing to the U.S. District Court District of New Jersey, dated December 31st, 2020, states that the materials include compound data, strategic plans related to translational and biomarker data, therapeutic program reviews, abstract publications, plans for Congressional presentations, drug monitoring, and compound publication.
In many regards, the incoming Biden Administration is expected to be a redux of the Obama Administration, likely with strong support for scientific research and a reinvigoration of the Affordable Care Act. Yet concerns of pricing controls still loom.
Janet Woodcock, the longtime director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration is set to take over the top spot of the regulatory agency on an interim basis following the presidential inauguration of Joe Biden.
Merck announced the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for V114, its 15-valent pneumococcal conjugate vaccine, for Priority Review.
Slaoui will stay on as an adviser for one month. His resignation from the vaccine program was made at the request of the incoming Biden administration.
The U.S. Food and Drug Administration is experiencing abrupt and noticeable personnel changes as it continues to clash with the Health and Human Services, the department that oversees the agency and its operations.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 12, 2021.
On Friday, the U.S. Food and Drug Administration (FDA) issued an official alert stating that it could trigger false negatives in COVID-19 tests.
Company will need to provide a new assay to satisfy FDA before commencing Phase I trials.