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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Earlier this week, an HIV-prevention advocacy group, PrEP4All Collaboration, filed a petition with the U.S. Patent and Trademark Office (PTO) alleging that Gilead Sciences intentionally delayed the development of a safer HIV drug.
Two weeks after the pharmaceutical industry predicted dire consequences for innovation if the prescription price reduction plan proposed by House Speaker Nancy Pelosi passes, the White House is now echoing those concerns but suggesting even worse outcomes than industry analysts predict.
The U.S. Food and Drug Administration approved Genentech’s Tecentriq plus chemotherapy as a first-line treatment of metastatic non-squamous non-small cell lung cancer.
New certification demonstrates commitment to the highest standards of data protection across the company’s operations, systems, and products
In March, the FDA issued a Complete Response Letter for Zynquista as a treatment for type 1 diabetes.
In a filing with the court, Seattle Genetics claimed the right to arbitration to resolve the dispute with Daiichi Sankyo, as is required by the 2008 collaboration agreement.
Promore Pharma AB announces that the new share issue with preferential rights for existing shareholders has been completed.
Eisai Co., Ltd. has announced that LENVIMA, the orally available kinase inhibitor discovered by Eisai, has been accepted by the National Medical Products Administration of China for an application for the additional indication of differentiated thyroid cancer.
The Institute of Cancer Research, London, welcomes the approval by NICE of the innovative targeted cancer treatment palbociclib for women with advanced breast cancer who have already received hormone therapy.
Cardiovascular disease is currently the leading cause of death globally.