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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Bragar Eagel & Squire, P.C. announces that a class action lawsuit has been filed in the U.S. District Court for the Southern District of New York on behalf of all persons or entities who purchased or otherwise acquired Alnylam Pharmaceuticals, Inc. (ALNY) securities between February 15, 2018 through September 12, 2018 (the “Class Period”).
Without regard for clear Congressional intent, the United States Drug Enforcement Administration (DEA) continues to act contrary to the express authorizations provided for in Section 7606 of the Agricultural Act of 2014 (the “Farm Bill”) and the Ninth Circuit Court of Appeals’ order in HIA v. DEA III (April 2018).
Netherlands Enterprise Agency grants through a financial loan (“Innovatiekrediet”) €2.7 million for the development of a diagnostic skin cancer test.
It looks to be a pretty busy week for the U.S. Food and Drug Administration (FDA), with a number of target action dates for various drugs. Some were delayed, and some were already approved, but there are still a number on the schedule. Here’s a look.
Advanced Bifurcation Systems today announced that the Company has submitted a proposal to the U.S. Federal Drug Administration (“FDA”) for a clinical study leading to an IDE for its bifurcation technology. Concurrently, the Company is defining a regulatory and clinical strategy for Europe to receive a CE mark.
Advanced Bifurcation Systems today announced that the Company has been granted four additional patents, three in the U.S. and one in Europe.
A study aimed at demonstrating the clinical superiority of THN201 over a standard of care treatment for this severely debilitating symptom
The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company’s Emgality (galcanezumab-gnlm) for migraine prevention.
The DEA has reclassified GW Pharmaceutical’s cannabidiol epilepsy treatment Epidiolex as a Schedule V product, which will clear the way for commercialization within the next six weeks.
SB 1121 Contains Common Sense, Bipartisan Fix to Unintended Consequences of Data Privacy Bill