Legal
The settlement agreement will extend market exclusivity for AbbVie’s JAK inhibitor in the U.S. until 2037—providing pediatric exclusivity is granted.
Generate:Biomedicines’ Nicole Clouse is one of the key legal minds trying to understand who owns what AI creates. The answers are critical to the future of biotech.
Vanda claims that two generics to its sleep disorder drug Hetlioz were approved despite inadequate data and is requesting that FDA Commissioner Marty Makary revisit the decision.
WARN notices provide a heads up that staff will soon be unemployed, but the act that mandates them has some nuances. An attorney explains how the law works, common misconceptions about it and how it helps those about to lose their jobs.
Texas Attorney General Ken Paxton claims that through an alleged kickback scheme Eli Lilly “fraudulently sought to maximize profits at taxpayer expense.”
A U.K. Court of Appeals ruling confirms the validity of a patent covering modifications of mRNA used in Moderna’s vaccines.
The high court’s order blocks a May decision by a California court that temporarily blocked the efforts of Health Secretary Robert F. Kennedy Jr. to drastically reduce the size of his agency’s workforce.
Analysts said the deal with Novo was likely giving Hims “‘credibility’ or increased consumer traffic,” adding that the “litigation risk is back on the table” now that the Danish pharma has stepped away.
After the FDA rejection of Zurzuvae in one type of depression and the triple failure of neuro asset dalzanemdor, Sage was searching for a path forward at the end of December 2024. Biogen CEO Chris Viehbacher spied a possible deal, but the smaller company wasn’t interested.
As an office of the executive branch, the Department of Health and Human Services “does not have the authority” to implement sweeping changes to the structure of the agency as created by Congress, a judge wrote.
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