Legal
GSK’s departure comes as the industry anticipates the incoming Trump administration and as it continues to grapple with the threat of the BIOSECURE Act and losses of legal challenges to the IRA’s drug price negotiation program.
A suit against Novartis and Vitaris by Henrietta Lacks’ estate hinges on questions about the morality and legality of using the line for biopharmaceutical research.
The Big Pharma companies made a last-ditch effort asking a U.S. appeals court to reconsider their lawsuits against the Inflation Reduction Act’s Medicare drug price negotiations, which they contend infringe on their constitutional rights.
Monday’s lawsuits from Eli Lilly are the first to be filed by the pharma since the regulator officially removed tirzepatide from its drug shortage database earlier this month.
With Friday’s ruling by New Jersey District Judge Zahid Quraishi, Novartis joins a growing list of pharmaceutical companies that have failed in their legal challenges to the Inflation Reduction Act.
The lawsuits claim that Moderna used and profited from crucial mRNA technology in its COVID-19 vaccine Spikevax and respiratory syncytial virus shot mResvia.
While the regulator conducts another review into the supply of Eli Lilly’s tirzepatide, compounders will be able to continue selling their own remixed versions of the blockbuster drug.
The U.S. Department of Justice alleged that Teva violated the Anti-Kickback Statute and the False Claims Act. The payment is in addition to the criminal penalty paid by Teva USA under its deferred prosecution agreement.
The settlement, which is at the low end of Jefferies analysts’ $2 billion to $3.5 billion estimate, will resolve 93% of the product liability cases regarding allegations that GSK’s heartburn drug could cause cancer. Analysts say separate concerns remain about its vaccines business.
Alongside the settlement, Novo and Viatris have asked the U.S. Patent and Trademark Office to terminate its review of the validity of the Danish drugmaker’s semaglutide patents.
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