Legal
Beyond the legal action, Eli Lilly is calling on healthcare providers, regulatory authorities, online platforms and even logistics companies to help stem the illegal sale of its next-generation asset for weight loss.
A legal dispute between the FDA and Eli Lilly over whether the highly anticipated obesity candidate retatrutide is indeed a biologic has come to a head as the company prepares to submit the medicine for approval.
Shareholders allege that Novo Nordisk withheld information about crucial protocol changes in a Phase 3 study of the weight loss drug CagriSema, which led investors to buy company shares “at artificially inflated prices.”
The settlements delay the entry of generic copies of Pfizer’s Vyndamax by almost three years, stabilizing sales of a drug that generated $3.8 billion in the U.S. last year.
Fresh off a major clinical win, Revolution Medicines alleges that Erasca’s pancreatic cancer drug infringes on key patent protections and that the rival has “improperly compared” the companies’ assets publicly.
A Massachusetts judge called Kennedy’s efforts to reform the CDC’s vaccines advisory panel a “procedural failure,” adding that the new committee members do not “comport with governing law.”
The settlement, which requires Moderna to pay the plaintiffs $950 million upfront plus up to $1.3 billion in contingent commitments, is an outcome “better than feared,” according to analysts.
A lower court had previously ruled for Sarepta in the companies’ long-running dispute, finding that REGENXBIO’s AAV patent was invalid because its elements were naturally occurring. The appeals court on Friday said that this original decision adopts a “narrow” view of the invention.
Arbutus alleges that Moderna’s COVID-19 vaccine infringes on patents protecting its lipid nanoparticle delivery technology.
AbbVie contends that Botox should have been excluded from the IRA drug price negotiation program because it is a plasma-derived product.
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