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Post-Mensing Blues: Generic Mfrs. Still Face Product Liability Claims

 
• By Brenda Sandburg

While the Supreme Court’s ruling last year found that failure-to-warn claims against generic manufacturers are preempted by federal law, some courts have refused to dismiss all claims.

Generic manufacturers breathed a collective sigh of relief when the Supreme Court ruled last year that they cannot be held liable for inadequate label warnings. However, they are not completely free from litigation as courts have issued conflicting decisions as to whether they can be sued on other grounds.

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Lilly Targets Sale Of Repackaged, Redosed Zepbound, Mounjaro In Lawsuit

 
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Eli Lilly is seeking an injunction barring a weight loss clinic from dispensing modified versions of its GLP-1 products.

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Filing in the Whole Women’s Health mifepristone case defends the FDA’s 2023 decision on the abortion pill safety program, but experts warn it does not necessarily signal the Trump Administration position in other mifepristone cases attempting to restrict medication abortion access.

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HHS Wants 340B Rebate Debate Out Of Courts, Returned To Government

 
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An HHS legal brief argues company lawsuits seeking immediate clearance to use rebates in 340B are premature and that the department has merely used a ‘measured approach’ in weighing the possibility. Past experience suggests otherwise, a pricing expert said.

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Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Chikungunya At US CDC: Bavarian Nordic’s Vimkunya Recommended, Valneva’s Ixchiq Adjusted

 
• By Bridget Silverman

Bavarian Nordic's Vimkunya added the US CDC immunization committee's recommendation to its FDA approval, while Valneva's Ixchiq faces a precaution for use in people aged 65 and older.

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.