Liabilities Update: AbbVie Wins AndroGel Re-Trial; Actavis To Settle Out Of Testosterone MDL

For second time, judge finds problem with jury verdict against AbbVie; Bayer withdraws its appeal of Xarelto pre-trial rulings pending outcome of Supreme Court case.

Courthouse Pillars & Stairs

AbbVie Inc. won another reprieve in AndroGel product liability litigation as a judge vacated a $140m jury verdict and ordered a new trial. It is the second bellwether trial in which the judge has found the jury reached a problematic verdict, giving AbbVie another chance to beat the allegations, or at least get a verdict with lower damages.

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Mifepristone Filing Supports 2023 US FDA Actions, But Experts Caution Against Overanalyzing

 

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.

Supreme Court May Be Next After Federal Circuit Refuses To Rehear Teva Inhaler Patents Case

 

Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

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.

Kennedy’s Pullback of Public Comment Policy Make May Rules Vulnerable to Lawsuits

 

The Health and Human Services Department's decision to eliminate the Richardson Waiver may be a blow for transparency, but will not completely eliminate scrutiny of regulations, experts said.

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England’s NICE To ‘Explore’ Severity Modifier Changes As Cost-Effectiveness Threshold Branded ‘Ridiculous’

 

Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Peter Marks Resigns From US FDA, Warns Kennedy Does Not Want Truth On Vaccines

 

In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."