The lawsuit filed by the Pharmaceutical Research and Manufacturers of America and co-plaintiffs against the federal government over the Medicare price negotiation program has run aground over a jurisdictional issue that is likely to come up again in similar industry lawsuits.
PhRMA’s Lawsuit Against Medicare Trips Over ‘Administrative Remedy’ Standard; Will Others?
West Texas District Court dismisses lawsuit against Medicare price negotiation program on jurisdictional grounds without considering the merits of the case. PhRMA is weighing next steps.
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Wide-ranging executive order to lower drug prices also hints at changes in upcoming guidance on the Medicare price negotiation program but few other potentially impactful near-term actions.
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Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.
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The African Medicines Agency is to appoint a director general and become operational at the end of this month.
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The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.
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Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.
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The European Medicines Agency has launched a phased initiative to consolidate the wide array of training materials for the Clinical Trials Information System, aiming to eliminate duplication, ensure consistency, improve accessibility and enhance user-friendliness.
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India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.