If you are interested in the future of pharmaceutical risk management, you might want to start by reading a 15-year-old report.
After REMS: An Interview With Amgen’s Paul Seligman
Health care reform means a lot of things for the pharmaceutical industry. Will it also mean the end of REMS? The former head of FDA’s drug safety office thinks that is a question worth asking.
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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.
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The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.
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The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
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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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Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.
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The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.
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An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.