CMS Now Needs to Approve Medicare Ads That Mention Plan Benefits

The U.S. government has expressed concern over misleading marketing by some Medicare Advantage and Part D plans. Now, a much wider range of marketing materials will need to be approved by the government prior to distribution. Jon Zucker and Taylor Andelman explain the changes.

Clinical Decision Support Software Approach Updated in the U.S. but Still Confused in Europe

The U.S. has issued final guidance on clinical decision support (CDS) software but, in the EU, the treatment is less nuanced and needs clarifying. Ioana Ratescu of Novartis and Eva von Mühlenen, Deeona Gaskin, and Zina Chatzidimitriadou of Sidley explain.

Impact Of Inflation Reduction Act On Drug Development For U.S. Market

The U.S. Inflation Reduction Act (IRA) is reshaping the commercial landscape for drug development, with smaller biotechs and investors in particular thinking hard about how to adapt to the new environment. Meena Datta explains the challenges posed to the biopharma industry by the IRA.

New Guidance on Appeals Against UK Health Tech Appraisals Applies From June

The UK’s National Institute for Health and Care Excellence (NICE) has clarified its guidelines on the process of appealing against its guidance for technology appraisals and highly specialised technologies, the decisions of which are crucial to the life sciences industry. Maria Isabel Manley and Victoria Kerr explain the changes.

European Parliament’s Position on the AI Act Moots Significant Changes

The European Parliament’s provisional agreement on the EU’s AI Act encompasses generative AI and imposes the requirements that are applicable to high-risk AI systems onto general purpose AI. As negotiations continue, Josefine Sommer, Eva von Mühlenen and Zina Chatzidimitriadou explain.

The EU’s Pharmaceutical Review Needs To Remain Grounded In Economic Reality

The Review proposes to reduce IP rights across the board, with incentives to prolong them. Can any of these incentives work? Maarten Meulenbelt, Chris Boyle, and Zina Chatzidimitriadou discuss how the real-world effects of the Review have not been assessed, and where there is room for improvement in its critical provisions.

FDA Offers New Clinical Trial Guidance for Oncology Accelerated Approval

FDA details its view of the “limitations” of single-arm trials in oncology drug development and invites comment on its favored approach going forward.  Becky Wood, Emily Marden, and Julea Lipiz explain. 



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