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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Jon S. Zuckerhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJon S. Zucker2023-05-26 09:28:122023-05-30 13:26:49CMS Now Needs to Approve Medicare Ads That Mention Plan Benefits
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Eva von Mühlenenhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngEva von Mühlenen2023-05-25 09:02:392023-05-18 10:07:05Clinical Decision Support Software Approach Updated in the U.S. but Still Confused in Europe
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Meenakshi Dattahttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMeenakshi Datta2023-05-23 09:08:292023-05-23 10:05:12Impact Of Inflation Reduction Act On Drug Development For U.S. Market
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Maria Isabel Manleyhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaria Isabel Manley2023-05-19 11:15:522023-05-19 11:15:52New Guidance on Appeals Against UK Health Tech Appraisals Applies From June
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Josefine Sommerhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJosefine Sommer2023-05-18 09:11:302023-05-18 09:11:30European Parliament’s Position on the AI Act Moots Significant Changes
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 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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Rebecca K. Woodhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngRebecca K. Wood2023-03-27 06:55:182023-03-26 22:29:58FDA Offers New Clinical Trial Guidance for Oncology Accelerated Approval
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.
Jon S. Zucker
Washington D.C.
jzucker@sidley.com
Taylor Andelman
Washington, D.C.
tandelman@sidley.com
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.
Eva von Mühlenen
Geneva
evonmuehlenen@sidley.com
Deeona R. Gaskin
Washington D.C.
dgaskin@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
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.
Meenakshi Datta
Chicago
mdatta@sidley.com
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.
Maria Isabel Manley
London
mmanley@sidley.com
Victoria Kerr
London
vkerr@sidley.com
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.
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Eva von Mühlenen
Geneva
evonmuehlenen@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
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.
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
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.
Rebecca K. Wood
Washington, D.C.
rwood@sidley.com
Emily Marden
San Francisco
emarden@sidley.com
Julea Lipiz
Washington, D.C.
jlipiz@sidley.com
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