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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Seven Things Life Sciences Buyers and Sellers Should Know About CVRs
The life sciences industry has recently seen a proliferation of Contingent Value Rights (CVRs), the public M&A equivalent of the earnout used in private deals. Sally Wagner Partin, Sharon Flanagan, and Hannah Brown explain what you need to know about them.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Sally Wagner Partin
San Francisco, Palo Alto
swagnerpartin@sidley.com
Sharon Flanagan
San Francisco, Palo Alto
sflanagan@sidley.com
Hannah Brown
San Francisco
hbrown@sidley.com
U.S. and EU Expand Mutual Recognition Agreement to Include Animal Drugs
Sites making animal drugs need to be inspection-ready, as a single inspection report can now be relied upon by regulators in both the U.S. and some EU member states. Multi-jurisdictional regulatory actions could ensue. Christopher Fanelli, Chris Boyle and Yuzhi Hu explain.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Christopher A. Fanelli
Washington, D.C.
cfanelli@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Yuzhi Hu
Five Tips for Bringing a Complex Digital Health Product to Market
Bringing a sophisticated digital health product comprised of a combination of hardware and software to market can be tricky. Meena Datta and Deeona Gaskin advise on how to do so successfully by factoring in FDA marketing and reimbursement pathways, including insurers and employer-sponsored health plans.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Meenakshi Datta
Chicago
mdatta@sidley.com
Deeona R. Gaskin
Washington D.C.
dgaskin@sidley.com
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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
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.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
Rebecca K. Wood
Washington, D.C.
rwood@sidley.com
Emily Marden
San Francisco
emarden@sidley.com
Julea Lipiz
Washington, D.C.
jlipiz@sidley.com