A U.S. Supreme Court ruling which overturned the famous Chevron ruling by deciding courts should not defer to an agency’s interpretation of the law is likely to usher in a new era of both opportunity and risk for life sciences companies seeking to review FDA decisions. Michael Varrone explains.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Michael Varronehttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMichael Varrone2024-10-07 09:38:412024-10-07 09:38:41Life Sciences Companies See New Path Open for Challenging FDA Decisions
The U.S. Senate may still reject the U.S. BIOSECURE Act , but the House of Representatives has now passed a version of the bill. Biotechs in both the P.R.C. and the U.S. therefore need to prepare for the new environment which it heralds. Michael Borden, Andrew Shoyer, and Ruchun Ji set out five steps to take now.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-16.png606833Michael E. Bordenhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMichael E. Borden2024-09-13 10:48:152024-09-16 09:38:29As U.S. Biosecure Act Passes the House, Four Things Biotechs Can Do to Prepare
The EU’s proposal to speed up generic and biosimilar market access by expanding the “Bolar exemption” to pricing and reimbursement procedures raises significant international IP law concerns, as it is probably incompatible with its obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Maarten Meulenbelt, Chris Boyle, Lauren Shapiro, Maryanne Kamau, and Alix Vermulst explain.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Maarten Meulenbelthttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaarten Meulenbelt2024-09-09 09:51:372024-09-09 09:51:37Are the revisions to the EU’s ‘Bolar’ system compatible with TRIPS?
For both small startups and R&D departments within larger companies, making investment funds work for an AI-based product is not just about securing initial funding but about making sure the investor understands the challenges of the healthcare sector. Chad Ehrenkranz talks to physician-executive and startup advisor Rick Abramson, MD, about the challenges.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-10.png606833Chad Ehrenkranzhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngChad Ehrenkranz2024-08-28 12:06:352024-08-28 12:06:35How to Secure Investment as a Healthcare AI Innovator
Both U.S. and P.R.C.-based biotechs are anxiously watching attempts to pass the U.S. BIOSECURE Act into law. Michael Borden and Andrew Shoyer explain what this month’s developments mean, and why the legislation, even with so much attention and publicity, may never actually become law.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Michael E. Bordenhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMichael E. Borden2024-08-19 09:07:372024-08-16 10:21:03How, When, and If the U.S. BIOSECURE Act Is Likely to Become Law
Investors are eyeing up the opportunities to invest in healthcare AI as it pushes the healthcare industry into new and exciting territory. R&D is currently focused on genomic sequencing, mapping, understanding populations and the treatment of rare diseases and hereditary cancer. AI applications are fundamentally altering how such R&D is conducted, as well as changing healthcare services to improve patient experience and outcomes. The advent of AI has dramatically altered the cost of capital, with private equity firms prepared to invest substantial sums into early adopters. These evolving opportunities raise important questions.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-06.png606833Chad Ehrenkranzhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngChad Ehrenkranz2024-08-06 10:23:162024-08-06 10:26:10Investor Attitudes to Healthcare AI Technologies
Concerns about the PRC’s medical devices procurement practices have led the EU to launch an investigation which could lead to the EU subjecting PRC companies, including MedTech companies, to market access restrictions in the EU. Sven De Knop, Lei Li and Maryanne Kamau explain.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Sven De Knophttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngSven De Knop2024-07-02 10:20:232024-07-02 10:21:01EU Investigation Into PRC Public Procurement for MedTech May Impact EU Market Access for PRC Companies
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Life Sciences Companies See New Path Open for Challenging FDA Decisions
A U.S. Supreme Court ruling which overturned the famous Chevron ruling by deciding courts should not defer to an agency’s interpretation of the law is likely to usher in a new era of both opportunity and risk for life sciences companies seeking to review FDA decisions. Michael Varrone explains.
Michael Varrone
Washington, D.C.
michael.varrone@sidley.com
As U.S. Biosecure Act Passes the House, Four Things Biotechs Can Do to Prepare
The U.S. Senate may still reject the U.S. BIOSECURE Act , but the House of Representatives has now passed a version of the bill. Biotechs in both the P.R.C. and the U.S. therefore need to prepare for the new environment which it heralds. Michael Borden, Andrew Shoyer, and Ruchun Ji set out five steps to take now.
Michael E. Borden
Washington, D.C.
mborden@sidley.com
Andrew W. Shoyer
Washington, D.C.
ashoyer@sidley.com
Ruchun Ji
Beijing, Palo Alto
rji@sidley.com
Are the revisions to the EU’s ‘Bolar’ system compatible with TRIPS?
The EU’s proposal to speed up generic and biosimilar market access by expanding the “Bolar exemption” to pricing and reimbursement procedures raises significant international IP law concerns, as it is probably incompatible with its obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Maarten Meulenbelt, Chris Boyle, Lauren Shapiro, Maryanne Kamau, and Alix Vermulst explain.
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Lauren Shapiro
Washington, D.C.
lshapiro@sidley.com
Maryanne W. Kamau
Brussels
mkamau@sidley.com
Alix Vermulst
Brussels
alix.vermulst@sidley.com
How to Secure Investment as a Healthcare AI Innovator
For both small startups and R&D departments within larger companies, making investment funds work for an AI-based product is not just about securing initial funding but about making sure the investor understands the challenges of the healthcare sector. Chad Ehrenkranz talks to physician-executive and startup advisor Rick Abramson, MD, about the challenges.
Chad Ehrenkranz
New York, Miami
chad.ehrenkranz@sidley.com
How, When, and If the U.S. BIOSECURE Act Is Likely to Become Law
Both U.S. and P.R.C.-based biotechs are anxiously watching attempts to pass the U.S. BIOSECURE Act into law. Michael Borden and Andrew Shoyer explain what this month’s developments mean, and why the legislation, even with so much attention and publicity, may never actually become law.
Michael E. Borden
Washington, D.C.
mborden@sidley.com
Andrew W. Shoyer
Washington, D.C.
ashoyer@sidley.com
Investor Attitudes to Healthcare AI Technologies
Investors are eyeing up the opportunities to invest in healthcare AI as it pushes the healthcare industry into new and exciting territory. R&D is currently focused on genomic sequencing, mapping, understanding populations and the treatment of rare diseases and hereditary cancer. AI applications are fundamentally altering how such R&D is conducted, as well as changing healthcare services to improve patient experience and outcomes. The advent of AI has dramatically altered the cost of capital, with private equity firms prepared to invest substantial sums into early adopters. These evolving opportunities raise important questions.
Chad Ehrenkranz
New York, Miami
chad.ehrenkranz@sidley.com
EU Investigation Into PRC Public Procurement for MedTech May Impact EU Market Access for PRC Companies
Concerns about the PRC’s medical devices procurement practices have led the EU to launch an investigation which could lead to the EU subjecting PRC companies, including MedTech companies, to market access restrictions in the EU. Sven De Knop, Lei Li and Maryanne Kamau explain.
Sven De Knop
Brussels
sdeknop@sidley.com
Lei Li
Beijing, Shanghai
lei.li@sidley.com
Maryanne W. Kamau
Brussels
mkamau@sidley.com
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