Developing a cell or gene therapy (CGT) involves a range of regulatory considerations and challenges. Emily Marden and Jaclyn Fonteyne point to some key factors that are currently the focus of FDA attention and may merit consideration by sponsors early in the development process.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Emily Mardenhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngEmily Marden2023-07-25 09:17:032024-11-15 15:38:37Four Tips for Successful Development of Cell and Gene Therapies
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-02.png606833Sally Wagner Partinhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngSally Wagner Partin2023-06-29 09:26:422023-08-15 11:37:14Seven Things Life Sciences Buyers and Sellers Should Know About CVRs
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Christopher A. Fanellihttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngChristopher A. Fanelli2023-06-20 09:26:422024-11-15 15:38:14U.S. and EU Expand Mutual Recognition Agreement to Include Animal Drugs
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.
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 Datta2023-06-08 14:01:322024-11-15 15:37:48Five Tips for Bringing a Complex Digital Health Product to Market
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/6/2023/05/Telehealth-2.jpg606833Jon S. Zuckerhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJon S. Zucker2023-05-26 09:28:122023-08-15 11:35:58CMS 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 09:02:392024-11-15 15:37:20Clinical 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
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Four Tips for Successful Development of Cell and Gene Therapies
Developing a cell or gene therapy (CGT) involves a range of regulatory considerations and challenges. Emily Marden and Jaclyn Fonteyne point to some key factors that are currently the focus of FDA attention and may merit consideration by sponsors early in the development process.
Emily Marden
San Francisco
emarden@sidley.com
Jaclyn G. Fonteyne
Washington, D.C.
jaclyn.fonteyne@sidley.com
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.
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.
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.
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.
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
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