Maarten Meulenbelt explains why even companies headquartered in China or California need to be aware that the trend for ‘replacement pharmacy compounding’ may spread.
Over the last few years, the Netherlands has begun to develop its own pharmacy-compounded products as an alternative to authorised products, and as a benchmark for pricing and reimbursement of the authorised products that they seek to replace. (more…)
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-15.png606833Maarten Meulenbelthttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaarten Meulenbelt2022-04-27 15:15:492022-05-10 11:29:09Why International Pharma Companies Need to Watch What Is Happening in the Netherlands
Life sciences companies are increasingly looking to the courtroom to resolve their disputes which were simmering during the pandemic. Ching-Lee Fukuda explains why litigation in the fields of biologics and medtech is now particularly likely, and how companies can best prepare for claims in these areas.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Ching-Lee Fukudahttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngChing-Lee Fukuda2022-04-27 15:14:272022-04-29 16:04:47How to Guard Against Biologics and Medtech Patents Litigation
Andrew Harper in San Francisco and Francesca Blythe in London look at some of the drivers that are fueling interest in digital health products aimed at women.
The term ‘Femtech’ was coined by the founder of a fertility app company in response to her experience that male investors often struggle with the specifics of discussing products focused on women’s reproductive health. However, Femtech covers a wider range of products than the purely fertility-focused, including all health software and tech-enabled products that cater to female biological needs and to the wider wellness market for all those who identify as women.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Francesca Blythehttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngFrancesca Blythe2021-12-20 15:01:472022-10-12 13:41:02Why Venture Capital Investors Are Focused on Femtech
China’s first dedicated law on personal data protection comes into effect this month. Sidley counsel Jing Lu looks at how the new Personal Information Protection Law (PIPL) differs from Europe’s General Data Protection Regulation (GDPR).
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Chen Yanghttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngChen Yang2021-11-23 15:02:312022-04-27 13:24:24If Your Company Is GDPR Compliant, Are You Ready for China’s PIPL?
Meena Datta examines proposed new legislation that would authorise the Health and Human Services Secretary to negotiate prices directly with prescription drug manufacturers.
Becky Wood in Washington, D.C., Emily Marden in Palo Alto, and Josefine Sommer in Brussels look at new FDA guidance on the use of real-world data to support new indications and post-approval study requirements.
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 Sommer2021-10-28 14:50:012022-04-27 14:20:10Regulators Offer Fresh Guidance on Using Real-World Data to Support Regulatory Decisions
Elizabeth Curtin in Chicago and Jonathan Tomlin in London consider why any litigation arising over medtech that uses AI is likely to become complex. They consider how manufacturers of AI can support physicians’ medical judgments and help guard against the danger that they might themselves inadvertently become ‘insurers’ of medical outcomes.
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Why International Pharma Companies Need to Watch What Is Happening in the Netherlands
Maarten Meulenbelt explains why even companies headquartered in China or California need to be aware that the trend for ‘replacement pharmacy compounding’ may spread.
Over the last few years, the Netherlands has begun to develop its own pharmacy-compounded products as an alternative to authorised products, and as a benchmark for pricing and reimbursement of the authorised products that they seek to replace. (more…)
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
How to Guard Against Biologics and Medtech Patents Litigation
Life sciences companies are increasingly looking to the courtroom to resolve their disputes which were simmering during the pandemic. Ching-Lee Fukuda explains why litigation in the fields of biologics and medtech is now particularly likely, and how companies can best prepare for claims in these areas.
(more…)
Ching-Lee Fukuda
New York
clfukuda@sidley.com
Why Venture Capital Investors Are Focused on Femtech
Andrew Harper in San Francisco and Francesca Blythe in London look at some of the drivers that are fueling interest in digital health products aimed at women.
The term ‘Femtech’ was coined by the founder of a fertility app company in response to her experience that male investors often struggle with the specifics of discussing products focused on women’s reproductive health. However, Femtech covers a wider range of products than the purely fertility-focused, including all health software and tech-enabled products that cater to female biological needs and to the wider wellness market for all those who identify as women.
(more…)
Francesca Blythe
London
fblythe@sidley.com
Andrew Harper
Palo Alto, San Francisco
aharper@sidley.com
If Your Company Is GDPR Compliant, Are You Ready for China’s PIPL?
China’s first dedicated law on personal data protection comes into effect this month. Sidley counsel Jing Lu looks at how the new Personal Information Protection Law (PIPL) differs from Europe’s General Data Protection Regulation (GDPR).
(more…)
Chen Yang
Sydney, Hong Kong
cyang@sidley.com
U.S. Looks to Introduce European-Style Drug Price Controls
Meena Datta examines proposed new legislation that would authorise the Health and Human Services Secretary to negotiate prices directly with prescription drug manufacturers.
(more…)
Meenakshi Datta
Chicago
mdatta@sidley.com
Regulators Offer Fresh Guidance on Using Real-World Data to Support Regulatory Decisions
Becky Wood in Washington, D.C., Emily Marden in Palo Alto, and Josefine Sommer in Brussels look at new FDA guidance on the use of real-world data to support new indications and post-approval study requirements.
(more…)
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Rebecca K. Wood
Washington, D.C.
rwood@sidley.com
How Artificial Intelligence Manufacturers Can Protect Themselves Against Future Negligence Claims
Elizabeth Curtin in Chicago and Jonathan Tomlin in London consider why any litigation arising over medtech that uses AI is likely to become complex. They consider how manufacturers of AI can support physicians’ medical judgments and help guard against the danger that they might themselves inadvertently become ‘insurers’ of medical outcomes.
(more…)
Jonathan Tomlin
London
jtomlin@sidley.com
Elizabeth C. Curtin
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