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Inspiring Women in the Life Sciences Industry: what we can learn from them
By Lyndsey Hudson
As someone who believes strongly in empowering women in the workplace and building a diverse and inclusive culture, I really enjoyed...
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Global Life Sciences Supply Chain Insights - At the Intersection of Science and Law Podcast Series
By Lauren Murzda Richard Taylor
Published in Chambers Expert Focus US partner Lauren Murdza and UK partner Richard Taylor share their insights on supply chain issues in...
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Thaler Shut Down: High Court of Australia confirms AI incapable of being an "inventor"
By Nicholas Tyacke Robynne Sanders Greg Bodulovic +3 more...
Artificial intelligence (AI) is playing an increasingly relevant and important role in our lives.  Be it through your personal devices,...
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SPACs targeting Latin America-based life sciences and healthtech companies
By Bruna Rocha Juliana Marcondes
The SPAC structure not only enables the target companies to be listed in the United States’ public stock market through a simpler and...
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California strengthens protections for mental health information exchanged through digital health applications
By Andrew Serwin Kristi Kung Bethany Hills
With the mounting mental health crisis intensified by the COVID-19 pandemic, the telemental health industry has exploded in recent years....
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Considering Modifications to Existing FDA Regulatory Incentives to Achieve Greater Racial and Ethnic Diversity in Clinical Trials for Drug Approvals
By Kirsten Axelsen
When clinical trials for new drug approvals fail to adequately represent racial and ethnic groups, there is a lost opportunity to collect...
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Your clinical decision support software may now be regulated by FDA as a medical device: 4 key takeaways from FDA’s webinar on the Final CDS Guidance
By Keo Shaw Bethany Hills Danny Tobey
In the wake of FDA’s long-awaited final guidance for the regulation of Clinical Decision Support Software, many software developers and...
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Advocate General against a stricter standard of proof of harm in merger cases
By Joost Haans
Yesterday (20 October 2022), Advocate General (AG) Kokott of the European Court of Justice issued her Opinion in relation to the appeal...
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The potential for unintended consequences in the Inflation Reduction Act
By Jim Greenwood Alex Pinson Jamie Gregorian
The Inflation Reduction Act (IRA) significantly impacts the US economic model for prescription drug innovation through the imposition of...
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EU Pharma & Medical Device Regulation 2023
By Marco de Morpurgo Nicola Landolfi
Our EU Life Sciences Regulatory team led by Marco de Morpurgo and Nicola Landolfi have produced a guide on EU Pharma & Medical Device...
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The latest legislative changes in the pharmaceutical industry in Poland
By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Urszula Grębowska
In our latest report, we provide an update on the key legislative changes proposed and introduced in the pharmaceutical sector in Poland.
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Organoids: science fiction or the future of pre-clinical studies?
By Marion Abecassis Ruth Faragher
New technologies based on human cells are increasingly seen as key to reducing the time and cost in bringing drugs to market. This is an...
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New IFPMA/EFPIA guidance on social media and digital channels
By Marco de Morpurgo Carlotta Busani
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical...
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Your clinical decision support software may now be regulated by FDA as a medical device
By Bethany Hills Danny Tobey Dan Kagan +1 more...
Clinical Decision Support (CDS) software is an area driven by innovative technologies that is often intertwined with traditional clinical...
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Anvisa’s new rules on the regulation of medical devices - Brazil
By Bruna Rocha Juliana Marcondes Victoria Cristofaro
As previously shared when the new regulatory framework for software as a medical device (“SaMDs”) was presented earlier this year (here),...
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Italy reintroduces payback systems for medical devices. How can companies act to avoid excessive spending
By Giorgia Romitelli Roberta Moffa
With Law Decree no. 115/2022 (Aiuti Bis Decree), the Italian Government reactivated the so-called “payback” system for medical devices....
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