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.

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.

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.

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. 

Missing Numbers: Seeking to Substantiate The Leaked EU Pharmaceutical Review

Pharma companies are currently assessing how the Pharma Review will affect their portfolios. Maarten Meulenbelt and Maria Koutsoupia discuss the need for analysis from the EU to support the Review’s claims, for example on the allegedly ‘invisible’ effect of losing €640 million in annual orphan drug revenues.

Six Surprises In The Leaked European Pharmaceutical Review

On 31 January 2023, the internally circulated version of the European Commission’s far-reaching overhaul of the EU’s pharma legislation was leaked, and published by Politico. Here, initial impressions of the biggest surprises in the document are given by Maarten Meulenbelt, Chris Boyle, and Zina Chatzidimitriadou.

Biden Administration Moves to Boost the Bioeconomy

A new Executive Order in the U.S. aims to ease the path to market for products that use synthetic biology or genome editing. Emily Marden explains the thinking behind the announcement and its efforts to streamline the current U.S. framework for biotech.

Remote Regulatory Assessment Oversight Tools Piloted During the COVID-19 Pandemic Are Here to Stay

Chris Fanelli explains what the U.S. Food and Drug Administration’s new draft guidance on remote regulatory assessments means for site inspections in the future, and how manufacturing facilities can prepare for requests for Remote Regulatory Assessments.

Podcast: How the EU’s New Revised Annex 1, Eudralex Volume 4 (GMP), Will Affect the Manufacturing of Sterile Medicinal Products in the EU and U.S.

Jay Jariwala in Washington, D.C. and Josefine Sommer in Brussels talk to Raj Pai about how they expect the EU’s new revised Annex 1, EudraLex Volume 4 (GMP), to affect the manufacturing of sterile medicinal products. They discuss how the update reflects changes in the manufacturing environment and how the new Annex 1 is likely to be considered within the U.S. regulatory framework. Prior to joining Sidley, Jay worked for the Office of Compliance at the Center for Drug Evaluation and Research, a branch of the U.S. Food and Drug Administration, and he brings this experience to bear in considering the impact of Annex 1.

Could the European Health Data Space Push the EU Above Other Key Markets Such As the U.S. and China?

Eva von Mühlenen and Alejandro Bes of Novartis consider how the proposed European Health Data Space may speed up research for medicinal products by increasing access to health data, with the help of data scientists within the EU. This development is likely to generate five sticking points that the life sciences industry will need to address, they add.