The U.S. Department of Justice may clamp down on life sciences companies that share board members with alleged competitors

The Biden administration is conducting investigations into potential antitrust violations to which the life sciences industry may be particularly vulnerable because having board members sit on more than one company is relatively common. Benjamin Nagin and Kristina Gliklad explain.

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.

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Chris Fanelli explains what the U.S. Food and Drug Administration’s new draft guidance on remote regulatory assessments means for site inspections in the future, and how manufacturing facilities can prepare for requests for Remote Regulatory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

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Unprecedented Sanctions Against Russia Continue to Impact Pharma Supply Chains

Justine Fassion considers how the various sanctions against Russia are impacting pharmaceutical supply chains, and explains why pharma companies will be affected despite the existence of humanitarian exceptions.

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.

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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.

The Top Three Pandemic Manufacturing Inspection Techniques That Are Here to Stay

With many pharmaceutical manufacturing facilities unaccustomed to in-person GMP inspections since the pandemic, Arif Noorani, Josefine Sommer, and Daniel Roberts examine how inspection techniques have evolved.

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