European Court of Justice Judgment Relating to Orphan Market Exclusivity

In a recent judgment, the Court of Justice of the European Union (CJEU) has shed light on the scope of the ‘clinical superiority’ criteria providing for a derogation to orphan market exclusivity which is key to protect the orphan molecule from competition for the period of market exclusivity (10 or 12 years as the case may be). Marie Manley, Chris Boyle, and Alix Vermulst examine the impact of this judgment on pharmaceutical companies.

European Regulator Clarifies Guidance on the Use of AI in the Medicinal Product Lifecycle

The European Medicines Agency (EMA) has published a final reflection paper on the use of AI in the drug lifecycle, which provides important insights into the expectations from the EMA to clinical trial sponsors, as well as marketing authorization (MA) applicants and holders who use AI systems. Josefine Sommer and Zina Chatzidimitriadou explain.

Life Sciences Companies See New Path Open for Challenging FDA Decisions

A U.S. Supreme Court ruling which overturned the famous Chevron ruling by deciding courts should not defer to an agency’s interpretation of the law is likely to usher in a new era of both opportunity and risk for life sciences companies seeking to review FDA decisions. Michael Varrone explains.

As U.S. Biosecure Act Passes the House, Four Things Biotechs Can Do to Prepare

The U.S. Senate may still reject the U.S. BIOSECURE Act , but the House of Representatives has now passed a version of the bill. Biotechs in both the P.R.C. and the U.S. therefore need to prepare for the new environment which it heralds. Michael Borden, Andrew Shoyer, and Ruchun Ji set out five steps to take now.

Are the revisions to the EU’s ‘Bolar’ system compatible with TRIPS?

The EU’s proposal to speed up generic and biosimilar market access by expanding the “Bolar exemption” to pricing and reimbursement procedures raises significant international IP law concerns, as it is probably incompatible with its obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Maarten Meulenbelt, Chris Boyle, Lauren Shapiro, Maryanne Kamau, and Alix Vermulst explain.

How to Secure Investment as a Healthcare AI Innovator

For both small startups and R&D departments within larger companies, making investment funds work for an AI-based product is not just about securing initial funding but about making sure the investor understands the challenges of the healthcare sector. Chad Ehrenkranz talks to physician-executive and startup advisor Rick Abramson, MD, about the challenges.

How, When, and If the U.S. BIOSECURE Act Is Likely to Become Law

Both U.S. and P.R.C.-based biotechs are anxiously watching attempts to pass the U.S. BIOSECURE Act into law. Michael Borden and Andrew Shoyer explain what this month’s developments mean, and why the legislation, even with so much attention and publicity, may never actually become law.

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