Sidley Global Life Sciences

Early-stage strategic partnerships can provide life sciences companies with critical advantages — from reducing risk and providing regulatory insight to offering non-dilutive capital.   At the same time, these collaborations raise important legal and regulatory questions around structure, intellectual property, commercialization, and long-term strategy.   Sidley lawyers Adam Welland, Meenakshi Datta, Mathew Eapen, and Torrey Cope outline the key considerations for development-stage companies and their investors in our latest article: https://bit.ly/3Kv2uXc.   #LifeSciences #Biotech #StrategicPartnerships

Sidley has been recognized as a Life Cycle Firm for the fifth consecutive year by LMG Life Sciences — highlighting the firm’s depth and breadth to handle legal issues across the entire life span of a life sciences product. Overall, Sidley received 11 practice rankings and 29 lawyer rankings in the 2025 edition of LMG Life Sciences. Read more here: https://bit.ly/4mMaX5Q.

Now that the dust has settled on FDA’s single-day issuance of over 100 “cease-and-desist” letters aimed at prescription drug advertisements, biopharmaceutical companies are left holding a mixed bag.   The issuance, part of a broader “crackdown” announced by the Trump Administration, reflects a highly skewed view of the benefits and risks of drug ads from a public health perspective and raises many significant legal and regulatory issues. It also remains to be seen whether these developments are the leading edge of sustained FDA enforcement in this space.   Here is our take on what the letters may mean from a practical perspective and how companies may want to approach risk management going forward. Read more here: https://bit.ly/4pKaXWC. 

The European Health Data Space Regulation took effect on March 26, 2025. This blog marks the beginning of a dedicated series of blogs exploring the implementation of the EHDS Regulation, with a particular focus on secondary use obligations.   Read more in the blog post by Josefine Sommer, Francesca Blythe, and Belinda V. Baum: "Navigating the European Health Data Space Regulation: What Life Sciences Companies Need to Know About Secondary Use Implementation (Now) – A Tracking Tool (September 2025)."

Thank you to everyone who joined Sidley partners Ruchun Ji and Arif Noorani in Singapore last week for EBD Group’s Asia Bio Partnering Forum. Ruchun moderated the “The Art of the Deal: NewCos and the Next Chapter of Biotech Strategy” panel, exploring the evolving art of the deal — what’s working, what’s next, and how pharma, VCs, and startups are collaborating to build the next generation of biotech success stories.   Arif spoke on the “From Regulation to Realisation — Building Ecosystems for Emerging Therapeutics in APAC” panel, sharing insights on how biotech companies and regional stakeholders can align strategies to bring these therapies to market faster and more effectively.

The U.S. Food and Drug Administration has issued a much-anticipated risk-based framework for using remote and collaborative tools in lieu of, or in support of, traditional on-site inspections for pending applications. It is expected to use these tools to streamline manufacturing facility assessments, especially for domestic facilities under the Pre-Check and Commissioner’s Priority Review Voucher programs.   Read our insights here: https://bit.ly/47Ql4ma.

We were delighted to bring together colleagues and industry leaders for Sidley’s 2025 Medicaid Drug Rebate Program (MDRP) Cocktail Reception in Chicago. Hosted by members of our Drug Pricing team — Meenakshi Datta, Trevor Wear, Donielle McCutcheon, Catherine Starks, Rina Mady, Kim Schroer, and Nicole Koshevatskiy — the evening provided a wonderful opportunity to connect after Day 1 of the MDRP Summit. Thank you to all who joined us for an evening of insightful conversations and new connections. For more insights, explore our latest Drug Pricing Updates: • Major U.S. Government Price Reporting Proposals Warrant Industry Comment: https://bit.ly/46djASd. • Key Inflation Reduction Act Amendment Broadens U.S. Protection for Orphan Drugs: https://bit.ly/44Q8FeT. • CMS Sets Stage for 2028 Medicare Drug Price Negotiations — First Look at Negotiations for Part B: https://bit.ly/3H0PKpD.

Rare disease and specialty product manufacturers face myriad complexities when preparing for product launch, including developing a distribution network that addresses patient need and strategic and regulatory considerations. Such manufacturers must consider not only state laws governing licensure and distribution networks but also the overlay of federal healthcare laws that have implications for how distributor arrangements are negotiated, structured, and documented. Read our insights here: https://bit.ly/46nibGX.

European pharmacovigilance (PV) frameworks have been updated to provide risk-based, data-driven oversight of processes to increase transparency and better protect animal health, public health, and the environment. Though this can add to the administrative burden for marketing authorization holders, robust PV systems can help create added value for manufacturers by continuously delivering critical data to support product development, while strengthening confidence in the safety and reliability of veterinary medicines. Read our insights here: https://bit.ly/4n8emNc