Sidley Global Life Sciences

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

Thank you to everyone who joined us last week for our inaugural Singapore Life Sciences Roundtable. This first-of-its-kind event brought together senior legal and compliance leaders from multinational pharmaceutical, medtech, and biotech companies to discuss how global developments are reshaping the life sciences sector across APAC. We are especially grateful to our distinguished speakers — Shu Min Ho, Arif Noorani, Alun Evans, and Yuet Ming Tham — for sharing their insights on the new DOJ white collar enforcement playbook and its impact on APAC operations and compliance, paradigm-shifting FDA regulatory developments under the new U.S. administration, and key considerations in navigating life sciences transactions in the region, including deal risks, regulatory scrutiny, and cross-border trends. We look forward to continuing these conversations and strengthening collaboration across the life sciences community.

Hong Kong has recently emerged as the number one IPO venue globally, and one of the sectors driving this is biotech. For China-based biotechs looking to float, Hong Kong is a natural destination. But biotechs based anywhere in the world may wish to ride the current wave, as Meng Ding explains. Read more in the blog post: "Now Is The Right Time For A Hong Kong Biotech Listing."

Thanks to everyone who joined Sidley partners Chris Fanelli and Ruchun Ji last week in Shanghai for the 18th Parenteral Drug Industry Congress.    Chris shared his insights on “FDA Requirements for Ophthalmic Products” and “How To Deal with FDA 483 Inspections, Warning Letters and Import Alerts,” while Ruchun explored “U.S. Outbound Investment Rules and the America First Investment Policy - Their Impact and Opportunities for Chinese Manufacturers.”