On June 24, 2026, the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) issued a Request for Information (“RFI”) seeking stakeholder input on payments received by individuals in connection with clinical trial participation. Specifically, OIG is seeking to identify ways it might: (i) modify…
The Department of Defense has published its updated Section 1260H list of “Chinese military companies” this week, and WuXi AppTec along with 27 other new entities were identified on the list. (Federal Register notice available here: https://public-inspection.federalregister.gov/2026-11571.pdf.) DoD noted that WuXi AppTec is named on the basis of indirect…
On April 15, 2026, the U.S. Food and Drug Administration (“FDA”) announced that it will convene a public meeting of the Pharmacy Compounding Advisory Committee (“PCAC”) on July 23-24, 2026, to consider whether to recommend seven (7) peptide bulk drug substances for inclusion on the list of substances that may…
Regulation (EU) 2023/2854 (the Data Act) entered into force across the EU on 12 September 2025. It forms a key part of the EU’s broader data strategy and establishes a comprehensive framework for how data is accessed, used, and shared across connected products, digital services, and data processing services, including…
To help companies and investors stay ahead of the rapidly evolving regulatory landscape across pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, our Life Sciences Regulatory & Compliance team provides timely insights into key developments. Each quarter, we publish a tracker spotlighting the most impactful regulatory updates—essential intelligence for industry…
The first half of 2025 has seen an acceleration of M&A activity, including large-scale life sciences transactions, such as Merck’s $3.9 billion acquisition of SpringWorks, Sanofi’s $9.5 billion acquisition of Blueprint Medicines, and Johnson & Johnson’s $14.6 billion acquisition of Intra-Cellular Therapies, as well as notable developments in litigation and…
FDA is now accepting submissions to the Commissioner’s National Priority Voucher (CNPV) pilot program, and with only five vouchers to be awarded as part of the initial year of the program, the competition is anticipated to be fierce. It has been a little over a month since the FDA announced the CNPV…
The Trump administration recently announced the renewal of a new cross-agency collaboration between the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) in the form of the DOJ-HHS False Claims Act Working Group. The Working Group will be jointly led by Deputy Assistant Attorney General…
On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced publication of over 200 complete response letters (CRLs) issued in response to applications submitted to FDA for approval of drugs or biologics between 2020 and 2024. The FDA has described this move as a step toward the Agency’s…
To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, our Life Sciences Regulatory & Compliance team has provided an overview of key developments. We update and publish a quarterly tracker detailing these developments. You can read…