Food, Drugs, Healthcare, Life Sciences

The FDA's rescheduling of marijuana from Schedule I to Schedule III signals accepted medical use and lower abuse potential, creating new opportunities for business consolidation. As pharmaceutical and agricultural firms eye the cannabis industry, companies must strategically position themselves as either consolidators or attractive acquisition targets in this evolving landscape.

The SEC and FDA have formalized their information-sharing practices through a new memorandum of understanding that streamlines how the agencies exchange nonpublic information about FDA-regulated products and companies. This framework has significant implications for life sciences companies, particularly regarding how public statements about FDA interactions may be scrutinized against the complete regulatory record, and raises important questions about access to FDA materials during SEC enforcement proceedin

The SEC and FDA have formalized an information-sharing agreement that fundamentally changes how life sciences companies must approach their public disclosures about FDA interactions. This memorandum of understanding creates a direct pathway for the SEC to access previously confidential FDA records, including meeting minutes and Complete Response Letters, to verify the accuracy of companies' public statements.

The federal government's healthcare fraud crackdown on the West Coast has moved from announcement to action, with California serving as an early test case for more aggressive enforcement. Advanced data analytics and artificial intelligence are fundamentally changing how investigations begin, allowing regulators to identify suspicious billing patterns and reimbursement anomalies far more quickly than traditional methods. Healthcare providers and organizations that once viewed smaller billing discrepancies as

A federal court in Florida has granted a rare motion to redact physician-defendants' names from all unsealed filings in a dismissed False Claims Act qui tam case, marking a significant departure from the prevailing judicial approach that typically denies such requests. The decision introduces a novel analytical framework distinguishing between the public's interest in understanding case allegations versus knowing the identities of accused parties, particularly where the government declined to intervene afte

Federal and state healthcare transparency requirements are rapidly evolving, creating new compliance obligations for private equity sponsors and strategic acquirers in healthcare transactions. As CMS expands ownership disclosure rules and states implement transaction review regimes, deal teams must navigate an increasingly complex regulatory landscape that affects diligence, timing, and closing processes.

The Patent Trial and Appeal Board has reaffirmed the Broad Institute's priority over the University of California in a high-stakes patent interference dispute involving CRISPR-Cas9 technology for eukaryotic cells. Following a Federal Circuit remand, the Board applied first-to-invent principles to determine which party successfully demonstrated conception and reduction to practice of this groundbreaking gene-editing system.

Takeda Pharmaceuticals has initiated its second BPCIA lawsuit over vedolizumab biosimilars, this time targeting Alvotech's AVT16 product with allegations of patent infringement across six method-of-treatment patents. The complaint raises questions about confidential access procedures and whether Alvotech's proposed confidentiality agreement exceeded statutory requirements under the BPCIA framework.

U.S. life sciences policy toward China is evolving from list-based compliance to comprehensive capability control, integrating FDA pilots, trade measures, outbound-investment rules, and the BIOSECURE Act into a unified architecture. This shift accelerates domestic discovery and manufacturing while restricting channels for capital, data, IP, and know-how transfer to strategic competitors. Senior leaders must now treat national security as a core variable in product development, capital allocation, and transa