United States: Life Sciences, Biotechnology & Nanotechnology

Bergeson & Campbell provides comprehensive coverage of federal regulatory developments affecting chemicals, pesticides, and related products, including EPA's latest TSCA risk evaluations, FIFRA pesticide updates, and emerging policy initiatives across environmental and chemical safety programs.

InvaGen Pharmaceuticals Inc., a Cipla Limited subsidiary, has entered into a strategic partnership with Qilu Pharmaceutical Co., Ltd. for the licensing and supply of QL2107, a biosimilar to Merck's KEYTRUDA® (pembrolizumab), in the United States. This collaboration represents the latest in a series of partnering transactions directed to pembrolizumab biosimilar candidates, with Qilu handling development and regulatory registration while Cipla USA manages commercialization.

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage.

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

AbbVie has submitted a regulatory application to the European Medicines Agency seeking approval for SKYRIZI (risankizumab) subcutaneous induction treatment for adults with moderately to severely active Crohn's disease. The application, supported by positive Phase 3 AFFIRM study data, follows a similar FDA submission and could provide patients with an alternative to intravenous infusion for their induction doses.

The American Chemical Society has announced the 2026 Green Chemistry Challenge Award winners, recognizing groundbreaking innovations across nine categories that transform how industries approach sustainability.

Partners Emmanuelle Trombe and Anthony Paronneau examine China's emergence as a global biotechnology innovation hub, exploring cross-border collaboration models and critical considerations for life sciences companies engaging in China-related transactions. The analysis covers intellectual property protection, regulatory compliance frameworks, data management protocols, and foreign investment screening requirements.

FDA-related uncertainty is fundamentally reshaping transaction strategy across the life sciences sector, introducing new complexity into deal structuring and valuation despite strong M&A activity. Shifting regulatory signals, leadership changes, and evolving policy priorities are forcing acquirors to adapt through more creative structuring and strategic, targeted acquisitions.

The Federal Circuit vacated a PTAB decision on patent obviousness, establishing that a provisional application must provide written description support for at least one published claim to qualify as prior art under its earlier filing date. This ruling clarifies the requirements for claiming priority from provisional applications and impacts how patent practitioners should approach provisional filing strategies.