United States: Food, Drugs, Healthcare, Life Sciences

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.

Two recent lawsuits claim supplement labels may mislead consumers by highlighting creatine content per serving on the front panel without clearly showing that a serving includes multiple gummies or tablets.

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

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.

Kentucky's Attorney General has filed a lawsuit against reproductive health nonprofit Mayday Health, claiming the organization violated state law by advertising mail-order abortion pills through gas station displays and aerial banners. The case raises critical questions about state authority to regulate speech related to products that may be illegal under local law, while similar legal battles unfold in South Dakota involving constitutional challenges and preliminary injunctions.

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 Department of Justice declined to prosecute Campus Eye Management under its new Corporate Enforcement Policy after the healthcare company voluntarily disclosed Medicare fraud involving unnecessary diagnostic tests and kickback schemes. While the company avoided prosecution through cooperation and remediation, DOJ simultaneously indicted its founder and former CEO, raising critical questions about how healthcare organizations should balance voluntary disclosure, individual accountability, and compliance