EU Biotech Act I: Parliament and Council back Europe’s biotech competitiveness agenda – SPC incentive now the key battleground
Momentum is building behind the European Biotech Act I. The European Parliament and the Council of the EU broadly back the competitiveness agenda, with strong cross-party support for faster clinical trials, strategic-project funding, and regulatory simplification, and Member States showing less resistance than expected. The supplementary protection certificate (SPC) extension is the main open point – and the clearest test of how far Europe will go to attract biotechnology research, development, manufacturing, and investment.
The Commission presented its proposal in December 2025 (see our initial Sidley blog post here). This update focuses on how the package has evolved since then and what the latest developments in Parliament and the Council mean for biopharmaceutical developers and investors.
HHS Secretary Announces Intent to Extend HHS-OIG Exclusion Authority to CMS, Expanding the Administration’s Anti-Fraud Campaign
HHS Secretary Robert F. Kennedy Jr. recently announced that he would give CMS the authority to exclude individuals and entities from participation in federal health care programs, an authority previously held only by HHS-OIG. While the announcement has not been formalized since announced in July, the announcement signals a potentially far-reaching expansion of CMS’s enforcement powers, which in turn would have implications for healthcare providers, suppliers, manufacturers, vendors, and other industry stakeholders.
When AI Changes The Deal: Seven AI-related Considerations for Life Sciences M&A Dealmakers
Sally Wagner Partin, Sharon R. Flanagan, and Torrey Cope consider how AI is reshaping drug development, particularly at the stages of target and compound identification, and set out the implications of those changes for valuation, diligence, risk, milestone design, and timing in life sciences transactions.
