After failing to pass in the previous Congress, a revised version of the “BIOSECURE Act” (“the Act”) was signed into law by President Trump…
- EU Pharma Package: When Will the New Rules Apply?
- The UK-Switzerland FTA and the Internationalisation of Pharmaceutical Exclusivity
- Impact of MFN Pricing on Transactions
- United States: HHS-OIG Issues Unfavorable Advisory Opinion on Physician Royalty Arrangements with Device Company
- United States: President Trump Tariffs on Patented Pharmaceuticals Under Section 232
- The US BIOSECURE Act Becomes Law: Implications for Collaborations with “Biotechnology Companies of Concern”
- Manufacturing Site Divestitures: Best Practices for Successful Execution
- Medical Device AI in Limbo: EU’s Digital Overhaul or Digital Headache for Pharma and Medtech?
Pharmaceutical companies are increasingly outsourcing complex manufacturing activities to contract development and manufacturing organizations, or CDMOs. This enables pharmaceutical companies to streamline their operations…
Medical Device AI in Limbo: EU’s Digital Overhaul or Digital Headache for Pharma and Medtech?
The EU ended 2025 with a legislative blitz – AI, cybersecurity, data use, data protection, and medical devices were all subject to proposals promising…
Today the European Commission has finally published its Proposal to revise the EU Pharmaceutical legislation, the most momentous…
On 26 April 2023 the European Commission published its Proposals to Reform the EU pharmaceutical legislation.[1] We continue…
In brief Reimbursing medicinal products is critical to ensure that treatments are widely available to patients. This is…
The Proposal to revise the EU Pharmaceutical legislation has generated unprecedented levels of attention, not only across the…
As previously covered in this blog, on 26 April 2023 the European Commission published a set of proposals…
As already well noted on this blog, on 26 April 2023 the European Commission published a set of…





