EU
27 April 2021 - Posted by: Lukas Rengier
On 4 March 2021, the European Commission (Commission) opened a formal investigation into alleged anti-competitive conduct by the pharmaceutical company Teva. The Commission suspects Teva of having deployed a strategy with the intention of delaying the market entry of generic drugs that competed with Teva’s originator drug Copaxone. This may have amounted to an abuse › Read More
Patent settlements and competition law – guidance from Europe’s top court
15 April 2021 - Posted by: Lukas Rengier
On 25 March 2021, the European Court of Justice (ECJ) ruled for the second time on a “pay-for-delay” settlement. These are settlements of a patent dispute that involve payments or other value transfers from the originator manufacturer to the generic manufacturer in return for a delayed market entry. The ECJ dismissed appeals by the originator › Read More
23 March 2021 - Posted by: Thomas Masterman
Key points Working group’s goal is “concrete and actionable” updates to pharmaceutical merger analysis. Focus will include new theories of harm beyond the traditional approach of assessing overlaps in products and pipeline products. Stated intention is to take an “aggressive” approach to tackling anticompetitive pharmaceutical mergers. Overview On March 16, the U.S. Federal Trade Commission › Read More
Regulatory considerations for Covid-19 next generation vaccines
12 March 2021 - Posted by: Rafi Allos
As next generation Covid-19 vaccine developers consider whether ethical and practical clinical efficacy trials can be conducted, they might consider whether vaccine efficacy can instead be inferred. We consider the alternative routes for vaccine developers of using an immune correlate of protection or immunobridging studies and some potential risks associated with such approaches. Setting the › Read More
EMA advises study sponsors to amend Informed Consent Forms
05 March 2021 - Posted by: Nieke Vanavermaete
Consent Forms (ICF) to include an explicit reference as to the possibility that EU inspectors would have access to medical records and personal data of clinical trial participants. In February 2021, the European Medicines Agency updated its guidance in the form of questions and answers (Q&As) on Good Clinical Practice (GCP). GCP is a code › Read More