18
Sep
The Italian Competition Authority launches an investigation into suspected pay-for-delay agreements between 8 pharma companies concerning a biosimilar drug (Biogen / Samsung / Genentech...)
On May 21, 2024, the Italian Competition Authority (the AGCM or ICA) opened new proceedings against eight pharmaceutical companies to investigate suspected pay-for-delay practices in breach of the prohibition on anti-competitive agreements (Article 101 TFEU).
17
Sep
The Italian Council of State upholds the Competition Authority’s €3.2M fine for abuse of dominance by negotiating an unjustifiably high reimbursement price for an “orphan” drug (Leadiant Biosciences)
With judgement No. 2967 of March 29, 2024, The Council of State [1] (Italy’s top administrative court) upheld a fine against the pharmaceutical group Leadiant (“Leadiant”) by the Italian Competition Authority (the AGCM or the “ICA”) for abuse of a dominant position pursuant to Article 102 of the Treaty on the Functioning of the European Union (TFEU).
29
May
Bolar exemption, UPCA and Pharma Package: What to expect? An Italian perspective
This article has been first published on April 29, 2024 on the International Bar Association (IBA)'s newsletter.
18
Apr
Chatbots and virtual assistants: How might they be used in pharmaceuticals?
The pharmaceutical sector is not immune to the paradigm shift in user/patient relations, connected to the development and implementation of artificial intelligence systems: when browsing the web and using smartphone applications, users increasingly encounter chatbots and virtual assistants that interact with them.
3
Apr
Article 22 EUMR is still up in the air: Advocate General’s opinion in the Illumina/Grail saga
Advocate General Nicholas Emiliou advised setting aside the General Court’s judgment and annulling the decision of the European Commission to accept the request from certain Member States to review the transaction under Article 22 of the EU Merger Regulation.
19
Jan
Recent legislative news in the life sciences sector under the Budget Law
The so-called “Budget Law” for 2024 wields significant impact on the life sciences sector, and allocates to the healthcare sector EUR 3 billion for 2024, EUR 4 billion for 2025, and EUR 4.2 billion for 2026.
