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19 Apr
Council of State revokes previous judgements in a medical oxygen cartel case due to omission of decisive facts and arguments in the reasoning
On February 15, 2022, Italy’s Consiglio di Stato revoked its previous rulings confirming fines levied on five companies by the Italian Competition Authority for participating in a medical oxygen cartel, as it found manifest omission of facts and reasoning in the judgements, and asked the ICA to produce a set of documents acquired during the proceedings so it can re-examine the case.
3 Feb
Italian Competition Authority confirms its approach to RPM in a recent investigation into a manufacturer of products sold in pharmacies (probiotics)
In May 2021, the Italian Competition Authority (AGCM or ICA) launched an investigation into restrictions on resale prices that a pharmaceutical company, SOFAR, was alleged to have imposed upon its distribution network for a probiotic product (Enterolactis Plus).
11 Jun 21
Italian Competition Authority investigates orphan drug manufacturer (Leadiant) for excessive pricing
In October 2019, the Italian Competition Authority launched an investigation into abuse of dominance pursuant to Article 102 TFEU against the Leadiant group in connection with the marketing in Italy of the “orphan” drug Chenodeoxycholic Acid Leadiant, used to treat an ultra-rare disease.
4 May 21
Farmaci orfani: tensioni negoziali tra interesse pubblico e concorrenza
15 Apr 21
Pay-for-delay: The Court of Justice clarifies the scope of “by object” restrictions and “potential competition” in patent settlement cases
On March 25, 2021, the Court of Justice of the European Union ruled on appeal in the Lundbeck case, confirming the previous judgement of the General Court that upheld the decision of the European Commission on pharmaceutical “pay-for-delay” agreements.
14 Apr 21
COVID-19 vaccine production: The European Commission issues a comfort letter on cooperation between companies in the supply chain
On March 25, 2021, the European Commission (hereinafter, the “Commission”) issued a “comfort letter” on the compliance of the “Matchmaking Event – Towards COVID-19 vaccines upscale production” (hereinafter, the “Matchmaking Event” or the “Event”) with EU competition law.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
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Our highly-ranked team of professionals will provide newsinsights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

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June 6, 2022
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
April 27, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation...
April 5, 2022
Electronic prescriptions: the current modalities of transmission from doctors to patients and from patients to pharmacies are extended until 31st December 2022
March 24, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on appropriate surveillance of devices covered by certificates according to the MD Directives, under the transitional prov...
March 21, 2022
Published Decree of Health Ministry identifying the ethics committees of national significance for clinical trials of medicinal products and medical devices
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