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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.
15 Oct 20
Italian Competition Authority says that the rules on the remuneration of health care services provided by pharmacies are anti-competitive
The Italian Competition Authority once again criticizes the introduction of legislative provisions that reserve only to pharmacies the provision of certain public health services paid by the NHS
9 Jun 20
Italian Competition Authority approves two emergency cooperation projects: one for joint distribution of surgical masks and one common moratorium scheme on consumer lending
On May 27, 2020, for the first time the Italian Competition Authority (“AGCM”) applied its communication on cooperation agreements in the context of the COVID-19 emergency (“Italian Communication”), applicable since April 24, 2020.
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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December 13, 2021
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the operational and practical implementation of Articles 13&14 and other related obligations f...
October 27, 2021
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the applicability of MDR requirements to 'legacy devices' and 'old' devices
October 19, 2021
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the classification of medical devices
September 29, 2021
EU pharmaceutical strategy: today the Commission launched a public consultation on the revision of the EU general pharmaceuticals legislation (open until December 21, 2021)
August 4, 2021
Clinical Trials Regulation: EMA and European Commission confirmed that the Clinical Trials Information System (CTIS) will go-live on January 31, 2022
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