Portolano Cavallo

Life Sciences


Portolano Cavallo Life Sciences Blog
2 Oct 19
Excessive pricing abuses in the pharmaceuticals sector: complying with a cease-and-desist order. The Italian case of Aspen v AGCM
On 29 September 2016, the Italian Competition Authority (the AGCM or ICA) fined the Aspen Group (Aspen) €5m for a violation of article 102(a) of the Treaty on the Functioning of the European Union.
8 Jun 19
The EU Court of Justice holds that colluding to disseminate information constitute a restriction of competition “by object” (Roche / Novartis)
On January 23rd, 2018, the ECJ delivered its preliminary ruling on the Roche/Novartis v. Commission case (C-179/16), concerning the compatibility of an agreement entered into between Roche and Novartis with Article 101 TFEU.
7 Jun 19
Regulations on the shortage of medicines in the Draft law converting the “Calabria” Law Decree
On May 3, 2019, Law Decree No. 35 of April 20, 2019 (the “Calabria Decree “) entered into force. The Calabria Decree includes significant provisions relating to the shortage of medicines.
6 Jun 19
Artificial intelligence software: FDA news
On April 2, 2019, a discussion paper describing a proposal for a regulatory framework for modifications to Artificial Intelligence-based medical devices that are already on the market, was published by the Food and Drug Administration (FDA), in view of the future formulation of guidelines that relate to this issue.
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 news, insights 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.

March 20, 2023
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical device...
January 31, 2023
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization proced...
December 19, 2022
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
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