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14 Oct 20
Clinical trials: National Coordination Center of Ethics Committees issues Guidelines for the collection of informed consent
The National Coordination Center of Territorial Ethics Committees for clinical trials on medicines and medical devices (“National Coordination Center”) has drawn up guidelines for the collection of informed consent (“Guidelines”) for participation in clinical trials, pursuant to Legislative Decree No. 211 of June 24, 2003 and Regulation (EU) 536/2014.
10 Sep 20
Life Sciences M&A trends: earnout clauses, general outlook, and a few drafting tips
Earnout payments are a common and widely used tool for pricing targets operating in the life sciences, although there are various nuances depending on the specific sub-sector (biotech, pharma, med-tech, and so on).
10 Jun 20
The new CJEU judgment on Regulation No. 469/2009/EC, in Royalty Pharma case C- 650/17 and the role of independent inventive activity
In the new case Royalty Pharma C-650/17 the CJEU provided further clarifications on the interpretation of Article 3(a) of Regulation No. 469/2009/EC for products covered by a functional definition but developed after the filing date of the patent as a result of an independent inventive step.
27 Mar 20
CJEU Advocate General says that samples of pharmaceutical products cannot be provided to pharmacists
On 30 January 2020, the conclusions of CJEU Advocate General Giovanni Pitruzzella were published on a preliminary ruling from the Bundesgerichtshof, the German Federal Court of Justice, in case C-786/18 (Ratiopharm v Novartis Consumer Health) regarding the free distribution of samples of medicines by the pharmaceutical companies.
11 Feb 20
Medicine and medical device e-commerce: regulatory restrictions and opportunities
More and more healthcare and pharmaceutical companies are entering the world of e-commerce.
7 Feb 20
Venture capital watch: an overview of 2019 investments
We recently attended the country-focused seminar Healthcare: Italy on the Move 2020 during the weeklong J.P. Morgan Annual Healthcare Conference in San Francisco.
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.

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October 6, 2023
CBD products: the Administrative Court suspended until October 24 the recent Decree of the Italian Ministry of Health listing cannabidiol for oral use among narcotic drugs, due to the lack o...
October 4, 2023
The Guidelines for regulating contractual relations between universities and research institutes and private sponsors were adopted by the relevant Italian Ministries following the amendment ...
September 21, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
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