Portolano Cavallo

Life Sciences

Blog

8 Nov 23
Digital therapeutics: A bill for regulation in Italy
Bill 1208 “Provisions on digital therapies” was presented in June 2023: the document is designed to regulate in Italy new technologies that offer therapeutic interventions guided by advanced software programs, with a focus on reimbursement.
14 Sep 23
Digital Therapeutics: EFPIA recommendations for access to digital therapies in the EU
The European Federation of Pharmaceutical Manufacturers & Associations ("EFPIA") published a report on Improving access to digital therapeutics in Europe, aiming to promote a structured approach to the regulation of digital therapeutics ("DTx") on the European market.
13 Sep 23
Sunshine Act: Draft decree for the Sanità Trasparente electronic register published
Now available the draft decree and technical specifications envisaged by the Sunshine Act, establishing the structure and technical characteristics of the “Sanità Trasparente” electronic register, and the modalities for manufacturing companies to transmit notifications.
19 Jun 23
Non-promotional communication: Boost for digital from the Farmindustria Code?
The recent amendments to the Farmindustria Code on non-promotional drug interactions may boost pharmaceutical companies’ communication via digital and other channels.
6 Oct 22
In a first, the European Commission blocks a below-threshold transaction under the EU Merger Regulation (Grail/Illumina)
On September 6, 2022, the European Commission (the “Commission”) blocked the acquisition of Grail by Illumina—although the deal didn’t meet the turnover threshold of the EU or any Member State—arguing that the merger would have prevented innovation and competition in the blood-based early cancer detection test market.
5 Oct 22
<!--:it-->European Health Data Space: Early indications of the future of circulation of health information in the European Union<!--:-->
The establishment of a European Health Data Space sits within the broader framework of the strategy developed by European institutions to create a single market for data.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
...
Read more
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.

Close
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 ...
Search by...
Search
Follow us on
Follow us on