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Portolano Cavallo Life Sciences Blog
14 Apr
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.
13 Apr
EU and the Digital Green Certificate: New challenges and opportunities during the COVID-19 pandemic
On March 17, 2021, the European Commission presented a proposal to create a Digital Green Certificate to facilitate the free movement of citizens within Member States during the COVID-19 pandemic while ensuring public health safety.
12 Apr
The Italian Medicines Agency provides additional information on the new simplified classification procedure for generics and biosimilars
The Italian Drug Agency (AIFA) provided further information on the new simplified pricing and reimbursement procedure introduced in October 2020 for generics and biosimilars.
12 Apr
COVID-19: Transparency mechanism in the export of COVID-19 vaccines outside EU
Due to persistent delays in deliveries of vaccines to the EU, on March 11, 2021 the European Commission adopted the new Implementing Regulation (EU) 2021/442, renewing, with amendments, through the end of June, the transparency and authorization mechanism for COVID-19 vaccine exports.
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 25, 2021
Clinical trials: EMA launches public consultation on draft guideline for using computerized systems and electronic data
June 9, 2021
The Medical Device Coordination Group endorsed new FAQ on the European Medical Device Nomenclature (EMDN), that aims at supporting the functioning of the European database on medical devices...
May 25, 2021
The Italian Data Protection Authority published guidelines on the role of the Data Protection Officer in public entities: important news for hospitals and healthcare facilities
May 4, 2021
European Health Union: Commission publishes open public consultation on the European Health Data Space
April 22, 2021
Clinical Trial Regulation: Clinical trial EU Portal and Database, essential for the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 20...
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