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6 Oct
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
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.
6 Jul
Clinical trials and pharmacovigilance: Spanish Code of Conduct leads the way in data management
In an effort to expand the regulatory framework with self-regulatory instruments, the Spanish Data Protection Authority recently approved a “Code of conduct for the processing of personal data in the field of clinical trials and other clinical research and of pharmacovigilance” supported by Farmaindustria, the national trade association for the pharmaceutical industry in Spain.
6 Jul
Draft EMA guidelines on transparency in clinical trials: Protecting commercially confidential information
On April 7, 2022, the EMA published draft guidelines on the transparency of information uploaded to the Clinical Trial Information System for the specific purpose of giving operational guidance on the management of commercially confidential information and personal data
19 Apr
The new decree on non-profit studies: Data and results may now be sold
On February 16, 2022, more than two years later than planned, the Ministerial Decree of November 30, 2021, containing measures to facilitate and support the development of nonprofit clinical trials of medicinal products and observational studies, as well as to regulate the transfer of data and results of nonprofit trials for registration purposes, was finally published in the Official Gazette.
Published Decree of Health Ministry providing measures to enhance no-profit clinical trials and to regulate transfers of data and results of no-profit studies for registration purposes
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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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...
July 19, 2022
Guidelines for the implementation of the Electronic Health Record (EHR) to ensure dissemination, uniformity and accessibility of the EHR at national level now published in the Official Gazet...
June 6, 2022
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
April 27, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation...
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