Portolano Cavallo

Life Sciences

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26 Feb 21
Foreign investment control regulations: extension of COVID-19–related rules and new list and definition of strategic assets with a brief focus on the health industry
At the end of 2020, important regulatory measures regarding Italian foreign investment control regulations (known as the Golden Powers) were enacted: (i) a revised list and definition of critical and strategic assets in sectors relevant for the purposes of these regulations entered into force with effect from January 14, 2021, and (ii) the COVID-19 emergency rules providing for a temporary broadening of the scope of notification duties (which, among other things, also involve intra-EU transactions) have been extended through June 30, 2021.
15 Oct 20
Foreign investment control in the life science sector: the scope of the Italian Government’s powers also in the context of the current COVID-19 pandemic
Some recent cases in the news, as well as steps taken to increase the regulatory powers of the government in the current emergency situation via the Decreto Liquidità[1], have prompted us to draft this overview of measures that provide the government with special powers that it may exercise to prohibit or impose conditions upon extraordinary corporate transactions of foreign parties involving Italian target companies (known as the Golden Power) operating, among others, in the life sciences sector.
11 Jun 20
Venture Capital watch: how COVID-19 is affecting and will affect VC transactions with a specific focus on the life sciences and healthcare sectors
The COVID-19 outbreak has already affected VC transactions all over the world, and it will continue to do so during the coming months.
11 Jun 20
Acquisitions of companies involved in the medical devices business fall under the Italian foreign investment control
More than 2 months ago the Italian Government issued certain measures[1] with the purpose of expanding its power to veto or impose conditions on acquisitions of, or other transactions involving, Italian targets operating in certain strategic sectors.
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.
5 Feb 19
Benefit companies: an overview from a corporate perspective
Italy was the first European country to issue a regulation on benefit companies (in Italian “società benefit”), importing the model from the US.
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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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...
April 5, 2022
Electronic prescriptions: the current modalities of transmission from doctors to patients and from patients to pharmacies are extended until 31st December 2022
March 24, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on appropriate surveillance of devices covered by certificates according to the MD Directives, under the transitional prov...
March 21, 2022
Published Decree of Health Ministry identifying the ethics committees of national significance for clinical trials of medicinal products and medical devices
February 23, 2022
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
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