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Life Sciences & Healthcare

CMS Adonnino Ascoli & Cavasola Scamoni has developed a broad expertise in the field of life sciences. Our life sciences & healthcare practice includes the assistance of clients which operate in the fields of pharmaceuticals, biotechnology medical devices and more generally health care services. We regularly advise life science & healthcare companies on corporate governance matters and licensing and contracts, as well as day-to-day corporate issues.

Our team can count on professionals “borrowed” on a regular basis, to life sciences from other departments of the firm including team of corporate and intellectual property professionals who can boast a significant experience securing and defending patent positions and regulatory law issues in order for companies to comply with the Italian regulatory law.

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Pharmaceuticals
Today the pharmaceutical industry is rapidly growing. This is a highly complex industry and represents one of the fastest growing on the market. For t

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20/06/2024
Italian Supreme Court Upholds OECD Transfer Pricing Rules
The decisions of the Italian Supreme Court nos. 10577/2024 and 10499/2024 (concerning the same case for corporate income tax and regional income tax purposes) confirm important principles regarding transfer...
20/06/2024
Cannabis law and legislation in Italy
Medical use Growing, selling and importing medical cannabis is allowed on the condition that the authorisation of the Ministry of Health is obtained. Cultivation, sale and import are currently mainly...
13/06/2024
What’s in a name? The use of a product code in a clinical trial protocol...
The use of product or sponsor codes in clinical trial related documents is common practice in the pharmaceutical space. However, such codes may not always be sufficient to disregard a publication as relevant...
22/05/2024
Digital nomad tax insights
The new visa for digital nomads might become a particularly interesting option for workers who may benefit from the so called “impatriate” tax regime following their relocation to Italy. The Decree...
21/05/2024
Consultation of the European Commission on Vifor's commitments concerning...
In response to the Preliminary Assessment stating the potential abuse of its dominant position, Vifor proposed several commitments to rectify the potential competition law infringement. The European Commission...
16/05/2024
A broader interpretation of "substance or composition" - good news for...
A recent decision from the EPO Boards of Appeal (T 1252/20) potentially paves the way for more diverse products to be patentable in Europe using the medical use claim format.The back­ground:Art­icle 53(c)...
08/05/2024
Pharmaceutical advertising regulation and medical device advertising in...
1.  Which laws are applicable regarding advertising of medicines and medical devices? Advertising of medicines is regulated in a specific section of Legislative Decree no. 219/2006 (“ Code of Medicines”)...
11/04/2024
Navigating clinical trial disclosures: No reasonable expectation of success...
Recent EPO Board of Appeal decision T 1437/21 adds to a growing number of decisions concerning the patentability of second or further medical use inventions where the prior art relates to a clinical trial...
25/03/2024
Patentability of inventions relating to diagnostic methods at the EPO
Under Article 53(c) of the European Patent Convention (EPC), diagnostic methods practised on the human or animal body are excluded from patentability. The purpose behind this exclusion is to avoid patent...
30/01/2024
What’s in a name? Updated EMA guideline on naming medicinal products processed...
The updated EMA Guideline on the acceptability of names for human medicinal products processed through the centralised procedure was adopted by CHMP in December 2023 and came into effect on 1 January...
08/01/2024
Adapting to the new EU Data Act: implications for medical devices and other...
In recent years, the European Commission developed a European data strategy, which aims to create a single European market in which data can circulate freely. As the European Commission has emphasized...
18/12/2023
Digital health apps and telemedicine in Italy
Digital Health Apps/Software 1. How is the software within digital health apps classified in your jurisdiction, and what regulation(s) apply? 1.1 Is it considered a “medical device” or a “product”...
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