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15 Nov
The Consolidated Act on Rare Diseases is finally approved
After three years, Italy has finally adopted its first law on rare diseases. On November 3, 2021, the Italian Senate unanimously approved the Consolidated Act on Rare Diseases, or “Testo Unico sulle malattie rare”.
8 Sep
Artificial Intelligence and Machine Learning in Clinical Trials: Regulatory attempts by European and national authorities
In the last few years, use of Artificial Intelligence and Machine Learning systems in the performance of Clinical Trials has increased.
11 Jun
Italian Competition Authority investigates orphan drug manufacturer (Leadiant) for excessive pricing
In October 2019, the Italian Competition Authority launched an investigation into abuse of dominance pursuant to Article 102 TFEU against the Leadiant group in connection with the marketing in Italy of the “orphan” drug Chenodeoxycholic Acid Leadiant, used to treat an ultra-rare disease.
1 Jun
Online sales of counterfeit medicines: AIFA recommendations and actions to combat the issue
On April 9, 2021, the Italian Medicines Agency, or Agenzia Italiana del Farmaco (the “AIFA” or the “Agency”) published a Nota informativa notice containing details regarding risks stemming from online purchases of medicines.
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.
9 Apr
Parallel import of medicines: New simplified AIFA procedure for negotiating price and reimbursement
On March 25, 2020, the Italian Agency of Medicines (AIFA) published a resolution on the simplified procedure for negotiating the price and reimbursement of parallel imported medicines.
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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October 27, 2021
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the applicability of MDR requirements to 'legacy devices' and 'old' devices
October 19, 2021
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the classification of medical devices
September 29, 2021
EU pharmaceutical strategy: today the Commission launched a public consultation on the revision of the EU general pharmaceuticals legislation (open until December 21, 2021)
August 4, 2021
Clinical Trials Regulation: EMA and European Commission confirmed that the Clinical Trials Information System (CTIS) will go-live on January 31, 2022
June 25, 2021
Clinical trials: EMA launches public consultation on draft guideline for using computerized systems and electronic data
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