PORTOLANO CAVALLO INFORM@ LIFE SCIENCES - Portolano Cavallo

LIFE SCIENCES

December 2019
EU commission publishes a new version of the draft Q&A on the application of the clinical trials regulation
Regional Administrative Court of Tuscany: recent judgment on biosimilars
News about advertising medical devices on Facebook: updates from the Ministry of Health
Italian Medicines Agency: publication of the final version of the agreement on conducting clinical trials on medicines
New European Guidance on the qualification and classification of software as medical devices
Pharmaceutical trademarks: the proof of genuine use and proper reason for non-use
Case-law clarifications concerning telemedicine
The First Italian Case on Electronic Cigarettes’ Advertising
Medical Devices Regulation: transitional provisions on the validity of certificates issued under the former Directives
Under what circumstances may an incumbent associate with a competitor in a public tender? The ICA provides useful guidance in the field of plasma derivatives.
October 2019
Ban on the marketing of Cannabis sativa L and its derivatives for recreational use: the ruling of the Unified Divisions of the Supreme Court of Cassation
Artificial Intelligence in healthcare between opportunities and new challenges
The ranitidine case: a test for the new class action?
Interruption in the marketing of medicines: AIFA provides clarifications to MAHs on their communication duty
New criteria for the negotiation of prices for medicines
Excessive pricing abuses in the pharmaceuticals sector: complying with a cease-and-desist order. The Italian case of Aspen v AGCM
June 2019
The EU Court of Justice holds that colluding to disseminate information constitute a restriction of competition “by object” (Roche / Novartis)
Regulations on the shortage of medicines in the Draft law converting the “Calabria” Law Decree
Artificial intelligence software: FDA news
Breaking news on the supplementary protective certificate for medicinal products

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