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Portolano Cavallo Life Sciences Blog
11 Oct 19
New criteria for the negotiation of prices for medicines
On August 1, 2019, the Ministry of Health announced the approval of a Ministerial Decree, issued in agreement with the Ministry of Economy and Finance, which sets new criteria for the price negotiation procedure between the medicine marketing authorisation holder (MAH) and the Italian Agency of Medicines (AIFA) in order to establish the price for medicines that will be reimbursed by the National Health Service (NHS).
2 Oct 19
Excessive pricing abuses in the pharmaceuticals sector: complying with a cease-and-desist order. The Italian case of Aspen v AGCM
On 29 September 2016, the Italian Competition Authority (the AGCM or ICA) fined the Aspen Group (Aspen) €5m for a violation of article 102(a) of the Treaty on the Functioning of the European Union.
8 Jun 19
The EU Court of Justice holds that colluding to disseminate information constitute a restriction of competition “by object” (Roche / Novartis)
On January 23rd, 2018, the ECJ delivered its preliminary ruling on the Roche/Novartis v. Commission case (C-179/16), concerning the compatibility of an agreement entered into between Roche and Novartis with Article 101 TFEU.
7 Jun 19
Regulations on the shortage of medicines in the Draft law converting the “Calabria” Law Decree
On May 3, 2019, Law Decree No. 35 of April 20, 2019 (the “Calabria Decree “) entered into force. The Calabria Decree includes significant provisions relating to the shortage of 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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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...
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...
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