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Portolano Cavallo Life Sciences Blog
4 Sep 17
The European Commission keeps targeting certain patent settlements between pharma companies as anticompetitive agreements: Cephalon and Teva formally accused of “pay-for-delay” in relation to a settlement the parties concluded in 2005
On July 17, 2017 Margrethe Vestagher, the head of antitrust at the European Commission (“Commission”), announced that its services sent a “statement of objections”[1] to the US-based originator company Cephalon Inc (Cephalon) and the Israeli generic company Teva Pharmaceutical Industry Ltd (Teva), accusing the two firms of infringing Article 101 of the TFEU (which prohibits anticompetitive agreements between independent undertakings) when they entered into a patent settlement agreement that, allegedly, had the objective of delaying the marketing in the EEA of a generic version of modafinil – a blockbuster drug for sleep disorders – despite the relevant patents had expired.
3 Sep 17
New consent for processing sensitive data not needed after change of data controller: data protection thoughts and M&A
For the first time in Italy, a court has affirmed that when a data controller changes, there is no need to acquire new consent from the participants of a research project involving the processing of sensitive data, if the research purposes do not change.
2 Sep 17
Consultation opened on the new EMA’s concept paper on development and lifecycle of personalised medicines and companion diagnostics
The EMA has released for public consultation a concept paper on the development and lifecycle of personalised medicines and companion diagnostics.
1 Sep 17
EMA publishes the revised guideline on first-in-human clinical trials
The EMA, in cooperation with the European Commission and the representatives of the Member States of the European Union through the EU Clinical Trials Facilitation Group (CTFG), has revised its guidance on first-in-human clinical trials, to further help stakeholders identify and mitigate risks for trial participants.
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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