EMA has launched a public consultation on key principles for the electronic product information of EU medicines
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Nov 17
Published the new ministerial decree on compassionate use of medicinal products
On 7 September 2017, the Italian Ministry of Health issued a new decree on compassionate use of medicinal products (“Decree”) that, starting from 2 December 2017, will replace the previous ministerial decree of 8 May 2003.
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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.
