Source: Leaders League(more…)
European Data Protection Board Clarifies the Interplay Between the EU Clinical Trials Regulation and the General Data Protection RegulationApril 8th, 2019 | Posted by in eHealth | Guidelines | Privacy - (0 Comments)
On 23 January 2019, the EU Data Protection Board (“EDPB” – the gathering of all European Union (EU) data protection authorities) adopted opinion no. 3/2019 (the “Opinion”) on the interplay between the Clinical Trials Regulation no. 536/2014 “CTR”) and the General Data Protection Regulation (“GDPR”). Anticipating the application of CTR (currently expected to occur in 2020) following the implementation of the EU portal and the EU database of the European Medicines Agency, the Opinion provides clarification on (i) the different legal bases for the processing of personal data operations related to a specific clinical trial, from commencement of the clinical trial until the deletion of personal data collected during the clinical trial (“Primary Use”); and (ii) the further use of the same personal data set for any other scientific purposes (“Secondary Use”). Without establishing a legal basis, no one can process the personal data needed to run a clinical trial or to use the personal data for other research.(more…)
Prima Biomed Ltd. (ASX:PRR) entered into an agreement to acquire Immutep, S.A. for $28 million in cash, shares and warrants on October 2, 2014. Acquisition funding of the total consideration of up to approximately $28 million will be funded with up to $18 million in cash, partly based on the achievement of key milestones, the issue of Prima ordinary shares totaling approximately $3 million and based on a VWAP calculation and the issue of 200 million warrants equating to a consideration value of approximately $7 million. In order to fund the acquisition and provide ongoing working capital, Prima Biomed has secured an investment agreement with Bergen Global Opportunity Fund, LP managed by Bergen Asset Management for up to $37.4 million. Immutep’s founder and Scientific and Medical Director, Frederic Triebel will join Prima as its Chief Scientific Officer, along with his scientific team, to oversee the LAG-3 development program and to advise on the ongoing development of CVac. The deal is subject to approval of Prima Biomed Ltd. shareholders. As of November 14, 2014, the transaction was approved by shareholders of Prima Biomed Ltd.
Adam Holdsworth from ProActive Capital, Matthew Gregorowski from Citadel Communications and Axel Muhlhaus from edicto GmbH acted as the public relation advisors in this transaction. Jean-Patrice Labautière, François Lan, Alexandre Brossier, Claude-Etienne Armingaud, Ariane Samson-Divisia, Julie Bouchard, Bertrand Dussert and Glenn Hughes of K&L Gates acted as legal advisors to Prima Biomed Ltd. Pascale Gallien and Vincent Maufront of Heenan Paris acted as legal advisors for shareholders of Immutep.
Prima Biomed Ltd. (ASX:PRR) completed the acquisition of Immutep, S.A. for $25 million in cash, shares and warrants on December 17, 2014. Prima made upfront cash payment of $10.8 million with the remaining cash component of $7.2 million partly payable on the achievement of a predetermined milestone and partly payable after 12 months subject to the satisfaction of warranty retention arrangements. The total consideration paid by Prima for the acquisition is estimated to be approximately $25 million as opposed to the previously $28 million. The difference is attributable to the reduction in value of the warrants based on the Black Scholes option pricing model using updated market data.