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EIPG Newsletter

Spain: LIF-neutralizing antibodies coupled to immunotherapy to promote tumor regression

MSC-1 is a first-in-class LIF-neutralizing antibody created at the VHIO in Barcelona. First data published in Nature Communications show it may be able to promote tumor regression, thanks to a double mechanism of action

Authorities ask to publish results of clinical studies and the latest news on open...

The EU Commission, EMA and HMA signed a joint letter to ask sponsor to timely publish results of clinical studiesin the EudraCT database. The entry into force of Plan S for open access publishing has been postponed to 1 January 2021 to allow to better prepare the transition

Comments from stakeholders to EMA’s Regulatory Science Strategy 2025

EFPIA, Vaccines Europe, EPHA and other stakeholders released their comments to the draft EMA’s Regulatory Science Strategy 2025 after the closure of the public consultation period

The importance of IP to boost company’s success

A report published by the EPO and EUIPO discusses the impact of intellectual property rights - including patents, trademarks and design - on the success of high growth firms (HGFs)

EIPG Draft Code of Practice for Qualified Persons, updates to EudraLex, medicines shortages and...

After the recent General Assembly, the new EIPG Draft Code of Practice for Qualified Persons has been published in the Members Area of the association's website. The EU Commission released updates to EudraLex vol. 2A and 2C. News on reporting and communication on medicines shortages and open consultations

EMA’s updates on the business continuity plan and preparation for the Brexit

EMA’s Board meeting in June 2019 still delayed many regulatory activities due to an estimated 20-25% loss of staff after the move to Amsterdam. Transfer of MAs from UK to EU-27 countries is almost completed in preparation to the Brexit, and some additional workload came also from the entry in force of other pieces of European legislation

Trends for the global pharmaceutical market to 2024

Keytruda is expected to replace Humira as the top selling drug by 2024, according to a report from EvaluatePharma. R&D investments should reduce, while 400 new products should exit pipelines, mainly in the immune-oncology and orphan diseases areas

EU Commission report indicates the 100 top breakthrough innovation to 2038

Hundred breakthrough technologies might revolutionise the current model of society in twenty years' time, says a strategical report from the European Commission. Radical innovation should occur also at the social level, and global value networks are expected to become the reference points for prioritisation of activities and communication and decision-making

Italy: The 2019 AFI Symposium

More than 1,300 professionals from the pharmaceutical industry and 100 sponsors attended the annual meeting of the Associazione Farmaceutici Industria. The debate was centred this year on challenges to be addressed to face the new wave of innovation and globalisation in the sector of life sciences

Report of the EIPG General Assembly in Budapest

Many themes regarding industrial pharmacists have been addressed by delegates during the 2019 EIPG General Assembly, from education to the role of QP, to issues posed by the coming into force of the FMD legislation. Claude Farrugia has been re-elected as EIPG president for a second three-years mandate