Alnylam opens new European office in Maidenhead, UK

Thursday, September 22, 2016

Alnylam Pharmaceuticals, an RNAi therapeutics company, has announced the expansion of its global footprint with the opening of a new development and commercial hub in Maidenhead, U.K. In anticipation of substantial growth across Alnylam over the next five years, the office opens with a core clinical development, regulatory affairs and commercial team and space for an additional 100 employees.

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GSK deal with Italian Medicines Agency highlights performance-based curative model

Monday, August 29, 2016

GlaxoSmithKline (GSK) has signed a pay-for-performance deal with the Italian Medicines Agency (AIFA) to boost usage of Strimvelis, the pharmaceutical company’s gene therapy treatment developed for ADA-SCID, a rare genetic disorder in children. The key to the contract, however, is that the drug must work. If treatment doesn’t provide a cure, GSK must return a portion of the funds paid by AIFA based on the terms of the agreement.

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EMA publishes adaptive pathways report

Tuesday, August 9, 2016

The EMA has published a final report on the experience gained during its pilot project on adaptive pathways, a product development concept for medicines that address patients’ unmet medical needs.

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EMA updates organizational structure

Tuesday, August 2, 2016

The EMA has announced organizational adjustments and important strategic amendments of its corporate management structure that will result in a leaner, more streamlined architecture and improved administrative support. Building on the 2013/2014 reorganization of the agency, the changes fine-tune the re-engineered organizational model to further improve efficiency and effectiveness of EMA’s operations. All changes will come into effect on September 1, 2016.

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EMA proposes changes to first-in-human trials spurred by January’s Bial trial deaths

Monday, August 1, 2016

Are the risks faced by phase I clinical trial participants too great? The European Medicines Agency (EMA), the European Commission and the Member States of the European Union (EU) believe so. Together, they’re proposing changes to current guidance on first-in-human clinical trials that would, if successful, improve strategies for identifying and mitigating risks to study subjects.

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