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March 08, 2019
OSE Immunotherapeutics has been granted authorization to commence a Phase I clinical trial for checkpoint inhibitor BI 765063 (previously OSE-172).
March 02, 2019
The European generics and biosimilars sector is working on the creation of a single pathway to accelerate development of and access to medicines.
March 01, 2019
Aclaris Therapeutics has been granted a marketing approval from the Swedish Medical Products Agency for ESKATA.
Recipharm has received ISO 45001 certification for its Wasserberg facility in Germany as a result of the facility’s program to enhance sustainability and safety.
February 22, 2019
The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has issued a recommendation for the suspension of fenspiride medicines across the whole of the European Union.
February 21, 2019
The Swiss Agency for Therapeutic Products has begun entering GMP compliance information in the European Union’s EudraGMDP database.
February 15, 2019
The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.
A taskforce evaluated the advantage of using Big Data in the evaluation of the benefits versus risks of medications.
February 14, 2019
Big data technology company, Aigenpulse, has been granted with International Organization for Standardization (ISO) 9001:2015 and ISO 27001:2013 certification.
Zogenix has submitted an NDA to the US Food and Drug Administration and an MAA to the European Medicines Agency for FINTEPLA.