OR WAIT null SECS
April 01, 2019
Uncertainty remains around the UK’s departure from the EU, potentially causing irreparable damage to the bio/pharma sector.
March 29, 2019
ABPI has asked for a temporary ban to be put in place on drug exports by wholesalers to protect the National Health Service (NHS) from potential shortages in a ‘no-deal’ Brexit scenario.
March 26, 2019
The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.
March 08, 2019
The Regulatory Affairs Professional Society (RAPS) has unveiled the details of its inaugural European regulatory conference, RAPS Regulatory Conference-Europe 2019.
Orion Corporation and Bayer have announced the submission of a marketing authorization application to the EMA for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer.
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.