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March 23, 2017
The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.
March 02, 2017
Efforts to harmonize the fragmented regulatory framework for pharmaceuticals in the European Union continue to be a challenge.
February 24, 2017
The agency’s CHMP recommended six drugs for market approval, including one orphan drug, during its February meeting.
February 15, 2017
The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.
Baricitinib (Olumiant) is the first JAK inhibitor licensed to treat rheumatoid arthritis in Europe.
February 10, 2017
EMA announces that the European Union’s PAS Register has received its 1000th upload.
Pharmaceutical Technology spoke with Tommy Fanning, head of biopharmaceuticals for IDA Ireland, to get a perspective on how Brexit may affect the pharmaceutical industry.
February 02, 2017
Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.
January 27, 2017
The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.
January 19, 2017
The agency published an overview of marketing authorizations made in 2016.