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February 19, 2019
In a deal worth $530 million, the companies will develop and commercialize an anti-epileptic drug candidate in Europe.
February 15, 2019
A taskforce evaluated the advantage of using Big Data in the evaluation of the benefits versus risks of medications.
The guidance explains the process of applying for competitive generic therapy designation.
The drug is approved in the United States specifically for treating acquired thrombotic thrombocytopenic purpura, a rare blood-clotting disorder.
The approval expands use of the drug, Egaten (triclabendazole), which has been by the WHO since 2005 for treating liver fluke infestation.
The approval expands the indications for Sprycel (dasatinib) in Europe.
February 14, 2019
Zogenix has submitted an NDA to the US Food and Drug Administration and an MAA to the European Medicines Agency for FINTEPLA.
February 06, 2019
The agency recommended six medicines for approval at its January 2019 meeting, including treatments for lung cancer, HIV-1, and autoimmune disorders.
February 02, 2019
Robotic isolators and single-use technologies are gaining ground, according to aseptic processing consultant Jim Agalloco.
The market for biosimilars in Europe remains consistently robust, with 16 new biosimilars approved in 2018.