Europe

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Pharma

EU regulator backs Bayer, GSK drugs, knocks back Novartis, Teva

LONDON (Reuters) – European drugs regulators gave their backing on Friday for marketing approval to be granted for Bayer’s drug Adempas, designed to treat pulmonary hypertension, and for GlaxoSmithKline’s diabetes medicine Eperzan. The regulator also backed a new drug from Dainippon Sumitomo Pharma called Latuda, for the treatment of schizophrenia, and Bemfola, a new biosimilar […]

Pharma

Novartis plans to submit more information on heart failure drug to EU

ZURICH (Reuters) – Novartis said it would ask the European health regulator to look at its heart failure drug serelaxin again after the body took an unfavorable position on it Friday. “Novartis announced today it will shortly submit a revised filing package, including new data analyses, for re-examination for conditional approval of RLX030, or serelaxin,” […]

Devices & Diagnostics

BSX receives CE Mark for deep brain stimulation system as dystonia treatment

Boston Scientific (BSX) announced it has received the CE Mark for its Vercise Deep Brain Stimulation System for the treatment of dystonia, “a neurological movement disorder characterized by involuntary muscle contractions.” Dystonia is the third most common movement disorder after Parkinson’s disease and essential tremor, and more than 500,000 patients in Europe have it, according […]