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

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[January 24, 2014]   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 medicine for the treatment of infertility.

But the European Medicine Agency (EMA) decided against recommending Teva's new multiple sclerosis pill Nerventra, or laquinimod, and recommended rejecting an application from the Swiss drugmaker Novartis to market its heart failure drug serelaxin.

EMA's committee also issued negative opinions for two so-called orphan medicines  Masiviera from France AB Science, intended for the treatment of certain types of advanced pancreatic cancer  and Translarna, from PTC Therapeutics, designed to treat Duchenne muscular dystrophy.

Recommendations for marketing approval by the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

(Reporting by Kate Kelland; editing by Tom Pfeiffer)

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