Look back at pharma news to Oct 21

23 October 2016

By Barbara Obstoj-Cardwell. Editor

PTC Therapeutics is having a tough time convincing regulators on both sides of the Atlantic Ocean to reconsider the marketing application for its Duchenne muscular dystrophy drug Translarna, wrote Adam Feuerstein on The Street.

On Monday, PTC said the US Food and Drug Administration denied an appeal of the Translarna refuse-to-file letter issued last February. In Europe, where PTC is trying to convert a conditional approval of Translarna into a full approval, regulators have requested additional information, citing a "major objection" to the drug's risk-benefit profile, the company said. PTC shares were down 21% to $10.87 in Monday premarket trading.

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