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PTC Therapeutics, Inc.

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Latest From PTC Therapeutics, Inc.

First Nasal Adrenaline Spray Among 10 Products Heading For EU-Wide Approval

The June meeting of the European Medicines Agency's human medicines committee brought mixed fortunes for companies. 10 new products were recommended for pan-EU approval, two drugs were rejected, while the conditional approval of one drug is set to be revoked. PTC Therapeutics again faced disappointment regarding its Duchenne muscular dystrophy drug Translarna, but has vowed to fight back.

Europe Drug Review

US Rejected Drug Odronextamab Among 11 EU Marketing Hopefuls

Regeneron, whose blood cancer treatment odronextamab was recently turned down by the US regulator but not for reasons relating to efficacy or safety, could soon learn whether its product will be among the drugs to get the thumbs up from the CHMP, the European Medicines Agency’s human medicines committee.

Europe Drug Review

First Drug Treatment For Myopia Among 14 New EU Filings

Vyluma’s eyedrop for treating myopia in children and Vertex’s next-generation triple combination treatment for cystic fibrosis are among the latest drugs that the European Medicines Agency has begun reviewing for potential EU marketing approval.

Europe Drug Review

New Promise, Looming Competition For DMD In China

With several new drugs progressing for the estimated 70,000 patients in China with DMD, a recent setback for Nippon Shinyaku's contender and progress for Chinese gene therapy developers are adding both uncertainty and likely competition in an untapped market with pressing medical need.

China Clinical Trials
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