CHMP Again Recommends Against Translarna Renewal
PTC Therapeutics: CHMP Again Recommends Against Translarna Renewal
PTC Therapeutics has suffered another setback in its bid to keep its Duchenne muscular dystrophy drug Translarna on the market in Europe. PTC on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use has once again recommended against renewal of the conditional marketing authorization for Translarna.
CHMP Maintains Negative Opinion on Translarna™ Reexamination
PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has maintained its negative opinion on the renewal of the conditional marketing authorization of Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne Muscular Dystrophy (nmDMD) following re-examination.
After hitting a wall with the FDA last year, Novo Nordisk has picked up backing from European drug reviewers for its novel ...
EMA re-confirms non-renewal of conditional marketing authorisation of Duchenne muscular dystrophy medicine, Translarna: Amsterdam, The Netherlands Monday, October 21, 2024, 10:00 ...
European regulators have for the fourth time issued a negative opinion on PTC's Translarna. Elsewhere, Amylyx read out data ...
It is a disease for which very few treatment options are available. Translarna was authorized in the European Union in 2014 ...
In draft guidance published on Friday, it emerged NICE does not recommend PTC Therapeutics’ Translarna (ataluren) for the treatment of Duchenne muscular dystrophy (DMD) caused by a nonsense ...
Last week’s significant news included Denmark-based CNS drugmaker Lundbeck reaching agreement to acquire US firm Longboard ...
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