MHRA extends access to Santhera’s DMD drug via the EAMS
The scientific opinion has been extended for one year while the drug is under regulatory review
Read Moreby Selina McKee | Jun 23, 2020 | News | 0
The scientific opinion has been extended for one year while the drug is under regulatory review
Read Moreby Selina McKee | Dec 23, 2019 | News | 0
Sarepta will receive $1.15 billion upfront and an equity investment
Read Moreby Anna Smith | Feb 8, 2019 | News | 0
Solid Biosciences’ shares have taken a hit after early results from a study of SGT-001 microdystrophin gene transfer for the treatment of Duchenne muscular dystrophy (DMD) fell short.
Read Moreby Selina McKee | Nov 13, 2018 | News | 0
Evox Therapeutics has secured £655,000 in funding from Duchenne UK, to support exploration of its exosome-based therapeutic platform for the condition.
Read Moreby Selina McKee | Jun 28, 2018 | News | 0
Shares in Oxford University spin out Summit Therapeutics have taken a nosedive after the firm’s flagship drug ezutromid failed to hit targets in a mid-stage trial in patients with Duchenne muscular dystrophy (DMD).
Read Moreby Selina McKee | May 4, 2018 | News | 0
Sarepta has indicated a delay to getting its Duchenne muscular dystrophy therapy Exondys approved in Europe, revealing that the European Medicine Agency’s Committee for Medicinal Products for Human Use’s trend vote was negative.
Read Moreby Selina McKee | Oct 26, 2017 | News | 0
PTC Therapeutics will need to carry out at least one further trial to demonstrate the effectiveness of its Duchenne Muscular Dystrophy therapy Translarna if it is to have a chance of bagging its approval in the US.
Read Moreby Selina McKee | Feb 10, 2017 | News | 0
US regulators have issued a green light for Marathon Pharmaceuticals’ Emflaza to treat patients age five years and older with Duchenne muscular dystrophy (DMD), a rare genetic disorder affecting around 15,000 people in the country that causes progressive muscle deterioration and weakness.
Read Moreby Selina McKee | Oct 18, 2016 | News | 0
PTC Therapeutics has been denied its first appeal contesting US regulators’ refusal to accept its marketing application for Translarna as a treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).
Read Moreby Selina McKee | Sep 20, 2016 | News | 0
The US Food and Drug Administration has granted a conditional approval to Sarepta’s Exondys 51, the first drug cleared to treat patients with Duchenne muscular dystrophy (DMD).
Read Moreby Selina McKee | Jul 8, 2016 | News | 0
Children in England suffering from a rare form of muscular dystrophy will soon be able to access the only drug licensed for their condition after a ground-breaking agreement was reached between NHS England and PTC Therapeutics.
Read Moreby Selina McKee | Jun 22, 2016 | News | 0
European regulators have validated Santhera’s marketing application for Raxone as a treatment for certain patients with Duchenne muscular dystrophy.
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