Santhera submits marketing authorisation application for vamorolone
The anti-inflammatory treatment is for Duchenne muscular dystrophy
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Tag: Santhera
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
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EMA validates Santhera’s Puldysa MAA
Santhera expects an opinion by the CHMP around mid 2020.
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MHRA renews EAMS scientific opinion for Puldysa in DMD
The drug has been available in the UK through EAMS since June 2017.
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Santhera’s Syros succesful in DMD study
Santhera Pharmaceuticals has announced results from its Syros DMD study.
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Santhera’s cystic fibrosis drug POL6014 in line for orphan status
Santhera says its experimental cystic fibrosis drug POL6014 is likely to be designated an orphan drug in the next 30 days, putting the firm in line to receive regulatory and financial incentives for its further development.
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Early access to Santhera’s DMD therapy Raxone extended in the UK
UK regulators have renewed the scientific opinion for Santhera’s Raxone, extending its availability to patients with Duchenne muscular dystrophy (DMD) through the Early Access to Medicines Scheme (EAMS) for another year.
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Santhera’s Raxone fails in MS trial
Santhera has been hit with more bad news regarding its flagship mitochondrial disease therapy idebenone, after it failed to hit targets in a trial assessing its potential in multiple sclerosis.
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EU advisors reject Santhera’s Raxone for muscular dystrophy
Santhera’s attempt to win approval for Raxone as a treatment for Duchenne Muscular Dystrophy (DMD) in Europe has hit a giant setback after receiving a negative opinion from European Medicines Agency advisors.
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DMD patients in the UK win early access to Santhera’s Raxone
Santhera Pharmaceuticals’ Raxone has become the first drug for Duchenne Muscular Dystrophy (DMD) to join the UK’s Early Access to Medicines Scheme (EAMS).
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Three new medicines cleared for use by NHS Scotland
The Scottish Medicines Consortium has endorsed three medicines for routine use by NHS Scotland, offering new options to treat a rare eye disease, lupus and infertility.
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EU regulators review Santhera’s Raxone for Duchenne
European regulators have validated Santhera’s marketing application for Raxone as a treatment for certain patients with Duchenne muscular dystrophy.
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