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Santhera Pharmaceuticals - Articles and news items

duchenne-muscular-dystrophy

Santhera’s Duchenne muscular dystrophy treatment receives Australian orphan drug designation

Industry news / 13 September 2016 / Niamh Louise Marriott, Digital Content Producer

The Australian Therapeutic Goods Administration (TGA) has granted orphan drug designation to Santhera Pharmaceutical’s idebenone (raxone) for the treatment of Duchenne muscular dystrophy (DMD). The product has already received ODD from European, Swiss and US authorities…

dystrophy-fda-grant

FDA grants Santhera $246,000 for muscular dystrophy trial

Industry news / 30 August 2016 / Niamh Louise Marriott, Digital Content Producer

The FDA have granted Santhera an award of $246,000 in support of its ongoing Phase I trial with omigapil (callisto) incongenital muscular dystrophy (CMD)…

raxone

Santhera launches Raxone in its first EU market

Industry news / 2 October 2015 / Victoria White

Raxone is also the first approved treatment for any mitochondrial disease, a therapeutic area which is in the focus of Santhera…

raxone

EC grants marketing authorisation for Raxone in Leber’s Hereditary Optic Neuropathy

Industry news / 9 September 2015 / Victoria White

Raxone is the first approved treatment for Leber’s Hereditary Optic Neuropathy, and for a mitochondrial disease, in the EU…

raxone

CHMP recommends granting marketing authorisation to Raxone for the treatment of Leber’s Hereditary Optic Neuropathy (LHON)

Industry news / 26 June 2015 / Victoria White

CHMP has recommended granting marketing authorisation to Raxone for the treatment of visual impairment in patients with Leber’s Hereditary Optic Neuropathy…

drisapersen

Results from Phase III trial of Raxone/Catena in patients with DMD published

Industry news / 21 April 2015 / Victoria White

Results of the double-blind placebo-controlled Phase III trial demonstrating efficacy and safety of Raxone/Catena in patients with DMD have been published…

 

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