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| Article 1 to 10 out of 26 concerning Santhera Pharmaceuticals AG
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Santhera's Omigapil Receives Orphan Drug Designation from FDA and EMEA
(18 Aug 2008)
Santhera Pharmaceuticals announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to SNT-317/omigapil for treatment of Congenital Muscular Dystrophy. This severe, genetically determined neuromuscular condition ...
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Santhera Provides Update on Clinical/Regulatory Processes with SNT-MC17/Idebenone for the Treatment of Friedreich's Ataxia
(12 Aug 2008)
Santhera Pharmaceuticals gave an update on the clinical and regulatory processes surrounding the commercialization of SNT-MC17/idebenone for the treatment of Friedreich's Ataxia. The Company requested reexamination of the negative opinion by the ...
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Santhera Starts Phase IIb Clinical Trial with JP-1730 in Dyskinesia in Parkinson's Disease
(12 Nov 2007)
Santhera Pharmaceuticals and Juvantia Pharma Ltd announced that the first patient has been enrolled into a Phase IIb clinical trial to evaluate JP-1730 (INN: fipamezole) for the treatment of Dyskinesia in Parkinson's Disease (DPD). The study is ...
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Santhera Reports Encouraging, First Data from Phase IIa Clinical Trial with SNT-MC17 in Duchenne Muscular Dystrophy
(01 Nov 2007)
Santhera Pharmaceuticals announced positive, first results from a 12 month Phase IIa clinical trial with SNT-MC17 (INN: idebenone) in Duchenne Muscular Dystrophy (DMD) as measured by cardiac and respiratory parameters. Santhera therefore is ...
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Santhera's CSO Thomas Meier Receives BioValley Award for Scientific and Entrepreneurial Merits
(25 Oct 2007)
Santhera Pharmaceuticals announced that Thomas Meier, Chief Scientific Officer of Santhera, has been honored with the prestigious BioValley Basel Award 2007 "s'Goldig Läggerli" for his contributions to the greater Basel area, his merits in advancing ...
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Swissmedic accepts Santhera's filing of SNT-MC17 in Friedreich's Ataxia
(05 Oct 2007)
Santhera Pharmaceuticals and Takeda Pharma AG announced that Swissmedic has accepted the filing of an application for authorization for Santhera's lead compound SNT-MC17 for the treatment of Friedreich's Ataxia (FRDA). SNT-MC17 has shown clinical ...
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Santhera: Start of US phase III clinical trial with SNT-MC17
(01 Oct 2007)
Fast-track designation granted by FDA.
Santhera Pharmaceuticals announced that it has reached an agreement with the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure relating to the Phase III clinical trial to evaluate SNT-MC17 (INN: idebenone) ...
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Santhera to Seek Canadian Market Approval for SNT-MC17 in Friedreich's Ataxia
(24 Sep 2007)
Santhera Pharmaceuticals announces that, with the recent positive decision from Health Canada on eligibility, the Company will file a New Drug Submission (NDS) for SNT-MC17 (INN: idebenone) for the treatment of Friedreich's Ataxia (FRDA). The ...
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European EMEA acceptance of Marketing Authorization Application filing for SNT-MC17 in Friedreich's Ataxia by Santhera
(20 Aug 2007)
Santhera Pharmaceuticals and Takeda Pharmaceutical Company Limited (TSE:4502, "Takeda"), jointly announced that the European Medicines Agency (EMEA) has accepted the filing of the Marketing Authorization Application (MAA) for Santhera's lead ...
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Santhera and Takeda Extend European Marketing Collaboration for SNT-MC17 into Duchenne Muscular Dystrophy
(06 Aug 2007)
Santhera Pharmaceuticals and Takeda Pharmaceutical Company Limited announced they have extended their existing commercialization partnership for SNT-MC17 (INN: idebenone) in the European Union and Switzerland to cover the compound's second ...
Additional information
Santhera Pharmaceuticals AG
Liestal, Switzerland
Company
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