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December 19, 2012
16:12 EDTGSK, FOLDAmicus Theraputics and GlaxoSmithKline report results from Phase 3 Fabry study
Amicus Therapeutics (FOLD) and GlaxoSmithKline (GSK) announced the 6-month primary treatment period results from the first Phase 3 global registration study of investigational oral migalastat HCl monotherapy in males and females with Fabry disease who had genetic mutations identified as amenable to migalastat HCl in a cell-based assay. The pre-designated primary endpoint was the number of patients who demonstrated a 50% or greater reduction in kidney interstitial capillary globotriaosylceramide-3 after 6 months of treatment with migalastat HCl compared to placebo. 13/32 (41%) in the migalastat HCl treatment group achieved the endpoint versus 9/32 (28%) in the placebo group. This difference did not achieve statistical significance. A pre-specified secondary analysis assessing the absolute percent change in kidney interstitial capillary GL-3 from baseline to month 6 showed a median reduction of 41% in the migalastat HCl group versus a median reduction of 6% in the placebo group. To date, no drug-related serious adverse events have been observed.
News For FOLD;GSK From The Last 14 Days
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November 24, 2015
11:16 EDTGSKAdaptimmune initiates Phase I/II trial of affinity enhanced T-cell therapy
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November 23, 2015
08:08 EDTGSKIdera Pharmaceuticals announces partnership with GSK
Idera Pharmaceuticals (IDRA) announced it has entered into an exclusive worldwide collaboration and license agreement with GSK (GSK) to research, develop and commercialize selected molecules from Idera's 3rd generation antisense platform for the treatment of selected targets in renal disease. Under the terms of the agreement, Idera is eligible to receive approximately $100M in development and regulatory milestone payments, including a $2.5M upfront payment. Additionally, Idera is eligible to receive royalties on all sales upon commercialization at varying rates up to five percent on annual net sales in excess of $500M.
November 19, 2015
07:34 EDTFOLDGoldman Sachs to hold a conference
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November 18, 2015
08:11 EDTGSKIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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