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News Breaks
December 19, 2012
16:12 EDTFOLD, GSKAmicus 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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October 20, 2014
09:09 EDTGSKEMA encourages applications for orphan designation for Ebola treatments
The European Medicines Agency encourages developers of treatments or vaccines against Ebola to apply for orphan designation. Applications for orphan designation of Ebola medicines will be treated as a priority and EMA has committed to fast-tracking their evaluation, the regulator announced. Drug companies that are working on experimental Ebola vaccines and treatments include Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX), NewLink Genetics (NLNK) and GlaxoSmithKline (GSK).
07:19 EDTGSKIBC Life Sciences to hold a conference
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07:10 EDTFOLDAmerican Society of Human Genetics to hold annual meeting
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October 19, 2014
19:46 EDTFOLDAmicus announces additional positive data from from Fabry monotherapy study
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October 17, 2014
14:50 EDTGSKBARDA asks labs to ramp up Zmapp production, Reuters says
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11:17 EDTGSKGSK says Ebola vaccine too late for current epidemic, BBC reports
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October 14, 2014
13:09 EDTGSKGlaxoSmithKline seeks binding bids for mature drugs, Reuters reports
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11:23 EDTGSKBIND Therapeutics and The Conference Forum hold a conference
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11:19 EDTGSKNIH says several potential Ebola treatments under development
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10:10 EDTGSKNIH director says supporting BioCryst, Chimerix Ebola treatments
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October 13, 2014
07:12 EDTGSKOligonucleotide Therapeutics Society to hold annual meeting
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October 9, 2014
07:02 EDTGSKIsis Pharmaceuticals receives $18M milestone payment from GlaxoSmithKline
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October 8, 2014
15:03 EDTFOLDUCLA researchers report positive results in mouse model of Parkinsonís
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06:11 EDTGSKNovartis says expects three executive committee members to leave
Novartis (NVS) confirmed that following completion of the transactions with GlaxoSmithKline (GSK) and Eli Lilly and Company (LLY) in the coming months, that the three business leaders of the Novartis divisions at the center of the transaction will leave the Executive Committee of Novartis. The expected changes to the ECN are subject to the closing of the transactions announced on April 22 - Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with Eli Lilly for its Animal Health Business to close in the first quarter of 2015. George Gunn, currently Division Head, Novartis Animal Health, will reach his contractual retirement age in July 2015 and will retire from Novartis. Upon closing of the Animal Health transaction with Lilly he will leave the ECN. Brian McNamara, currently Division Head, Novartis OTC, will transition to GSK as Head of Americas and Europe for the consumer health businesses, reporting to the President of GSK Consumer Healthcare, effective at closing of the transaction. Andrin Oswald, currently Division Head, Novartis Vaccines, will be leaving Novartis to pursue other opportunities following closing of the transaction with GSK.

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