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News Breaks
February 19, 2013
07:08 EDTISIS, GSKIsis Pharmaceuticals initiates Phase 2/3 study of ISIS-TTR Rx
Isis Pharmaceuticals (ISIS) has earned a $7.5M milestone payment from GlaxoSmithKline (GSK) related to the initiation of a Phase 2/3 clinical study for ISIS-TTRRx. ISIS-TTRRx is an antisense drug in development with GlaxoSmithKline for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues. Isis and GSK recently amended the clinical development plan and financial terms relating to ISIS-TTRRx to support this registration-directed Phase 2/3 clinical study on ISIS-TTRRx. The Phase 2/3 study of ISIS-TTRRx is a randomized, double-blinded, placebo-controlled, international study designed to support an application for marketing approval of ISIS-TTRRx in patients with FAP. The fifteen month study will enroll approximately 200 patients randomized 2:1 to receive 300 mg/week of ISIS-TTRRx or placebo and will measure the effects of ISIS-TTRRx on neurological dysfunction and on quality-of-life. The United States Food and Drug administration granted ISIS-TTRRx fast track designation and orphan drug status for the treatment of FAP.
News For ISIS;GSK From The Last 14 Days
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September 19, 2014
05:58 EDTGSKGlaxoSmithKline to pay GBP 297M fine to Chinese government
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September 17, 2014
14:57 EDTGSKProsensa announces commencement of re-dosing of drisapersen
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07:39 EDTGSKMorningstar to hold a conference
Management Behind the Moat Conference to be held in Chicago on September 17-18.
07:29 EDTISISIsis Pharmaceuticals earns $4M from Achaogen for Phase 3 study of plazomicin
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September 16, 2014
07:33 EDTGSKMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
07:31 EDTGSKEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
September 15, 2014
16:10 EDTGSKFive Prime announces option exercise by GlaxoSmithKline to obtain license
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07:27 EDTGSKIBC Life Sciences to hold a conference
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September 10, 2014
09:58 EDTGSKGlaxoSmithKline has a conference call hosted by JPMorgan
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September 9, 2014
06:25 EDTGSKDocuments show DOJ probed GSK China unit in 2012, Reuters says
Internal documents revealed that a U.S. anti-bribery investigation into GlaxoSmithKline (GSK) touched on the firm's Chinese consumer healthcare division two years ago, which infers that the company's compliance issues in the country could be broader than initially discovered, according to Reuters, citing the documents. Reference Link
September 8, 2014
08:48 EDTGSKGilead announces AMBITION study results in collaboration with Glaxo
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September 7, 2014
13:57 EDTGSKGlaxoSmithKline Ebola vaccine works in tests on monkeys, Bloomberg says
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