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February 10, 2014
08:31 EDTSRPTSarepta reports results from Phase 1 study of Marburg drug candidate
Sarepta Therapeutics announced positive safety results from a Phase I multiple ascending dose study of AVI-7288 in healthy volunteers. AVI-7288, which uses Sarepta’s advanced and proprietary PMOplus chemistry, is the company’s lead drug candidate for the treatment of Marburg virus infection. Sarepta has been developing AVI-7288 under a Department of Defense contract managed by the Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office. The Phase I clinical study was a randomized, double-blind, placebo-controlled trial that enrolled 40 healthy adult volunteers, and was designed to characterize the safety, tolerability and pharmacokinetics of AVI-7288 after daily repeat dosing. In each of five cohorts, six subjects received AVI-7288 and two subjects received placebo, daily for 14 days. Results showed that AVI-7288 was well tolerated through the highest dose tested, 16 mg/kg per day, which is higher than the anticipated therapeutic dose, with no reported serious or clinically significant adverse events. An independent Data and Safety Monitoring Board reviewed blinded safety results from the study and recommended continued clinical development of AVI-7288.
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October 27, 2014
10:00 EDTSRPTSarepta approval still expected, says Needham
Needham said the FDA's request for additional data for Sarepta's NDA Duchenne muscular dystrophy treatment is a setback but the firm ultimately expects approval.
09:14 EDTSRPTOn The Fly: Pre-market Movers
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09:07 EDTSRPTFDA decision 'a major stumble' for Sarepta, says Roth Capital
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09:02 EDTSRPTProsensa may benefit most from Sarepta news, says Roth Capital
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08:50 EDTSRPTProsensa up 16% after FDA requires additional data from Sarepta
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07:48 EDTSRPTSarepta to host conference call
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07:27 EDTSRPTYoung NYC boy tested for Ebola, NY Post reports
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07:05 EDTSRPTSarepta says additional data now required for NDA submission for eteplirsen
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October 26, 2014
14:40 EDTSRPTFDA issues Emergency Use Authorization for Ebola diagnostic tests
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October 24, 2014
10:55 EDTSRPTDallas nurse now Ebola virus free, to be released, NBC reports
NBC and other media outlets cites NIH on Nina Pham's release. Drug companies that are working on experimental Ebola vaccines or treatments include Peregrine (PPHM), Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX) and NewLink Genetics (NLNK). Some companies that offer protective clothing and waste disposal include Lakeland Industries (LAKE), Alpha Pro Tech (APT) and Sharps Compliance (SMED). Reference Link
October 23, 2014
15:25 EDTSRPTNew York confirms health care worker being tested for Ebola
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14:58 EDTSRPTNew York doctor rushed to hospital with Ebola-like symptoms, NY Post reports
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06:22 EDTSRPTEU to boost Ebola research with EUR 24.4M
The European Commission has today announced EUR 24.4M from the EU budget for urgently needed Ebola research. The funding will go to five projects, ranging from a large-scale clinical trial of a potential vaccine, to testing existing and novel compounds to treat Ebola. The money from Horizon 2020, the EU research and innovation program, will be provided via a fast-track procedure in order to start work as soon as possible. The Commission is also working with industry on the further development of vaccines, drugs and diagnostics for Ebola and other haemorrhagic diseases within the Innovative Medicines Initiative. The funding will be provided following proposals from teams across the EU and in numerous 3rd countries, which were evaluated by an independent group of experts. The Commission has also asked the European and Developing Countries Clinical Trials Partnership to include emerging epidemics of concern to Africa, including Ebola, in its work plan. This will allow to fund clinical trials on drugs, vaccines and diagnostics in upcoming calls. Drug companies that are working on experimental Ebola vaccines or treatments include Peregrine (PPHM), Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX) and NewLink Genetics (NLNK). Some companies that offer protective clothing and waste disposal include Lakeland Industries (LAKE), Alpha Pro Tech (APT) and Sharps Compliance (SMED).
October 22, 2014
06:41 EDTSRPTWHO fast-tracking testing of two Ebola vaccines, Guardian reports
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October 20, 2014
09:09 EDTSRPTEMA 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).
October 19, 2014
16:44 EDTSRPTEbola drug discovery efforts intensify, WSJ says
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13:39 EDTSRPTCarnival cruise passenger tests negative for Ebola, Reuters says
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October 17, 2014
14:50 EDTSRPTBARDA asks labs to ramp up Zmapp production, Reuters says
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09:46 EDTSRPTSarepta soars after publication of Ebola drug candidate data
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09:17 EDTSRPTOn The Fly: Pre-market Movers
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