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Tag: clinical trial
GSK hopes big clinical trial can breathe new life into lung drug
2015-08-13 20:06:52| Biotech - Topix.net
GlaxoSmithKline is banking on a major clinical trial to revive its flagging respiratory medicine business, with billions of dollars of sales riding on a positive result. Data from the so-called SUMMIT study, designed to show GSK's Breo can prolong lives of patients with chronic lung disease, are expected as early as next month, nine years after a similar study with GSK's older drug Advair failed by a whisker.
Premarket Biotech Digest: Gilead HIV, Eliquis Trial Errors, Clinical Trial Phases
2015-08-04 07:51:25| Biotech - Topix.net
This may be FDA 101 for some people, but many lay investors may not be aware of the precise details; so I am providing this brief note following the FDA itself. All new drugs and almost all drugs applying for new indications must go through a clinical research where it is tested in human subjects prior to FDA approval.
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errors
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digest
Immunocore And Lilly Announce Immunotherapy-Based Clinical Trial Collaboration In Melanoma
2015-07-01 08:13:50| drugdiscoveryonline Home Page
Immunocore Limited and Eli Lilly and Company recently announced that they have entered into an immunotherapy-based clinical trial collaboration to explore the utility of Immunocore’s lead T-cell receptor based investigational therapeutic, IMCgp100, in combination with Lilly’s galunisertib (LY2157299) and merestinib (LY2801653) for the treatment of melanoma
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Cavion to Present Clinical Trial Data at ASCO
2015-05-29 02:53:23| Logistics - Topix.net
Cavion LLC, a pharmaceutical company developing T-type calcium channel inhibitors for the treatment of solid tumors and neurologic diseases, announced today that Matthias Holdhoff, MD, PhD of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins will present preliminary results from an ongoing multi-site National Cancer Institute Adult Brain Tumor Consortium and Cavion-sponsored Phase 1b clinical trial at the 2015 Annual Meeting of the American Society of Clinical Oncology on June 1. This dose escalation trial, which completed enrollment in November 2014, evaluates the safety and pharmacokinetics of Cavion's novel cancer drug mibefradil when sequentially administered with temozolomide in patients with recurrent high-grade glioma.
Tags: data
present
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clinical
Alnylam files clinical trial application for alpha-1 liver disease, presents data at DDW
2015-05-19 09:30:24| Biotech - Topix.net
Alnylam Pharmaceuticals, Inc. has announced that it has filed a Clinical Trial Application with the U.K. Medicines and Healthcare products Regulatory Agency to initiate a Phase 1/2 clinical trial with ALN-AAT, a subcutaneously administered investigational RNAi therapeutic targeting alpha-1 antitrypsin for the treatment of AAT deficiency-associated liver disease . As per the CTA filing, the intended clinical study of ALN-AAT will be performed in normal healthy volunteers, and, then, in subjects with alpha-1 liver disease.
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application
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trial