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GLG News by QT Interval Prolongation Experts (US)

Evan Siegel, MPhil, PhD, Adjunct Professor
University of Queensland
Analysis of: FDA Removes Partial Hold on TELCYTA Clinical Development (www.prnewswire.com)
This announcement indicates that clinical development can now proceed under the IND for all outstanding and recently submitted protocols. It does not mean that the initial reason for clinical hold has been fully satisfied throughout the rest of the clinical development program. That will be dtermined...
Evan Siegel, MPhil, PhD, Adjunct Professor
University of Queensland
Analysis of: Pfizer Abandons Exubera, Posts 77% Earnings Decline (online.wsj.com)
The user-friendly and health care provider comfort aspects of an product with otherwise proven safety and efficacy must be considered when deciding how, when, and in what manner to develop f drug product. Despite the desirability of a non-injectibel insulin, the inhaled route of administration and...
Analysis of: Pfizer Abandons Exubera, Posts 77% Earnings Decline (online.wsj.com)
Ask any patient with diabetes what they want for a therapeutic option and they'll tell you non-injectable insulin.  They understand that all the other medications are a poor substitution for the replacement of pancreatic insulin and they are tired of taking multiple pills each day. So why did...
Analysis of: Enrollment Reaches 110 Patients In Investigator Initiated, Randomized Trial Of OrbusNeich's Genous(TM) Bio-Engineered R Stent(TM) (www.medicalnewstoday.com)
The failure of drug eluting stents in the eyes of the public and in the medical community is probably not a failure of the device as much as a failure of patient managment.  It is clear that atherothrombotic vascular disease requires a life-long commitment to blood pressure, cholesterol, and blood...
Analysis of: Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Schizophrenia (www.pipelinereview.com:80)
Forest Laboratories, Inc (NYSE:FRX) and Gedeon Richter announced preliminary top line results from a Phase II-B ranomized, double-blind placebo-controlled, 6 week study of RGH-188 for the acute treatment of schizophrenia in 389 patients. These results have prompted the companies to announce their intentions...
Eric Gruff, PhD MBA, Principal
Eric Gruff, PhD MBA, Principal
E4 Consulting
Analysis of: Generic Drugs: Dangerous Differences? (abcnews.go.com)
A recent study by ConsumerLab.com suggests that some generic versions of pharmaceutical products may not be bioequivalent to their brand name counterparts. The difference seems to be in the release rates for extended-release (ER) dosage forms as determined by in vitro ("test tube") analysis of...
Analysis of: ThromboGenics and BioInvent Announce Successful Completion of Phase I Clinical Trial of the Anticoagulant TB-402 (www.pipelinereview.com)
The IDEAL anticoagulant is: 1. Efficacious - Prevents thrombosis 2. Safe - Low risk of bleeding 3. Titratable - Offers predictable, adjustable, therapeutic effect tailorable to individual patient needs 4. Reversible - Can be actively TURNED OFF if/when necessary (or "dialed down") 5. Convenient - Bolus...
Eric Gruff, PhD MBA, Principal
Eric Gruff, PhD MBA, Principal
E4 Consulting
Analysis of: Wyeth Pharmaceuticals Acquires Haptogen Ltd. to Boost Biotechnology Drug Discovery (www.pipelinereview.com)
Wyeth's acquisition of Haptogen, a Scottish biotechnology company specializing in novel protein-based therapeutics, is a promising development for Wyeth's biotechnology pipeline. This is a welcome addition for Wyeth, but the key will be translating the increased pipeline into additional drugs on the...
Analysis of: Investigational Agent Targeting Metabotropic Glutamate 2/3 Receptors Demonstrates Antipsychotic Activity in Humans, Study in Nature Medicine Finds (www.pipelinereview.com)
The announcement of Eli Lilly’s (NYS:LLY) successful proof of concept study with LY2140023 in patients with schizophrenia represents a new milestone in the pharmacological treatment of schizophrenia and related psychotic disorders. Not since the introduction of thorazine or risperidone have we witnessed...
Eric Gruff, PhD MBA, Principal
Eric Gruff, PhD MBA, Principal
E4 Consulting
Analysis of: Microsoft launches Web site to hold medical records (uk.reuters.com)
Microsoft's HealthVault will store medical information in an encrypted database available via the Web. In addition, there will be access to health information available to the public. Putting secured health data online seems like a great idea provided that personal information remains out of reach of...

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