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GLG News by Physicians who Treat Neuropathy (US)

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February 11, 2008
Right data, wrong interpretation?
Analysis of: Diabetes Study Partially Halted After Deaths | www.nytimes.com
Author: GLG Expert Contributor
That more people died in the "tight" control group is true, but was it tight control that was responsible or could it have been the means by which it was controlled?  It was not rosigitazone (Avandia) or hypoglycemia responsible for the deaths, according to the articles (the scientific article...
Joseph BassFebruary 8, 2008
Warning on A1C Targets and Diabetes Death in ACCORD Trial
Analysis of: Hault of ACCORD Study Intensive Treatment Arm | www.nhlbi.nih.gov
Author: Joseph Bass, Division Head of Endocrinology and Metabolism, Evanston Northwestern Healthcare
Increased death from intensive A1C lowering in diabetic subjects raises new concerns about diabetes therapy, insulin use in combination with oral agents, and clinical biomarkers of disease complications.
Joseph BassFebruary 5, 2008
Predicting Winners in Oral Diabetes Competition: Galvus, Alogliptin & Januvia
Analysis of: Galvus(R), A New Treatment For Patients With Type 2 Diabetes, Receives European Approval For Label Update Paving The Way For EU Launches | www.pipelinereview.com
Author: Joseph Bass, Division Head of Endocrinology and Metabolism, Evanston Northwestern Healthcare
Oral therapies improve complianceEU approval of Galvus does not erase US doubts
Daniel WynnFebruary 4, 2008
SILENOR -- A Sleeper among Hypnotics
Analysis of: Somaxon Pharmaceuticals Submits New Drug Application For SILENOR(TM) For The Treatment Of Insomnia | www.pipelinereview.com
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.
Somaxon Pharmaceuticals has submitted a NDA for Silenor for the treatment of insomnia.  The active ingredient is doxepin, which has been available for years.The effect of the drug can be expected to be very modest, side effects unfavorable when compared to Ambien or Lunesta, and with both significant...
February 4, 2008
Galvus Receives Approval, But A Larger Battle Remains
Analysis of: Galvus(R), A New Treatment For Patients With Type 2 Diabetes, Receives European Approval For Label Update Paving The Way For EU Launches | www.pipelinereview.com
Author: GLG Expert Contributor
Galvus receives European approval, but has significant barriers for prescribing. This places Galvus significantly behind Januvia as a diabetes treatment option
February 4, 2008
Stay Alert for Registration Trial Results
Analysis of: Denosumab Osteoporosis Study Met Primary and All Secondary Bone Mineral Density Endpoints in a Head-to-Head Comparison with Weekly Alendronate (FOSAMAX(R)) | www.pipelinereview.com
Author: GLG Expert Contributor
After the many false hopes raised using surrogate markers, we certainly want to wait for definitive end-point trial results involving fracture rate and possible long-term side effects.  However the 40% greater increase in BMD compared to the standard of bisphosphonate therapy is quite exciting. ...
Daniel WynnJanuary 18, 2008
Major Win For Glaxo with Xenoport for Restless Legs syndrome -- Next Blockbuster?
Analysis of: GlaxoSmithKline and XenoPort report positive top-line results of second phase 3 restless legs syndrome trial for XP13512/GSK1838262 | www.pipelinereview.com
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.
Xenoport's trial for XP13512 in restless legs syndrome (RLS) shows strongly positive 9 month data in second phase 3  trial, should be a major win in the marketplace.  RLS represent a major unmet need, for drugs with sustained efficacy and high tolerability.
January 18, 2008
Outsourcing of compassionate use of drugs?
Analysis of: No right to experimental drugs for dying patients: Supreme Court | news.yahoo.com
Author: Dan Streja, Clinical Professor of Medicine, University of California, Los Angeles
The Supreme Court has rejected the use of experimental drugs by the dying patients on the grounds that "The framers (of the US constitution) understood that the pursuit of life is an inalienable right that should not be abridged without due process of law." Over the years our patients with terminal...
January 14, 2008
Major Boon for Diabetes Companies, if only...
Analysis of: Diabetes legislation proposed | www.bizjournals.com
Author: GLG Expert Contributor
Diabesity is pandemic, too late diagnosed, too little treated.  ADA recommendations for screening with fasting blood sugars result in relatively late diagnoses since the FBS doesn't usually rise until the disease has been present for several years. 
Joseph BassJanuary 9, 2008
Alogliptin on the diabetes horizon.
Analysis of: Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S. | www.pipelinereview.com
Author: Joseph Bass, Division Head of Endocrinology and Metabolism, Evanston Northwestern Healthcare
Diabetes is on the rise globallyExisting oral therapeutics have significant drawbacks but are cheap (generic) and some have been in use for many years.

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