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GLG News by Parkinson's Disease Neurologists (US)

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Daniel WynnNovember 17, 2008
"Tamper-Proof" -- A Significant Gain to Whom??
Analysis of: FDA Asks if Pain Pill Is Tamper-Proof | online.wsj.com
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.
Abuse resistant long acting narcotics offer benefit as they are less desirable to those who might wish a quick high via snorting, injecting crushed time-release narcotic. Unfortunately, given the higher cost than long acting generics and increased pressure on physicians to prescribe generics, expect...
September 1, 2008
The Devil Is in the Details
Analysis of: ADAGIO Trial Results Show Teva's AZILECT(R) 1 Mg Tablets Slow Progression Of Parkinson's Disease | www.medicalnewstoday.com
Author: GLG Expert Contributor
This large study shows that PD patients' severity of motor dysfunction is better on rasagiline than on placebo.
June 26, 2008
Arm Chair Analysis from Monday Morning Quarterbacks provides unrealistic expectations and inappropriate rules
Analysis of: Doctors Say Medication Is Overused in Dementia | www.nytimes.com
Author: GLG Expert Contributor
Medications used for realistic indications and with clinically appropriate symptomatic targets are indicated and provide effectiveness that additional staff cannot offer.  Decision making in health care is too often made by those who do not really provide clinical service but provide arm chair...
Daniel WynnJune 5, 2008
Novartis and Multiple Sclerosis: A Major Commitment
Analysis of: Extavia® approved in E.U for treatment of multiple sclerosis, first in planned portfolio of therapies from Novartis | www.asia-manufacturing.com
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.
Extavia, Novartis' brand of  interferon beta 1b, has been approved for the  treatment of multiple sclerosis by the European Union.  With FTY72, Fingolimod, Novartis has the eye on filing NDA by the end of 2009.  While essentially identical to Bayer's Betaferon interferon beta 1b,...
Daniel WynnJune 2, 2008
Abbott's ABT-089 --Much More than a Treatment for ADHD
Analysis of: Abbott Scientists Present A New Approach for Treating Attention-Deficit Hyperactivity Disorder | biz.yahoo.com
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.
The data on ABT-089 in adults has been released with positive results, whereas the adolescent/childhood trial is on-going for this novel compound for ADHD.  The key difference is the potential to improve learning, not simply regain attention and lessen hyperactivity.
Daniel WynnApril 24, 2008
COPAXONE from the START of MS
Analysis of: Teva Seeks Approval for the Extension of its Indication to Include the Treatment of Patients with a First Clinical Event Suggestive of MS | www.pipelinereview.com
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.
Copaxone has become the leading treatment for relapsing remitting MS in the US.  The results of the PRECISE trial will likely add to TEVA's sales momentum and boost sales further.
Daniel WynnFebruary 15, 2008
Win for Talecris' Gamunex IVIG in Inflammatory Polyneuropathy
Analysis of: Positive Results from Phase III Trial of Gamunex in Patients with CIDP | pharmalive.com
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.
Talecris' form of IVIG, Gamunex was studied in the largest trial of IVIG in chronic inflammatory polyradiculoneuropathy (CIDP), with more than twice as many patients moving into remission.  CIDP is a common acquired autoimmune peripheral neuropathy, which if not treated, may lead to a peripheral...
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...
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.
October 30, 2006
FDA approval for severe Alzheimer's disease
Analysis of: Aricept (donepezil) Wins Indication for Severe Alzheimer's | www.medpagetoday.com
Author: GLG Expert Contributor
It is long waited decision. I have been using donepezil for last 4 to 5 years in moderate to severe Alzheimer's disease with good results. Only, I did not have statistical data.

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