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GLG News by Neurologists who Treat Neuromuscular Disorders (US)

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December 1, 2008
Miami Site May Succeed in Quick Recruitment of a Study Population
Analysis of: Miami Jewish Home and Hospital, Berma Research Group and Segal Institute for Clinical Research Enrolling Local Patients in Study of Investigational Therapy to Treat Alzheimer's Disease | pharmalive.com
Author: GLG Expert Contributor
The CONNECTION study is important in that Dimebon has a mode of action different from all other current treatments. If the results of the phase II study are corroborated, Dimebon may be an important, additional treatment modality.
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...
November 10, 2008
Wild speculation
Analysis of: Autism linked with rainfall in study | www.boston.com
Author: GLG Expert Contributor
I do not believe that any conclusions can be drawn from these data unless they can be confirmed by a larger, more wide ranging population sampling.
November 4, 2008
Vimpat approved ONLY for adjunctive therapy of epilepsy
Analysis of: UCB's Vimpat(R) approved by U.S. FDA as adjunctive therapy for partial onset seizures in adults | www.pipelinereview.com
Author: GLG Expert Contributor
Vimpat was developed to have applicability to other disease processes including neuropathic pain. The limited indication approved for Vimpat suggests the data for other potential uses was not very robust (that had been my observation based on the neuropathic pain studies). Although UCB may be developing...
November 3, 2008
UCB's Vimpat (lacosamide) receives FDA approval
Analysis of: UCB's Vimpat(R) approved by U.S. FDA as adjunctive therapy for partial onset seizures in adults | www.pipelinereview.com
Author: GLG Expert Contributor
FDA has approved lacosamide for add-on therapy of partial onset seizures.  It will be marketed by UCB under the brand name Vimpat.
September 2, 2008
Azilect
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 is a well conceived study and totally convincing
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.
February 21, 2008
More than just AVASTIN
Analysis of: Genentech has billions at stake in FDA battle | sanfrancisco.bizjournals.com
Author: GLG Expert Contributor
Genentech will have more battles to fight in the future aside from Avastin.  This medication appears extremely promising for the treatment of breast cancer, however, physicians are still mixed in their opinions about its place in the treatment of breast cancer.

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