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GLG News by Physicians who Treat Migraine Headaches (US)

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November 24, 2008
More work needs to be done
Analysis of: FDA Faults Wrinkle Fillers Over Warnings | online.wsj.com
Author: GLG Expert Contributor
Dermal Fillers are a popular and growing procedure that is poorly regulated.  Although problems arise in their administration, it is not clear whether it is due to the product or user technique.  That key difference is essential to quantify before issuing warnings
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...
August 6, 2008
as medicine becomes an expected no cost right it looses value & reimbursement
Analysis of: As Doctors Cater to Looks, Skin Patients Wait | www.nytimes.com
Author: GLG Expert Contributor
With excellent patient satisfaction, ease of use and excellent cash based reimbursement, there is a rapidly growing aesthetic & skin care business to dermatologic practice.  This has clearly impacted access to care by patients with skin disease in my area.  Perhaps a better question is...
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.
May 12, 2008
Sustained-release opioids
Analysis of: New Abbott Study of Investigational Vicodin CR(TM) Meets Primary Efficacy Endpoints in Phase III Trial | www.prnewswire.com
Author: GLG Expert Contributor
The availability of any existing opioid molecule as a sustained-release preparation, eg Vicodin CR, is an advance in pain management.  That being said, however, there is little evidence that the risk of abuse or addiction is less with SR opioids.  In fact, the (usually) higher doses is SR...
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...
January 21, 2008
Excellent posible new addition to Antidepresant trreatment
Analysis of: CeNeRx BioPharma Announces Successful Completion of Phase l Clinical Program for Novel Antidepressant Agent Tyrima(TM) | www.pipelinereview.com
Author: GLG Expert Contributor
I feel that this drug could make a major impact on treatment of depression due to it unique mechanism of action eg increasing all three neurotransmitters without the old side effects of MAOI.

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