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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
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...
June 5, 2008Novartis 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,...
June 2, 2008Abbott'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.
April 24, 2008COPAXONE 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
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.
February 15, 2008Win 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...
February 4, 2008SILENOR -- 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 18, 2008Major 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.
June 11, 2007
effective treatment?
Analysis of: Acorda Therapeutics Begins Second Phase 3 Clinical Trial of Fampridine-SR in Multiple Sclerosis | pharmalive.com
Author: GLG Expert Contributor
Analysis of: Acorda Therapeutics Begins Second Phase 3 Clinical Trial of Fampridine-SR in Multiple Sclerosis | pharmalive.com
Author: GLG Expert Contributor
I am not sure that 4-aminopyridine, a long known drug, will efectively improve walking. As important as the walking ability are other clinical features of MS, e.g. ataxia, dementia or bladder dysfunction. This should also be tested.
June 4, 2007
Urgent need for clinical trials in ALS
Analysis of: Avicena Highlights Key Collaborators in Amyotrophic Lateral Sclerosis (ALS) Dose Escalation Study | pharmalive.com
Author: GLG Expert Contributor
Analysis of: Avicena Highlights Key Collaborators in Amyotrophic Lateral Sclerosis (ALS) Dose Escalation Study | pharmalive.com
Author: GLG Expert Contributor
There is not much information of the drug ALS-02 in the paper. The term neuroprotection is defined not very well and describes a great number of different molecular mechanisms. The low number of patients will not allow implications for clinical efficacy.
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