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GLG News by Neurolgists who Treat PML

Analysis of: Tysabri - Multiple Sclerosis patient with progressive multifocal leukoencephalopathy has died (www.msrc.co.uk)
Out of 4 post-relaunch PML cases announced, the first one has died. This is big news, as the announcement of a death may really make some people think about the drug under much more stark conditions.
Analysis of: Elan, Biogen report 4th case of brain disease in 2008 for MS patient on Tysabri drug (money.cnn.com)
On December 11, a 4th person was identified with PML since the drug relaunch. No clinical details have been provided, although this person received 26 months of treatment and resides in Europe. A total of 7 cases have been identified with inclusion of the 3 in the clinical trials.
Analysis of: Novartis’s Multiple Sclerosis Drug Cuts Relapse Rates (www.bloomberg.com)
FTY720 may be among the first and the most promising oral therapies to arrive on the scene for MS . On December 12, Novartis reported the initial results of the 1-year TRANSFORMS study in relapsing MS. Compared with Avonex, FTY720 reduced relapses by an additional 40-50%. The annual relapse rate...
Analysis of: Study Results: Multiple Sclerosis Patients Have Significant and Sustained Reduction in Disability and Risk Of Relapse On Alemtuzumab Versus Approved Therapy, Rebif(R) (www.marketwatch.com)
Out of a crowded field of new MS therapeutics in phase III study, alemtuzumab has clearly distinguished itself from the rest. Although not a cure, the efficacy is nothing short of jaw-dropping. Most MS therapeutics are pitted against placebo, with a 30-60% reduction in relapse rate compared to taking...
Analysis of: Suspected PML Cases For Biogen, Elan MS Drug Not Alarming (www.djnewsplus.com)
The next generation of MS therapeutics is beginning to emerge, and it appears to be a crowded field of contenders. To be determined over the next several years is how the standard agents will fit with the newer agents, what level of efficacy and/or convenience is needed to balance safety and risk, and...
Daniel Wynn, MD, Director, Clinical Research
Daniel Wynn, MD, Director, Clinical Research
Consultants In Neurology Ltd.
Analysis of: FDA Asks if Pain Pill Is Tamper-Proof (online.wsj.com)
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...
Analysis of: Doctors Say Medication Is Overused in Dementia (www.nytimes.com)
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 Wynn, MD, Director, Clinical Research
Daniel Wynn, MD, Director, Clinical Research
Consultants In Neurology Ltd.
Analysis of: Extavia® approved in E.U for treatment of multiple sclerosis, first in planned portfolio of therapies from Novartis (www.asia-manufacturing.com)
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 Wynn, MD, Director, Clinical Research
Daniel Wynn, MD, Director, Clinical Research
Consultants In Neurology Ltd.
Analysis of: Abbott Scientists Present A New Approach for Treating Attention-Deficit Hyperactivity Disorder (biz.yahoo.com)
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 Wynn, MD, Director, Clinical Research
Daniel Wynn, MD, Director, Clinical Research
Consultants In Neurology Ltd.
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)
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.

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