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February 27, 2008
Eli Lilly & Company Develops Novel Antipsychotic for Treating Schizophrenia
Analysis of: Daring to Think Differently About Schizophrenia | www.nytimes.com
Author: GLG Expert Contributor
All currently marketed antipsychotic medications for treating  schizophrenia  rely on mechanisms of action  which target  dopamine and  serotonin receptors.  Although these medications reduce delusions and hallucinations without inducing symptoms of Parkinson's Disease...
Louis SanfilippoFebruary 25, 2008
Lundbeck’s Pipeline Advances with Lu AA34893 for Bipolar Depression
Analysis of: Lundbeck further strengthens pipeline by moving Lu AA34893 into clinical phase II | www.pipelinereview.com
Author: Louis Sanfilippo, President, LCS Group, LLC
Lundbeck’s pipeline has been gathering some real momentum in recent months, having advanced a number of investigational CNS drugs.  The initiation of this 600 person Phase II study of Lu AA34893 in bipolar depression, yet another Lundbeck drug candidate shrouded in some mystery (ie, we know that...
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...
Louis SanfilippoFebruary 12, 2008
Extending The Life of a Branded Drug
Analysis of: Indication Expansion: Opportunities for successful lifecycle management | www.pipelinereview.com
Author: Louis Sanfilippo, President, LCS Group, LLC
New clinical indications add to a drug’s period of FDA market exclusivity (different than patent exclusivity) and is a common strategy used by pharmaceutical companies to generate additional revenue from a drug, in pharmaspeak referred to as creating a “successful lifecycle management” strategy.      ...
Louis SanfilippoFebruary 6, 2008
Somaxon and Silenor, A Win-Lose Situation?
Analysis of: Somaxon Pharmaceuticals Submits New Drug Application For SILENOR(TM) For The Treatment Of Insomnia | www.pipelinereview.com
Author: Louis Sanfilippo, President, LCS Group, LLC
The NDA submission of Somaxon’s Silenor, a reformulation of the tricyclic antidepressant doxepin at very low doses, for the treatment of insomnia is not particularly compelling news clinically.  Low doses of doxepin provide an anti-histamine effect with less norepinephrine or serotonin reuptake...
February 5, 2008
More questions raised than answers
Analysis of: Chantix And Suicide: The Latest Numbers | www.pharmalot.com
Author: GLG Expert Contributor
No good data that Chantix is associated with suicide Need more controlled research to answer questions Scary adverse events are not the same as side effects directly linked to medication
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 29, 2008
How do we like our drug reps? Nothing new here but the reps' problems are increasing.
Analysis of: 19 Percent of Office-Based Physicians Refuse to See Pharmaceutical, Biotech and Medical Device Sales Reps | www.drugs.com
Author: GLG Expert Contributor
This article is important primarily to those companies and reps who do not pay attention.  Doctors are human and will be most pleased to see those reps who comply with the physician's stated needs.  If the days or hours are limited or an appointment required, the reps need to stay within those...
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.
January 18, 2008
Quality or Profit ?
Analysis of: Insurers Stop Paying for Care Linked to Errors | online.wsj.com
Author: GLG Expert Contributor
Patient safety or corporate profits via any excuse for payment ?

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