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GLG News by Psychiatrists

Analysis of: Memory Pharmaceuticals & Roche Expand Development Program for MEM 3454 in Schizophrenia (www.pipelinereview.com)
The focus of Memory Pharmaceuticals & Roche Expansion of their Development Program for MEM 3454 in schizophrenia is symptomatic of a trend in schizophrenia research that has identified cognitive deficits as the fundamental abnormality in brain functioning.  It is an eminently reasonable...
Louis Sanfilippo, MD, President
Louis Sanfilippo, MD, President
LCS Group, LLC
Analysis of: Lundbeck further strengthens pipeline by moving Lu AA34893 into clinical phase II (www.pipelinereview.com)
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...
Analysis of: Memory Pharmaceuticals & Roche Expand Development Program for MEM 3454 in Schizophrenia (www.pipelinereview.com)
This article is showing a promising developmental stage for MEM 3454 undertaken by Memory Pharmaceuticals and will be funded by Roche. MEM 3454 has already received positive outcome from a clinical trial in 2007 by the Memory Pharmaceuticals to improve cognitive abilities of Alzheimers patients. To...
Analysis of: Genentech has billions at stake in FDA battle (sanfrancisco.bizjournals.com)
The brief article is providing an overview of Avastin's future for the treatment of breast cancer. Despite the 'waiting stage' to hear from FDA, physicians are already prescribing it on the ground of 'Compendia listing' status, which is based mainly on clinical trial data. Such an advance stage for...
Analysis of: NRDL Announces Second Drug Development Agreement with Eli Lilly and Company (www.pipelinereview.com)
The news is showing increasing efforts to develop drugs for multiple therapeutic areas from two companies, thereby equalizing risks and rewards associated with drug development and marketing, with additional aim of strengthening the capabilities of pharmaceutical companies. This is a good sign for...
Louis Sanfilippo, MD, President
Louis Sanfilippo, MD, President
LCS Group, LLC
Analysis of: Indication Expansion: Opportunities for successful lifecycle management (www.pipelinereview.com)
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.      ...
Analysis of: AP IMPACT: FDA faults drug plants (seattlepi.nwsource.com)
Quality is critical in human pharmaceutical processes from research and development through to manufacturing and commercialization of pharmaceuticals for human consumption. Slippage in quality norms may reflect an underlying shift in culture within an organization.  FDA compliance and inspectional...
Analysis of: FDA Advisory Committee Supports Efficacy and Safety of Zyprexa (www.fiercebiotech.com)
Long-acting neuroleptics are extremely beneficial in treatment of non-compliant chronically mentally ill because it allows more medical oversight and assurance of compliance with pharmacotherapy.  Olanzapine is a particularly bad atypical (new generation) neuroleptic when it comes to weight gain...
Analysis of: FDA Agrees To Review Cimzia(R) File For The Treatment Of Rheumatoid Arthritis (www.medicalnewstoday.com)
Cimzia(R) (certolizumab pegol) for the treatment of adult patients with active rheumatoid arthritis (RA) was approved in Switzerland in late 2007 for the treatment of Crohn's disease. The marketing of Cimzia to the European Medicines Agency (EMEA) is also underway. It thus shows a growing interest to...
Analysis of: Lilly Gets Support for Version (online.wsj.com)
Lilly's new Long-Acting Zyprexa will face FDA panel scrutiny and a likely focus of concern will be the sedation problem occurring in some patients soon after injection.  However, this should not be a deal-breaker..given the high degree of efficacy of this medication in schizoprenic (and bipolar...

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