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September 18, 2007
Shire Takes Proactive Stance Regarding Daytrana Skin Patches
Analysis of: Shire withdraws some ADHD skin patches | www.reuters.com
Author: Lawrence Ginsberg, President, Red Oak Psychiatry Associates, P. A.
1. Shire has withdrawn patches that had defective patch liners. 2. This defect is not related to safety or efficacy issues. 3. The cost to Shire is less than $10 million.
September 14, 2007
Eli Lilly May Dominate the Antipsychotic Market with LY2140023
Analysis of: Investigational Agent Targeting Metabotropic Glutamate 2/3 Receptors Demonstrates Antipsychotic Activity in Humans, Study in Nature Medicine Finds | www.pipelinereview.com
Author: GLG Expert Contributor
Eli Lilly reported that the prodrug mGluR2/3 agonist LY2140023 met all end points in a randomized, three-armed, double-blind, placebo controlled, 4-week proof-of-concept trial that enrolled schizophrenia patients.
Louis SanfilippoSeptember 13, 2007
The Lundbeck-Takeda Alliance: A Strong CNS IP/Drug Development Platform
Analysis of: Lundbeck and Takeda form Alliance to Develop and Commercialize a Portfolio of Novel Compounds in the US and Japan for the Treatment of Mood and Anxiety Disorders | www.pipelinereview.com
Author: Louis Sanfilippo, President, LCS Group, LLC
Lundbeck’s LUAA21004 and LU24530 are among several drugs licensed to Takeda, the others earlier in development, that may offer unique biological and clinical profiles as compared with existing antidepressants and anti-anxiety drugs. Lundbeck’s platform includes about 6 drugs, covering a potentially...
September 12, 2007
New Potentially Effective Antidepressants to be Marketed by a Potentially Effective Alliance
Analysis of: Lundbeck and Takeda form Alliance to Develop and Commercialize a Portfolio of Novel Compounds in the US and Japan for the Treatment of Mood and Anxiety Disorders | www.pipelinereview.com
Author: Lawrence Ginsberg, President, Red Oak Psychiatry Associates, P. A.
1. Lu AA21004 and Lu AA24530 are two compounds with a great deal of potential and will be co-marketed jointly by Takeda and Lundbeck. 2. Lu AA21004 is the more advanced of the compounds and is currently in phase II development for the treatment of major depression. 3. The compounds potentially address...
September 11, 2007
LY2140023: An Antipsychotic With A New Mechanism of Action
Analysis of: Investigational Agent Targeting Metabotropic Glutamate 2/3 Receptors Demonstrates Antipsychotic Activity in Humans, Study in Nature Medicine Finds | www.pipelinereview.com
Author: Lawrence Ginsberg, President, Red Oak Psychiatry Associates, P. A.
1. LY2140023 is an antipsychotic agent that is a metabotropic glutamate 2/3 receptor agonist. This agent has a new mechanism of action that is efficacious in treating schizophrenia and potentially other neuropsychiatric conditions. 2. LY2140023 in addition to separating from placebo in a statistically...
September 10, 2007
Actelion Has A Non-Sedative-Hypnotic Sleep Aid That Appears Effective and Safe
Analysis of: Actelion Sleep Aid Does Well | online.wsj.com
Author: Lawrence Ginsberg, President, Red Oak Psychiatry Associates, P. A.
1. The Actelion agent (ACT-078573) is not a sedative-hypnotic but is an orexin receptor antagonist. 2. This agent may have a safety and tolerability profile that is better than the sedative-hypnotics. 3. The above implications would make Actelion a prime acquisition for a big-pharma company with a less...
September 10, 2007
Bipolar Disorder in Children: Higher Incidence or More Accurate Diagnosis
Analysis of: Bipolar Disorder Among Kids in U.S. Rising, Study Suggests | online.wsj.com
Author: Lawrence Ginsberg, President, Red Oak Psychiatry Associates, P. A.
1. A recent psychiatric journal reported a higher incidence of bipolar disorders in the pediatric population and a subsequent increase in antipsychotic medication use in children. 2. Assessment tools (bipolar disorder questionnaires) have significantly increased awareness of bipolar disorder symptomatology...
September 5, 2007
Pediatric Bipolar Disorder is an Urgent Public Health Problem
Analysis of: Bipolar Disorder Among Kids in U.S. Rising, Study Suggests | online.wsj.com
Author: GLG Expert Contributor
1. Pediatric bipolar disorder is an urgent public health problem 2. There is added recognition that this can occur in children 3. Very difficult to diagnose-need comprehensive assessment to ensure accurate diagnosis and as importantly not 'overdiagnosing'
September 4, 2007
Vyvanse: Pros and cons
Analysis of: Shire's New ADHD medication, VYVANSE(TM) (lisdexamfetamine dimesylate) Now Available in U.S. Pharmacies Nationwide | www.eurekalert.org
Author: Lawrence Ginsberg, President, Red Oak Psychiatry Associates, P. A.
I am a psychiatrist in private practice in a major metropolitan area that has a diverse population. I offer the following observations based on my clinical post-marketing experience. I have already prescribed Vyvanse to a few hundred patients. My observations: 1. Duration of action: This is a huge issue....
September 3, 2007
Bifeprunox: A Drug Not Approved By The FDA Because It Lacks Efficacy
Analysis of: Wyeth's Schizophrenia Pill Is Rejected by U.S. FDA | www.bloomberg.com
Author: Lawrence Ginsberg, President, Red Oak Psychiatry Associates, P. A.
1. This agent despite a favorable side effect profile lacks efficacy as compared to other antipsychotic agents already approved by the FDA. 2. This is a temporary setback for Wyeth. 3. This in the long run is to Wyeth's advantage as such an agent would have done poorly in a competitive atypical antipsychotic...

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