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Not Another mGluR Drug: The Competition Is On.

January 9, 2008

Pfizer and Taisho Finalize Agreement for Novel Schizophrenia Drug Candidate | www.pipelinereview.com

Pfizer Inc (NYSE:PFE) and Taisho Pharmaceutical Co., Ltd. (OTC:TSOPF.PK) announced the signing of a definitive agreement for worldwide collaboration to research, develop and commercialize TS-032.   TS-032 is a metabotropic glutamate receptor (mGluR) agonist, a novel drug candidate for the treatment of schizophrenia.  This represents the third mGluR drug in development for schizophrenia to enter the spotlight in a very short period of time.

Merck’s Agreement With Addex To Develop ADX63365: Eli Lilly May Have Competition In Groundbreaking Glutamate-Based Treatment of Schizophrenia.

January 8, 2008

Addex and Merck & Co., Inc. Enter License Agreement to Develop a Drug Candidate for Schizophrenia | www.pipelinereview.com

Addex Pharmaceuticals (Swiss:ADXN.SW) announced on January 3, 2008 an exclusive worldwide license agreement with Merck & Co., Inc. (NYSE:MRK) to develop ADX63365, a potent and selective positive allosteric modulator of the metabotropic glutamate receptor subtype 5 (mGluR5) with potential for the treatment of schizophrenia.

EPIX Pharmaceuticals’ PRX-03140 Demonstrates Short-Term Pro-cognitive Effects In Patients With Alzheimer’s Disease, Longer Studies Are Needed To Evaluate It’s Potential Disease Modifying Effects.

December 21, 2007

EPIX Pharmaceuticals Reports Compelling Clinical Results for PRX-03140 in Alzheimer's Disease | www.pipelinereview.com

1. The results of this study demonstrtae a treatment in development, PRX-03140, which may provide stronger pro-cognitive effects than those currently available for Alzheimer's disease. 2. PRX-03140 may be a disease altering alternative to other treatments currently in development. 3. The mechanism of action of PRX-03140 is very unique in the treatment of Alzheimer's disease.

Does The FDA Acceptance of The NDA for Asenapine Signal A Good Outlook for Schering-Plough (NYSE: SGP)?

December 7, 2007

Schering-Plough Announces Asenapine NDA Accepted for Filing by the U.S. FDA | www.pipelinereview.com

On November 26 Schering-Plough Corporation (NYSE: SGP) announced the acceptance of the New Drug Application (NDA) for asenapine by the U.S. Food and Drug Administration (FDA). Schering-Plough is seeking marketing approval from the FDA for the treatment of schizophrenia and acute mania or mixed episodes associated with Bipolar I Disorder. On the basis of recent positive data, which the company believes confirms asenapine’s benefits, this recent announcement signals Schering-Plough’s confidence they will receive a positive review from the FDA. However, does this data really warrant such confidence?

An Assessment of The Preliminary Top Line Results for The Phase II-B RGH-188 Treatmen Trial In Schizophrenia

October 19, 2007

Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Schizophrenia | www.pipelinereview.com

Forest Laboratories, Inc (NYSE:FRX) and Gedeon Richter announced preliminary top line results from a Phase II-B ranomized, double-blind placebo-controlled, 6 week study of RGH-188 for the acute treatment of schizophrenia in 389 patients. These results have prompted the companies to announce their intentions to continue development of RHG-188, but is this assessment of the preliminary results too optimistic?

LY2140023: Eli Lilly’s Investigational Antipsychotic Already Shows Promise And There Be More Good News To Come.

October 9, 2007

Investigational Agent Targeting Metabotropic Glutamate 2/3 Receptors Demonstrates Antipsychotic Activity in Humans, Study in Nature Medicine Finds | www.pipelinereview.com

The announcement of Eli Lilly’s (NYS:LLY) successful proof of concept study with LY2140023 in patients with schizophrenia represents a new milestone in the pharmacological treatment of schizophrenia and related psychotic disorders. Not since the introduction of thorazine or risperidone have we witnessed such a significant advance in the treatment of schizophrenia. To date, all treatments have been based on the blockade of dopamine activity at D2 receptors with additional activity at serotonin 5HT2 receptor for the newer generation antipsychotic medications. However, the field has been aware of the involvement of glutamate in the development of schizophrenia for years and LY2140023 represents the first successful large scale test of a monotherapeutic treatment approach based on this neurochemical.

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