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GLG News by Imitrex Prescribers (US)

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July 31, 2007
BMS/Otsuka’s Abilify: New Target, Huge Market!
Analysis of: ABILIFY(R) (aripiprazole) Supplemental New Drug Application Receives Priority Review by U.S. Food And Drug Administration for Adjunctive Treatment in Adults With Major Depressive Disorder | www.pipelinereview.com
Author: GLG Expert Contributor
The FDA granted BMS/Otsuka a priority review of Abilify as an adjunctive therapy to standard antidepressants in adults with major depressive disorder who failed to respond adequately to one or more antidepressant.
July 30, 2007
Branded drugs have value in epilepsy, but future is unclear
Analysis of: Industry Fights Switch to Generics for Epilepsy | online.wsj.com
Author: GLG Expert Contributor
The epilepsy foundation and major drug manufacturers have teamed up to protect reimbursments for branded anti-epilepsy drugs.
July 30, 2007
Wyeth’s Pristiq: Gone with the Wind
Analysis of: Wyeth Receives Approvable Letter from FDA for PRISTIQ for the Treatment of Vasomotor Symptoms Associated with Menopause | www.pipelinereview.com
Author: GLG Expert Contributor
The FDA surprised Wyeth with an approvable letter for Pristiq for treatment of moderate-to-severe vasomotor symptoms associated with menopause.  The content of the letter sent investors to the sidelines and the company lost more than 10% of its market cap in one day!
July 30, 2007
Branded drugs have value in epilepsy, but future is unclear
Analysis of: Industry Fights Switch to Generics for Epilepsy | online.wsj.com
Author: GLG Expert Contributor
The epilepsy foundation and major drug manufacturers have teamed up to protect reimbursments for branded anti-epilepsy drugs.
July 23, 2007
Device attacks ischemic stroke without mercy
Analysis of: Multi MERCI(R) Trial Demonstrates Better Outcomes For Patients Suffering Ischemic Stroke | www.medicalnewstoday.com
Author: GLG Expert Contributor
The article reports on the results of recent research showing the effectiveness of the Merci(R) Retrieval System.  This pivotal study has contributed to the device receiving FDA approval
July 10, 2007
Alkermes’s ALKS 29: Another Shot at Alcoholism
Analysis of: Alkermes Announces Positive Results from Phase 1/2 Clinical Study of ALKS 29 | www.pipelinereview.com
Author: GLG Expert Contributor
Alkermes’s new compound ALKS 29 achieved preliminary success in a “proof of concept” trial to treat 150 alcoholic dependent patients.  The 8-week trial met its end points including improvement in % of days abstinent, % of heavy drinking days, and average number of drinks/day.
July 2, 2007
Invega is Ready for the EU, But is the EU Ready for Invega?!
Analysis of: INVEGA(TM) Receives Marketing Authorization In European Union For Treatment Of Schizophrenia | www.pipelinereview.com
Author: GLG Expert Contributor
The EU approved marketing of the antipsychotic drug Invega for treatment of schizophrenia in Europe.  This is welcomed news for Janssen, which also market the drug in USA.
June 28, 2007
Pfizer’s Lyrica Wins the Race
Analysis of: Pfizer’s Lyrica Receives FDA Approval for Fibromyalgia | www.medadnews.com
Author: GLG Expert Contributor
Lyrica became the first FDA-approved drug for management of fibromyalgia; a chronic and relentless pain condition that can limit daily activities of patients.
June 27, 2007
Acadia’s ACP104: A Major Hurdle to Clear
Analysis of: ACADIA Pharmaceuticals Initiates Phase IIb Clinical Trial with ACP-104 in Patients with Schizophrenia | www.pipelinereview.com
Author: GLG Expert Contributor
Acadia Pharmaceuticals (Nasdaq: ACAD) initiated a 6-week phase IIb trial to test efficacy and safety of ACP104 in 250 acute schizophrenia patients.
June 27, 2007
Cephalon’s Nuvigil™ is Approved, but Don’t Hold Your Breath!
Analysis of: Cephalon Receives FDA Approval of NUVIGIL(TM) for the Treatment of Excessive Sleepiness Associated with Three Disorders | www.pipelinereview.com
Author: GLG Expert Contributor
Modafinil’s active isomer armodafinil (Nuvigil™) was recently approved by FDA for treatment of excessive sleepiness associated with obstructive apnea, narcolepsy and shift work sleep disorder.

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