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GLG News by Psychiatrists (US)

Joseph Bertino, Independent Consultant

Joseph BertinoIndependent ConsultantBertino Consulting What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Gene Targeted Drug Therapy for Heart Failure

September 23, 2008

Gene Targeted Drug Therapy for Heart Failure | www.bio-medicine.org

-Another step towards invididualized medicine -Proves that old drugs can be reinvented for useful purposes -Advances pharmacogenetics forward

Joseph Bertino, Independent Consultant

Joseph BertinoIndependent ConsultantBertino Consulting What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Astra-Zeneca and Abbott partner on promoting Crestor..should Pfizer beware?

August 15, 2008

Abbott signs deal to promote Crestor in U.S. | www.chicagotribune.com

-Crestor sold 2.8 billion dollars in sales in the recent year, will this partnership result in long term exponential growth? -What are the implications for Crestor with generic simvastatin and with Lipitor going generic in the next few years? -Is a combination product going to bolster Crestor sales?

Joseph Bertino, Independent Consultant

Joseph BertinoIndependent ConsultantBertino Consulting What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

The New PhRMA “Code on Interactions with Health Care Professionals”: What will it mean?

July 17, 2008

PhRMA “Code on Interactions with Health Care Professionals” | www.thepinksheet.com

-The new code will limit all gifts and meals to healthcare professionals, thus reducing pharmaceutical representative contact time. -Medical education programs will follow guidelines established by professional education groups -The guidelines do not go far enough for sales representative-healthcare professional interactions

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Neuronal nicotinic receptor agonists potential breakthrough for ADHD research

May 12, 2008

Abbott Scientists Present A New Approach for Treating Attention-Deficit Hyperactivity Disorder | biz.yahoo.com

1. Effective treatment for ADHD 2. Well tolerated with few side effects 3. Help with smoking, a big problem in ADHD patients important 4. Advantage in not being Schedule II may be helpful

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Important New Data for Children and Adolescents

May 12, 2008

FDA Approves Strattera® for Maintenance of ADHD in Children and Adolescents | newsroom.lilly.com

1. Important new finding given safety concerns raised about this and other treatmetns 2. Nice to have data back up what has long been done clinically 3. Stimulants still first line and lack of active comparator trial

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Exciting new treatment for OCD and Social Anxiety Disorder

March 7, 2008

FDA Approves Luvox CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder and Obsessive Compulsive Disorder | pharmalive.com

1. Controlled release preparations are often better tolerated with fewer side effects than immediate release preparations 2. OCD and SAD are severe, highly prevalent and chronically disabling conditions 3. Despite presence of SSRIs and other treatment, e.g, cognitive behavioral therapy, up to 1/3 of patients with OCD or SAD do not respond to currently available treatments and among responders many do so only partially

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

FDA Approval of Abilify for Pediatric Bipolar disorder is a Major Advance

March 7, 2008

U.S. Food and Drug Administration Approves Abilify (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age) | pharmalive.com

1. Despite common use of multiple psychotropic medications for bipolar disorder in youth, there are few FDA-approved treatments 2. Abilify is one of the safest and best tolerated of the atypical antipsychotics with fewer side effects than some of the other atypical antipsychotic medications 3. This treatment offers new hope to many children and their families

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

More questions raised than answers

February 5, 2008

Chantix And Suicide: The Latest Numbers | www.pharmalot.com

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

Joseph Bertino, Independent Consultant

Joseph BertinoIndependent ConsultantBertino Consulting What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Non-Inferiority Studies: What do the numbers mean, how does the FDA interpret them?

October 11, 2007

Efficacy of Iclaprim in Complicated Skin and Skin Structure Infections: Preliminary Results of ASSIST-1 | www.idsociety.org

A recent abstract for the 2007 Infectious Diseases Society of American (IDSA) meeting has generated some concern among financial analysts.  This non-inferiority study on iclaprim versus linezolid for treatment of complicated skin and skin structure infections showed that “The 95% CI for treatment difference (ICL-LZD) in the PP population was -8.4, -1.0%.” Because the 95% CI did not reach or cross 0, many individuals fear that the FDA will hold up approval of this compound. 2007 Infectious Diseases Society of American (IDSA) Abstract: http://www.abstractsonline.com/viewer/viewAbstractPrintFriendly.asp?CKey={1E0D62C0-A5C5-49E5-883B-C0A0DC4D4745}&SKey={713BCC51-9119-49CC-BE88-A6043DC73587}&MKey={2BC0388C-EE56-4FA2-A529-EC82E2C7362A}&AKey={456A1804-CC97-4677-BF53-D872148C9EF7}

Lawrence GinsbergPresidentRED OAK PSYCHIATRY ASSOCIATES, P. A. What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Vanda"s Iloperidone: Lemonade or Lemon

October 11, 2007

Vanda Pharmaceuticals Submits Iloperidone New Drug Application | www.pipelinereview.com

1. Iloperidone has demonstrated efficacy in treating positive and negative symptoms of schizophrenia and also has a favorable safety profile. 2. Vanda has utilized pharmacogenetic studies to identify a group of schizophrenic patients that will benefit from this agent that binds to a number of serotonin and dopamine receptors. 3. Two out of three previous Novartis Iloperidone trials were failed trials but they utilized low to medium doses of Iloperidone.

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