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GLG News by Generic Drug Economic Experts

Adam Fein, Founder & President

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC 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.

Diversion Risk for AmerisourceBergen?

March 11, 2008

Feds Raid Drugstores, Mission Hills Home | www.msnbc.msn.com

The DEA’s aggressive enforcement efforts for the diversion of controlled substances and other prescription drugs may mean business disruptions for wholesalers besides Cardinal Health (CAH), including AmerisourceBergen (ABC).  For better (or perhaps worse), the DEA now considers distributors and wholesalers to be responsible for ensuring that a pharmacy is only dispensing prescriptions issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. What impact will these new responsibilities have on wholesalers' revenues and customer relationships?

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

Adam Fein, Founder & President

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC 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 Darkside of Hospital Pharmacy Outsourcing?

March 6, 2008

Your Hospital's Deadly Secret | www.portfolio.com

A new article is highly critical of the pharmacy outsourcing businesses run by the big 3 wholesalers -- AmerisourceBergen (ABC), Cardinal Health (CAH), and McKesson (MCK). But after reading the article, I’m still not sure whether (a) there systemic flaws in the wholesalers' pharmacy outsourcing business or (b) the story simply highlight the tragic mistakes of a few individuals at a single facility.

Adam Fein, Founder & President

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC 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.

Cardinal Health's Customer Problems Deepen

March 3, 2008

Cardinal Health's Compliance Efforts Rile Some Customers | online.wsj.com

Cardinal Health (CAH) recently stopped shipping controlled substances to certain customers so as to avoid a Drug Enforcement Agency (DEA) suspension of its license at a fourth facility.  It appears that Cardinal Health’s new role as supply chain enforcer is angering some of the customers who have been tagged as “diverters.”  I also suspect that their actions will hurt the company’s efforts to regain or build market share among independents.  

Adam Fein, Founder & President

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC 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 Myth of Drug Price Transparency

March 3, 2008

Report: State Drug Price Sites Flawed | ap.google.com

An interesting new report finds that the drug price comparison web sites run by 10 U.S. states are not always useful or usable.  The wide variations in pharmacy prices for a common, high volume generic make me wonder about the efficiency of the pharmacy market and the value of apparent transparency.  However, I suppose that the persistence of these price differences is good news for pharmacies such as CVS Caremark (CVS) and Walgreens (WAG).

Hany Salama, Vice President, Commercial Operations

Hany SalamaVice President, Commercial OperationsNEOSTRATA COMPANY, INC. 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.

Sterile Injectables Contract Manufacturing Market Outlook

February 28, 2008

Jubilant News for Hollister-Stier | www.contractpharma.com

As demand of the sterile injectables products grows, more and more contract manufacturers are evaluating this landscape as a potential opportunity for growth.  The major concerns in this market outlook are how complex is the technology, how much capacity is needed and will this technology be the future for the pharmaceutical and biotech companies and are contract manufacturers ready/capable of the challenges. 

Joseph SchappertMedical Director PROVIDENCE HEALTH CARE 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.

Novel molecules and diagnostic tests

February 19, 2008

Kidney Cancer Drug Linked to Higher Rate of Heart Problems | www.washingtonpost.com

Diagnostic tools are availible to identify these adverse effects at an early stage in their clinical development. These tools should mitigate the seriousness of these adverse events.

Taral Patel, Oncologist

Taral PatelOncologistMID-OHIO ONCOLOGY & HEMOTOLOGY INC 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.

Avastin In Breast cancer

February 19, 2008

In Second Trial, Avastin Is Found Effective in Treating Breast Cancer | www.nytimes.com

New data with low and high dose of Avastin with Taxoter

Taral Patel, Oncologist

Taral PatelOncologistMID-OHIO ONCOLOGY & HEMOTOLOGY INC 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.

improve Overall survival in prostate cancer

February 19, 2008

Dendreon Presents Data Correlating the Cumulative Potency of PROVENGE(R) to Overall Survival | www.pipelinereview.com

esults showed that PROVENGE patients experienced improved survival if they received more cells across the three doses of PROVENGE (higher cumulative TNC count (p=0.019)) or higher cumulative CD54 upregulation values (p=0.009). The effect on survival for TNCs appeared to reflect in part the patients' baseline prognostic factors. However, the CD54 upregulation ratio appeared to be an independent predictor of survival in patients who received PROVENGE, as the correlation remained strong even after adjusting for baseline prognostic factors (p=0.022). Data is very impressive. This may lead FDA approval in prostate cancer in next 3-6 months.

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