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GLG News by Generic Pharmaceuticals Regulation Experts: Healthcare Consultants

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November 13, 2008
Tamper Proof Narcotic Pain pill? YES
Analysis of: FDA Asks if Pain Pill Is Tamper-Proof | online.wsj.com
Author: David Zimmerman, President/Owner, Doctors of Pharmacy, Inc.
This drug will allow patients in severe pain to get the necessary pain relief and not have to worry about the other patients that abuse the drug.
October 17, 2008
The Hazards of Herbal Self-Medication
Analysis of: St John's Wort 'as good as Prozac' | ukpress.google.com
Author: GLG Expert Contributor
St. John's Wort has long been promoted as "herbal Prozac", claiming the added benefits of being natural and affordable. If fact, reading the proponents' comments, one would think St. John's Wort is health food.   The concentration of hypericin, the key pharmacologically active constituent...
Joseph BertinoSeptember 23, 2008
Gene Targeted Drug Therapy for Heart Failure
Analysis of: Gene Targeted Drug Therapy for Heart Failure | www.bio-medicine.org
Author: Joseph Bertino, Independent Consultant, Bertino Consulting
-Another step towards invididualized medicine -Proves that old drugs can be reinvented for useful purposes -Advances pharmacogenetics forward
Eric GruffAugust 21, 2008
Link to Pancreatitis is Bound to Negatively Impact Byetta Sales
Analysis of: FDA Alert: Hemorrhagic or Necrotizing Pancreatitis in Patients Taking Byetta | www.fda.gov
Author: Eric Gruff, Principal, E4 Consulting
The recent publication of new cases of pancreatitis that are occurring in patients taking Byetta (exenatide) can't be good for Amylin/Lilly. While Byetta and investigational GLP-1 analogs are still very viable therapeutics for Type 2 Diabetes, prescribers will have to reassess the risk-benefit ratio...
Joseph BertinoAugust 15, 2008
Astra-Zeneca and Abbott partner on promoting Crestor..should Pfizer beware?
Analysis of: Abbott signs deal to promote Crestor in U.S. | www.chicagotribune.com
Author: Joseph Bertino, Independent Consultant, Bertino Consulting
-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
July 17, 2008
A Complex Personal and Societal Issue
Analysis of: Costly Cancer Drug Offers Hope, but Also a Dilemma | www.nytimes.com
Author: Evan Siegel, Adjunct Professor , University of Queensland
The issues associated with expensive therapeutics are multifaceted and involve personal, professional and societal components. Value related to medical treatment is uniquely assessed by each individual with respect to his/her financial burden, overall lifestyle and quality of life, societal role,...
Joseph BertinoJuly 17, 2008
The New PhRMA “Code on Interactions with Health Care Professionals”: What will it mean?
Analysis of: PhRMA “Code on Interactions with Health Care Professionals” | www.thepinksheet.com
Author: Joseph Bertino, Independent Consultant, Bertino Consulting
-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...
July 8, 2008
A Word to the Wise...
Analysis of: Drug Makers Say FDA Safety Focus Is Slowing New-Medicine Pipeline | online.wsj.com
Author: Evan Siegel, Adjunct Professor , University of Queensland
1. Sponsors need to be "squeaky clean" with respect to their assessment of signals of toxicity in drug develpment programs. 2. This assessment should be made at the preclinical and early clinical stages of the process, irrespective of political and financial considerations. 3. The per cent of failures...
May 1, 2008
Expect speeder FDA reviews in a year maybe.
Analysis of: FDA Embarks on Major Hiring Initiative for its Public Health Mission | pharmalive.com
Author: GLG Expert Contributor
In this publications there is am implication that the FDA will approve things faster as the FDA will after hiring so many people with fancy science backgrounds.  This might be true but it probably won't be the case.
Eric GruffApril 21, 2008
Tainted Heparin Will Mean More Scrutiny of Drug Manufacturers
Analysis of: UPDATE: FDA Head Sees Economic Fraud Behind Tainted Heparin | www.reuters.com
Author: Eric Gruff, Principal, E4 Consulting
Regardless of the reason (greed, carelessness, incompetence, etc.) that Chinese heparin became tainted, the end result will be increased scrutiny on imported raw materials and other ingredients, not only from China, but from all 3rd World suppliers. How the FDA and other regulatory agencies actually...

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