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GLG News by Generic Pharmaceuticals Regulation Experts: Healthcare Consultants

Evan Siegel, MPhil, PhD, Adjunct Professor
University of Queensland
Analysis of: Pfizer Abandons Exubera, Posts 77% Earnings Decline (online.wsj.com)
The user-friendly and health care provider comfort aspects of an product with otherwise proven safety and efficacy must be considered when deciding how, when, and in what manner to develop f drug product. Despite the desirability of a non-injectibel insulin, the inhaled route of administration and...
David Zimmerman, PharmD, President/Owner
Doctors of Pharmacy, Inc.
October 19, 2007
A can of tennis balls?
Analysis of: Pfizer Abandons Exubera, Posts 77% Earnings Decline (online.wsj.com)
Exubera is a great product. However, the delivery system was difficult to use and educate the patients how to use. Hopefully, the next generation of the product will be in a smaller more user friendly cannister.
Eric Gruff, PhD MBA, Principal
Eric Gruff, PhD MBA, Principal
E4 Consulting
Analysis of: Generic Drugs: Dangerous Differences? (abcnews.go.com)
A recent study by ConsumerLab.com suggests that some generic versions of pharmaceutical products may not be bioequivalent to their brand name counterparts. The difference seems to be in the release rates for extended-release (ER) dosage forms as determined by in vitro ("test tube") analysis of...
Analysis of: Boehringer Ingelheim News Page -- 5th Bullet Point (www.boehringer-ingelheim.com)
There is no pharmacological cure for Hypoactive Sexual Desire Disorder (HSDD) and Flibanserin could be the first a blockbuster at that! One in 5 women (and men) suffer from HSDD.
Joseph Bertino, Pharm.D., Independent Consultant
Joseph Bertino, Pharm.D., Independent Consultant
Bertino Consulting
Analysis of: 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...
Eric Gruff, PhD MBA, Principal
Eric Gruff, PhD MBA, Principal
E4 Consulting
Analysis of: Wyeth Pharmaceuticals Acquires Haptogen Ltd. to Boost Biotechnology Drug Discovery (www.pipelinereview.com)
Wyeth's acquisition of Haptogen, a Scottish biotechnology company specializing in novel protein-based therapeutics, is a promising development for Wyeth's biotechnology pipeline. This is a welcome addition for Wyeth, but the key will be translating the increased pipeline into additional drugs on the...
Analysis of: Microsoft launches Web site to hold medical records (uk.reuters.com)
Microsoft has run out of operating systems and is turning to a never ending source of revenue namely the medical field. Will it work for them?
Analysis of: Prexige, Anti-inflammatory Drug, Withdrawn In Canada (www.medicalnewstoday.com)
The recall appears to be involuntary which makes Novartis Pharmaceuticals Canada look less than responsible. Liver-related adverse events are serious.
Analysis of: PDL BioPharma to Actively Seek Sale of Entire Company or Its Key Assets (www.pipelinereview.com)
PDL BioPharma is going through some major restructuring. The best that can be expected is a ROI by way of sale, having capital to make one special medication by contract or otherwise.
Analysis of: Some babies get too much fluoride (www.mlive.com)
Fluorine is an perhaps the most reactive element on the periodic table. The young body needs a small amount of it in the form of a molecule. Too much of this good thing causes fluorosis.

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