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GLG News by Generic Pharmaceuticals Regulation Experts: Healthcare Consultants

Analysis of: MediGene: European Approval Procedure for the Six-Months Dosage of Cancer Drug Eligard(R) Successfully Completed (www.pipelinereview.com)
The approval of Eligard® by MediGene AG in the EU bodes well for its approval in the US. It has a relatively long and respectable dosing span of up to 6 months.
Analysis of: Doctors Offering No-Interest Loans to Patients (www.nytimes.com)
The contracts will govern who maintains a zero percent loan, as prescribed by known-to-be faulty US credit scoring. Banks stand to gain.
Analysis of: GE Healthcare Signs Imaging Solutions Agreement With Novation (www.medicalnewstoday.com)
Novation’s products will complement GE’s broad line of Health care services.
Eric Gruff, PhD MBA, Principal
Eric Gruff, PhD MBA, Principal
E4 Consulting
Analysis of: Liraglutide improves glucose control and lowers body weight in two phase 3 studies comprising more than 2,000 patients (www.pipelinereview.com)
The results of two Phase III trials conducted by Novo Nordisk on liraglutide, a once-daily dosed GLP-1 analog, indicate significant glucose lowering efficacy and weight loss. On a positive note, Novo has to be relieved that they are seeing the same magnitude of HbA1c reduction and weight loss...
Analysis of: GSK Receives Decision From FDA On Advair 500/50 For COPD (www.medicalnewstoday.com)
GlaxoSmithKline is a strong company and the delays to market will not have a significant effect on the bottom line, though it will have an effect.
Analysis of: Wyeth's Schizophrenia Pill Is Rejected by U.S. FDA (www.bloomberg.com)
Effexor was launched when Research was based in Rouses Point, and it could be again with little effort. But now with scores of "dead" or back to the drawing board drugs developed by Wyeth in Pearl River – this compliance company will continue to suffer the management of a NYC suburb vs. a quiet countryside. Wyeth...
Analysis of: Johnson & Johnson Statement on Civil Complaint Against The American National Red Cross and Commercial Licensees (www.pipelinereview.com)
The National Red Cross apparently in an effort to gain financial supporters will find a way to not enjoin the new supporters, or those supporters will not seek the well known cross and they will do so voluntarily. Johnson and Johnson has a vested interest to continue to donate to the Red Cross – it...
Analysis of: Iomai Vaccine Confers Statistically Significant Protection Against Travelers' Diarrhea in Phase 2 Study (www.pipelinereview.com)
The reduction of E. coli infection targets travelers and people in regions of lesser sanitation. This product has the potential to cure many people of illness.
Analysis of: New Drug Application for Investigational HIV Treatment TMC125 Submitted to U.S. Food and Drug Administration (www.therapeuticsdaily.com)
Tibotec Pharmaceuticals Ltd. NDA for TMC125 etravirine is on the FDA "Fast Track" and should not be.
Analysis of: Wyeth Receives Approvable Letter from FDA for PRISTIQ for the Treatment of Vasomotor Symptoms Associated with Menopause (www.pipelinereview.com)
An approvable letter is the FDA’s way of saying get ready your very likely to be approved, but there may be catches.

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