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GLG News by Medical Device Experts

Analysis of: Ceregene Presents Long-Term Follow-Up from Phase 1 Trial of CERE-120 in Parkinson's Disease (www.pipelinereview.com)
This is a very significant event for Ceregene.  Previous studies, with drug treatment, on treatment for parkinsons have shown that the placebo effect only lasts for three months.  The symptoms of Parkinson's  increase 5-10% per year( as part of the natural progression of the disorder). ...
Kenneth Edelson, Owner
Kenneth Edelson, MD
Analysis of: Ipsen and Medicis announce submission of Reloxin(R) in aesthetics to the FDA (www.pipelinereview.com)
Lowering cost of Botox is key, but not enough to induce patients to undergo Botox treatments.
Ken Powell, President
Ken Powell, President
Genesis Business Development, LLC
December 14, 2007
Genetic Testing
Analysis of: As gene tests spread, questions follow (online.wsj.com)
Genetic screening for disease states, cancer, cancer progression and other metabolic conditions often promise much, but fail to deliver the clinical sensitivity and specificity of traditional diagnostic tests.  The relatively low predictive value and nominal regulation of...
Ken Powell, President
Ken Powell, President
Genesis Business Development, LLC
December 13, 2007
Chlamydia Rapid Test
Analysis of: Chlamydia rapid test (www.medcompare.com)
A new rapid test for chlamydia trachoma, the world's most prevalent sexually transmitted bacterial disease will improve the efficiency of existing screening programs and make testing accessible to developing countries that often do not have the healthcare infrastructure to support diagnosis and treatment....
Kenneth Edelson, Owner
Kenneth Edelson, MD
Analysis of: Ipsen and Medicis announce submission of Reloxin(R) in aesthetics to the FDA (www.pipelinereview.com)
For too long Allergan has monopolized the therapeutic and cosmetic market of botulinum toxin type A, and has taken full advantage of that monopoly by raising the price of Botox almost biannually. Reloxin studies are very favorable when compared to Botox, and may even surpass it in one or two aspects....
Analysis of: Amarin Commences First Clinical Trial in Cardiovascular Program (www.pipelinereview.com)
EPA for the treatment of cadiovascular and CNS related moving disorder.
Analysis of: The Battle Over Health Care (www.nytimes.com)
1. If Members of Congress and those running for president in 2008 do not recognize that this nation is in a health care crisis, we have only ourselves to blame---we put them into office to better our lives, and they are not doing the job at all, particlarly when it comes to ensuring health care services...
Ken Powell, President
Ken Powell, President
Genesis Business Development, LLC
Analysis of: Putting Superbugs on the Defensive (online.wsj.com)
Two recent articles in the 10/23/07 Wall Street Journal indicate that recent media attention on "superbugs", such as MRSA and others are resulting in legislation on the state and federal level.  This legislation is likely to accelerate the unanticipated rate of growth for certain infection...
Ken Powell, President
Ken Powell, President
Genesis Business Development, LLC
Analysis of: Human Papillomavirus DNA versus Pap Screening Tests for Cervical Cancer (content.nejm.org)
A recent study of 10,154 women, published this week in the New England of Journal of Medicine, found that using the HPV (human papilloma virus) DNA test to screen for cervical cancer was twice as accurate as the traditional Pap smear.  The sensitivity of the molecular...
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...

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