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GLG News by Pulmonologists (US)

Warren Botnick, MD, President
PSS Clinical Research
Analysis of: Newly Discovered Fatty Acids May Lead To Novel Treatments For COPD And Asthma (www.medicalnewstoday.com)
Eicosanoids appear promising in the treatment of such airways diseases as COPD and asthma, which affect millions worldwide.  Any alternative to current anti-inflammatory therapy, which consists almost entirely of forms of corticosteroids, would almost certainly be welcomed and adopted in widespread...
Warren Botnick, MD, President
PSS Clinical Research
Analysis of: Basilea Announces Positive Top-line Data from Phase III Study of Ceftobiprole in Community-acquired Pneumonia Requiring Hospitalization (www.pipelinereview.com)
Cephalosporins have been standard therapy for pneumonia for many years, but to date this class of drug has been ineffective against MRSA.  Ceftobiprole appears to represent a breakthrough in this regard.  I would expect the drug to be well tolerated and, for the most part, to cause few major...
Warren Botnick, MD, President
PSS Clinical Research
Analysis of: GlaxoSmithKline and Sepracor Inc. announce international alliance for commercilisation of Lunivia (www.pipelinereview.com)
Though the potential international market for eszopiclone is large, interest in the product among sleep specialists in the US has leveled off.  Its success internationally may well depend more on distancing the product from other agents such as the Ambien "family," a decidedly difficult task, and...
September 17, 2007
Evista dual benefit
Analysis of: FDA approves Lilly's Evista for breast cancer (www.marketwatch.com)
THE indication for breast cancer reduction gives the drug a dual benefit not only for osteoporosis . THe black box waring indicates that there is not an increased risk of stroke, but there is an increased risk of a stroke being fatal.
Warren Botnick, MD, President
PSS Clinical Research
Analysis of: Dabigatran Etexilate As Effective As Enoxaparin In Lowering Blood Clot Risk After Hip Replacement (www.medicalnewstoday.com)
These data help strengthen the growing perception that oral agents in general, direct thrombin inhibitors in particular, and perhaps specifically dabigatran, represent the future of anticoagulation therapy.  Safety data are of paramount importance, given the prior failure of ximelagatran in this...
Warren Botnick, MD, President
PSS Clinical Research
Analysis of: ThromboGenics and BioInvent Announce Successful Completion of Phase I Clinical Trial of the Anticoagulant TB-402 (www.pipelinereview.com)
Phase I data are promising for prevention on VTE, a major worldwide health problem.  However, inhibition of factor VIII raises grave safey concerns, despite safety profile in this study.  Long duration of action and cost also will be important considerations (current drug costs for this indication can...
September 7, 2007
Kudos to the FDA!
Analysis of: FDA Issues Warning Letter To Melanocorp, Inc. For Illegal Sale Of Melanotan II -Agency Warns Consumers About Using And Purchasing Unapproved Product (www.medicalnewstoday.com)
The web based marketing of cyber snake oil is of concern to practitioners of medicine in every venue. Although there are many products have failed to pass sucessfully through the FDA process, this compound among others hallmarks a federal agency's ability to prevent sale of a possible useless or dangerous...
Analysis of: J&J Ends Plan to Seek Wider Procrit Use (online.wsj.com)
This study, published this week in The New England Journal of Medicine, randomized 1,460 critically ill patients to receive erythropoietin (Epo) or placebo.  Although patients receiving Epo did achieve a statistically greater rise in hemoglobin at the end of the study period, but surprisingly...
David Engler, MD, Physician
David Engler, MD, Physician
The Allergy Clinic
Analysis of: Current Contents: Withdrawal of albuterol inhalers containing CFC propellants (nejm.org)
Key Points of this article: 1)  CFC helps destroy the ozone layer in the stratosphere 2)  CFC albuterol is being banned in 2008 3)  CFC-containing metaproterenol (Alupent and generics) will still be available 4)  CFC-containing Combivent (albuterol plus ipratropium) will...
David Engler, MD, Physician
David Engler, MD, Physician
The Allergy Clinic
Analysis of: New antihistamine gets FDA green light.(RX CARE)(Levocetirizine (Xyzal) by UCB Inc. and Sanofi-Aventis ) (www.therapeuticsdaily.com)
Take Zyrtec and sort out the right-handed molecules from the lefties.  Send all the lefties home, and you have levocetirizine, a.k.a. Xyzal.  Like Zyrtec, Xyzal is owned by UCB http://www.ucb-pharma.com/products/ .  But unlike Zyrtec, Xyzal will not be marketed by Pfizer.  Instead,...

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