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GLG News by Pediatricians in Private Practice (US)

Analysis of: New Study Suggests J&J Coated Stent Tops Boston Sci's Device (money.cnn.com)
The most important result of this trial is the fact that there was no difference in overall mortality between either of the drug-eluting stents and bare metal stents. To that end, one would conclude that the best stent available, if they all have similar mortality figures, would be the one that is cheapest,...
Analysis of: Ibuprofen Can Enhance Longevity And Quality Of Life For Children With Cystic Fibrosis By Slowing Rate Of Decline In Lung Function, Canadian Study (www.medicalnewstoday.com)
Medical News Today should revise or retract the title of its article covering a recently published study on the use of ibuprofen in children with CF. Despite the article's title, ibuprofen was not found to "enhance longevity," slow the "rate of decline of lung function," nor improve the "quality of...
Analysis of: Ranbaxy Gains Approval To Manufacture And Market Carvedilol Tablets In The U.S. Market (www.medicalnewstoday.com)
When the advantages of administering carvedilol to patients with congestive heart failure became apparent in the mid-1990s, it was preceived as a very innovative drug: giving beta-blockers to patients with CHF was treaded with caution, and many physicians did not feel comfortable prescribing a drug...
Analysis of: Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility (www.pipelinereview.com)
Watson Pharmaceuticals' decision to open a generics plant in Goa, India is a clear sign that the U.S. generics industry (and U.S. pharma in general) sees its competition emerging in India. India's generics industry is quite sophisticated, with high-quality products with worldwide demand and ascendant...
Analysis of: Germany Bans Use of Cough Drugs With Clobutinol (www.medscape.com)
Clobutinol, a centrally acting cough suppressant (meaning that it works at the level of the brain to suppress the cough reflex), was voluntarily withdrawn from the marketplace by B.I., and now officially banned by a German regulatory agency, following reports that the drug may precipitate life-threatening...
Analysis of: Nasal Decongestants Get New Sales Restrictions, UK (www.medicalnewstoday.com)
The MHRA -- the UK's version of the FDA -- is pondering action to restrict the volume of sales of pseudoephedrine and ephedrine, two OTC nasal decongestant products with amphetamine properties. The motivation behind the recommendation is a hope to curtail the rampant black market production of...
Analysis of: YM BioSciences USA Cleared By US FDA To Initiate Phase II Clinical Trial Of Nimotuzumab In Children With Inoperable, Recurrent Brain Cancer (www.medicalnewstoday.com)
The current YM Biosciences trial of nimotuzumab for DIPG is not placebo-controlled, which is acceptable: the prognosis is so grim, and patients have so few options, that a placebo arm is generally not considered necessary. The trial is scheduled to be 18 months long: though a short interval, this...
Analysis of: Nexavar Significantly Improved Overall Survival in Phase 3 Asia-Pacific Liver Cancer Trial (www.therapeuticsdaily.com)
The recent announcement that Bayer/Onyx's joint chemotherapeutic, Nexavar, demonstrated an increased time to progression in patients with advanced hepatocellular carcinoma has resulted in a cessation of the trial and an opening of enrollment to the protocol.  This reward was well-deserved: in addition...
Analysis of: Targeted Genetics Reports Interim Phase II Data From HIV/AIDS Vaccine Clinical Trial (www.therapeuticsdaily.com)
The results of recent phase II trials on a novel HIV/AIDS vaccine produced by Targeted Genetics (TGEN) produced reassuring short-term safety data, but little insight into the vaccine's ability to deliver on its clinical endpoint -- reduced HIV infection rates.  Safety data was consistent with most...
Analysis of: Rotarix BLA from GSK and AVANT accepted for review by FDA (www.pipelinereview.com)
Rotarix is an excellent vaccine for the prevention of rotavirus infection, one of the most common causes of diarrhea, dehydration and hospitalization in American children.  But like so much of GSK's vaccine pipeline, Rotarix's impact on infant health -- on which it has the potential to be substantial...

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