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GLG News by Pediatricians who Treat RSV (US)

Analysis of: France Backs Sanofi's HPV Vaccine Gardasil Over Glaxo's (online.wsj.com)
Sanofi's Gardisil, the first-to-market HPV vaccine for adolescent females, has been fairly widely accepted in the US, albeit with some concerns regarding adverse reactions and cost.  It is likely that EU sales will gradually increase as the vaccine is accepted in Europe as well.
Analysis of: DC passes pharma rep licensing bill (www.fiercepharma.com)
OK, so now to peddle pharmaceuticals to doctors in D.C., a drug company will have to license their reps.  This will be a pain in the neck to the reps and those who supervise them, and will probably result in a small increase in the cost of doing business for detail people -- but I don't see how...
Analysis of: QuatRx Pharmaceuticals Announces Positive Phase 3 Results for Study of Ophena(TM) (ospemifene) to Treat Postmenopausal Vaginal Syndrome (www.prnewswire.com)
Before addressing all the practical obstacles that might face Ophena, it might be helpful to acknowledge all the problems already faced by established drugs that are similar to it. The most similar would be Evista, another selective estrogen receptor modulator used primarily for osteoporosis, which...
Analysis of: Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) (www.fda.gov)
Intranasal desmopressin is rarely used now for nocturnal enuresis.  Most pediatricians have already converted to oral formulations.
Analysis of: BHARAT BIOTECH LAUNCHES TWO NEW VACCINES IN INDIA (Bio-Hib and Comvac4-HB vaccines) (www.therapeuticsdaily.com)
-Bharat has gotten approval in India to sell 2 vaccinations that are used for children -Approval in India means only that the drugs can be sold and used in India -Although the Indian market is large, there may be many competing approved products already available in India and this has little implication...
Analysis of: Meridian Bioscience Receives FDA Clearance For Two New Rapid Tests For The Detection Of Influenza And Respiratory Syncytial Virus (www.medicalnewstoday.com)
Meridian's new RSV and Influenza A/B testing should provide new weapons for pediatricians during the upcoming flu and upper respiratory infection season.
Analysis of: New data for Menveo(TM) vaccine show excellent immune response and broad protection for infants against meningococcal meningitis (www.pipelinereview.com)
Novartis should be applauded for completing the earliest stages of a conjugated meningococcal vaccine for infants and young toddlers.  However, it is conceivable that Novartis' Menveo may be cannibalized in the market by sanofi's Menactra. Menactra is an already FDA-approved conjugated meningococcal...
Analysis of: FDA Issues Early Communication about an Ongoing Safety Review Of Aprotinin Injection (www.medicalnewstoday.com)
Aprotinin, a complex bovine protein with effects on clot dissolution, coagulation and enzymatic digestion, is without a doubt an innovative product. But innovation alone should not be the standard when the purpose of a drug is to improve patient outcomes. And so, whereas aprotinin is undoubtedly...
Analysis of: UCB Announces Initiation of Phase III Clinical Programme for RikeltaTM (brivaracetam) as Adjunctive Treatment in Partial-Onset Epilepsy (www.pipelinereview.com)
Epilepsy patients who have already failed to achieve control on two or three different regimens (be they single or multiple drug regimens) are unlikely to find success with any new regimen -- that's just the nature of the disease, unfortunately.  Failure on seizure medications is more a prognostic...
Analysis of: Sanofi Pasteur Receives FDA Approval of Meningococcal Vaccine for Children (pharmalive.com)
-Menactra recently gained approval for children 2-10 years old -Unless the ACIP changes its recommended age for routine use (currently 11), this will have little impact -Most children will only need this in this expanded age range for travel to some parts of the world.

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