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GLG News by Adolescent Medicine Specialists: Pediatricians

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January 9, 2007
MedImmune's FluMist approved for refrigerator storage for 07-08 season
Analysis of: FDA Approves MedImmune's Refrigerated Formulation of FluMist | phx.corporate-ir.net
Author: GLG Expert Contributor
- MedImmune's FluMist has been approved in a new form that will allow storage in a standard medical refrigerator for next flu season (the current product must be stored in a cumbersome box in a freezer).-Along with the pending application for age down to 1 year, FluMist's prospects are improving.
January 8, 2007
Vyvanse approvable and likely to be on market in next 3-5 months
Analysis of: New River Pharmaceuticals And Shire Receive Approvable Letter For VYVANSE™ (lisdexamfetamine Dimesylate) For The Treatment Of ADHD | www.medicalnewstoday.com
Author: GLG Expert Contributor
-Vyvanse, a novel prodrug for ADHD will be approved in the next few months according to both its developers and the FDA.   -Shire and New River had been hoping for relaxed "scheduling" compared to traditional stimulants.-The DEA is unlikely to go along with this and is leaning...
January 3, 2007
Success of Retail Clinics in Pediatrics Will Depend on perceived value
Analysis of: Retail Medical Clinics Draw Patients & Payers | www.managedcaremag.com
Author: GLG Expert Contributor
Retail Medical Clinics (RMCs) will succed where they have a perceived advantage over a physician's office in price, wait time, or in furthering a patient's agenda.  If they offer a no-wait visit for a sore throat while a spouse shops at Wal-Mart, many will be likely to use them.  The...
January 3, 2007
News not new, consistent with development intent.
Analysis of: New Study Supports Low Abuse Potential Of Leading ADHD Medication, CONCERTA® (methylphenidate HCl) | www.medicalnewstoday.com
Author: GLG Expert Contributor
Concerta's low(er) abuse potential vs. straight Ritalin is well-known.  At its introduction several years ago this was a big selling point, as it was the only approved ADHD drug that was hard to crush and sniff.As other harder-to-abuse drugs come to market (Shire has one that is awaiting approval)...
December 11, 2006
Universal use of Zostavax is a fantasy
Analysis of: FDA approves Zostavax, Merck's new vaccine for preventing shingles in adults 60 and older | www.therapeuticsdaily.com
Author: GLG Expert Contributor
-Zostavax is being touted as a "homer" by some in this thread. Although clearly beneficial, other more important vaccines that are supposedly "universal" are already routinely not given to a large fraction of the elderly.-Vaccines for special populations are only as universal as the care that delivers...
December 11, 2006
Numax is effective, but at what price?
Analysis of: Numax(R) Achieves Primary Endpoint In Preliminary Analysis of Data From Comparative Phase 3 Trial With Synagis(R) | biz.yahoo.com
Author: GLG Expert Contributor
-Numax, if approved, is certain to be more expensive than its parent compound Synagis.-Synagis already works extremely well and is extremely expensive. The only reason for development of Numax is patent protection and higher margin. This may be a reason in and of itself for the FDA to decline to approve...
November 13, 2006
random thoughts
Analysis of: Skin patches instead of shots? | news.yahoo.com
Author: GLG Expert Contributor
We need to separate the concepts of Checkups from "Shots." This delivery system adds credence to this  - it is impossible to talk to a parent, whose child is screaming after a vaccine, or who is stressed because the parent has "threatened" the child with a "shot."  (grounds for dismissal from...
November 1, 2006
Merck's Prevnar (pneumococcal vaccine) works too well
Analysis of: Pneumococcal Disease Vaccine | www.medicalnewstoday.com
Author: GLG Expert Contributor
-Merck's Prevnar (strep pneumoniae) vaccine is approved in the US as a 4-dose schedule-This article in the Lancet found that 2 or 3 doses worked about as well as the 4-dose schedule currently approved in the US-This may allow expansion of use outside of the usual 1st world but is unlikely to cause a...
November 1, 2006
Gardasil's European Vacation
Analysis of: Sanofi Pasteur Begins Selling Merck's HPV Vaccine Gardasil In Six E.U. Countries | www.medicalnewstoday.com
Author: GLG Expert Contributor
-The EU has approved Merck's Gardsail for use in Europe to prevent cervical cancer-Merck has partnered with Sanofi to sell Gardasil in 6 European countries to start-Besides being a public health boon, the partnership will benefit both Merck and it's Europe-savvy partner, Sanofi-Aventis

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