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GLG News by Adolescent Medicine Specialists: Pediatricians

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June 30, 2008
Who cares?
Analysis of: Taro Receives Final FDA Approval For RX Cetirizine Hydrochloride Syrup ANDA | www.medicalnewstoday.com
Author: GLG Expert Contributor
Taro just got approval for Rx cetirizine - big whoop!  Zyrtec has been OTC in all forms (tablet, chewable and syrup) since 11/07.  Do you know anyone who will write a prescription for an OTC drug or an insurance company that will cover it?
June 27, 2008
GSK completes pediatric DTP+ line with (awfully named) Kinrix
Analysis of: FDA Approves GlaxoSmithKline's New Combination Vaccine For Children | www.medicalnewstoday.com
Author: GLG Expert Contributor
Glaxo has just gotten approval for Kinrix (DTaP-IPV).  It's products for infants and toddlers, Pediarix (DTaP-HepB-IPV) and Infanrix (DTaP) are used in children under 2; Kinrix will be used for the 4-6 year booster dose, reducing by 1 the number of vacthat children get at this age.
June 11, 2008
BPA uncertainty will cause short-term opportunity regardless of ultimate conclusions
Analysis of: FDA's Chief Scientist Asks Science Board Subcommittee To Review Research On Bisphenol-A | www.medicalnewstoday.com
Author: GLG Expert Contributor
The FDA is opening investigations into whether the widely used plastic additive bisphenol A may have various effects on humans, based on animal models. Several companies are already touting their "BPA-free" status; as the FDA investigation will take a prolonged period to review and summarize available...
June 9, 2008
Could be a smart move or could backfire
Analysis of: Datacsope stock soars on takeover tlaks | www.northjersey.com
Author: GLG Expert Contributor
-Datascope has decided to exit the monitor market by selling a chunk of itself off, possibly making itself into a takeover candidate.  The remaining units make stents, balloon catheters and other cardiac equipment.  -One other effect is that it has placed itself into direct (rather than indirect)...
June 9, 2008
Pipeline or Preening for an Aquirer?
Analysis of: Novartis presents full pipeline of novel vaccines addressing significant unmet needs | www.pipelinereview.com
Author: GLG Expert Contributor
-Novartis' press conference discussed a "full pipline" of new vaccines, but the majority are still Phase I. -The meningitis vaccines being developed are not yet ready to go, and the one that is closest to being filed already has a competitor on the market.
June 2, 2008
Big opportunity for Glaxo
Analysis of: GlaxoSmithKline given OK to sell bird-flu vaccine in Europe | www.bizjournals.com
Author: GLG Expert Contributor
-Glaxo's pre-pandemic flu vaccine is a double opportunity - a chance to contract now with multiple governments to supply a pre-pandemic vaccine as well as a natural segue to become their future supplier of actual pandemic flu vaccine (when developed).  -When pandemic flu hits, the race will be...
May 21, 2008
GSK gets there first (for a change)
Analysis of: EU Approves GSK's Pre-Pandemic Bird Flu Vaccine | www.medicalnewstoday.com
Author: GLG Expert Contributor
Glaxo's new pandemic flu vaccine was just approved for sale and use in the EU.  It has or is trying to establish contracts with multiple countries to supply stockpiles with values in the 100's of millions
May 13, 2008
Lily's impact likely minimal
Analysis of: FDA Approves Strattera® for Maintenance of ADHD in Children and Adolescents | newsroom.lilly.com
Author: GLG Expert Contributor
Strattera has been approved for "maintenance treatment" for ADHD, however this probably changes nothing for prescribers or patients.  Those who are on it will continue to take it, but no one will be changing to Strattera because of this new classification.
May 12, 2008
Will Strattera be around in 3 years?
Analysis of: FDA Approves Strattera® for Maintenance of ADHD in Children and Adolescents | newsroom.lilly.com
Author: GLG Expert Contributor
My personal prediction is that this product will NOT be on the market in 3-5 years.  My clinical experience never approached that which the research would suggest.  I suspect that the "research" that was done on this product is frought with company incentives.
May 5, 2008
In Rotateq v. Rotarix, cost is only 1 issue
Analysis of: FDA Approves ROTARIX(R) Rotavirus Vaccine | www.pipelinereview.com
Author: GLG Expert Contributor
-Rotateq and Rotarix are the only two approved rotavirus vaccines in the US.  It's unclear how Rotarix will be priced, and since it is a 2-dose series vs. Rotateq's 3-dose series, the cost will be very important. -However, there are other factors as well, such as Merck being first to market...

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