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GLG News by Gardasil Prescribers (US)

June 30, 2008
Who cares?
Analysis of: Taro Receives Final FDA Approval For RX Cetirizine Hydrochloride Syrup ANDA (www.medicalnewstoday.com)
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?
Analysis of: FDA Approves GlaxoSmithKline's New Combination Vaccine For Children (www.medicalnewstoday.com)
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.
Analysis of: Most Doctors Aren’t Using Electronic Health Records (www.nytimes.com)
While all can agree that universal use of EMR/EHR would be beneficial, the cost burden of implementing these systems generally rests with the physician, who will generally see the least benefit (as opposed to insurance companies, Medicare, patients, etc.)
Analysis of: Researchers Fail to Reveal Full Drug Pay (www.nytimes.com)
While I knew (from the required disclosures) that these researchers receive income from speaking for the pharmaceutical companies about their products, I am troubled more by the amounts involved. A speaker who is acting as a paid spokesman for ANY product deserves to be paid for his/her time, and physicians...
Analysis of: FDA's Chief Scientist Asks Science Board Subcommittee To Review Research On Bisphenol-A (www.medicalnewstoday.com)
Gee, remember when Nalgene was the way to go, because it was safer/healthier than phthalates? Now Nalgene is suspect, since it may contain BPA. Metal is no good, especially aluminum. And if the inner lining is some epoxy coating, there are yet other things to worry about. I THINK glass is still safe...
Analysis of: FDA's Chief Scientist Asks Science Board Subcommittee To Review Research On Bisphenol-A (www.medicalnewstoday.com)
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...
Analysis of: Datacsope stock soars on takeover tlaks (www.northjersey.com)
-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)...
Analysis of: Novartis presents full pipeline of novel vaccines addressing significant unmet needs (www.pipelinereview.com)
-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.
Analysis of: GlaxoSmithKline given OK to sell bird-flu vaccine in Europe (www.bizjournals.com)
Whether or not the bird flu ever becomes a threat to humans, Glaxo has won here. Since it will be impossible to rule out a serious risk of epidemics, an effective vaccine will have to be purchased and stockpiled by governments and other health care systems.
Analysis of: AstraZeneca Submits an sNDA for SYMBICORT(R) for the Treatment of Asthma in Children as Young as Age Six (www.pipelinereview.com)
Symbicort has proven safe and effective in ages 12 and up, and should confer its benefits on younger patients as well.    

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