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GLG News by Adolescent Medicine Specialists: Pediatricians

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March 26, 2007
Canada Getting on Board for Universal Gardasil (HPV vaccine) use
Analysis of: Canadian Government Includes $258M In Budget For HPV Vaccination | www.medicalnewstoday.com
Author: GLG Expert Contributor
-Canada has just allocated $250 million MORE dollars for HPV vaccine purchase this year.-Merck has the only approved product in Canada (and elsewhere); the nearest competitor is likely a year or more away.-As more countries find the money for these programs it will become harder and harder...
March 5, 2007
Virginia to become second state to enforce Gardasil use
Analysis of: Va. set to mandate Gardasil | www.boston.com
Author: GLG Expert Contributor
-Texas was the first state to enforce guidelines written by the AAP and CDC to give Gardasil to 11-12 year old girls; now Virginia is poised to become #2.-This mandatory vaccination program makes a guideline compulsory for school attendance-Merck is the maker of Gardasil; Glaxo is developing a similar...
February 27, 2007
Merck's UK Clinical Gardasil Trial halted early
Analysis of: Merck, Sanofi end Gardasil studies due to success | today.reuters.com
Author: GLG Expert Contributor
Merck's Gardasil, approved for use in the US last year, is being developed for use in the UK.A clinical trial to test Gardasil's effectiveness in England was just halted because it was so effective - continuing the trial would have been unethical to those in the placebo arm.England will become another...
February 14, 2007
Rotateq may be associated with intussusception
Analysis of: FDA Public Health Notification: Information on RotaTeq and Intussusception | www.fda.gov
Author: GLG Expert Contributor
-Rotateq is a second-generation vaccine to prevent rotavirus. Merck is now working with governments across the world to try to expand its use.-The prior product was pulled off the market due to an association with intussusception.  -The FDA is analyzing case reports of infants developing intussusception...
February 14, 2007
Little effect likely of OTC fat blocker
Analysis of: FDA OKs First Nonprescription Diet Pill | www.washingtonpost.com
Author: GLG Expert Contributor
-The first OTC diet aid (a weaker form of orlistat) has been approved for adult use-Side effects including "anal leakage" will limit the number of people willing to give it a try-Price and limited weight loss potential will also cut the potential market 
February 5, 2007
Pentacel not the first 5-in-1 vaccine out there. GSK got there first!
Analysis of: FDA Advisers Endorse Childhood Vaccine | users1.wsj.com
Author: GLG Expert Contributor
- Pentacel is Sanofi's entry into the new multiple-antigen market- The space is already occupied by Glaxo's Pediarix, which covers almost the same diseases but was approved in the US 2 years ago.- There's room for both, but both will need successors as desire grows for a single all-in-one "supershot"...
February 5, 2007
Yaz's new indication unlikely to make much difference
Analysis of: FDA Approves New Indication for Yaz to Treat Acne | www.pharmalive.com
Author: GLG Expert Contributor
- Several OCPs are approved for use to treat acne; the first (Ortho Tri-Cyclen) was approved for this indication in 1997. In addition, most OCPs using the newer progestins have the same effect, even if not specifically labeled for this use.-Yaz and its parent compound Yazmin are and will remain very...
February 5, 2007
Gardasil unlikely to gain approval for men
Analysis of: New Vaccine for Cervical Cancer Could Prove Useful in Men, Too | www.nytimes.com
Author: GLG Expert Contributor
- Gardasil, approved for females age 9-27 for prevention of HPV, has been tested overseas in males to prevent the same virus from causing anal cancer.- The FDA is unlikely to get the chance to approve Gardasil for this indication because Merck is unlikely to do the research that proves whether or not...
February 5, 2007
US Government Encouraging More Players onto Field in Vaccine Game
Analysis of: Vaccine Makers Receive Immunity From the U.S. | online.wsj.com
Author: GLG Expert Contributor
-Action was taken this week to remove the potential of lawsuits over side effects from drug companies developing avian flu vaccines-This is one of the few inducements that Washington can give that matters to pharmaceutical makers that may encourage them to either get into research for flu drugs or to...
February 5, 2007
Texas is only the first
Analysis of: Texas governor orders anti-cancer vaccine for schoolgirls | www.usatoday.com
Author: GLG Expert Contributor
-HPV vaccine is a groundbreaking advance in cancer prevention. As states realize that mandating its use will save dollars in cancer treatment starting in the next 10 years, it will be required more and more (thank goodness!)-Insurance companies and individuals, not individual state governments shoulder...

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