GLG News by Adolescent Medicine Specialists: Pediatricians
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February 11, 2008
DPI for 4+ year olds - love it!
Analysis of: FDA Approves ASMANEX (R) TWISTHALER(R) (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children Ages 4-11 | www.pipelinereview.com
Author: GLG Expert Contributor
Analysis of: FDA Approves ASMANEX (R) TWISTHALER(R) (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children Ages 4-11 | www.pipelinereview.com
Author: GLG Expert Contributor
-Dry powder inhalers (DPIs) for kids are big news as traditional MDIs can be hard to use -If the device is easy to use, other meds (like albuterol) might be made available to use this way as well
December 7, 2007
Approval in India means little in U.S.
Analysis of: BHARAT BIOTECH LAUNCHES TWO NEW VACCINES IN INDIA (Bio-Hib and Comvac4-HB vaccines) | www.therapeuticsdaily.com
Author: GLG Expert Contributor
Analysis of: BHARAT BIOTECH LAUNCHES TWO NEW VACCINES IN INDIA (Bio-Hib and Comvac4-HB vaccines) | www.therapeuticsdaily.com
Author: GLG Expert Contributor
-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...
October 29, 2007
Addition of meningococcal vaccine for younger children won't add much value
Analysis of: Sanofi Pasteur Receives FDA Approval of Meningococcal Vaccine for Children | pharmalive.com
Author: GLG Expert Contributor
Analysis of: Sanofi Pasteur Receives FDA Approval of Meningococcal Vaccine for Children | pharmalive.com
Author: GLG Expert Contributor
-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.
October 15, 2007
Genentech MUST take the stance it has - both legally and fiscally
Analysis of: Maker Seeks to Restrict Cancer Drug Used on Eye | www.nytimes.com
Author: GLG Expert Contributor
Analysis of: Maker Seeks to Restrict Cancer Drug Used on Eye | www.nytimes.com
Author: GLG Expert Contributor
-Avastin has been repackaged by some compounding pharmacies in place of Lucentis for an indication for which Avastin is not approved. They are both Genentech drugs, but with Lucentis being much more expensive. -This is a bit like grinding up amoxicillin tablets, making them into a suspension,...
October 2, 2007
FluMist add-on approval makes toddlers the ideal target market
Analysis of: FDA Approves Expanded Label For FluMist(R) To Include Children Two To Five Years Of Age | www.medicalnewstoday.com
Author: GLG Expert Contributor
Analysis of: FDA Approves Expanded Label For FluMist(R) To Include Children Two To Five Years Of Age | www.medicalnewstoday.com
Author: GLG Expert Contributor
-FluMist indications were just expanded, reducing the minimum age of administration to 2 years old (from 5). -This will make FluMist a desired product (by name) for parents seeking to protect their toddlers and preschoolers from flu but who also desire not to cause pain/crying/suffering. ...
August 9, 2007
wanning immunity as a future public health issue
Analysis of: Hepatitis B Vaccine Protection May Not Be Long-Lasting | www.medpagetoday.com
Author: GLG Expert Contributor
Analysis of: Hepatitis B Vaccine Protection May Not Be Long-Lasting | www.medpagetoday.com
Author: GLG Expert Contributor
I have long been concerned about this issue - not only for Hep B, but moreover for Varicella, and measles, etc. It is my prediction that, before the end of my medical career, immunizations will take a greater part in the Family Medicine/Internal Medicine practices, and people will need to receive...
July 5, 2007
Rotarix may gain approval, but when and does it matter in the near term?
Analysis of: AVANT's Partner, GlaxoSmithKline, Files Rotarix(R) Application for U.S. Marketing Approval with the FDA | www.pipelinereview.com
Author: GLG Expert Contributor
Analysis of: AVANT's Partner, GlaxoSmithKline, Files Rotarix(R) Application for U.S. Marketing Approval with the FDA | www.pipelinereview.com
Author: GLG Expert Contributor
-Rotarix (rotavirus vaccine) has been submitted for approval by Glaxo -Merck's Rotateq has been on the market for over a year now and has contracts with major players already in place -By the time GSK gets marketing approval, it will be a long time before they can convince enough clients to change ...
April 9, 2007
Second dose of varicella is in the future for all - so what?
Analysis of: Vaccines: What Does Cervical Cancer Have To Do With Chickenpox? | blogs.wsj.com
Author: GLG Expert Contributor
Analysis of: Vaccines: What Does Cervical Cancer Have To Do With Chickenpox? | blogs.wsj.com
Author: GLG Expert Contributor
-Varivax protects 85-90% of chuildren from chickenpox with a single dose; this rises to 96-99% with a second dose.-Virtually all vaccines are given in multiple doses, not solely Varivax-The CDC mandated a second dse of VZV vaccine for 4-year olds last year; the recommendation will expand to older people...
April 9, 2007
Cervarix (HPV vaccine) submitted to FDA
Analysis of: GlaxoSmithKline Submits Biologics License Application To US Food And Drug Administration For Cervarix | www.medicalnewstoday.com
Author: GLG Expert Contributor
Analysis of: GlaxoSmithKline Submits Biologics License Application To US Food And Drug Administration For Cervarix | www.medicalnewstoday.com
Author: GLG Expert Contributor
-GSK has submitted Cervarix to the US FDA-It is unclear how long approval may take, or if the FDA will request more data before final consideration, or for what ages it might be approved-Merck's Gardasil continues to gain in first-to-market status as states consider ways to pay for HPV vaccine and contemplate...
March 26, 2007
Wyeth's Prevnar becomes WHO's posterchild
Analysis of: Wyeth Salutes World Health Organization Call To Action To Combat Pneumococcal Disease | www.medicalnewstoday.com
Author: GLG Expert Contributor
Analysis of: Wyeth Salutes World Health Organization Call To Action To Combat Pneumococcal Disease | www.medicalnewstoday.com
Author: GLG Expert Contributor
- The WHO has embraced the use of pneumococcal conjugate vaccine in the developing world- Wyeth's Prevnar 7-valent vaccine for strep pneumo is now a standard of care for use in the US (4 doses for every child under 5)- Expansion of Prevnar's market to the rest of the world, even with price concessions...
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November 24, 2008
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