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All GLG News Analyses Filed Under: Infectious Disease

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Posted July 5, 2007

Pfizer Receives Approvable Letter From FDA For Maraviroc
Analysis of: Pfizer Receives Approvable Letter From FDA For Maraviroc | www.pipelinereview.com
Author: GLG Member Program Contributor

While ideally Maraviroc would now be approved the requests from the FDA do not require new clinical trials. The main issues relate to the failings of other drugs in this class Aplaviroc (Ono/GSK) discontinued for hepatotoxicity and questions over malignancies with Vicriviroc (Schering-Plough). Data...

Posted June 25, 2007

Cethromycin Achieves Primary Endpoint In Pivotal Phase 3 Pneumonia Clinical Trial
Analysis of: Cethromycin Achieves Primary Endpoint In Pivotal Phase 3 Pneumonia Clinical Trial | www.medicalnewstoday.com
Author: GLG Member Program Contributor

This study showed the non-inferiority and safety of cethromycin in CAP, in a randomized trial comparing cethromycin to clarithromycin. This was a multi-center, multinational study with about 225 patients in both arms and showed good responses in both groups (about 92% and 96%). The dose of Biaxin...

Posted June 25, 2007

The study shows non-inferiority of the drug compared to Biaxin. Side efffects are similar. Is a once a day preparation that better than a twice a day?

Posted June 15, 2007

Novartis Optaflu Flu Vaccine Gains EU Approval
Analysis of: Novartis Optaflu Flu Vaccine Gains EU Approval | www.medscape.com
Author: GLG Member Program Contributor

If clearly shown to be antigenically better, there will be a place for the vaccine in the US market. Otherwise, it will likely be used in those few patients that have a true egg allergy, and cannot take the regular vaccine. The new technolgy is good, but at what extra cost to the consumer or 3rd party...

Posted June 15, 2007

Pfizer's Antifungal Drug Eraxis Good As Injections For Fighting Invasive Candidiasis
Analysis of: Pfizer's Antifungal Drug Eraxis Good As Injections For Fighting Invasive Candidiasis | www.therapeuticsdaily.com
Author: GLG Member Program Contributor

Any new medication will likely cost more than an established drug. There will need to be good reasons to use the new medication. Being non-inferior is not one of them.

Posted June 15, 2007

GlaxoSmithKline's application for DTaP-IPV vaccine is accepted for review by the FDA
Analysis of: GlaxoSmithKline's application for DTaP-IPV vaccine is accepted for review by the FDA | www.pipelinereview.com
Author: GLG Member Program Contributor

How practical is it to have developed this combination vaccine that is only indicated for ONE dose at 4-6 yo?? Think about it: we will be expected to buy, store, and administer this vaccine to children only one time in their life? At what cost? Any added benefit besides one less shot?

Posted June 12, 2007

Pfizer To Launch Antiretroviral Maraviroc In July After FDA Tests Conclude, Official Says
Analysis of: Pfizer To Launch Antiretroviral Maraviroc In July After FDA Tests Conclude, Official Says | www.medicalnewstoday.com
Author: GLG Member Program Contributor

Maraviroc will aid decrease HIV drug resistence. Because maraviroc's mechanism of action is different from the other antiretrovirals, its use can help those patients with HIV resistant mutations.

Posted May 30, 2007

CDC warns about contact lens solution
Analysis of: CDC warns about contact lens solution | news.yahoo.com
Author: GLG Member Program Contributor

This is not exactly the same as seen last year in B&L Renu product. The acantamoeba is commonly found in water. The main problem with Complete is that it does not successfully kill off the acantameoba after a patients contact lenses have been exposed to it.

Posted May 30, 2007

CDC warns about contact lens solution
Analysis of: CDC warns about contact lens solution | news.yahoo.com
Author: GLG Member Program Contributor

This is not the same as the Fusarium fungal outbreak seen last year in B&L Renu with Mositureloc product. This outbreak is with an Amoeba which is commonly found in water. The issue with Complete is that it does not successfully disinfect and kill off this...

Posted May 30, 2007

CDC warns about contact lens solution
Analysis of: CDC warns about contact lens solution | news.yahoo.com
Author: GLG Member Program Contributor

This article reports a contact lens associated infection with Advanced Medical Optics contact lens solution. Despite owning less than 10% of the Market Share, AMO Complete® MoisturePlus™ (AMOCMP) multipurpose cleaning solution has been implicated in 60% of the cases of Acanthamoeba...

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