Arena Will Move 5-HT2A Antagonist Into Phase III For Insomnia In 2008
This article was originally published in The Pink Sheet Daily
Executive Summary
Phase II data show that APD125 significantly improves sleep maintenance in chronic insomnia patients.
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Barr's adenovirus vaccines constitute its first biologics BLA: Barr's adenovirus types 4 and 7 live oral vaccines carry an FDA user fee date of July 31, 2009, making it the company's first in-house biologics to reach FDA review. Barr, through its Duramed subsidiary, entered into a multi-year agreement in 2001 to develop the vaccines for the U.S. Department of Defense. The vaccine product is administered as an oral enteric-coated tablet with an inner tablet core containing live adenovirus - type 4 or type 7 - surrounded by an outer tablet coat and a final enteric coat. The type 4 and type 7 vaccine tablets are taken together to prevent wild type 4 adenovirus-associated acute respiratory disease and to induce neutralizing antibody to type 7 adenovirus. The BLA is supported by a Phase III placebo-controlled study in more than 4,000 male and female Navy and Army recruits
R&D IN BRIEF
Barr's adenovirus vaccines constitute its first biologics BLA: Barr's adenovirus types 4 and 7 live oral vaccines carry an FDA user fee date of July 31, 2009, making it the company's first in-house biologics to reach FDA review. Barr, through its Duramed subsidiary, entered into a multi-year agreement in 2001 to develop the vaccines for the U.S. Department of Defense. The vaccine product is administered as an oral enteric-coated tablet with an inner tablet core containing live adenovirus - type 4 or type 7 - surrounded by an outer tablet coat and a final enteric coat. The type 4 and type 7 vaccine tablets are taken together to prevent wild type 4 adenovirus-associated acute respiratory disease and to induce neutralizing antibody to type 7 adenovirus. The BLA is supported by a Phase III placebo-controlled study in more than 4,000 male and female Navy and Army recruits
Lilly Licenses Merck KGaA Insomnia Agent EMD 281014
Phase I 5-HT2a antagonist also has potential for use in other central nervous system disorders, Lilly says. Possible benefits in sleep category include less next-day side effects and use in broad patient population.