Sanofi Pasteur Aims To Bring Flu Jab To The Masses In America
This article was originally published in The Pink Sheet Daily
Growth spurts in flu, meningitis and whooping cough expected as firm targets those shy of immunization.
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Regulatory News, In Brief
FDA advice on antibiotic development for skin infections: Non-inferiority trials are not appropriate for studying antibacterial drugs to treat mild skin conditions such as impetigo and minor cutaneous abscesses, FDA says in a long-awaited draft guidance released Aug. 26. In recommending that only placebo- or active-controlled superiority studies be employed for these conditions, the agency followed the November 2008 recommendations of its Anti-Infective Drugs Advisory Committee (1"The Pink Sheet," Nov. 24, 2008). The document, which updates a 1998 guidance, adopts new nomenclature for skin infections, eschewing the terms complicated and uncomplicated skin and skin structure infections for acute bacterial SSSI and milder skin infections. ABSSSIs include cellulitis/erysipelas, wound infections, major cutaneous abscesses and burn infections. Non-inferiority trials, as well as superiority trials, are acceptable for ABSSSIs
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.