FDA taking more cautious approach to non-inferiority trials
The FDA is taking a more conservative approach to data from non-inferiority trials when reviewing NDAs, according to a GAO report.
Archives for August 29, 2010
Appointments at Discovery Labs, NewAge Industries and Jennerex – People on the move
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Discovery Labs, NewAge Industries and Jennerex.
Aterovax and Biomnis join to offer sPLA2 biomarker to trial sector
Aterovax has teamed up with Biomnis to target the clinical trial industry with a new atherosclerosis biomarker, sPLA2, designed to give researchers better insight into a candidate heart drug’s therapeutic potential.
KCAS talks biomarker strategy development
Biomarkers are critical to discovery and can help pharmaceutical firms make development a more efficient and cost effective process accord to bioanalysis services provider KCAS.
Lonza buys Vivante to expand custom biologics biz
Lonza buys viral-based biologics maker Vivante GMP Solutions to broaden custom manufacturing offering.
Contractors poaching regulatory, quality and clinical talent, says ZRG
ZRG Partners says there was a “fight for talent” in hiring, firing and vacancies in Q2, with the outsourcing and pharmaceutical sectors battling for employees within regulatory, quality and clinical roles.