Bilcare doubles Crickhowell trial supply capacity
Indian CMO Bilcare says need to test new drugs in diverse patient groups drove expansion of its cold chain clinical trial supply packaging and storage facility in Crickhowell, Wales.
Archives for March 16, 2010
Patheon posts Q1 loss, but upbeat on 2010; Orexigen deal
Patheon attributes Q1 loss to charges and plant closure costs and says there has been “an encouraging increase in new sales activity” in calendar 2010.
FDA wants more data on Afrezza's "clinical utility"; MannKind's shares fall
US Food and Drug Administration (FDA) request for more Afrezza data is not safety related and will not require new clinical trials, says developer MannKind.
Appointments at Pacific Biomarkers, Halloran Consulting Group and Venn Life Sciences – People on the move
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Pacific Biomarkers, Halloran Consulting Group and Venn Life Sciences.
FDA pandemic guidance is “unnecessarily burdensome”
GSK, Genentech, BIO and PDA have stated that it is “unnecessarily burdensome” for pandemic production plans to conform to parts of 21 CFR and requested that the FDA revises its draft guidance.
INC forms ePRO partnership with invivodata
INC Research is partnering with invivodata to add ePRO to its offering, selecting the eClinical firm over its competitors in part because it understands the “aggressive” approach the CRO takes.
Genzyme addresses impurity problem at Ireland Cerezyme plant
US drugmaker Genzyme has detected an impurity in one vial of the Gaucher’s disease drug Cerezyme produced at its manufacturing facility in Waterford, Ireland.