Remediation to continue through 2014 at Hospira's Rocky Mount
Remediation at troubled Rocky Mount facility will continue into 2014 Hopira says as it awaits an inspection by the US Food and Drug Administration (FDA).
Archives for November 7, 2013
Roche to re-enter antibiotics market…again
Roche could restart its antibiotic development activities if a superbug busting drug candidate being developed by new partner Polyphor fulfils its early clinical promise.
Covance partnership aims to expand next-gen sequencing offering
Covance and Pathoquest have announced an exclusive agreement to collaborate in providing next-generation sequencing (NGS)-based biosafety assessments.
US FDA, EMA offer more guidance on QBD for design space verification
The US FDA and European Medicines Agency (EMA) is now offering additional joint guidance on the concept of quality-by-design (QBD) that focuses mostly on design space verification.
CROs turn to app platform to speed development of CTMS modules
Plagued with tighter deadlines and calls for more efficiency, CROs (contract research organizations) seem to be increasingly turning to apps and cloud-based systems to develop CTMS (clinical trial management system) modules.
update
Evonik to raise excipient prices 10% in 2014 citing 'costs'
Evonik Industries has announced plans to increase what it charges for excipients used in modified release formulations next year, citing rising costs.
SAFC to offer integrated catalysis services in deal with CatSci
CatScI says pharma demand for catalysis services is increasing due to a greater focus on economic sustainability as it inks a deal with SAFC for its chemical processes.
CRL reports preclinical growth; may benefit from Big Pharma R&D cuts
Third quarter growth in preclinical services was due to gain in market share and demand from Big Pharma, Charler River Laboratories (CRL) says as it reports solid Q3 earnings.