Indian API maker slammed with US FDA Warning over data issues
Failure in maintaining test and production data has landed an Indian API maker with a Warning Letter from the US Food and Drug Administration (FDA).
Archives for March 25, 2014
Covance to bring more biologics bioanalysis capacity online in 2014
Covance has announced that its recently expanded large molecule bioanalytical space at its laboratory facility in Indianapolis will come online in late 2014.
Cevec's cell line bypasses problems that have held back RSV vaccine
An expression system developed by Cevec Pharmaceuticals has achieved 'very high' titres and bypassed problems that beset other platforms, moving the possibility of a commercial respiratory syncytial virus (RSV) one step closer.
News from Interphex 2014
Catalent commits to ADCs by upping its stake in Redwood
Catalent has increased its stake in Redwood Biosciences telling us it is committed to the development of antibody-drug conjugates (ADCs) and the SMARTag technology platform.
AmerisourceBergen to launch $100m distribution JV in Brazil
AmerisourceBergen (ABC) plans to buy a minority stake in a Brazilian drug wholesaler and outlined plans for a $100m distribution services joint-venture in the rapidly expanding market.
US FDA issues new bioavailability guidelines
The US FDA has published guidance of how sponsors should best document the bioavailability of products for investigational new drug applications (INDs) and new drug applications (NDAs).
AMRI to acquire CDMO Cedarburg for $41M
AMRI will acquire Cedarburg Pharmaceuticals for $38.2m (€27.7) in cash, plus $2.8m of assumed liabilities, to expand its API and drug development offerings.