News & Analysis on Clinical Trial Services & Contract Research And Development
From July the EC will require that gelatin used in parenteral drugs is sourced from countries in World Organisation for Animal Health's (OIE) lowest risk categories for bovine spongiform encephalopathy (BSE).
Quintiles will help South Korea develop its clinical research infrastructure under a new collaboration with the Korea National Enterprise for Clinical trials (KoNECT).
German transdermal drug developer, Labtec, has opened what it claims is Europe’s most modern manufacturing facility for the production of transdermal drug delivery systems (TDS) and oral dispersible films (ODF) using its proprietary RapidFilm technology.
ACRO has welcomed new draft guidance on SAE reporting in trials issued by India's CDSCO, but has raised some concerns about the determination of causality and compensation.
Irish pharma giant Elan is investing $20m (€14m) in US drug developer Proteostasis Therapeutics to speed the research and development of disease modifying, small molecule drugs and diagnostics for the treatment of neurodegenerative disorders.
UK-based contract manufacturing organisation (CMO) SCM Pharma has struck a deal with urology experts Speciality European Pharma (SEP) to help bring SEP's oncology product, Plenaxis, to the European market.
The US Food and Drug Administration (FDA) has published a list of all the drug manufacturing facilities it has inspected between October 2008 and September 2010 as part of Government transparency efforts.