Patheon adds development services at Italian plant
Canadian CMO Patheon has set up a pharmaceutical development services (PDS) sterile products suite at its manufacturing facility in Ferentino, Italy.
Archives for September 29, 2009
FDA issues cancer vaccine trial guidance
Clinical trials of cancer vaccines should enrol patients with no evidence of residual disease, according to FDA guidance, but this will increase development times compared to cytotoxic agents.
Benefits of SMS for trial recruitment are self-evident, says Axiom
Axiom Accelerated Patient Recruitment hopes its new range of SMS, text messaging, services can help CROs and pharma sponsors reach more potential study participants.
Savvion and Patni to bring BPM to drug development
US companies Savvion and Patni Life Sciences hope their new alliance help pharmas biotechs and CROs meet regulatory challenges “across the drug development cycle.”
ClearTrial software aims to streamline clinical trials
ClearTrial has expanded its eClinical offering to create “the only system in the industry” that can provide fast and accurate project tracking, management of accrued liabilities and midstream study adjustments.
Caraco enters into consent decree with FDA
Caraco Pharmaceutical Laboratories has entered into a consent decree with the FDA which details a series of measures that must be fulfilled to allow the company to resume manufacturing.
ATMI launches single-use powder transfer bag
ATMI has launched a powder transfer bag, for substances such as APIs and excipients, which it claims has three times the shelf life of alternatives, increases process efficiency and improves safety.