FDA posts guidance on Phase I CMC for live biotherapeutics
The US FDA has published final guidance on the CMC data needed to support early phase trials of live biotherapeutics.
Archives for February 27, 2012
News from Biomatters, Seattle Genetics, and Permeon – People on the move
in-PharmaTechnologist presents its weekly round-up of the latest appointments within the pharmaceutical industry, including news from Biomatters, Seattle Genetics, and Permeon.
EXCLUSIVE
Social networking is key to trial recruitment success, says expert
Pharma companies must become more involved in building patient communities through social media if they want to see a successful trial recruitment process according to Patient Nucleus founder Jamie Blackburn.
Sole suppliers must alert FDA to CMO production interruptions
Sole suppliers that outsource manufacture must alert the FDA of interruptions at their CMOs, the Agency wrote in draft drug shortages guidance.
Glenmark recalling birth control pills after packaging error
Glenmark is recalling incorrectly packaged birth control pills from the US, less than one month after Pfizer took similar actions.
TIBCO & ChemAxon ally to speed compound selection process
TIBCO and ChemAxon have combined forces over their chemical analysis software in a bid to “speed up and refine” the compound selection process.
Grindeks posts jump in API sales after expanding range by 50%
API sales at Latvia-based Grindeks jumped last year as it benefited from expanding its portfolio by 50 per cent.