Venn buys human skin substitute
Clinical research group Venn Life Sciences has acquired the rights to LabSkin (pictured), a human skin substitute that behaves like the real thing, from dermatology CRO Evocutis.
Archives for March 4, 2014
CMO 'Jubilant' after US FDA deems Canada plant 'acceptable'
Jubilant HollisterStier says the Warning Letter in place at its Montreal, Canada facility did not affect manufacturing or business as - twelve months later – the US FDA upgrades the site to ‘acceptable.’
New Zealand looks to revise its abbreviated process policy
The New Zealand Medicines and Medical Services Safety Authority is looking to update its abbreviated evaluation process, which is intended to be a simpler and quicker process than the standard evaluation process.
Lilly looks local with Brazilian packaging investment
Eli Lilly says investment in its Sao Paolo, Brazil packaging plant will support growth for the local market.
Demand for plasmid production growing says Cobra Biologics
Cobra Biologics is looking for more scientists with plasmid production skills after BioCancell became the fifth firm in a year to ask the CMO to manufacture a DNA-based gene therapy candidate.
EMA finalizes guidance on process validation for manufacturers
The European Medicines Agency (EMA) stressed the potential benefits of continuous process validation in guidance issued this week and underlined that data submitted by drugmakers must demonstrate the adequacy of production operations at each site.
US FDA outlines new data requirements for HIV vaccine developers
The US FDA outlined in draft guidance the ways in which sponsors must submit data for their HIV vaccines and other treatments.