breaking news
Novo Nordisk subpoenaed over Danish manufacturing site
Novo Nordisk has been served with a subpoena over alleged manufacturing issues at its site in Kalundborg, Denmark.
Archives for October 27, 2014
Superbug-driven surge in polymyxin demand prompts EMA to reassess safety info
A superbug-fuelled resurgence of polymyxin antibiotics has prompted the European Medicines Agency (EMA) to re-examine safety warnings for the side effect heavy anti-infectives
WuXi partnership to bring genomic profiling to Chinese clinical trials
CRO WuXi PharmaTech is collaborating with Foundation Medicine to provide genomic profiling to biopharma companies conducting clinical trials in China.
Tower of Basel: Roche spends $3bn on giant R&D site
Roche has announced plans to invest 3bn Swiss Francs ($3.2bn) in a 433-ft R&D centre and extra offices for 3,600 employees.
Lawyers question legality of US FDA final guidance on delaying, denying inspections
What may seem to be relatively minor changes between the FDA’s draft and final guidance on delaying, denying, limiting or refusing a facility inspection could actually be more major as two lawyers called the final guidance, “critically vague and legally...
Report predicts increased outsourcing across all phases will be a boon for larger CROs
Mid-size and large sponsors foresee increases in RFP (request for proposal) volume for outsourced clinical services across all phases through December 2014, especially for larger CROs, according to a new report.