US FDA wants CRO and sponsor feeback on data exchange standards
The US FDA wants CROs, sponsors and the wider industry to debate the pros and cons of current and evolving approaches to sharing study data.
Archives for August 13, 2012
Icon readies itself for translational medicine boom with Manchester expansion
Icon has boosted its Phase I translational medicine services in Manchester, UK, in preparation for what it believes will be a boom in the drug development area.
Low demand for ‘Lipitor’ intermediate hits Codexis in Q2; job cuts expected
A drop in atorvastatin–related orders hurt Codexis in Q2 but the firm's pharma business is unlikely to face cuts.
UK overhauls drug laws with new Human Medicines Regulations
New Human Medicines Regulations came into effect this morning, overhauling the UK's regulations on drug manufacturing, importation, distribution, packaging and pharmacovigilance.
Wuxi grows revs thanks to lab biz, but margins suffer on costs
Chinese CRO Wuxi Pharmatech posted impressive revenue growth for Q2 driven by demand for lab services, but the firm still faced margin pressure due partly to rising labour costs.
FDA and EMA set out efforts to mitigate GMP-related shortages
Regulators on both sides of the Atlantic address the shortages that occur when drugmakers fail to comply with GMP in documents published this week.
Difficult new biz acquisitions drag PDI's Q2 profits
Longer-than-expected ramp up in new business gains for PDI has dragged on Q2 earnings results for the firm.
Sanofi gets US FDA OK for talking injection device
Sanofi has received US FDA approval for an auto-injector that gives audio and visual cues to assist in the injection process.
US Government must 'get a handle' on biosecurity, say experts
US biosecurity experts are calling on industry and the Government to “get a handle” on the supply chain for drugs used in times of pandemic or bio attack.