US FDA warns CRO for 'incorrect archiving of study materials'
The US FDA has issued a warning letter to North American Science Associates, following an inspection of the CRO’s Brooklyn Park facility in Minnesota.
Archives for August 20, 2018
Sygnature Discovery doubling DMPK department, recruitment program ongoing
Sygnature Discovery is adding a new facility at Alderley Park in Cheshire, UK in response to an increasing demand for outsourced preclinical research services.
CROs respond: FDA guidance on expansion cohort use in FIH trials a ‘welcome step’
Industry executives are welcoming the FDA’s draft guidance on expansion cohort use in first-in-human clinical trials – the increasing use of which is evidence of a changing drug development paradigm, says CRO.
Syneos acquires consulting firm to boost regulatory, safety, pharmacovigilance capabilities
Syneos Health has acquired the UK-based advisory firm Kinapse in a deal that will double its consulting footprint in Europe and further strengthen its commercial offerings – one company's fastest-growing lines of business, says CEO.
GSK to exit manufacturing site in Ireland, cuts 165 jobs
Disappointing sales prompted the decision to close GSK’s skincare manufacturing facility in Sligo, Republic of Ireland.
Teva set to launch generic EpiPen amid global shortage
Teva announced that its generic version of Mylan’s EpiPen product has been approved by the US FDA.
Rapid Novor expands proteomics lab with third mass spectrometer
Rapid Novor has expanded its proteomics lab with the addition of a third mass spectrometer – enabling the company to take on more projects, says CEO.
Pfizer signs $425m mRNA flu vaccine agreement with BioNTech
BioNTech signed a collaboration agreement with Pfizer to conduct joint research on a mRNA-based flu vaccine.