CMO PCI Synthesis lands 12 new biotech, medtech clients amid growth
Contract manufacturer PCI Synthesis has signed up a dozen new Boston-based biotech and medtech customers as local demand has grown.
Archives for June 14, 2015
API plant inspections to continue despite rule change say South African regulators
South African regulators will continue to inspect all local and some international API sites despite relaxing facility assessment rules last week.
Canadian CRO leverages site relationships to target early-phase US biotech trials
Canada’s only oncology-focused CRO Scimega has created a program that allows it to align more closely with investigative sites across nine provinces.
EMA PSUR database fit for purpose
Drugmakers will be able to upload drug safety data to a single website from next year after a database developed by the EMA has been deemed fit for purpose by independent auditors.
US FDA teams with PatientsLikeMe to access post-market patient data
PatientsLikeMe says a deal allowing the US FDA to use its patient-generated data is an “unprecedented step toward enhancing post-market surveillance.”
Mammary glands in a dish: Scientists recreate tissues for better models; spin out CRO planned
Researchers say a hydrogel that prompts cells to form tissue-like structures in vitro could be used to make more accurate preclinical disease models.
Akebia signs up Quintiles for Phase III study
Akebia Therapeutics has signed a master services agreement with CRO Quintiles in connection with its planned Phase III studies for Akebia’s lead product candidate for the treatment of anemia secondary to chronic kidney disease in non-dialysis patients.