Italian regulator slams simvastatin-maker Krebs for GMP deviations
APIs made by Krebs Biochemicals and Industries at its facility in Visakhapatnam, India pose a ‘critical risk’ to public health according to Italian regulators.
APIs made by Krebs Biochemicals and Industries at its facility in Visakhapatnam, India pose a ‘critical risk’ to public health according to Italian regulators.
Recombinant albumin supplier Albumedix will help Hebei Changshan Biochem Pharma develop a once-a-week diabetes treatment.
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French investigators reviewing the Phase I trial in which one volunteer died and five others were hospitalized in January have criticised CRO Biotrial over how it conducted the study.
Patients must be more involved in trials according to ex Google Chief Health Strategist, who told sponsors and CROS that increasing engagement is key to moving forward.
Crown Bioscience has launched an oncology service platform to improve preclinical studies using patient-derived xenograft (PDX) models.
Italian API firm Olon SpA has signed a definitive agreement to buy Infa Group in a deal designed to strengthen its portfolio.
Indian API maker JP Laboratories is unable to sustain GMP compliance at its facility in Daund, Maharashtra according to the Italian Medicines Agency (IMA).