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AstraZeneca and its global biologics research and development arm, MedImmune, announced that the US Food and Drug Administration (FDA) has accepted the first Biologics License Application (BLA) for durvalumab, a PD-L1 human monoclonal antibody (mAb), and granted priority review status with a Prescription Drug User Fee Act (PDUFA) set for the second quarter of 2017.
Exact Imaging, the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, has received FDA 510(k) clearance for its ExactVu micro-ultrasound system.
Biotage, a leading global supplier of solutions and technology for analytical, medicinal and peptide chemistry, is pleased to announce the launch of Biotage SNAP Bio C18 and Biotage SNAP Bio C4 cartridges - a new range of high performance flash cartridges with wide pore media (300 Å) for reversed phase purification of peptides and other larger molecules.
AstraZeneca and Eli Lilly and Company announced a worldwide agreement to co-develop MEDI1814, an antibody selective for amyloid-beta 42 (Aβ42), which is currently in Phase I trials as a potential disease-modifying treatment for Alzheimer’s disease (AD). This agreement builds on the existing collaboration related to AZD3293, a BACE inhibitor in two pivotal Phase III trials.
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