Ocular Therapeutix receives CRL from FDA for its NDA for Dextenza
FDA reports deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility.
Celgene decides against pursuing new indication for its Revlimid
Data from a Phase III study indicate overall survival showed no benefit of Revlimid.
BMS announces new research collaboration with Janssen in immuno-oncology
The research will evaluate Opdivo and live attenuated double–deleted Listerial monocytogenes cancer immunotherapy
Axol Bioscience and Metrion Biosciences announce research collaboration
The human cell culture specialists join experts in ion channel research to study human iPSC-derived cardiomyocytes for drug discovery applications.
Top 3 therapy areas account for 68% of overall pharmaceutical industry pipeline
Oncology, infectious diseases and central nervous system disorders accounted for a combined 68% of the overall pharmaceutical industry pipeline as of Q1 2016, says GBI Research.
Shire launches pediatric indication for immunodeficiency treatment HyQvia in Europe
HyQvia is the only subcutaneous IG treatment for primary and certain secondary immunodeficiencies that can be administered in one site, once a month.
FDA grants QIDP and Fast Track designations to MCB3837
Morphochem’s novel intravenous antibacterial to treat C. difficile infections.
AbbVie and BMS announce oncology clinical collaboration to evaluate the combination of Rova-T plus Opdivo and Opdivo + Yervoy regimen
Collaboration will explore the safety and potential enhanced efficacy of combining checkpoint inhibitors with a cancer stem cell-targeting antibody drug conjugate in SCLC.
Innova Biosciences introduces InnovaCoat GOLD-Carboxyl nanoparticles
Functionalized gold nanoparticles for easy, fast covalent conjugation of antibodies.