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July 27, 2016
The affinity purification company will set up shop at the former Merck & Co./GlycoFi facility in the Dartmouth Regional Technology Center in New Hampshire.
July 26, 2016
A new era has begun to address the deadly innovation gap in tackling the antimicrobial resistance crisis.
The therapeutic candidate AZD8601is an investigational mRNA-based therapy that will be tested for its ability to regulate the protein that influences vascular tissue growth.
The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.
On July 25, 2016 Kite Pharma entered into an agreement with the University of California, Los Angeles, (UCLA) to advance development of off-the-shelf allogenic T-cell therapies from renewable pluripotent stem cells. The company entered into an exclusive license agreement with UCLA for an artificial thymic organoid (ATO) cell culture system. The ATO replicates the human thymic environment to support efficient ex vivo differentiation of T-cells from primary and reprogrammed pluripotent stem cells.
July 25, 2016
The companies filed a BLA for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis.
The companies will test the efficacy of Rova-T in combination with Opdivo, and Opdivo + Yervoy as a treatment for extensive-stage small cell lung cancer.
July 22, 2016
The agency will review Mylan and Biocon’s biosimilar to pegfilgrastim.
The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.
July 21, 2016
Amgen and Allergan’s biosimilar to popular breast cancer drug Herceptin is comparable to the innovator molecule, Amgen recently announced.
