Biopharma News
FDA Grants Fast Track Designation for Decompensated Heart Failure Drug
January 16th 2020The drug is formulated to improve cardiac contractility with a reduced effect on heart rate, blood pressure, and myocardial oxygen consumption while potentially avoiding adverse events associated with current inotrope therapies.
Horizon Discovery, Mammoth Biosciences Sign Collaboration and License Agreement
January 15th 2020Horizon Discovery Group and Mammoth Biosciences have signed a collaboration and license agreement aimed at the development of the next generation of engineered Chinese hamster ovary (CHO) cell lines to improve biotherapeutics production.
Boehringer Ingelheim Biopharmaceuticals China Receives Approval Under Under China’s New MAH Model
January 3rd 2020Boehringer Ingelheim Biopharmaceuticals China is the first company to apply the adopted Marketing Authorization Holder system within the revised Chinese Drug Administration Law through its partnership with BeiGene for its monoclonal antibody, tislelizumab.
FDA Approves Fast Track Designation for Nasal Spray for Social Anxiety Disorder
December 12th 2019The rapid-onset CNS neuroactive nasal spray is distributed to patients in microgram doses and activates nasal chemosensory receptors that trigger neural circuits in the brain that suppress fear and anxiety associated with everyday social, work, or performance situations.
Investment and Skills Demand in UK Cell and Gene Therapy Industry Rising, According to Data
December 5th 2019Data released by the Cell and Gene Therapy Catapult (CGT Catapult) have shown that demands for specialist skills and investment in the cell and gene therapy industry in the United Kingdom are set to increase in the near future.
Sangamo Gains MHRA Authorization for Clinical Trial of CAR-Treg Therapy
November 21st 2019Sangamo Therapeutics has revealed that the United Kingdom’s Medicines Healthcare Products Regulatory Agency (MHRA) has authorized the first in-human clinical trial evaluating a chimeric antigen receptor regulatory T cell (CAR-Treg) therapy.
GE Healthcare Life Sciences to Expand KUBio Through Close Collaboration with Pharmadule Morimatsu
November 21st 2019GE Healthcare Life Sciences has announced it will be working closely with Pharmadule Morimatsu to expand its KUBio “factory in a box” so that biopharma manufacturers will be able to quickly scale up vaccines, viral vector-based therapies, and other novel modalities.