Phase I
Combination trial to evaluate safety and anti-tumor activity of agents that target B-cell cancers
For its 2019 list of the top 50 most innovative companies, Fast Company selected 10 from the biotech industry that are having a significant impact on the treatment of patients. The first five are highlighted.
The patients were part of a trial assessing Xencor’s mAb14045, a CD123 x CD3 bispecific antibody molecule being evaluated in patients with relapsed or refractory acute myeloid leukemia.
Four patients with spinal cord injuries will receive nerve cells made from induce pluripotent stem cells in hopes of regaining sensation and mobility lost as a result of the injury.
Combination of antibody drug conjugate and checkpoint inhibitor being evaluated for treatment of relapsed or refractory diffuse large B-cell, mantle cell and follicular lymphomas
Across parts of Europe, Asia and the rest of the globe, pharma and biotech companies have made strides and deals to advance their pipelines and technologies this week.
Shares of Brisbane, Calif.-based Sangamo Therapeutics plunged 30 percent Thursday after the company released preliminary results from a gene-editing trial that investors saw as less than stellar.
Thomas Wicks, chief strategy officer of New Jersey-based TrialScope, said transparency has picked up over the past few years, particularly as large pharma companies have begun to release information about their own clinical efforts.
Shares of Solid Biosciences have plunged more than 71 percent after the company revealed early data from a Phase I/II trial that showed low doses of its gene therapy treatment may lack the potential to be as effective a treatment for Duchenne muscular dystrophy as current products on the market.
Real-world evidence (RWE) or real-world data (RWD) relates to the collection of information about a drug’s safety and efficacy outside the structure of a clinical trial. Speaking yesterday, FDA Commissioner Scott Gottlieb laid out the FDA’s new framework for dealing with RWE and RWD.
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