Phase I
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.
Amgen and Allergan announced positive top-line results from a Phase I/Phase III trial of their biosimilar candidate, ABP 798, to Genentech and Biogen’s Rituxan (rituximab).
Pyrrolobenzodiazepine-based antibody drug conjugate targets AXL, a receptor tyrosine kinase highly expressed in solid tumors
CarTher today announces it has secured approval from the French National Agency for Medicines and Health Products Safety (ANSM) to start a Phase I-II clinical trial of its SonoCloud-9 device in the treatment of recurrent glioblastoma.
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Novel target class with dual action in inflammatory disorders
DTX401 Response Observed in All Three Patients, with Two Patients Demonstrating Clinically Meaningful Improvement in Time to Hypoglycemia
Potential for new immune-oncology therapy using an antibody drug conjugate that targets regulatory T cells
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