December 18, 2019 Impact: Moderate Gilead’s Kite subsidiary has announced that it has submitted a BLA for the investigational CAR-T KTE-X19 for the treatment of patients with relapsed or refractory mantle cell lymphoma (R/R MCL).
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December 5, 2019 Impact: High CymaBay Therapeutics has terminated its phase 2b study of PPARδ agonist, seladelpar, in patients with NASH due to atypical histological findings.
Planned, blinded histological assessments of liver biopsies…
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October 31, 2019 Impact: High China regulators have cleared the IND for the fully human BCMA CAR-T, CT-103A, in development by Nanjing Iaso and Innovent Biologics.
In the recent issue of BioWorld (pages 1 & 6), Brian Hall, VP…
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October 31, 2019 Impact: High In March this year, the aducanumab phase 3 Alzheimer's disease trials were stopped based on futility, meaning that it was statistically almost impossible for the study to meet its endpoint. The operative word…
October 11, 2019 Impact: High Merck has announced that the China NMPA (National Medical Products Administration) has approved the use of Keytruda (pembrolizumab) as a frontline monotherapy agent in patients with locally advanced or metastatic…
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October 1, 2019 Impact: High Merck and Eisai have announced that FDA has granted an accelerated approval to the combination treatment of Keytruda/Lenvima (pembrolizumab/lenvatinib) for patients with advanced endometrial carcinoma that…