Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Adial, Amarin, Axerovision, Bayer, Curevac, Genentech, Gennova, Gensight, GSK, HDT, J&J, Nocion, Pharmaxis, Poseida, Roche, Senhwa, SK Bioscience, Tauriga.
The race is on. After six years as the only FDA approved devices for left atrial appendage closure, Boston Scientific Corp.’s Watchman products face a challenger, Abbott Laboratories’ Amplatzer Amulet. With the Amulet’s FDA approval in mid-August and positive results in a head-to-head trial presented at the 2021 European Society of Cardiology Congress on Tuesday, the Watchman has reason to look over its shoulder at a competitor that could change the game entirely. The trial results were published simultaneously in Circulation.
Binhui Biopharmaceutical Co. Ltd.’s BS-001, a recombinant human oncolytic herpes simplex virus type-2 expressing GM-CSF for the potential treatment of solid tumors, has gained an IND approval from the FDA.
Recently published phase II data with Takeda Pharmaceutical Co. Ltd.’s TAK-906 (trazpiroben), a dopamine D2/D3 receptor antagonist, fueled hope for patients as Processa Pharmaceuticals Inc. proceeds with a different – and more focused – approach against gastroparesis.
Brii Biosciences Ltd. made strides toward getting its SARS-CoV-2 neutralizing monoclonal antibody combination therapy, BRII-196/BRII-198, to market with positive interim phase III data that show high-risk outpatients may benefit from the combination therapy up to 10 days following symptom onset.
Although COVID-19 is still dictating how things are done in the U.S. and throughout the world, the FDA looked beyond the pandemic in an update to its guidance on conducting clinical trials of medical products during the public health emergency.
Pfizer Inc. reported on Aug. 30, 2021, that its JAK inhibitor, abrocitinib, beat Dupixent (dupilumab, Regeneron Pharmaceuticals Inc./Sanofi SA) in a head-to-head study of patients with moderate to severe atopic dermatitis. In the JADE DARE study, a higher percentage of patients taking abrocitinib had a 4-point improvement in the severity of Peak Pruritus Numerical Rating Scale (PP-NRS4) from baseline to week two compared to Dupixent.
Questions regarding rates of cytokine release syndrome (CRS) cropped up during Poseida Therapeutics Inc.’s conference call on preliminary data from nine patients in the company’s phase I trial of P-PSMA-101, an autologous CAR T product candidate to treat patients with metastatic castrate-resistant prostate cancer (mCRPC).
Higher antibody titer levels were found in participants receiving two doses of Moderna Inc.’s COVID-19 vaccine compared to those receiving the Pfizer Inc.-Biontech SE vaccine, according to a research letter published in JAMA.
A closely watched phase IIb test of JNJ-9220, an investigational HIV vaccine regimen developed by Johnson & Johnson's Janssen Vaccines & Prevention BV, has been stopped because the regimen provided insufficient protection against HIV infection. Though safe, the candidate's efficacy was just 25.2%, according to statisticians who analyzed data from the study, called Imbokodo. Further analysis of the study will continue, and the study was deemed to have provided sufficient data for further immunological correlates research, according to J&J.
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