Adverse events and criteria for determining remission in an otherwise positive early study by Syndax Pharmaceuticals Inc. with oral menin inhibitor SNDX-5613 apparently gave Wall Street pause, and shares (NASDAQ:SNDX) closed at $13.42, down $5.96, or 31%.
PERTH, Australia – Implicit Bioscience Ltd.’s lead candidate, IC-14, is the first anti-CD14 monoclonal antibody (MAb) to progress to the clinic as it enters a phase II trial in the U.S. in COVID-19 patients.
LONDON – The EMA’s safety committee has concluded that unusual blood clots with low blood platelets are a rare side effect of Johnson & Johnson Inc.’s COVID-19 vaccine and that a warning should be added to the label. The decision is based on all available evidence, which currently consists of eight reports from the U.S. of serious cases of thrombosis, one of which was fatal. All cases were in people under 60 years of age, and within three weeks after vaccination, the majority in women. One case occurred during the clinical trials.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Autolus, Cyclo, Erytech, GW, J&J, Kalvista, Lexeo, Pharmather, Seelos, Transcenta, Vincerx, Y-mabs.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Argenx, Bluebird, Can-Fite, Cannabics, D&D, Elektrofi, Gain, Gamut, Hoth, Immunomic, Lamassu, Lineage, Oncotelic, Resverlogix, Seqirus, Sparingvision, Zentalis.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 180 Life Sciences, Alnylam, Bioarctic, Eisai, Eli Lilly, Incyte, Ionis, Janssen, Jazz, Leading, Medincell, Morphosys, Ripple, Siteone, Sorrento, Steba, Syndax, T3D.
The latest global regulatory news, changes and updates affecting biopharma, including: Enhertu gets first nod in Europe; At-home COVID-19 remedies sought; Fed Circuit: Appeal based on misreading of court’s decision; Russia expands access to certain pediatric treatments.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Active Biotech, Aerie, Agenus, Alk, Allogene, Anixa, Astellas, BMS, Curevac, Curis, Cytodyn, Eli Lilly, Istari, Mannkind, Mayne, Mithra, Sanofi, Seagen, Stuart, United, Xbiotech.
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