All the primary and secondary efficacy endpoints were met in Boulder, Colo.-based Brickell Biotech Inc.’s pivotal phase III study of the anticholinergic sofpironium bromide in treating primary axillary hyperhidrosis, which involves excessive sweating in the armpits that interferes with daily life and work.
BEIJING – Nasdaq-listed Chinese vaccine developer Sinovac Biotech Ltd., of Beijing, said the preliminary results of the phase I/II trials of its COVID-19 inactivated vaccine candidate, Coronavac, demonstrated favorable immunogenicity and safety profiles.
LONDON - The EU has secured a supply of the most advanced COVID-19 vaccine in development, in a deal with Astrazeneca plc for up to 400 million doses of AZD-1222, with deliveries starting by the end of 2020.
Creatv Microtech Inc. has developed a simple blood test that can predict response to chemoradiation and consolidated immunotherapy in patients with non-small-cell lung cancer (NSCLC).
HONG KONG – Singapore-based Tychan Pte. Ltd. is starting a phase I trial for a novel monoclonal antibody (MAb) that specifically targets SARS-CoV-2, the coronavirus that causes COVID-19. The trial is expected to take only around six weeks to complete.
HONG KONG – Takeda Pharmaceutical Co. Ltd. is preparing to take Takhzyro (lanadelumab) to the world stage after announcing its interim results for a phase III hereditary angioedema long-term prophylaxis (HELP) study.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, Atox, Aura, Bone Therapeutics, Cytodyn, Lilly, Noveome, Novo, Octimet, Otsuka, Pulmocide, Respivant, Verrica.
The U.S. FDA granted Gtx Medical BV a breakthrough device designation for its implantable Go-2 Targeted Epidural Spinal Stimulation (TESS) system. The device enabled patients who had sustained traumatic spinal cord injuries to regain voluntary control over previously paralyzed muscles and walk again four or more years after paralysis, according to a study previously published in Nature.
HONG KONG – Astellas Pharma Inc. reported positive results from phase III of its DOLOMITES study comparing the efficacy and safety of roxadustat to that of darbepoetin alfa in treating anemia in nondialysis-dependent, stage 3 to 5 chronic kidney disease (CKD) patients.
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