What could be the first newly approved antifungal in nearly 20 years based on a novel mechanism hit a bump as F2G Ltd. has received a complete response letter from the U.S. FDA. Read More
In a move that saw shares tumble by 26%, Biosenic SA has halted a phase IIb trial for its allogeneic stem cell therapy, Allob, after it failed to accelerate healing when given to patients two days after they sustained tibial fractures. The company plans to shift its focus to its late-stage arsenic trioxide candidate for chronic graft-vs.-host disease (GVHD). Read More
After raising AU$4 million (US$2.6 million), Argenica Therapeutics Pty. Ltd. is gearing up to begin phase II trials in ischemic stroke for ARG-007, a glutamate receptor modulator that is believed to reduce brain tissue death after stroke. Read More
If Eli Lilly and Co. had been hoping its migraine drug, Emgality (galcanezumab), would emerge with unequivocal superiority against Pfizer Inc.’s Nurtec ODT (rimegepant orally disintegrating tablet), giving the once-monthly injectable biologic an advantage in the highly competitive CGRP space, the pharma firm likely was disappointed. Findings from the phase IV Challenge-MIG study did not meet the primary endpoint, which called for Emgality’s statistical superiority over Nurtec ODT on the percentage of patients achieving a 50% or greater reduction in monthly migraine days. Read More
Could a bioactive peptide secreted in the saliva of ticks offer a useful therapy for people who have experienced intracerebral hemorrhage (ICH)? That’s the question Bioxodes SA has set out to answer, and the company is about to move its first-in-class drug candidate, Ir-CPI, which has dual anti-thrombotic and anti-inflammatory effects, into a phase IIa trial in patients with ICH. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bavarian Nordic, Clene, Corvus, Hutchmed, Innate, Innocare, Merck, Mustang, Neurona, Takeda, Tessa. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Evgen, Lanett, Merck, Molecular Templates and Prometheus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Genentech, GSK, Nanjing Leads Biolabs, Reata, Roche, TG Immunopharma, TME. Read More
