DUBLIN – Could a tyrosine kinase inhibitor approved for treating canine cancer offer clinical benefits in Alzheimer’s disease? That’s the bold claim AB Science SA is making, after unveiling top-line data from a phase IIb/III trial in which it reported that a subgroup of patients on a twice daily 4.5-mg/kg dose of oral masitinib experienced “a significant treatment effect” as compared with placebo after 24 weeks. Read More
A top-line Alzheimer's trial readout, once expected to catalyze value for the Vtv Therapeutics Inc. candidate azeliragon this year, instead hurried a 22.6% decline in company shares (NASDAQ:VTVT) to $2.30 after the phase II study found the drug yet again failed to deliver a statistically significant difference in cognitive decline vs. a placebo in people with mild probable Alzheimer’s disease (AD) and type 2 diabetes (T2D). Read More
Positive results from the triple-combination arm of Biolinerx Ltd.’s phase IIa study of motixafortide as a combination therapy in incredibly tough-to-handle stage IV pancreatic cancer point toward a next study, yet the stock took a battering. Read More
HONG KONG – Shanghai Junshi Biosciences Co. Ltd.’s toripalimab has reached its prespecified primary endpoint of progression-free survival at the interim analysis of a phase III study in non-small-cell lung cancer (NSCLC), as efforts to expand approval of the anti-PD-1 antibody into other cancer types are underway. Read More
A third-quarter progress report from the international advocacy group Alliance for Regenerative Medicine (ARM) has determined that the regenerative medicine and advanced therapy (RMAT) sector established a highwater mark of $15.9 billion in global financings, breaking the previous annual record of $13.5 billion that was set in 2018. Read More
The U.S. FDA’s intended use rule has been in flux for the past half-decade, with yet another draft rule making the rounds for comment. Despite any concerns that speech regarding off-label use might again be seen as a primary driver of prosecution, Sara Bloom, senior litigation counsel at the U.S. Department of Justice’s District of Massachusetts office, said distribution of the product in question is frequently the key feature where federal prosecutors are concerned. Bloom said communication of off-label use often serves primarily as a confirmatory element of the manufacturer’s intent rather than as the decisive part of the prosecution’s case. Read More
New hires and promotions in the biopharma industry, including: AB2, Aquestive, Atai, Cardurion, Enara, Leo, Lidds, Kymera, Recro, Rockwell, SAB, Sage, Xbrane, Xwpharma. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avadel, Daiichi, Esperion, Durect, Hemoshear, Kite, Novartis, Regeneron, Thetis. Read More
