With phase III data in hand from the Emergent-3 study of Karxt (xanomeline plus trospium) in adults with schizophrenia, Karuna Therapeutics Inc. continues to target mid-2023 for an NDA submission to the U.S. FDA. The 256-subject trial met its primary endpoint, with Karxt turning up a statistically significant and clinically meaningful 8.4-point reduction in Positive and Negative Syndrome Scale total score compared to placebo at the fifth week. Read More
Despite a failed phase III study, the U.S. FDA suggests in briefing documents that tofersen (BIIB-067) is effective for treating the rare, genetic disease superoxide dismutase 1 amyotrophic lateral sclerosis (ALS). The intrathecally injected therapy is being developing by Biogen Inc. and Ionis Pharmaceuticals Inc. and is at the heart of a March 22 meeting of the agency’s Peripheral and Central Nervous System Drugs Advisory Committee (adcom). Read More
If you believe the theme of the World Dementia Council (WDC) meeting in London this week, dementia is “in a new era,” where it will be possible to prevent, diagnose and treat neurodegenerative disease. That is not the case for most people living with dementia today, but the approval of the first disease-modifying drugs and the imminent arrival of new blood-based biomarkers is “a big moment,” Lenny Shallcross, executive director of WDC told the meeting on Mar. 20. Read More
Are deals such as M&As between biotechs and big pharma becoming a thing of the past? That was a key question posed during the opening keynote at this year’s BIO-Europe Spring conference in Basel, Switzerland. Although Susanne Kreutz, global head of corporate and business development of Basel-based Novartis AG, doesn’t think this is the case, she told delegates that she believes M&A will increasingly focus in on “high-quality, high-impact, late-stage assets, where reimbursement is securable and where regulatory paths appear.” Read More
Takeda Pharmaceutical Co. Ltd.’s oral allosteric tyrosine kinase 2 inhibitor TAK-279 (formerly NDI-034858) met primary and secondary endpoints in a phase IIb clinical trial in patients with moderate to severe plaque psoriasis, but analysts say it may be too little too late to make a big splash compared to competitors. Read More
Citing “serious breaches” of its code of practice, the Association of the British Pharmaceutical Industry (ABPI) suspended the membership of Novo Nordisk A/S in the trade organization for two years. The suspension marks the eighth time in 40 years that the association has invoked such sanctions. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acer, Bristol Myers Squibb, Canbridge, Hanmi, Janssen, Jounce, Leo, Matrivax, Merck, Pfizer. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ipsen, Kuria, Likang, Novartis, Pfizer, Sarepta. Read More
