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AbbVie is eyeing regulatory filings in 2027 for the skin disease drug lutikizumab after clearing multiple endpoints in a late-stage trial, but the results have disappointed some analysts, raising questions about its commercial prospects.
Troriluzole, in development for spinocerebellar ataxia, was rejected nearly a year ago when the FDA took issue with the design of Biohaven’s registrational study. The agency has now agreed to review a new application and render a decision in the first quarter of 2027.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
The sector’s IPO tally has surpassed each of the past four years, with four October debuts adding momentum—but activity still remains well below the COVID-19 boom that saw nearly 100 public debuts in 2021.
The approval of Hibsago has created a new market for a handful of biopharmas, including Gilead, Arrowhead, and Vir, to fill in.
Aside from RG6540, Roche also discontinued a host of other early-stage assets, including an antisense oligonucleotide for Alzheimer’s disease and a small-molecule candidate for geographic atrophy.
In this episode of Denatured, you’ll hear from Bruce Culleton, CEO at ProKidney and Demetri Maxim, CEO at Nephrogen. We discuss why kidney disease has long been a hard target for cell and gene therapies, and what new delivery strategies, therapeutic approaches and regulatory clarity mean for commercially viable products.
Brepocitinib is on a roll. After winning approval for an autoimmune skin disease, Roivant Sciences subsidiary Priovant’s drug hit all primary and secondary endpoints in a pair of Phase 3 non-infectious uveitis trials, leading analysts to say the candidate “looked superior to Humira.”
At the European Society for Medical Oncology meeting this weekend, Merck will showcase three late-stage trials of its Kelun-Biotech–partnered TROP2-directed antibody sac-TMT that VP of Chemistry Alan Northrup says gets the payload release “just right.”
The $100,000 H-1B visa fee has significantly affected who biopharma companies hire, according to two experts. It’s not the only program adjustment affecting foreign-born job seekers’ odds of working in the U.S.