Clinical research
CROs cite faster startup timelines, regulatory predictability and tax incentives as reasons for growing interest in Australia. State investments in manufacturing, translational research and advanced therapies aim to expand that advantage into a broader biotech ecosystem. The question remains whether Australia can support drug development at broader scale.
The disclosure—which came ahead of a presentation of data from the Phase 1 Breakfree-2 study at the ACTRIMS-ECTRIMS meeting—follows Bristol Myers Squibb’s late summer revelation that it had paused certain trials of zolacabtagene autoleucel.
A combination of Tango Therapeutics’ vopimetostat and Revolution Medicines’ recently approved Rasonque led to a response rate of 82% in an ongoing Phase 1/2 trial—a drop from 92% that was reported in June in fewer patients.
After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aardvark plans to resume testing the candidate next year.
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.
The approval of Hibsago has created a new market for a handful of biopharmas, including Gilead, Arrowhead, and Vir, to fill in.
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.”
China cracks down on some biotechnology ownership transfers—but will the new policy impact licensing deals?; Disc Medicine’s Phase 3 data sweep redeems rejected rare disease therapy, teeing up another FDA run; and the ESMO conference gets underway in Madrid this week, with much-anticipated data from Merck, and Summit Therapeutics.
Rapport Therapeutics clocked its second Phase 2 win in 14 months for RAP-219—which the company is positioning as a potential pipeline-in-a-product—this time showing improvement in symptoms of bipolar mania.
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