Canada’s Aurinia Pharmaceuticals expects to file a US NDA in the first half of next year on the use of its next-generation calcineurin inhibitor, voclosporin, in lupus nephritis, a condition with no approved therapies.

The first part of Aldeyra’s Phase III RENEW study of the aldehyde trap candidate, reproxalap, shows positive effects on one of two co-primary endpoints and indicates an induction-maintenance dosing regimen should be used in part 2 of the study, expected to start in the first half of next year.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Novel therapeutic strategies for Parkinson’s disease have brought a renewed sense of optimism to those researching this neurodegenerative disorder. Numerous treatment avenues are being explored, including small molecules, gene therapy, cell therapy and medical devices to stimulate nerves deep in the brain. Digital also gets a look-in, being useful for analyzing gait and other symptoms, and addressing both mental and physical issues.

The European Commission has approved Johnson & Johnson’s/Genmab’s CD38-targeted MAb, daratumumab, and Merck & Co’s checkpoint inhibitor, pembrolizumab, in two first-line additional indications, in multiple myeloma and head and neck cancer, respectively.