Novo Nordisk’s monlunabant showed signs of neuropsychiatric side effects in a mid-stage diabetic kidney disease study, despite a drug design intended to favor hitting its target receptor in peripheral tissues rather than the brain. Neuro effects were also reported last year in a Phase 2 test of this pill in obesity.
The FDA decision for Travere Therapeutics’ Filspari also expands its addressable patient population. The full approval comes nearly a year after the Travere drug narrowly missed the main goal of its confirmatory study.
The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes.
A pending CMS policy could cause havoc for independent kidney care facilities and patients who need life-sustaining treatments.
Vertex Pharmaceuticals gains a Phase 3-ready Alpine Immune Sciences drug with potential applications in a wide range of immunological disorders. The lead indication for the Alpine drug, povetacicept, is the chronic kidney disease IgA nephropathy.
Novartis’s iptacopan met the first of two main goals in its pivotal study in immunoglobulin A nephropathy, and the pharma giant plans to seek accelerated FDA approval next year. The drug could challenge two available therapies for the rare kidney disorder.
Novartis is acquiring Chinook Therapeutics in a $3.2 billion deal that brings two late-stage drug candidates for a rare kidney disorder. The Novartis drug pipeline already has a molecule in late-stage development for the same kidney disease, which could raise questions from antitrust regulators.
Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches.
Sparsentan failed to meet the main goal of a Phase 3 test in focal segmental glomerulosclerosis (FSGS). Nevertheless, Travere Therapeutics says the totality of data points to patient improvement in the rare kidney disorder and the biotech will talk with regulators about a potential path forward.
The serious adverse event reported in the early-stage study resolved quickly, but Chinook Therapeutics said it is suspected to be related to its experimental primary hyperoxaluria therapy. Meanwhile, Human Immunology Biosciences is looking ahead to Phase 3 after its rare kidney disease drug posted positive mid-stage data.
Travere Therapeutics drug Filspari won accelerated FDA approval to treat a rare disorder that can lead to kidney failure. The small molecule is also in late-stage testing for another rare kidney disease; analysts say each indication represents a blockbuster opportunity.
Atacicept, a Vera Therapeutics drug in development for the rare kidney disease immunoglobulin A nephropathy, is on its way to a pivotal test after achieving the main goal of a mid-stage clinical trial. But the results still fall short of data recently reported by a competitor that is addressing the same disease target.
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Human Immunology Biosciences aims to stand apart in autoimmune disease drug research with therapies that address cells at the root of a range of allergic and inflammatory disorders. The biotech has a lead program licensed from MorphoSys in clinical development for two rare kidney diseases and $120 million to support that antibody and other biologic drugs in its pipeline.
An Ionis Pharmaceuticals drug has positive Phase 2 results in immunoglobulin A nephropathy, leading Roche to exercise its option to license the rights to the molecule. The pharmaceutical giant gets a contender in the chase to win the first regulatory approval of a therapy for this rare kidney disease.
CSL Limited makes many of its therapies from donated plasma, which posed a challenge as pandemic lockdowns led to a steep drop in plasma collections. In acquiring Vifor Pharma, CSL not only diversifies, it also expands its presence in the fast-growing nephrology market.
Cigna Ventures and Blue Shield of California contributed to a funding round for Cricket Health, a startup that provides services to help patients identify chronic kidney disease and get support in treatment. The investment was led by Valtruis, a firm that invests in value-based care companies.
Vera Therapeutics raised $47.9 million from its IPO to continue clinical development of its lead asset, a potential treatment for the kidney disease IgA nephropathy. But the company is joining a crowded field of companies aiming to develop a drug for the rare disorder.