Renal

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.  

The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.

The Pink Sheet’s Drug Review Profile looks at the timeline behind the development and US FDA approval of Akebia’s Vafseo, a treatment for anemia in chronic kidney disease patients on dialysis.

With $150m in series A funding, the Versant- and Novartis-backed start-up is betting it can overcome the challenges to getting RNA medicines into the kidney.

The start-up launched last year with Phase III-ready upacicalcet, which has nearly completed two pivotal trials in secondary hyperparathyroidism and for which it has exclusive rights outside of Asia.

Global investment firm Carlyle has agreed to pay $3.8b for Baxter International’s Kidney Care unit. The newly spun-off business will be known as Vantive.

In this week's podcast edition of Five Must-Know Things: Amgen positions for obesity and diabetes; BMS returns TIGIT asset in pipeline reshuffle; is Kerendia the next jewel in Bayer’s crown?; Japan pharma firms cut jobs; and Sun Pharma seeks GLP-1 partner.

Nine new entries targeting a wide range of unmet medical needs. Several EU marketing approvals and two withdrawals. And an accelerated assessment tool that was seldom used. These were among the activities noted as part of the European Medicines Agency’s priority medicines scheme during the first half of 2024.

A Phase III trial testing pegcetacoplan in patients with two rare kidney diseases demonstrated impressive efficacy, outperforming what Novartis showed with Fabhalta in a similar trial.

US FDA approval in IgAN is just the first step in a much larger renal disease strategy for the company, which includes additional kidney indications for Fabhalta.

Major Japanese firm picks up US drug discovery platform company Jnana in apparent bid to strengthen discovery capabilities and build its mid-stage R&D presence in the renal area. 

A stacked user fee goal lineup sets the stage for market showdowns in primary biliary cholangitis and IgA nephropathy, the first psychedelic approval decision, and lots of targeted cancer therapies.

The UK major has raised its full-year sales and earnings forecast on strong demand in the second quarter for its cancer, rare disease and cardiovascular medicines.

Truvian Health said it raised $74m in venture capital funding, which the company plans to use in part to try to secure US FDA clearance for its blood testing platform.

Akebia says its price for Vafseo at about $15,500 per year, meant to reflect its potential value in dialysis as well as eventually in non-dialysis patients.

Akebia said it had set the price for Vafseo at about $15,500 per year, meant to reflect its potential value in dialysis as well as eventually in non-dialysis patients.

The US Federal Trade Commission wants to clean up the FDA’s Orange Book by purging medical device patents that the commission says should not be in the listing. The FTC argues improper patents in the Orange Book block lower-cost generic equivalents from coming to market. Medtech Insight spoke to attorney Sara Koblitz about the FTC’s delisting push.

In this week's podcast edition of Five Must-Know Things: ASCO preview; Asahi Kasei’s US acquisition; Novartis aims for renal disease dominance; paying for gene therapies; and US BIOSECURE Act diluted.

Asahi Kasei established a US presence and expertise in renal disease when it bought Veloxis in 2020 and will expand in both areas with Calliditas’s Tarpeyo for immunoglobulin A nephropathy (IgAN).

Fabhalta and atrasentan are odds-on for approval in C3 glomerulopathy and IgA nephropathy, respectively, but commercial success might be harder to come by.