Shares of FibroGen were down after the company unsuccessfully attempted to express confidence in the benefit/risk profile of its anemia drug roxadustat.

The U.S. Food and Drug Administration decided to put together an advisory committee meeting of outside experts to review a New Drug Application (NDA) for FibroGen and partner AstraZeneca’s investigational anemia therapy roxadustat.

FibroGen Provides More Support for Roxadustat in Anemia Associated with Kidney Disease Published: Oct. 26, 2020 By Mark Terry BioSpace   FibroGen presented data from two pooled analyses from its roxadustat global Phase III development program this weekend at the American Society of Nephrology (ASN) Kidney Week 2020 Reimagined conference. The analyses looked at associations between the […]

Shares of Cara Therapeutics were up in trading after the company struck a licensing agreement worth up to $290 million with Switzerland’s Vifor Pharma for the commercialization of a treatment for severe itching associated with chronic kidney disease.

Cambridge, Massachusetts-based Akebia Therapeutics announced topline results for PRO2TECT, the second of two Phase III cardiovascular outcomes programs evaluating the company’s vadadustat for treatment of anemia caused by chronic kidney disease in adults not on dialysis.

AstraZeneca’s Farxiga improved survival chances for patients suffering from kidney disease, underscoring the medicine’s role outside the drug’s established field of diabetes.

The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) for Tricida’s experimental chronic kidney disease treatment veverimer.

The U.S. Food and Drug Administration’s approval-review schedule for August includes the Biologics License Application for Bristol Myers Squibb and Juno Therapeutics’ lisocabtagene maraleucel (liso-cel) for relapsed or refractory large B-cell lymphoma after at least two previous therapies. 

Novo Nordisk is expanding the company’s presence in treating kidney disease with the acquisition of U.S.-based Corvidia Therapeutics for $2.1 billion.

Akebia Therapeutics’ investigational drug vadadustat hit the mark in the first of two Phase III trials in chronic kidney disease (CKD) patients who are on dialysis. In premarket trading, shares of Akebia were up more than 21 percent to $10.55.