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Akebia Therapeutics, Inc.

https://akebia.com/

Latest From Akebia Therapeutics, Inc.

PMDA Eyes More Japan-First Approvals In Access Push

Highlighting progress it has made over the past few years, Japan’s regulatory agency says it wants to raise even further the number of “Japan-first” approvals, as part of its stated mission to get safe and effective new drugs to patients more quickly.

Japan Approvals

Vifor Confident About Prospects For Pruritus Dialysis Drug Korsuva

Vifor CEO Stefan Schulze tells Scrip that an expanded deal with Korsuva developer Cara Therapeutics means the US biotech will not have to invest in a commercial organization as the Swiss firm will mobilize its well-established sales force to launch the treatment for dialysis patients with CKD-associated pruritus.

Deals Renal

Akebia's Vadadustat Misses In Non-Dialysis CKD, But Filings Still Planned For 2021

HIF-PHI inhibitor failed to show non-inferiority to ESAs in the primary cardiovascular safety endpoint of a Phase III program for the treatment of anemia due to chronic kidney disease.

Renal Clinical Trials

Japan Nods Include Global Firsts For Duvroq, Vafseo And First Local Biosimilar Humira

Japan’s regulators have approved a large batch of new products, including a novel antibody from Chugai, two world-first nods for the country’s second HIF-PH inhibitors and an asthma therapy, and the first Humira biosimilar in Japan – as well as five drugs from Novartis.

Japan Approvals
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Company Information

  • Industry
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Access Oncology
    • AOI Pharma, Inc.
    • Keryx Biopharmaceuticals Inc.
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