Akebia Therapeutics, Inc.
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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.
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.
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.
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.
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