Akebia Therapeutics
NEWS
In a regulatory filing, the Cambridge, Massachusetts-based company indicated that it plans to “refocus its strategic priorities” and lay off 42% of its workforce.
The FDA has rejected Cambridge, Mass.-based Akebia Therapeutics’ New D2rug Application (NDA) for vadadustat, a therapeutic for anemia due to chronic kidney disease (CKD).
The FDA has a very busy week ending the month of March and moving into April, highlighted by a big AdCom vote on Amylyx’s ALS candidate AMX0035 on March 30.
Akebia Therapeutics announced topline results for PRO2TECT, the second of two Phase III cardiovascular outcomes programs. The trial was evaluating the company’s vadadustat for treatment of anemia caused by chronic kidney disease in adults not on dialysis.
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, and investors are pleased.
The lynchpin to biotech and pharmaceutical drug development in the United States is arguably the greater Boston area, which includes the white hot square mile of talent and intellectual collaboration found in Kendall Square.
The U.S. Food and Drug Administration has been busy approving new treatments for various diseases. Two days into the new week and the regulatory agency has green lit two therapeutics, while other companies are planning to file for potential approval.
The U.S. Securities and Exchange Commission has leveled charges at a former Sangamo Therapeutics Inc. executive and others for an insider-trading scheme that netted more than $1.5 million in “illegal profits.”
Schultz Chan, the former director of biostatistics at Cambridge-based Akebia Therapeutics and Songjiang Wang, a director of statistical programming at Merrimack Pharmaceuticals (MACK) were convicted of insider trading by a federal grand jury in Boston.
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