A group of FDA advisers voted in favor of approving Rockwell Medical's iron-replacement treatment for dialysis patients, setting aside concerns about the drug's pivotal data and burnishing the company's hopes of finally launching its top prospect.
Amgen's in-development treatment for patients on kidney dialysis met its primary and secondary goals in a late-stage trial, step one in the drug's three-part Phase III program.
AstraZeneca has struck up a partnership with the Shenzhen University Health Science Center in Shanghai to collaborate on preclinical work for chronic kidney disease treatments, a growing problem among China's aging population.
La Jolla Pharmaceutical's chronic kidney disease drug hit its primary endpoint of improving organ function in a Phase II trial, the company said, and while the results sent the biotech's shares skyward by 75%, a quirk in dosing gave some analysts pause.
There's no word on the upfront, but Sanofi has committed to pay up to $198 million in milestones if the portfolio delivers an approved therapy that can be used to treat hyperphosphatemia, a condition characterized by elevated levels of phosphate in the blood of patients with end stage renal disease and other forms of chronic kidney disease.
Just weeks away from reporting key endpoint data from a Phase III trial of its lead therapy, Relypsa has mapped out plans to go public, shooting for a $126.5 million payday to help complete a prospective transformative leap into marketing.
Rockwell Medical shares surged early today after the biotech announced that its second, duplicate Phase III study for a new iron-delivery drug hit its primary and secondary endpoints, setting the stage for a new drug application.
AstraZeneca CEO Pascal Soriot has taken another step forward in his turnaround campaign, committing $350 million in cash and up to $465 million in milestones to partner up with FibroGen as it positions a lead anemia drug for late-stage trials.
Takeda Pharmaceuticals and Affymax ($AFFY) have sewn up another supply deal for their anemia drug Omontys. DSI Renal, one of the largest dialysis providers in the U.S., agreed to adopt Omontys to treat their patients with chronic kidney disease.
Malformed kidneys in newborn babies could be markers for mental illness and problems with behavior and understanding.