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Akebia Therapeutics has submitted a Formal Dispute Resolution Request with the FDA regarding the rejection of vadadustat in anemia due to chronic kidney disease.
BioAge Labs, PTC Therapeutics, Biogen and others highlighted novel mechanisms targeting newer pathways in neurodegenerative diseases at the recent Discovery on Target meeting.
In spite of positive Phase IIb results from a thrombosis prevention trial, Ionis is back on the market for a new partner after Bayer returned the rights to the drug to Ionis.
Galapagos’ new “forward faster” strategy will see the departure of the company’s fibrosis and kidney disease programs and 200 staff members.
Sanofi and AstraZeneca won European approval for the first preventative RSV treatment for a broad population of newborns and infants.
Arcus Biosciences and its collaboration partner Gilead Sciences announced during Arcus’ third-quarter report that the company had modified its ARC-10 Phase III trial.
Some executives might book a massage or practice meditation to deal with their stress. Others have a different way to let off steam–spending time with their pets.
The FDA is gearing up for deadlines and PDUFA dates in mid-November with Seagen, Provention, Clarus and Tolmar, and Ligand and Travere.
Apellis is submitting additional 24-month efficacy data to supplement the NDA for its intravitreal candidate pegcetacoplan for GA secondary to AMD.
Working to undo the sins of the past, Colossal Biosciences and the University of Melbourne are attempting to bring back the Tasmanian tiger in a project that could have big implications for human health.
Rubius Therapeutics plans to initiate a large restructuring initiative, which includes laying off 84% of its staff and a possible sale, the company announced Wednesday.
The executive shuffle continues across the biopharma industry as companies shore up leadership needs with these Movers & Shakers.
