Keyword: Kyowa Hakko Kirin
Japan’s Kyowa Kirin says it is putting quality assurance and pharmacovigilance with a reorganization that has the divisions report to the CEO.
HiFiBiO raises $67 million in series C. Kyowa Kirin wins long-awaited FDA nod for Parkinson's drug Nourianz. SEBI's initial probe clears Sun Pharma.
Spurned by the FDA in 2008, Kyowa Kirin's istradefylline, to be sold as Nourianz, has secured the U.S. go-ahead as an add-on Parkinson's drug.
With China's large and increasing chronic kidney disease population, roxadustat could hit $1 billion in that country alone by 2025.
Emgality will likely chase Amgen and Novartis’ first-in-class Aimovig and Teva's Ajovy in the CGRP migraine field.
Opdivo is priced in China at half its U.S. cost; Novartis names new chief for scandal-hit Korea unit; GSK's Indian consumer unit attracts new buyers.
A warning letter says a Japanese API maker admitted to the FDA that it had manipulated data during its API testing.
Lenvima's quarterly sales grow to $106 million; China makes 48-drug list for streamlined review; Samsung commits further investment in biologics.
Kyowa is also testing the drug in early-phase trials for solid tumors, in combo with its own IDO inhibitor KHK2455, BMS’ Opdivo and AZ’s Imfinzi.
Patients in the U.K. won't have access to X-linked hypophosphatemia med Crysvita under a ruling by NICE.