In a significant development for the treatment of kidney disease, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sibeprenlimab, an investigational drug developed by Otsuka Pharmaceutical Development & Commercialization, Inc., and Visterra, Inc., an Otsuka group company. This designation is a pivotal milestone in the fight against Immunoglobulin A nephropathy […]
Swiss pharmaceutical giant Novartis has wrapped up the previously announced $3.5 billion acquisition of Seattle-based biopharmaceutical firm Chinook Therapeutics, Inc. This deal propels Novartis deeper into the realm of kidney disease treatments, capitalizing on Chinook Therapeutics’ cutting-edge precision medicines. Chinook Therapeutics’ promising pipeline, boasting two advanced assets, atrasentan and zigakibart (BION-1301), specifically targets Immunoglobulin A […]
Gilead Sciences said that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Veklury (remdesivir) usage in COVID-19 patients with severe renal impairment, encompassing those on dialysis. This approval positions Veklury as the sole antiviral COVID-19 treatment approved for use in all stages of renal disease. It’s estimated […]
ProKidney, a late clinical-stage cellular therapeutics company, has announced plans to acquire a 210,000 square foot facility and approximately 22 acres of land in Greensboro, North Carolina. The move is aimed at meeting the company’s future commercial manufacturing needs for REACT, a renal autologous cell therapy currently in Phase 3 development for treating diabetic chronic […]
Novartis has announced its agreement to acquire Chinook Therapeutics, a clinical stage biopharmaceutical company based in Seattle, Washington in a deal worth up to around $3.5 billion. The acquisition will bring two late-stage medicines for rare, severe chronic kidney diseases into Novartis’ portfolio. It aligns with Novartis’ strategy to focus on innovative medicines and will […]
AstraZeneca has closed the previously announced $1.8 billion acquisition of US biopharmaceutical company CinCor Pharma. Under the terms of the agreement, AstraZeneca acquired all outstanding shares as well as the cash and marketable securities of CinCor Pharma for approximately $1.3bn upfront and around $500 million, respectively. Last month, AstraZeneca announced a definitive agreement to acquire […]
GSK has secured the approval of the US Food and Drug Administration (FDA) for the company’s Jesduvroq (daprodustat) for anaemia of chronic kidney disease (CKD) in adults on dialysis. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor indicated for the daily once treatment of anaemia due to CKD in adults on dialysis for at […]
AstraZeneca has agreed to acquire CinCor Pharma for a transaction value of around $1.8 billion, which includes an upfront cash payment of about $1.3 billion, plus potential contingent payment on regulatory submission of the latter’s baxdrostat product. Under the merger agreement, the British-Swedish biotechnology company will initiate a tender offer by 23 January 2023 to […]
AstraZeneca Pharma India has secured an import and market permission for Dapagliflozin (Forxiga) tablets of 10 mg from India’s Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services. Following the approval, AstraZeneca Pharma India is now allowed to deal in Dapagliflozin 10 mg in additional/expanded indication for lowering the risk of sustained eGFR […]
Roxadustat approval – Astellas Pharma and FibroGen have secured approval for EVRENZO (roxadustat) in Japan for the treatment of anemia associated with chronic kidney disease (CKD) in adults, who are not on dialysis. The approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) is the second in the country for roxadustat through the […]