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Green light for 8 new medicines

Written by | 15 Jul 2020

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended eight medicines for approval at its June 2020 meeting.

Phase III study FIDELIO-DKD of BAY 94 8862 meets primary endpoint in diabetic kidney disease.- Bayer

Written by | 11 Jul 2020

The Phase III study FIDELIO-DKD evaluating the efficacy and safety of BAY 94 8862 (finerenone), from Bayer, versus placebo when added to standard of care for chronic kidney… read more.

ChemoCentryx, Inc. has submitted a NDA to the FDA for avacopan for the treatment of patients with ANCA-associated vasculitis.

Written by | 10 Jul 2020

ChemoCentryx, Inc. confirmed that the Company has submitted a New Drug Application (NDA) to the FDA for avacopan for the treatment of patients with ANCA-associated vasculitis. The Company’s… read more.

Advisory Committee to meet to review data for terlipressin to treat hepatorenal syndrome.- Mallinckrodt

Written by | 8 Jul 2020

Mallinckrodt Plc ,announced that the Cardiovascular And Renal Drugs Advisory Committee of the FDA will, as expected, hold a virtual meeting to review data on terlipressin, an investigational… read more.

European Commission approves Invokana to treat diabetic kidney disease (DKD) in type 2 diabetes. – Mundipharma.

Written by | 8 Jul 2020

Mundipharma announces that the European Commission (EC) has approved the extension of the indication of Invokana (canagliflozin) to include important renal outcome data from the landmark Canagliflozin and… read more.

ACE inhibitors and ARBs lower colorectal cancer risk in some patients

Written by | 7 Jul 2020

Article written by Bruce Sylvester Patients being treated with angiotensin converting enzyme inhibitors (ACE-i) or angiotensin II receptor blockers (ARBs) for high blood pressure and other conditions appear… read more.

Approval of vadadustat as Vafseo in Japan for the treatment of anemia due to chronic kidney disease.- Mitsubishi Tanabe + Akebia

Written by | 7 Jul 2020

Akebia Therapeutics, Inc.announced the first regulatory approval of vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD)…. read more.

Cardiovascular and renal safety profile of linagliptin demonstrated in Asian adults with type 2 diabetes,- Boehringer + Eli Lilly

Written by | 5 Jul 2020

Boehringer Ingelheim have announced the results of a sub-group analysis from the CAROLINA cardiovascular outcome trial focusing on Asian adults with type 2 diabetes mellitus and elevated cardiovascular… read more.

Ibsrela filed with FDA for hyperphosphatemia in adult patients with chronic kidney disease on dialysis.- Ardelyx

Written by | 1 Jul 2020

Ardelyx announced the submission of a New Drug Application (NDA) for Ibsrela (tenapanor) to the FDA for the control of serum phosphorus (hyperphosphatemia) in adult patients with chronic… read more.

EU approves Ultomiris for patients with atypical hemolytic uremic syndrome.- Alexion Pharma

Written by | 30 Jun 2020

Alexion Pharmaceuticals announced that the European Commission has approved Ultomiris (ravulizumab)—the first and only long-acting C5 complement inhibitor administered every eight weeks*—for the treatment of adults and children… read more.

CHMP recommends Idefirix for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.. Hansa BioPharma

Written by | 28 Jun 2020

Hansa Biopharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending conditional approval of… read more.

FDA approves Crysvita for the treatment of fibroblast growth factor 23 -related hypophosphatemia in tumor-induced osteomalacia (TIO) Ultragenyx + Kyowa Kirin Co., Ltd.

Written by | 19 Jun 2020

Ultragenyx Pharmaceutical Inc.and Kyowa Kirin Co., Ltd. announced that the FDA has approved Crysvita (burosumab) for the treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia… read more.

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