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Recent Posts
- A Renaissance in Chronic Kidney Disease Treatment Is Underway
- Akebia Therapeutics Announces Approval of Vadadustat in Japan for the Treatment of Anemia Due to Chronic Kidney Disease in Dialysis-Dependent and Non-Dialysis Dependent Adult Patients
- Positive Top-Line Results from Global Phase 3 Program of Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis
- A proposed clinical trial for COVID-19 pneumonia
- Dapagliflozin–saxagliptin ‘attractive’ options for patients with type 2 diabetes with chronic kidney disease
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Author Archives: admin
Lokelma approved in the US for the treatment of adults with hyperkalemia
On May 18, 2018 AstraZeneca announced the FDA approval of their new drug Lokelma, for the treatment of hyperkalemia. The full new release is reproduced below: The US Food and Drug Administration (FDA) has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for … Continue reading
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Otsuka Announces Phase 3 Results for Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD)
November 04, 2017 12:03 PM Eastern Daylight Time TOKYO–(BUSINESS WIRE)–Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced detailed results from the Phase 3 REPRISE trial of tolvaptan, which is under investigation in the United States in patients with autosomal dominant polycystic kidney … Continue reading
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U.S. FDA APPROVES AURYXIA® (FERRIC CITRATE) TABLETS AS A TREATMENT FOR PEOPLE WITH IRON DEFICIENCY ANEMIA AND CHRONIC KIDNEY DISEASE, NOT ON DIALYSIS
BOSTON, Nov. 07, 2017 (GLOBE NEWSWIRE) — Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a company focused on bringing innovative medicines to people with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has approved Auryxia for an additional indication. … Continue reading
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Pharmalink AB announces the publication in Lancet of Phase 2b trial of Nefecon in primary IgA nephropathy. The data were also presented at the European Renal Association–European Dialysis and Transplant Association (ERA-EDTA) conference (Madrid, Spain)
Stockholm, Sweden – June 4, 2017 (see press release). The Phase 2b trial (known as the NEFIGAN trial), was presented in a special session co-hosted by The Lancet by lead author Bengt Fellström, MD, PhD, Professor of Nephrology at … Continue reading
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Amgen and AbbVie reach a settlement on Humira biosimilar patent litigation
From Reuters (September 28, 2017) Amgen Inc has reached a settlement with AbbVie Inc that will delay the U.S. launch of Amgen’s cheaper biosimilar version of AbbVie’s cash cow, the blockbuster rheumatoid arthritis drug Humira, until Jan. 31, 2023, the … Continue reading
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Merck Provides Update on REVEAL Outcomes Study of Anacetrapib
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the REVEAL (Randomized EValuation of the Effects of Anacetrapib through Lipid modification) outcomes study of anacetrapib met its primary endpoint, significantly reducing major … Continue reading
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New drugs to treat anemia of chronic kidney disease
Anemia is a major complication in patients with CKD, starting in pre-dialysis stages and worsening with worsening renal function and as dialysis is initiated. It can result in significant morbidity and impact quality of life. Current treatments include erythropoiesis stimulating … Continue reading
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FDA Endocrinologic and Metabolic Drugs Advisory Committee recommends approval of dapagliflozin for the treatment of type 2 diabetes in adults
Today, the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 10-4 in favor of the updated cardiovascular risk profile of the investigational sodium-glucose co-transporter 2 inhibitor, dapagliflozin. The committee also voted 13-1 in favor of the agent as an adjunct … Continue reading
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Combined ACE inhibition and angiotensin receptor blockade shows no advantage over single agent RAS inhibition in patients with diabetic nephropathy: VA-Nephron D study
The results of the recently completed VA-Nephron D study were presented at a Late Breaking Abstract Session at the ASN-Kidney Week and simultaneously published in the New England Journal of Medicine. The study randomized 1448 type 2 diabetic patients half … Continue reading
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FDA Advisory Committee recommends against approval of Tolvaptan for polycystic kidney disease
As noted in a previous posting, Tolvaptan, a vasopression type-2 receptor antagonist, currently approved for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, is also being developed for the treatment of autosomal dominant polycystic kidney disease (ADPKD). Otsuka pharmaceuticals … Continue reading
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