Category Archives: M Loghman-Adham, MD

Tricida Announces Positive Pivotal Phase 3 Clinical Trial Results for TRC101 in CKD Patients With Metabolic Acidosis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Tricida, Inc., a late-stage pharmaceutical company, announced results from its pivotal Phase 3 double-blind, randomized, placebo-controlled, multi-center Phase 3 clinical trial, TRCA-301, in 217 chronic kidney disease (CKD) patients with metabolic acidosis. TRC101 represents a first-in-class candidate … Continue reading

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AstraZeneca Reports Full Results from DECLARE-TIMI 58 Cardiovascular Outcomes Trial for FARXIGA (dapagliflozin)

November 12, 2018;  Reproduced from StreetInsider AstraZeneca today announced positive full results from the DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for FARXIGA (dapagliflozin). The data were presented as a late-breaking abstract (#19485) at the American Heart Association (AHA) Scientific Sessions … Continue reading

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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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