News
Orserdu Approved for ER+, HER2-, ESR1-Mutated Advanced or Metastatic Breast Cancer
In patients whose tumors had ESR1 mutations, elacestrant reduced the risk of progression or death by 45%.
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Drugs in the Pipeline
Novel Oral Anticoagulant Fast Tracked for Patients With ESRD and Atrial Fibrillation
Tecarfarin is a novel oral vitamin K antagonist with a similar mechanism of action to warfarin, though it is metabolized differently.
Drugs in the Pipeline
Novel Anticoagulant Therapy for Patients With ESRD Gets Fast Track Status
MK-2060 is an investigational monoclonal antibody designed to inhibit the activation of Factor XI and its ability to activate downstream proteins.
News
EndoClot PHS Approved to Control Bleeding During GI Procedures
EndoClot PHS is a single-use device consisting of a starch-based powder hemostat to control bleeding in the GI tract.
Drugs in the Pipeline
Dapagliflozin Under Review for Chronic Kidney Disease
The FDA has granted Priority Review to dapagliflozin (Farxiga) for the treatment of new or worsening CKD.
Drugs in the Pipeline
Dapagliflozin Gets Breakthrough Therapy Status for CKD Indication
The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.
Drugs in the Pipeline
Trial Investigating Dapagliflozin in CKD Meets All End Points
The multicenter, event-driven, double-blind, placebo-controlled trial compared the effect of dapagliflozin to placebo on renal outcomes and cardiovascular mortality in patients with CKD.
News
Lokelma Labeling Updated With Dosing for Hyperkalemia in Dialysis-Dependent ESRD
The prescribing information for Lokelma® (sodium zirconium cyclosilicate; AstraZeneca) has been updated to include a dosing regimen to treat hyperkalemia in patients with end-stage renal disease (ESRD) on chronic hemodialysis.
Drugs in the Pipeline
Dapagliflozin CKD Trial Stopped Early Due to “Overwhelming Efficacy”
The decision to stop the trial was made based on positive efficacy data following a recommendation from the study’s independent DMC.
AIBD 2019
Combination Biologics or Small Molecules vs Biologic Monotherapy in IBD
The following article is a part of conference coverage from the 2019 Advances in Inflammatory Bowel Diseases (AIBD) Meeting, being held in Orlando, Florida. The team at MPR will be reporting on the latest news and research conducted by leading experts gastroenterology. Check back for more from the 2019 AIBD Meeting. Combination biologic therapy may…
