Search Results for “dialysis” – Page 7 – media

NICE recommends Cara’s Kapruvia to treat CKD-associated pruritus

Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) have announced that the US’s National Institute for Health and Care Excellence (NICE) has recommended Kapruvia (difelikefalin) to treat chronic kidney disease (CKD)-associated pruritus. Kapruvia has been recommenced to treat moderate-to-severe CKD-associated pruritus in adult patients who are undergoing haemodialysis. This will allow patients in Northern Ireland, England, and Wales to get access to Kapruvia. The recommendation from NICE follows the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) authorisation of Kapruvia for the same indication in April last year. Cara Therapeutics president and CEO Christopher Posner said: “We are pleased that Kapruvia will be available to CKD patients in England, Wales and Northern Ireland who are undergoing haemodialysis and suffering from moderate-to-severe CKD-associated pruritus. “Together with VFMCRP, we are committed to bringing our first-of-its kind therapy to providers and patients around the world to help change the way pruritus ...
- Source: drugdu
- 213
- May 23, 2023
FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy. The regulatory agency has determined that the NDA is a class 2 review, which leads to a six-month review period from the date of resubmission. It has set a user fee goal date of 17 October this year. The biopharmaceutical company expects XPHOZAH to be commercially available in Q4 2023 after an approval from the regulatory body. Ardelyx president and CEO Mike Raab said: “The acceptance of our NDA is a significant milestone in our journey to bring XPHOZAH to patients. We are excited about the prospect of working collaboratively with the FDA to finalise this review over the next few months. “We are now in ...
- Source: drugdu
- 103
- May 22, 2023
Ardelyx resubmits NDA for Xphozah to US FDA

Ardelyx has resubmitted a new drug application (NDA) for Xphozah (tenapanor) to the US Food and Drug Administration (FDA). A first-in-class, phosphate absorption inhibitor, Xphozah will be used to control serum phosphate in adults with chronic kidney disease (CKD) on dialysis and who had an insufficient response or intolerance to a phosphate binder therapy. It has a new action mechanism and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3). This reduces the absorption of phosphate via the paracellular pathway, which is the main pathway of phosphate absorption. Diarrhea was the most common side effect using Xphozah in clinical trials. The NDA submission was supported by a comprehensive development programme, which included over 1,200 patients in three Phase III clinical trials, PHREEDOM, BLOCK and AMPLIFY, and two additional open-label Phase IV clinical trials, OPTIMIZE and NORMALIZE. The Phase III trials were ...
- Source: drugdu
- 135
- April 20, 2023
EC clears GSK’s Benlysta for lupus nephritis

The European Commission approved expanded use of GlaxoSmithKline’s intravenous and subcutaneous Benlysta (belimumab) in combination with background immunosuppressive therapies for adults with active lupus nephritis (LN). The drug is already on the market to treat systemic lupus erythematosus (SLE); this latest approval now provides physicians and patients in Europe with the first and only biologic treatment specifically designed to work in lupus and LN. “Active lupus nephritis, which causes inflammation in the kidneys, is one of the most serious consequences of systemic lupus erythematosus and occurs in more than 1 million patients worldwide,” noted Dr Hal Barron, GSK’s chief scientific officer and president R&D. “Benlysta is the first biologic approved to treat lupus and lupus nephritis, representing a significant new treatment option for patients and physicians across Europe dealing with this complex autoimmune disease.” The drug’s marketing submission was based on data from the BLISS-LN (Efficacy and Safety of Belimumab ...
- Source: drugdu
- 498
- May 10, 2021
GSK
HCV Patients can Donate Kidneys

A research team led by the University of Cincinnati revealed that patients in need of kidney can opt for transplantation by safely receiving a kidney from an HCV-infected donor. This report was published online in Annals of Internal Medicine.
- Source: MedPageToday
- 670
- July 11, 2018
hepatitis C kidney Researches
Mircera Gets FDA Nod For CKD-Related Drug

The recent research that achieved the FDA approval for Mircera, had 64 patients, aged between 5 to 17 years old who suffered from chronic kidney disease (CKD) and were on kidney dialysis at the beginning of the study.
- Source: MedPage Today
- 1,159
- June 13, 2018
chronic kidney disease New Approvals pharmaceutical
Preview — Global Pharmaceutical and Medical Device Exhibitions in the Second Quarter of 2018

Have you prepared for all the exhibitions you want to attend in the second quarter of 2018? Ddu, the leading global pharmaceutical & medical device B2B online platform, plans to attend a number of major international pharmaceutical and medical device exhibitions in the second quarter of this year. Here is a summary of each event:
- Source: Ddu
- 150,236
- March 16, 2018
Exhibitions & Activities medical device pharmaceutical
AliveCor smartphone add-on, algorithm discern high potassium levels in ECG data

An AliveCor algorithm has identified people with high potassium levels from electrocardiogram (ECG) data. Limited prospective clinical testing suggests pairing the algorithm with AliveCor’s smartphone and Apple Watch-based ECGs could enable the remote, noninvasive monitoring of potassium levels.
- Source: FierceBiotech
- 737
- March 13, 2018
ECG Researches wearables
chemoWave app offers patients support during chemotherapy

Following a soft launch last year, the chemoWave disease companion app has now been fully released for chemotherapy patients interested in better managing their care, symptoms, and side effects.
- Source: MobiHealthNews
- 576
- February 11, 2018
Chemotherapy Company Insight digital health mHealth
New AI technology significantly improves human kidney analysis

The ability to quantify the extent of kidney damage and predict the life remaining in the kidney, using an image obtained at the time when a patient visits the hospital for a kidney biopsy, now is possible using a computer model based on artificial intelligence (AI).
- Source: Medical Xpress
- 637
- January 12, 2018
AI kidney Researches

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