Hematuria News and Research

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In medicine, hematuria, or haematuria, is the presence of red blood cells (erythrocytes) in the urine. It may be idiopathic and/or benign, or it can be a sign that there is a kidney stone or a tumor in the urinary tract (kidneys, ureters, urinary bladder, prostate, and urethra), ranging from trivial to lethal.

Phase 3 study of KEYTRUDA monotherapy meets primary endpoint

Merck, known as MSD outside the United States and Canada, announced today that the pivotal Phase 3 KEYNOTE-048 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma, met a primary endpoint of overall survival as monotherapy in patients whose tumors expressed PD-L1.

25 Jul 2018

Merck announces FDA acceptance of supplemental Biologics License Application for KEYTRUDA

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has accepted for standard review a new supplemental Biologics License Application for KEYTRUDA, Merck's anti-PD-1 therapy, as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma and granted a Prescription Drug User Fee Act, or target action, date of February 16, 2019.

25 Jun 2018

NeoTract announces results of study measuring costs and patient outcomes of UroLift System

NeoTract, a wholly owned subsidiary of Teleflex Incorporated focused on addressing unmet needs in the field of urology, today announced the results of an independent analysis measuring costs and patient outcomes of the UroLift System compared to transurethral resection of the prostate.

8 Jun 2018

AUA recommends use of UroLift System for managing lower urinary tract symptoms attributed to BPH

NeoTract, a wholly owned subsidiary of Teleflex Incorporated focused on addressing unmet needs in the field of urology, today announced that the American Urological Association has recommended the use of the UroLift System as a standard of care treatment for lower urinary tract symptoms due to benign prostatic hyperplasia.

18 May 2018

New article explores cost-effectiveness of initial diagnostic protocols for microscopic hematuria

Detecting red blood cells in the urine of asymptomatic patients who don't see blood when they urinate (asymptomatic microscopic hematuria) is common but it can signal cancer in the genitourinary system.

17 Apr 2017

Pacific Edge announces commercial launch of Cxbladder Monitor in the U.S.

Pacific Edge Limited, a cancer diagnostics company developing and commercializing a suite of non-invasive tests for the detection and management of bladder cancer, announces today the commercial launch of the third product in the Company's Cxbladder family of products, Cxbladder Monitor, in the United States.

15 Dec 2016

World Kidney Day 2016 focuses on children

On Thursday March 10th we are celebrating the 11th edition of World Kidney Day (WKD), a joint initiative organized by the International Society of Nephrology (ISN) and the International Federation of Kidney Foundations (IFKF).

10 Mar 2016

RUVICA (ibrutinib) capsules approved for treatment-naïve CLL patients

The U.S. Food and Drug Administration has approved IMBRUVICA (ibrutinib) capsules for treatment-naïve patients with chronic lymphocytic leukemia (CLL).

4 Mar 2016

Turing Pharmaceuticals acquires rights to market Daraprim (pyrimethamine) in the U.S.

Turing Pharmaceuticals AG today announced that it has acquired the exclusive rights to market Daraprim (pyrimethamine) in the U.S. from Impax Laboratories, Inc. The acquisition by Turing is part of a strategic effort focused on treatments for toxoplasmosis and other serious infectious diseases. The company also announced plans to invest in the development of new drug candidates for toxoplasmosis.

10 Aug 2015

IMBRUVICA (ibrutinib) approved in Europe for treatment of Waldenstrom's macroglobulinemia

Today AbbVie announced the European Commission granted marketing authorization for IMBRUVICA (ibrutinib) as the first treatment option available in all 28 member states of the European Union for the treatment of Waldenstrom's macroglobulinemia (WM), a rare, slow growing blood cancer, in adult patients who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

12 Jul 2015

Pharmacyclics's Phase III RESONATE™ trial shows adherence to 420mg dose of IMBRUVICA improves outcomes in CLL patients

Pharmacyclics LLC today highlighted results from a sub-analysis of the Phase III RESONATE™ (PCYC-1112) trial, which found that previously-treated patients with chronic lymphocytic leukemia (CLL) who adhered to the recommended 420 mg dose of IMBRUVICA® (ibrutinib) experienced improved progression-free survival (PFS; the primary endpoint) as assessed by an Independent Review Committee (IRC), compared to patients who took lower doses or missed doses, regardless of high-risk genetic factors.

1 Jun 2015

Pharmacyclics’ Ibrutinib Phase Ib/II data show ibrutinib may be safe and effective in patients with cGVHD

Pharmacyclics LLC today announced interim results from the ongoing Phase Ib/II PCYC-1129 study suggesting that ibrutinib (IMBRUVICA) may be a safe and effective treatment for patients with chronic graft-versus-host-disease (cGVHD) who were either refractory to steroid treatment or were steroid-dependent.

1 Jun 2015

Phase III HELIOS trial results show ibrutinib combination therapy improves outcomes in CLL/SLL patients

Today, Pharmacyclics LLC announced the results of the Phase III HELIOS trial (CLL3001), which found that patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who received ibrutinib (IMBRUVICA) in combination with bendamustine and rituximab (BR) experienced an 80% reduction in the risk of progression or death compared to patients receiving placebo in combination with BR.

1 Jun 2015

Ibrutinib (IMBRUVICA) may be effective for pancreatic ductal adenocarcinoma

Ibrutinib (IMBRUVICA) data presented yesterday by Pharmacyclics, Inc. at the American Association for Cancer Research Annual Meeting suggest that ibrutinib may be an effective therapeutic option for pancreatic ductal adenocarcinoma (PDAC), as shown in both a transgenic mouse model and an in-vivo model of patient-derived xenograft (PDX) mice (grafts of tissue taken from a pancreatic cancer patient and grafted into a mouse).

20 Apr 2015

Pharmacyclics announces positive results from IMBRUVICA Phase II study in WM patients

Pharmacyclics, Inc. today announced longer-term data from a Phase II investigator-initiated study showing Waldenstrom's macroglobulinemia (WM) patients treated with IMBRUVICA (ibrutinib) experienced sustained disease control with an overall response rate (ORR) of 91% after a median of 19.1 months of treatment and a 2-year overall survival (OS) rate of 95%.

9 Apr 2015

New pre-clinical, clinical data for IMBRUVICA to be highlighted at AACR Annual Meeting

Pharmacyclics, Inc. today announced that new pre-clinical and clinical data for ibrutinib (IMBRUVICA) will be highlighted at the 2015 American Association for Cancer Research Annual Meeting to be held April 18 – 22, 2015, in Philadelphia, PA.

19 Mar 2015

$IMBRUVICA-rituximab combination well tolerated in patients with relapsed or refractory MCL$

IMBRUVICA-rituximab combination well tolerated in patients with relapsed or refractory MCL

New IMBRUVICA (ibrutinib) Phase II data announced by Pharmacyclics, Inc. today demonstrates its potential utility as a combination therapy when used with rituximab. Data suggest that the overall efficacy and safety profile of IMBRUVICA is well tolerated when combined with rituximab in patients with relapsed or refractory mantle cell lymphoma (MCL).

9 Dec 2014

Phase 2 RESONATE-17 study: IMBRUVICA (ibrutinib) improves survival in CLL patients with del 17p

Results from the Phase 2 RESONATE-17 (PCYC-1117) study show IMBRUVICA (ibrutinib) was associated with an 82.6 percent investigator-assessed overall response rate (ORR; the primary endpoint) and a 79 percent progression-free survival (PFS) rate at 12 months in people living with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have a genetic mutation known as deletion 17p (del 17p).

9 Dec 2014

Pembrolizumab shows promising results in patients with classical Hodgkin Lymphoma

Merck, known as MSD outside of Canada and the United States, announced today early study findings demonstrating that patients treated with pembrolizumab, the company's investigational anti-PD-1 cancer therapy, achieved an overall response rate of 66 percent, as assessed by International Harmonization Project response criteria (n=19/29: 95% CI, 46-82).

7 Dec 2014

IMBRUVICA demonstrates anti-tumor activity against multiple myeloma in Phase II study

New IMBRUVICA (ibrutinib) Phase II data announced here today by Pharmacyclics, Inc) during the 56th American Society of Hematology Annual Meeting suggests that IMBRUVICA demonstrates anti-tumor activity both as a single-agent and as combination therapy in heavily pre-treated patients with relapsed or relapsed/refractory multiple myeloma (MM).

7 Dec 2014

Hematuria News and Research

Further Reading

Phase 3 study of KEYTRUDA monotherapy meets primary endpoint

Merck announces FDA acceptance of supplemental Biologics License Application for KEYTRUDA

NeoTract announces results of study measuring costs and patient outcomes of UroLift System

AUA recommends use of UroLift System for managing lower urinary tract symptoms attributed to BPH

New article explores cost-effectiveness of initial diagnostic protocols for microscopic hematuria

Pacific Edge announces commercial launch of Cxbladder Monitor in the U.S.

World Kidney Day 2016 focuses on children

RUVICA (ibrutinib) capsules approved for treatment-naïve CLL patients

Turing Pharmaceuticals acquires rights to market Daraprim (pyrimethamine) in the U.S.

IMBRUVICA (ibrutinib) approved in Europe for treatment of Waldenstrom's macroglobulinemia

Pharmacyclics's Phase III RESONATE™ trial shows adherence to 420mg dose of IMBRUVICA improves outcomes in CLL patients

Pharmacyclics’ Ibrutinib Phase Ib/II data show ibrutinib may be safe and effective in patients with cGVHD

Phase III HELIOS trial results show ibrutinib combination therapy improves outcomes in CLL/SLL patients

Ibrutinib (IMBRUVICA) may be effective for pancreatic ductal adenocarcinoma

Pharmacyclics announces positive results from IMBRUVICA Phase II study in WM patients

New pre-clinical, clinical data for IMBRUVICA to be highlighted at AACR Annual Meeting

IMBRUVICA-rituximab combination well tolerated in patients with relapsed or refractory MCL

Phase 2 RESONATE-17 study: IMBRUVICA (ibrutinib) improves survival in CLL patients with del 17p

Pembrolizumab shows promising results in patients with classical Hodgkin Lymphoma

IMBRUVICA demonstrates anti-tumor activity against multiple myeloma in Phase II study

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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