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.

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

Alport syndrome: an interview with Dr Paul Grint, CMO, Regulus

Alport Syndrome was first described by a physician called Cecil Alport, back in the late 1920s. It's a genetic disease that affects a certain type of collagen involved in the functioning of the kidney, the ear, and the eye.

1 Dec 2014

Janssen announces submission of IMBRUVICA sNDA to FDA for WM treatment

Janssen Research & Development, LLC today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) to the U.S. Food and Drug Administration by its strategic partner Pharmacyclics, Inc.

20 Oct 2014

Pacific Edge signs agreement with SCPMG to evaluate Cxbladder User Program

Pacific Edge Ltd, a cancer diagnostics company, has signed an agreement with Southern California Permanente Medical Group (SCPMG) to research its User Program to evaluate its bladder cancer technology Cxbladder within the clinical settings of Kaiser Permanente's health care network.

3 Sep 2014

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Pharmacyclics, Inc. today announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval.

9 Jun 2014

Findings explain why women with bladder cancer are often diagnosed at later stage than men

Women with blood in their urine (hematuria) were less than half as likely as men with the same issue to be referred to a urologist for further tests, according to a new Vanderbilt University study.

28 May 2014

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc.

8 Apr 2014

Prostate cancer breakthroughs offer new hope for men

Men have lower life expectancy than women. This discrepancy is especially pronounced for African American men who live 6 fewer years than women. According to the CDC, life expectancy in the US is 76 years for men compared to 81 for women.

8 Apr 2014

Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

Astellas Pharma Inc. and Medivation Inc. today announced the submission of a variation to amend the European Marketing Authorization Application for XTANDI® (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.

4 Apr 2014

CSI's new Diamondback Peripheral 60cm systems receive FDA clearance for PAD treatment

Cardiovascular Systems, Inc., announced today it has received FDA clearance of its new Diamondback 360 60cm Peripheral Orbital Atherectomy Systems (OAS) for the treatment of peripheral arterial disease (PAD).

10 Mar 2014

Pharmacyclics total revenue for fourth quarter 2013 increases 113% to $123.6 million

Pharmacyclics, Inc. today reported financial results and recent developments for the quarter and year ended December 31, 2013.

20 Feb 2014

Chesapeake Urology for Kids introduced for pediatric care

Chesapeake Urology Associates, PA, the premier urology practice in Maryland and the Mid-Atlantic region, introduces Chesapeake Urology for Kids, a comprehensive program to treat urologic conditions in children from pre-natal to 18 years of age. This new division is being led by Robert Mevorach, MD, a fellowship trained pediatric urologist. An office exclusively for pediatric patients is now open at 25 Crossroads Drive in Owings Mills, Maryland.

31 Jan 2014

FDA approves Farxiga tablets to improve glycemic control in adults with type 2 diabetes mellitus

AstraZeneca and Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration approved Farxiga™ [far-SEE-ga] (dapagliflozin), a once-daily oral treatment indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

13 Jan 2014

Emergent BioSolutions enters into definitive agreement to acquire Cangene

Emergent BioSolutions Inc.announced that it has entered into a definitive agreement with Cangene Corporation (TSX: CNJ) under which Emergent will acquire all of the outstanding common shares of Cangene in an all-cash transaction valued at $3.24 per share on a fully diluted basis for an aggregate purchase price of $222 million.

12 Dec 2013

Pharmacyclics presents ibrutinib trial data for B-cell malignancies at ASH meeting

Pharmacyclics, Inc. today announced results of 40 clinical, non-clinical and pre-clinical presentations on ibrutinib (IMBRUVICA™) at the 55TH Annual meeting of the American Society of Hematology (ASH) held in New Orleans, Dec 7 - 10, 2013.

11 Dec 2013