Leukopenia News and Research

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Leukopenia is a decrease in the number of white blood cells (leukocytes) found in the blood, which places individuals at increased risk of infection.

FDA denies AstraZeneca Citizen Petitions on SEROQUEL labeling

AstraZeneca today announced that on March 7, 2012, the Food and Drug Administration denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labeling that omits certain hyperglycemia warning language that the FDA required AstraZeneca to include in the labeling for SEROQUEL (quetiapine fumarate) tablets and SEROQUEL XR (quetiapine fumarate) extended-release tablets.

12 Mar 2012

FDA issues Complete Response Letter to Eisai for Dacogen sNDA

Astex Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has issued a Complete Response Letter to partner Eisai for their supplemental New Drug Application (sNDA) for Dacogen (decitabine) for Injection for patients with acute myeloid leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction therapy.

7 Mar 2012

UCB initiates EXXELERATE study in rheumatoid arthritis

UCB today announced the start of the EXXELERATE study which will evaluate the short- and long-term efficacy of Cimzia (certolizumab pegol) plus methotrexate (MTX) compared with that of Humira(adalimumab) plus MTX in the treatment of moderate to severe rheumatoid arthritis (RA). The start of this study confirms previously announced plans.

21 Dec 2011

Celgene reports final results from REVLIMID plus VIDAZA phase II study on higher-risk MDS

Celgene International Sàrl, a subsidiary of Celgene Corporation, today reported final results from the phase II portion of a multi-center phase I/II study evaluating combination therapy with REVLIMID (lenalidomide) and VIDAZA (azacitidine) in patients with higher-risk myelodysplastic syndromes (MDS) not previously treated with either drug.

13 Dec 2011

Positive results from Puma's neratinib Phase II trials presented at CTRC-AACR San Antonio Breast Cancer Symposium

Puma Biotechnology, Inc., a development stage biopharmaceutical company, announced that results from ongoing Phase II clinical trials of Puma's investigational drug PB272 (neratinib) were presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium that is currently taking place in San Antonio, Texas.

9 Dec 2011

EC extends therapeutic indication for Soliris to treat atypical hemolytic uremic syndrome

Alexion Pharmaceuticals, Inc. today announced that the European Commission (EC) has extended the therapeutic indication for Soliris® (eculizumab) to include the treatment of pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS).

29 Nov 2011

UCB to sponsor several key sets of Cimzia data on RA at ACR 2011 meeting

UCB, a leading biopharmaceutical company at the forefront of immunology treatment and research, is proud to sponsor several key sets of Cimzia (certolizumab pegol) data at the American College of Rheumatology's 2011 Annual Scientific Meeting in Chicago, November 5-9.

7 Nov 2011

Rheumavax safe and feasible in treating RA

A vaccine designed to re-educate the immune system has been shown to be safe and feasible in the treatment of rheumatoid arthritis, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Chicago.

7 Nov 2011

Takeda receives FDA approval for VELCADE sNDA to treat MM

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE (bortezomib) for Injection, which updates the label to include additional long-term overall survival (OS) data from the VISTA trial.

2 Nov 2011

UCB to present new data on Cimzia at ACG annual scientific meeting

UCB, a leading biopharmaceutical company at the forefront of immunology treatment and research, will present new data on Cimzia at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place in Washington D.C. from October 28 to November 2.

1 Nov 2011

JCO publishes data from Celgene's ABRAXANE Phase II combination trial on pancreatic cancer

Celgene International Sàrl today announced that results from a clinical study of ABRAXANE in combination with gemcitabine in 67 patients with previously untreated advanced pancreatic cancer were published in an online article by the Journal of Clinical Oncology ahead of print.

7 Oct 2011

Genentech announces results of trastuzumab emtansine Phase II study on HER2-positive mBC

Genentech, a member of the Roche Group, today announced the results of the Phase II study TDM4450g in people with previously untreated HER2-positive metastatic breast cancer.

26 Sep 2011

Alexion receives FDA approval for Soliris to treat atypical Hemolytic Uremic Syndrome

The U.S. Food and Drug Administration today approved Soliris (eculizumab) to treat patients with atypical Hemolytic Uremic Syndrome (aHUS), a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke.

26 Sep 2011

Positive data from Aeterna Zentaris' AEZS-108 Phase 2 study on advanced endometrial cancer

Aeterna Zentaris Inc. earlier today, presented positive final Phase 2 efficacy and safety data for its targeted cytotoxic luteinizing hormone releasing hormone (LHRH) analog, AEZS-108, in advanced endometrial cancer.

14 Sep 2011

New clinical data on Bristol-Myers Squibb's NULOJIX to be presented at ESOT 2011 congress

Bristol-Myers Squibb Company today announced that new data on NULOJIX (belatacept) will be presented at the European Society for Organ Transplantation (ESOT) Congress on September 4 -7, 2011 in Glasgow, Scotland, United Kingdom.

2 Sep 2011

Millennium submits VELCADE sNDA to FDA to add OS data for previously untreated multiple myeloma

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced the submission of a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration for VELCADE® (bortezomib) for injection to add overall survival data after a five-year follow up to the product label.

20 Jul 2011

Eisai's DACOGEN sNDA for acute myeloid leukemia accepted by FDA for review

SuperGen, Inc., a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced that Eisai Inc. today released information that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) seeking approval of DACOGEN (decitabine) for injection in the treatment of acute myeloid leukemia.

14 Jul 2011

FDA accepts Eisai's DACOGEN sNDA for review to treat acute myeloid leukemia

Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) seeking approval of DACOGEN (decitabine) for injection in the treatment of acute myeloid leukemia.

13 Jul 2011

Health Canada grants market authorization for Sanofi-aventis Jevtana to treat prostate cancer

Sanofi-aventis announced today that Health Canada has granted market authorization for Jevtana injection in combination with prednisone for the treatment of patients with metastatic castration resistant prostate cancer, previously treated with a docetaxel-containing treatment regimen.

24 Jun 2011

FDA approves NULOJIX

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) approved NULOJIX, the first selective T-cell costimulation blocker indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids.

18 Jun 2011