Leukopenia News and Research

RSS

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

Celgene's ISTODAX sNDA granted FDA Priority Review classification for progressive/relapsed PTCL

Celgene Corporation today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review classification to its Supplemental New Drug Application (sNDA) regarding ISTODAX (romidepsin) for injection for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy.

28 Feb 2011

Phase II results of VELCADE in patients with aggressive lymphoma published in Journal of Clinical Oncology

Millennium: The Takeda Oncology Company today announced that Phase II results of a clinical trial examining VELCADE (bortezomib) in patients with previously untreated aggressive lymphoma were published in the Journal of Clinical Oncology.

5 Feb 2011

Sanofi-aventis announces publication of positive BSI-201 phase II results for breast cancer

Sanofi-aventis and its wholly-owned subsidiary, BiPar Sciences, today announced that The New England Journal of Medicine published the final phase II data for the investigational drug iniparib demonstrating significant clinical benefit in women with metastatic triple negative breast cancer when iniparib was administered in combination with chemotherapy agents gemcitabine/carboplatin.

6 Jan 2011

Celgene announces regulatory submissions for blood cancer therapies REVLIMID and ISTODAX

Celgene International Sàrl announced regulatory submissions for its blood cancer therapies REVLIMID (lenalidomide) and ISTODAX (romidepsin).

5 Jan 2011

GeparQuinto study data on bevacizumab plus chemotherapy in early breast cancer to be presented at 33rd CTRC-AACR

Results of the GeparQuinto study, randomized Phase III efficacy data on the use of bevacizumab plus chemotherapy to treat women with early breast cancer will be presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium.

13 Dec 2010

Sunovion reports results of Latuda third phase 3 worldwide clinical trial for schizophrenia

Sunovion Pharmaceuticals Inc. today announced the results of the PEARL 3 study, the third phase 3 worldwide clinical trial of Latuda® (lurasidone HCl) tablets, a once-daily atypical antipsychotic agent recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with schizophrenia. In this six-week, placebo-controlled trial, both fixed doses of LATUDA 80 and 160 mg once-daily, demonstrated statistically significant improvement in symptoms of schizophrenia versus placebo across both primary and secondary efficacy measures.

9 Dec 2010

Study comparing subcutaneous, intravenous administration of VELCADE in relapsed MM patients presented at ASH

Millennium: The Takeda Oncology Company today reported results from a randomized, international Phase III clinical trial comparing subcutaneous and intravenous administration of VELCADE (bortezomib) in patients with relapsed multiple myeloma. These data were presented at the 52nd annual meeting of the American Society of Hematology, held December 4-7 in Orlando, Florida.

8 Dec 2010

Pivotal Phase II study data of romidepsin in relapsed PTCL presented at ASH 2010

Celgene International Sàrl today announced that data from a pivotal Phase II, multicenter, international, open-label study of romidepsin (ISTODAX) in progressive or relapsed PTCL following prior systemic therapy were presented at the 52nd American Society of Hematology Annual Meeting.

6 Dec 2010

Investigational study data of REVLIMID with rituximab or rituximab-containing regimen in CLL patients presented at ASH

Celgene International Sàrl announced that clinical data from two investigational studies evaluating the use of REVLIMID (lenalidomide) either with rituximab or following a rituximab-containing regimen in patients with chronic lymphocytic leukaemia were presented at the 52nd American Society of Hematology annual meeting.

6 Dec 2010

VYTORIN reduces major vascular events in patients with chronic kidney disease

In a new investigational study of VYTORIN, the cholesterol-lowering medicine from Merck, VYTORIN 10/20 mg reduced the incidence of first major vascular events defined as non-fatal heart attacks or cardiac death, stroke or any revascularization procedure by a highly statistically significant 16.1 percent compared to placebo, Study of Heart and Renal Protection study involved more than 9,000 patients who, on average, had advanced or end-stage chronic kidney disease (CKD)

22 Nov 2010

Aeterna presents data on AEZS-108 Phase 2 study for endometrial cancer at EORTC-NCI-AACR Symposium

Aeterna Zentaris Inc., earlier today, presented Phase 2 positive efficacy and safety data for its compound, AEZS-108, in advanced endometrial cancer.

18 Nov 2010

FDA approves Halaven therapy for metastatic late-stage breast cancer

The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

16 Nov 2010

Colcrys safe for treating gout flares

Patients who experience gout flares can be treated safely with Colcrys (colchicine, USP), even in the presence of co-morbid conditions that often present physicians with treatment challenges, according to a new analysis presented here at the 74th Annual Scientific Meeting of the American College of Rheumatology (ACR).

9 Nov 2010

Sandoz initiates voluntary recall of Methotrexate Injection

Sandoz Inc. announced today it has initiated a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product ("methotrexate") to the consumer/user level. Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots.

28 Oct 2010

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

Results of a new international phase 4 study of patients with nosocomial pneumonia due to proven methicillin-resistant Staphylococcus aureus (MRSA) demonstrated that the antibiotic Zyvox® (linezolid) achieved a statistically significantly higher clinical success rate compared with vancomycin for the primary endpoint. The ZEPHyR (Linezolid in the treatment of subjects with nosocomial pneumonia proven to be due to methicillin-resistant Staphylococcus aureus) study was the largest ever conducted in this population.

21 Oct 2010

UCB presents P3, P4 clinical trial data for Crohn's disease at ACG Scientific Meeting

Findings from the PRECiSE 3 (P3) open label extension study for Cimzia, demonstrating the longest continuously running maintenance trial for an anti-TNF in Crohn's disease, will be exhibited at the 2010 Annual Scientific Meeting of the American College of Gastroenterology (ACG), taking place in San Antonio from October 15 – 20. Additionally, long-term efficacy data from the PRECiSE 4 (P4) clinical trial also will be presented at the meeting.

19 Oct 2010

ACG meeting to exhibit Cimzia data for Crohn's disease treatment

Studies and analyses of the Crohn's disease (CD) treatment Cimzia (certolizumab pegol) will be exhibited at the 2010 Annual Scientific Meeting of the American College of Gastroenterology, taking place in San Antonio from October 15 – 20.

18 Oct 2010

IDMC recommends early termination of Phase 3 intramuscular depot aripiprazole trial

Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announced today that an independent data monitoring committee (IDMC) has recommended the early termination of its Phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.

6 Oct 2010

Sanofi-aventis publishes Phase III TROPIC study data in The Lancet article

Sanofi-aventis announced today that data from the Phase III TROPIC study, which was the basis for the June 2010 U.S. Food and Drug Administration (FDA) approval of Jevtana (cabazitaxel) Injection, was published in the October 2, 2010 print edition of The Lancet in an article titled "Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial.

4 Oct 2010

Genmab reports top-line interim results from ofatumumab Phase II study in Diffuse Large B-Cell Lymphoma

Genmab A/S announced today top-line interim results from an initial Phase II single arm open label study of ofatumumab to evaluate the treatment of relapsed Diffuse Large B-Cell Lymphoma in patients ineligible for or relapsed following a stem cell transplant.

11 Aug 2010