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.

European Commission amends marketing authorisation for Celgene's REVLIMID

Celgene International Sàrl was today notified that the European Commission has amended the marketing authorisation for REVLIMID. This decision means that REVLIMID is now approved to treat patients with transfusion-dependent anaemia due to low or intermediate-1 risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

17 Jun 2013

Bayer HealthCare to present new data on oncology portfolio at ASCO meeting

Bayer HealthCare announced today that new data on the oncology portfolio, including Nexavar (sorafenib) tablets, Stivarga (regorafenib) tablets and the recently U.S. Food and Drug Administration approved product Xofigo (radium Ra 223 dichloride) injection will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology, May 31 – June 4, in Chicago, IL (USA).

16 May 2013

Prostate cancer drug Xofigo gets FDA approval

The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs.

16 May 2013

Sanofi, Regeneron enroll patients in two sarilumab Phase 3 trials for treatment of RA

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the COMPARE and ASCERTAIN trials of sarilumab, the first fully human monoclonal antibody directed against the IL-6 receptor, which is delivered by subcutaneous injection every other week, have enrolled their first patients.

15 May 2013

Otsuka receives FDA approval for ABILIFY MAINTENA to treat schizophrenia

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the U.S. Food and Drug Administration (FDA) has approved ABILIFY MAINTENA (aripiprazole) for extended- release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of schizophrenia.

1 Mar 2013

UCB seeks FDA and EMA marketing authorization for Cimzia to treat active psoriatic arthritis

UCB announced today two new regulatory filings with the US Food and Drug Administration (FDA) and with the European Medicines Agency (EMA) to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA) and for adult patients with active axial spondyloarthritis (axSpA).

20 Feb 2013

FDA approves Novartis’ Zortress to prevent organ rejection after liver transplantation in adults

Novartis announced today that the US Food and Drug Administration (FDA) has approved Zortress (everolimus) for the prophylaxis of organ rejection in adult patients receiving a liver transplant.

16 Feb 2013

Boehringer Ingelheim initiates enrollment in Phase III IFN-free HCV trial

Today, Boehringer Ingelheim announced that the first patients have been enrolled in the company's pivotal Phase III interferon (IFN)-free hepatitis C (HCV) clinical trial programme, HCVerso.

18 Jan 2013

FDA grants accelerated approval to ARIAD’s Iclusig for treatment of CML, Ph+ ALL

ARIAD Pharmaceuticals, Inc. today announced that following a priority review, the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Iclusig (ponatinib) for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.

14 Dec 2012

Celgene announces results from REVLIMID plus VIDAZA phase II study on AML

Celgene International Sàrl today announced that results from a study evaluating the combination of REVLIMID (lenalidomide) plus VIDAZA (azacitidine) in patients 60 years or older with untreated acute myeloid leukemia (AML) were presented at the American Society of Hematology annual meeting in Atlanta, GA.

11 Dec 2012

Results of Halaven Phase III study in metastatic breast cancer presented at 2012 CTRC-AACR SABCS

Results from the first large, global Phase III study of Halaven (eribulin mesylate) Injection in patients with early-stage metastatic breast cancer were presented today during the 2012 CTRC-AACR San Antonio Breast Cancer Symposium.

7 Dec 2012

FDA accepts Sunovion’s two LATUDA sNDAs for review

Sunovion Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental New Drug Applications (sNDAs) for the use of LATUDA as 1) monotherapy and 2) adjunctive therapy to lithium or valproate, both to treat adult patients with depressive episodes associated with bipolar I disorder (bipolar depression).

31 Oct 2012

Jennerex Phase 2 JX-594 clinical data for hepatocellular carcinoma presented at ILCA meeting

Jennerex, Inc., a private, clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic immunotherapies, presented Phase 2 clinical data of JX-594 delivered first intravenously and subsequently through intra-tumoral route demonstrating safety as well as disease control and tumor responses in patients with hepatocellular carcinoma (liver cancer, HCC).

17 Sep 2012

Combination therapy does not change safety and efficacy relationship of TORISEL for advanced RCC

Pfizer Inc. announced that the Phase 3 INTORACT trial (B1771006), evaluating the combination of bevacizumab plus TORISEL (temsirolimus) compared with bevacizumab plus interferon-alfa-2a (IFN-α-2a) in the first-line treatment of patients with advanced renal cell carcinoma (RCC) across risk groups, did not meet its primary endpoint of superiority in extending progression free survival (PFS) in the study population.

12 Aug 2012

No benefits to polychemotherapy after surgery in gastric cancer

Findings from the ITACA-S trial suggest that a more intensive postoperative chemotherapy regimen does not improve outcomes over a less-intensive regimen after radical resection in patients with gastric cancer.

7 Jun 2012

Adjuvant chemoradiotherapy boosts esophageal cancer survival

Chemoradiotherapy significantly improves the outcome of patients undergoing surgery for cancer of the esophagus or esophagogastric junction and is well tolerated, suggests research in The New England Journal of Medicine.

7 Jun 2012

Pfizer fails to meet primary endpoint in TORISEL Phase 3 study for advanced RCC

Pfizer Inc announced that the Phase 3 INTORSECT (B1771003) study, evaluating TORISEL(temsirolimus) in patients with advanced renal cell carcinoma (RCC) whose disease had progressed on or after SUTENT (sunitinib malate) therapy, did not meet the primary endpoint of prolonging progression free survival (PFS) when compared to sorafenib.

16 May 2012

Sunovion announces results from LATUDA open-label study for schizophrenia

Sunovion Pharmaceuticals Inc. today announced results from an open-label study that switched clinically stable, but symptomatic adult outpatients with schizophrenia from other antipsychotic agents to LATUDA.

10 May 2012

Otsuka announces results from aripiprazole Phase 3 trial on schizophrenia

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S today announced results from a Phase 3 clinical trial evaluating the efficacy, safety and tolerability of once-monthly aripiprazole intramuscular (IM) depot formulation for the maintenance treatment of adults with schizophrenia.

8 May 2012

Positive results from Dainippon Sumitomo Pharma's LATUDA trials for bipolar I depression

Dainippon Sumitomo Pharma Co., Ltd. announced today results from two Phase 3 clinical trials designed to evaluate the efficacy and safety of LATUDA as adjunctive therapy and monotherapy, respectively, in patients with bipolar I depression (PREVAIL 1 and PREVAIL 2; PRogram to EValuate the Antidepressant Impact of Lurasidone).

7 May 2012