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.

Positive final data from Phase 2 study of ISTODAX presented

Gloucester Pharmaceuticals announced today the presentation of positive final data from a Phase 2 study of ISTODAX® (romidepsin) in peripheral T-cell lymphoma (PTCL) conducted by the National Cancer Institute (NCI) at the 51st American Society of Hematology (ASH) Annual Meeting being held in New Orleans, LA.

6 Dec 2009

FDA approves Zyprexa in tablet form for schizophrenia and manic treatment

The U.S. Food and Drug Administration (FDA) today approved Zyprexa® (olanzapine) in tablet form as an option for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents aged 13-17 years old.

4 Dec 2009

FDA approves once-daily SEROQUEL XR Extended Release Tablets

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR® (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder (MDD).

4 Dec 2009

ISTODAX included in the updated NCCN Clinical Practice Guidelines in Oncology

Gloucester Pharmaceuticals announced today that ISTODAX® (romidepsin) has been included in the updated National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology™ as a suggested systemic treatment option for patients with mycosis fungoides and Sézary syndrome—two of the most common types of cutaneous T-cell lymphoma (CTCL).

4 Dec 2009

New data demonstrating the strength of Novartis' hematology portfolio to be presented

Novartis announced today that new data, including a late-breaking presentation on Tasigna® (nilotinib) 200 mg capsules in a form of chronic myeloid leukemia, demonstrate the strength of the company's hematology portfolio in advancing the care of patients.

2 Dec 2009

FDA approves sNDA for pediatric autism drug ABILIFY

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

20 Nov 2009

New data from CIMZIA WELCOME trial to be presented at the ACG meeting

According to new results from the WELCOME trial, exploratory data analyzing the impact of treatment with CIMZIA(®) (certolizumab pegol) - the only PEGylated anti-TNF (alpha) (Tumor Necrosis Factor alpha) - administered either every two weeks or every four weeks, showed that the majority of Crohn's disease patients in both dosing groups experienced no hospitalizations and surgical procedures during the course of the 26-week study.

28 Oct 2009

New data from efficacy study of CIMZIA in Crohn's disease patients presented

New data from an open-label extension study evaluating the long-term safety and efficacy of CIMZIA® (certolizumab pegol) in moderate to severe Crohn's disease patients demonstrate that 82 percent of patients actively treated with CIMZIA - the only PEGylated anti-TNF-alpha (Tumor Necrosis Factor alpha) - remained in long-term remission without dose escalation up to 3.5 years.

27 Oct 2009

Novartis' Tasigna capsules meets primary endpoint in comparison trial with Gleevec

Novartis announced today that Tasigna (nilotinib) 200 mg capsules met its primary endpoint in the first head-to-head comparison with the company's groundbreaking drug Gleevec (imatinib mesylate) tablets*. Tasigna produced faster and deeper responses than Gleevec when given as first-line therapy for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Tasigna was well tolerated in the study.

20 Oct 2009

UCB reports on the outcome of Cimzia and MTX treatment for rheumatoid arthritis

UCB today announced data that showed rapid and sustained improvements in ACR20, physical function, pain and fatigue of rheumatoid arthritis (RA) as early as the first week, and inhibition of progression of structural joint damage (seen at week 24) following treatment with Cimzia (certolizumab pegol), together with methotrexate (MTX), was sustained up to 100 weeks.

19 Oct 2009

Vanda Pharmaceuticals announces its agreement with Novartis Pharma AG

Vanda Pharmaceuticals Inc. announced today that it has entered into an agreement with Novartis Pharma AG to commercialize and develop Fanapt(TM) (iloperidone), Vanda's anti-psychotic, in the U.S. and Canada. Fanapt(TM) was approved by the U.S. Food and Drug Administration on May 6, 2009 for the acute treatment of schizophrenia in adults.

14 Oct 2009

Millennium's sNDA for VELCADE granted priority review by the FDA

Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the Company’s supplemental new drug application (sNDA) for VELCADE. The sNDA contains long-term overall survival (OS) data from the landmark VISTA trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

19 Sep 2009

Final results of SAPHRIS clinical study released

Schering-Plough Corporation today reported final results of a SAPHRIS(R) (asenapine) long-term schizophrenia relapse prevention clinical study.

14 Sep 2009

Millennium's sNDA to be reviewed by the FDA

The Takeda Oncology Company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) based on long- term overall survival (OS) data from the landmark VISTA1 trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

3 Sep 2009

FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA’s Oncologic Drugs Advisory Committee voted 9 to 3 that a randomized, controlled trial is needed to support the currently proposed label expansion for Clolar® (clofarabine) in adult myeloid leukemia (AML). The committee found that the single-arm clinical study results submitted to support the label expansion showed Clolar was an active agent in acute AML patients, but concluded that a randomized clinical trial should be necessary to better interpret Clolar’s efficacy and safety in the proposed patient population.

2 Sep 2009

Cimzia approved for treating adult patients with rheumatoid arthritis

UCB Canada Inc. announced today that Health Canada has approved Cimzia, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

1 Sep 2009

FDA approves the usage of Valcyte for preventing CMV disease in pediatric patients

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Valcyte(R) (valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients (4 months to 16 years of age) at high risk of developing CMV disease.

31 Aug 2009

Genzyme’s supplemental NDA for treating adult AML with Clolar to be discussed by the FDA

Genzyme Corporation (Nasdaq: GENZ) announced today that its supplemental New Drug Application for Clolar® (clofarabine) will be discussed Tuesday, September 1 at a public meeting of the FDA’s Oncologic Drugs Advisory Committee in Silver Spring, Maryland. The panel is expected to consider the clinical trial results Genzyme submitted to support the approval and labeling of Clolar to treat older adult patients with acute myeloid leukemia (AML), the most common type of acute leukemia in adults.

29 Aug 2009

Gene variants associated with survival advantage in African Americans with HIV

From the start of the HIV epidemic, it appeared that some of the people who were infected with the virus were able to ward off the fatal effects of the disease longer than others.

20 Jul 2009

Cimzia approved in U.S. for rheumatoid arthritis

UCB announced today that the U.S. Food and Drug Administration (FDA) approved Cimzia, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

13 May 2009