Thrombocytopenia News and Research

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Thrombocytopenia is a condition in which there is a lower-than-normal number of platelets in the blood. It may result in easy bruising and excessive bleeding from wounds or bleeding in mucous membranes and other tissues.

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

Schering-Plough to present data on boceprevir at the AASLD 2009 Annual Meeting

Schering-Plough announced that data on boceprevir, an investigational hepatitis C virus (HCV) protease inhibitor, will be reported in an oral presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston, Oct. 30-Nov. 3.

19 Oct 2009

NHLBI awards $16.7 million to develop new clinical strategies in stem cell therapy

9 Oct 2009

Hutchinson Center scientists awarded $16.7M to develop progenitor and stem cell tools

The National Heart, Lung and Blood Institute has awarded a total of $16.7 million to Irwin Bernstein, M.D., and Beverly Torok-Storb, Ph.D., both members of the Clinical Research Division at Fred Hutchinson Cancer Research Center. The Hutchinson Center grants represent part of a $170 million effort involving 18 teams of research scientists dedicated to developing stem- and progenitor-cell tools and therapies.

8 Oct 2009

Schering-Plough receives FDA recommendation approval for PEGINTRON

Schering-Plough Corp. announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for PEGINTRON® (pegylated interferon alfa-2b) in the adjuvant treatment of patients with Stage III malignant melanoma.

6 Oct 2009

FOLOTYN available for commercial sale in the United States

Allos Therapeutics, Inc. today announced that FOLOTYN (pralatrexate injection) is now available for commercial sale in the United States. The U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) on September 24, 2009. This indication is based on overall response rate.

6 Oct 2009

Novartis Oncology, Amgen, GlaxoSmithKline and Veridex honored with 2009 Prix Galien Award

The Prix Galien USA committee celebrated members of the science and biotechnology industries last night for the development and discovery of drugs and technologies that improve the human condition.

1 Oct 2009

National Institutes of Health awards $16.8 million grant to Hutchinson Center/UW group

The National Heart, Lung and Blood Institute of the National Institutes of Health has awarded a $16.8 million, seven-year grant to launch a bicoastal research partnership between Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium and Children's Hospital of Philadelphia.

30 Sep 2009

Heparin-induced skin lesions may indicate platelets deficit

Heparin, a commonly used anticoagulant, can cause skin lesions, reports a study http://www.cmaj.ca/press/cmaj081729.pdf in CMAJ (Canadian Medical Association Journal) www.cmaj.ca.

29 Sep 2009

FDA grants accelerated approval for Allos Therapeutics’ FOLOTYN

Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that last night the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYNTM (pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

28 Sep 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

Phase III EXTEND trial results of pixantrone announced

Cell Therapeutics, Inc. (CTI) today released updated 18-month follow-up clinical data for its phase III EXTEND (PIX 301) trial of pixantrone (BBR2778) for patients with advanced, relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). Responses were evaluated by an Independent Assessment Panel that was blinded to patient assignment.

16 Sep 2009

Phase 2 MS clinical trial data continues to show durable reductions in relapse rate

Genzyme Corporation reported today that four-year follow-up data from its completed Phase 2 multiple sclerosis (MS) trial continued to show durable reductions in relapse rate and sustained accumulation of disability three years after the majority of patients received their last course of the investigational compound alemtuzumab.

14 Sep 2009

AVONEX results in fewer injection site reactions, according to a clinical study

Data from an observational phase IV study of 499 patients entitled The Swiss MS Skin Project show that multiple sclerosis (MS) patients taking AVONEX (interferon beta-1a IM) reported significantly fewer injection site reactions (ISRs) compared to patients on Betaferon- (interferon beta-1b), Copaxone- (glatiramer Acetate) or Rebif - (interferon beta-1a).

13 Sep 2009

FDA approves Supplemental New Drug Application for DOXIL

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

10 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