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.

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

Soliris (Eculizumab) granted orphan drug designation in Europe and U.S. for atypical hemolytic uremic syndrome

Alexion Pharmaceuticals, Inc. has announced today that Soliris® (eculizumab), its first-in-class complement inhibitor, has been granted Orphan Medicinal Product Designation by the European Commission for the treatment of patients with atypical Hemolytic Uremic Syndrome (aHUS). AHUS is an ultra-rare, inherited, and life-threatening complement-inhibitor deficiency disease that often progresses to end-stage kidney disease or failure. The U.S. Food and Drug Administration granted orphan drug designation to Soliris for the same indication in May 2009. Soliris is not approved for the treatment of patients with aHUS.

6 Aug 2009

Sunitinib shows promise for advanced kidney cancer patients with poor prognosis

Sunitinib prolongs progression-free and overall survival, and is safe and well tolerated in advanced kidney cancer (metastatic renal cell carcinoma) patients with a poor prognosis such as the elderly and those whose cancer has spread to the brain, finds an Article published Online First (www.thelancet.com) and in the August edition of The Lancet Oncology.

16 Jul 2009

New peripherally inserted central catheter mimics nature

A novel coating being used on a new peripherally inserted central catheter (PICC) from r4 Vascular mimics the cell layer found on natural tissue surfaces.

30 Jun 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

Sanofi-aventis to acquire Oforta, oral chronic lymphocytic leukemia treatment

Sanofi-aventis U.S. announced today that it has acquired from biotechnology company Antisoma plc the U.S. commercial rights to Oforta (fludarabine phosphate film-coated tablets), an oral B-cell chronic lymphocytic leukemia (CLL) drug. Oforta is currently approved in the United States for use as a second-line therapy to treat adults with B-cell CLL.

12 May 2009

European Commission and US FDA approve intravenous formulation of temozolomide

Schering-Plough Corporation (NYSE:SGP) today announced that the European Commission and the US FDA both approved the intravenous (IV) formulation of temozolomide as an alternative to the already approved oral form of the drug.

5 Mar 2009

Onyx Pharmaceuticals acquires license option on novel JAK2 inhibitors from S*BIO

Onyx Pharmaceuticals, Inc. has announced that it has acquired an option to license rights to SB1518, an orally available, potent, and selective inhibitor of Janus Kinase 2 (JAK2), and SB1578, also a JAK2 inhibitor, from S*BIO Pte Ltd based in Singapore.

6 Jan 2009

$Proteolix announces positive data for carfilzomib in patients with relapsed and refractory multiple myeloma$

Proteolix announces positive data for carfilzomib in patients with relapsed and refractory multiple myeloma

Proteolix, Inc. today announced positive clinical data demonstrating that the company's lead product, carfilzomib, has single-agent activity and promotes durable responses in patients with relapsed and refractory multiple myeloma.

10 Dec 2008

VIDAZA (azacitidine) study reports survival benefit in higher-risk MDS extends to AML patients

Celgene International Sàrl (NASDAQ: CELG) today announced results from a subset analysis of the international phase III trial (AZA-001) demonstrating that the overall survival benefit observed in higher-risk MDS patients extended to patients with acute myeloid leukemia (AML).

10 Dec 2008

New data on ZOLINZA (vorinostat) in combination with Bortezomib

Results from two Phase 1 studies of ZOLINZA (vorinostat), Merck's oral histone deacetylase (HDAC) inhibitor, administered in combination with bortezomib, showed early anti-tumor activity in patients with relapsed and/or refractory multiple myeloma, including those previously treated with and no longer responding to bortezomib.

10 Dec 2008

Dacogen data presented on trial in seniors with acute myeloid leukemia

Eisai Corporation of North America has announced data from a Phase II trial evaluating a five-day dosing regimen of Dacogen(R) (decitabine for injection) in acute myeloid leukemia (AML), the most common form of leukemia.

10 Dec 2008

Novel therapeutic approaches for various forms of thrombocytopenia

Four studies that highlight significant advances in treatment and survival outcomes for patients with various forms of thrombocytopenia, a group of bleeding disorders characterized by a low number of platelets in the blood, were presented December 6 during the 50th Annual Meeting of the American Society of Hematology in San Francisco, CA.

8 Dec 2008

Incyte's selective Janus kinase inhibitor demonstrates rapid and durable clinical benefits in Myelofibrosis patients

Incyte Corporation will present updated results from an ongoing Phase II trial of INCB18424, its selective, orally available Janus kinase (JAK) inhibitor, in patients with myelofibrosis (MF) at the 50th American Society of Hematology (ASH) Annual Meeting.

8 Dec 2008

Allos Therapeutics announces results from phase 2 trial of Pralatrexate in peripheral T-cell lymphoma

Allos Therapeutics, Inc. has announced preliminary top line results from PROPEL, the Company's pivotal Phase 2 trial of pralatrexate (PDX) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), at the 50th Annual Meeting of the American Society of Hematology (abstract 261).

8 Dec 2008

Promacta (eltrombopag) shown to increase platelet counts and reduce bleeding in chronic immune thrombocytopenic

GlaxoSmithKline has announced positive safety and efficacy results from RAISE (RAndomized placebo- controlled ITP Study with Eltrombopag), a Phase III study of Promacta (eltrombopag) in adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who had received one or more prior ITP therapies.

7 Dec 2008

FDA accepts Zevalin supplemental biologics license application

Cell Therapeutics, Inc. (CTI) has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review, and has granted priority review status for, the supplemental Biologics License Application (sBLA) for use of Zevalin ([90Y]-ibritumomab tiuxetan) as consolidation therapy for patients with follicular B-cell non-Hodgkin's lymphoma who achieve a response to first-line therapy. Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need.

1 Dec 2008

Nplate receives positive opinion for marketing authorisation in Europe

Amgen has announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Nplate (romiplostim) in the European Union (EU).

21 Nov 2008

Ortho Biotech submits NDA for Trabectedin in relapsed ovarian cancer

Ortho Biotech Products, L.P. has announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for trabectedin when administered in combination with DOXIL (doxorubicin HCI liposome injection) for the treatment of women with relapsed ovarian cancer (ROC).

20 Nov 2008

FDA approves GSK's Promacta (Eltrombopag)

GlaxoSmithKline has announced that the United States Food and Drug Administration (FDA) granted accelerated approval for PROMACTA (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

20 Nov 2008

Thrombocytopenia News and Research

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

Soliris (Eculizumab) granted orphan drug designation in Europe and U.S. for atypical hemolytic uremic syndrome

Sunitinib shows promise for advanced kidney cancer patients with poor prognosis

New peripherally inserted central catheter mimics nature

Cimzia approved in U.S. for rheumatoid arthritis

Sanofi-aventis to acquire Oforta, oral chronic lymphocytic leukemia treatment

European Commission and US FDA approve intravenous formulation of temozolomide

Onyx Pharmaceuticals acquires license option on novel JAK2 inhibitors from S*BIO

Proteolix announces positive data for carfilzomib in patients with relapsed and refractory multiple myeloma

VIDAZA (azacitidine) study reports survival benefit in higher-risk MDS extends to AML patients

New data on ZOLINZA (vorinostat) in combination with Bortezomib

Dacogen data presented on trial in seniors with acute myeloid leukemia

Novel therapeutic approaches for various forms of thrombocytopenia

Incyte's selective Janus kinase inhibitor demonstrates rapid and durable clinical benefits in Myelofibrosis patients

Allos Therapeutics announces results from phase 2 trial of Pralatrexate in peripheral T-cell lymphoma

Promacta (eltrombopag) shown to increase platelet counts and reduce bleeding in chronic immune thrombocytopenic

FDA accepts Zevalin supplemental biologics license application

Nplate receives positive opinion for marketing authorisation in Europe

Ortho Biotech submits NDA for Trabectedin in relapsed ovarian cancer

FDA approves GSK's Promacta (Eltrombopag)

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