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.

Percutaneous hepatic perfusion extends survival time for melanoma patients

Melanoma of the eye frequently spreads to the liver and, once this has happened, there is no effective treatment and patients die within an average of two to four months. Only about one in ten patients live for a year. Now, final results from a phase III study have demonstrated that a new treatment significantly extends the time patients can live without the disease progressing.

26 Sep 2011

EMA CHMP adopts positive opinion for Soliris to treat atypical hemolytic uremic syndrome

Alexion Pharmaceuticals, Inc. today announced that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that the therapeutic indication for Soliris® (eculizumab) be extended to include the treatment of pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS) in Europe.

23 Sep 2011

E.U. CHMP issues positive opinion for use of Celgene's REVLIMID/dexamethasone MM drug

Celgene International Sàrl was notified today that the E.U. Committee for Medicinal Products for Human Use (CHMP), on behalf of the European Medicines Agency (EMA) has concluded an Article 20 review of REVLIMID and issued a positive opinion for the use of REVLIMID in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

23 Sep 2011

OptiScan's new bedside glucose monitoring system receives European CE Mark

OptiScan Biomedical Corporation, a developer of innovative continuous glucose monitoring systems for use in intensive care units (ICU), today announced that the company's OptiScanner Automatic Bedside Glucose Monitoring System has received CE Mark certification for use in the European Union.

19 Sep 2011

Positive topline data from 4SC's resminostat Phase II trial on Hodgkin's Lymphoma

4SC AG, a discovery and development company of targeted small molecule drugs for autoimmune diseases and cancer, today announced positive topline data from its Phase II SAPHIRE trial with resminostat, its oral pan HDAC inhibitor, in patients with relapsed/refractory Hodgkin's Lymphoma.

6 Sep 2011

FDA approves Seattle Genetics ADCETRIS drug to treat Hodgkin lymphoma, ALCL

Seattle Genetics, Inc. today announced that the U.S. Food and Drug Administration has granted accelerated approval of ADCETRISTM for two indications: (1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.

20 Aug 2011

Seattle Genetics receives FDA approval for Adcetris to treat Hodgkin lymphoma, ALCL

The U.S. Food and Drug Administration today approved Adcetris to treat Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma.

20 Aug 2011

Enrollment commences in Allos' FOLOTYN Phase 3 trial for peripheral T-cell lymphoma

Allos Therapeutics, Inc. today announced the enrollment of the first patient in a Phase 3 randomized clinical trial (PDX-017) evaluating FOLOTYN in patients with previously undiagnosed peripheral T-cell lymphoma.

18 Aug 2011

Amgen reports 8% increase in second quarter total product sales to $3,893 million

Amgen reported total revenue increased 4 percent during the second quarter of 2011 to $3,959 million versus $3,804 million in the second quarter of 2010. Total product sales increased 8 percent in the second quarter of 2011 to $3,893 million versus $3,613 million in the second quarter of 2010. The increase in total revenue in the second quarter of 2011 included a decline in other revenue due to certain milestone payments earned in the second quarter of 2010.

29 Jul 2011

Positive data from two GSK's Promacta Phase III studies on hepatitis C-related thrombocytopenia

Ligand Pharmaceuticals Incorporated today announced that its partner GlaxoSmithKline has announced that it received positive data from ENABLE-1, the first of two Phase III studies examining Promacta in patients with hepatitis C-related thrombocytopenia, and that full data will be released at an upcoming scientific conference.

27 Jul 2011

AMAG enters definitive merger agreement with Allos Therapeutics

AMAG Pharmaceuticals, Inc. and Allos Therapeutics, Inc. today announced that they have entered into a definitive merger agreement under which the companies will combine in an all-stock merger with a total equity value of approximately $686 million.

21 Jul 2011

Millennium submits VELCADE sNDA to FDA to add OS data for previously untreated multiple myeloma

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced the submission of a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration for VELCADE® (bortezomib) for injection to add overall survival data after a five-year follow up to the product label.

20 Jul 2011

Eisai's DACOGEN sNDA for acute myeloid leukemia accepted by FDA for review

SuperGen, Inc., a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced that Eisai Inc. today released information that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) seeking approval of DACOGEN (decitabine) for injection in the treatment of acute myeloid leukemia.

14 Jul 2011

FDA accepts Eisai's DACOGEN sNDA for review to treat acute myeloid leukemia

Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) seeking approval of DACOGEN (decitabine) for injection in the treatment of acute myeloid leukemia.

13 Jul 2011

Positive top-line results from alemtuzumab Phase 3 trial on multiple sclerosis

Sanofi and its subsidiary Genzyme announced today positive top-line results from CARE-MS I, the first of two randomized, Phase 3 clinical trials comparing the investigational drug alemtuzumab to the approved multiple sclerosis therapy Rebif in patients with relapsing-remitting multiple sclerosis.

11 Jul 2011

Pregnant women face higher risk of stroke

High blood pressure during pregnancy is a leading cause of maternal and fetal mortality worldwide.

8 Jul 2011

Amrubicin vs. topotecan Phase III trial against lung cancer presented at IASLC conference

Lung cancer patients given amrubicin (Calsed) as a second-line therapy had a significantly improved response rate and longer progression-free survival than patients treated with topotecan (Hycamtin), according to research presented at the 14th World Conference on Lung Cancer in Amsterdam, hosted by the International Association for the Study of Lung Cancer.

7 Jul 2011

Millennium reports ongoing MLN8237 Phase II study results on non-Hodgkin lymphoma

Millennium: The Takeda Oncology Company today announced the presentation of results from an ongoing Phase II study of MLN8237, an investigational Aurora A kinase inhibitor, in patients with relapsed/refractory aggressive B-cell and T-cell non-Hodgkin lymphoma.

24 Jun 2011

Health Canada grants market authorization for Sanofi-aventis Jevtana to treat prostate cancer

Sanofi-aventis announced today that Health Canada has granted market authorization for Jevtana injection in combination with prednisone for the treatment of patients with metastatic castration resistant prostate cancer, previously treated with a docetaxel-containing treatment regimen.

24 Jun 2011

Angioplasty may be an option for liver transplant candidates with heart disease

A small, retrospective study determined that percutaneous coronary intervention (PCI) was safe in patients with significant coronary artery disease (CAD) who were referred for liver transplantation. Larger studies are needed to determine the effectiveness of angioplasty in patients with end-stage liver disease (ESLD). Details of the study are available in the July issue of Liver Transplantation, published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases.

22 Jun 2011

Thrombocytopenia News and Research

Percutaneous hepatic perfusion extends survival time for melanoma patients

EMA CHMP adopts positive opinion for Soliris to treat atypical hemolytic uremic syndrome

E.U. CHMP issues positive opinion for use of Celgene's REVLIMID/dexamethasone MM drug

OptiScan's new bedside glucose monitoring system receives European CE Mark

Positive topline data from 4SC's resminostat Phase II trial on Hodgkin's Lymphoma

FDA approves Seattle Genetics ADCETRIS drug to treat Hodgkin lymphoma, ALCL

Seattle Genetics receives FDA approval for Adcetris to treat Hodgkin lymphoma, ALCL

Enrollment commences in Allos' FOLOTYN Phase 3 trial for peripheral T-cell lymphoma

Amgen reports 8% increase in second quarter total product sales to $3,893 million

Positive data from two GSK's Promacta Phase III studies on hepatitis C-related thrombocytopenia

AMAG enters definitive merger agreement with Allos Therapeutics

Millennium submits VELCADE sNDA to FDA to add OS data for previously untreated multiple myeloma

Eisai's DACOGEN sNDA for acute myeloid leukemia accepted by FDA for review

FDA accepts Eisai's DACOGEN sNDA for review to treat acute myeloid leukemia

Positive top-line results from alemtuzumab Phase 3 trial on multiple sclerosis

Pregnant women face higher risk of stroke

Amrubicin vs. topotecan Phase III trial against lung cancer presented at IASLC conference

Millennium reports ongoing MLN8237 Phase II study results on non-Hodgkin lymphoma

Health Canada grants market authorization for Sanofi-aventis Jevtana to treat prostate cancer

Angioplasty may be an option for liver transplant candidates with heart disease

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