Neutropenia News and Research

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Neutropenia is a hematological disorder characterized by an abnormally low number of neutrophils, the most important type of white blood cell, in the blood.

Hormone treatment with chemotherapy results in deadly side-effect in neuroblastoma children

Children given a hormone growth factor alongside chemotherapy for the aggressive cancer neuroblastoma are less likely to suffer a potentially deadly side-effect, according to a major international study published today (Tuesday) in the Journal of Clinical Oncology.

9 Sep 2010

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. The application requests authorization to manufacture and market generic versions of REVLIMID (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.

3 Sep 2010

BARDA awards contract to develop treatment for ionizing radiation exposure

The U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) today awarded a $153 million contract to Cellerant Therapeutics, Inc. of San Carlos, Calif., to continue developing a new way to treat an illness caused by exposure to high levels of ionizing radiation which can damage the body's cells - the type of radiation that would come from a nuclear blast.

3 Sep 2010

Cellerant Therapeutics signs contract with BARDA to develop CLT-008 therapy for ARS

Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has signed a contract valued at up to $153 million over five years with the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response of the Department of Health and Human Services, to develop CLT-008, a cellular therapy for the treatment of Acute Radiation Syndrome (ARS).

2 Sep 2010

Roche's MabThera continues to dwarf recently launched monoclonal antibodies: Report

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia, 41 percent of surveyed European hematologist-oncologists say that the favorable efficacy profile of Roche's MabThera (rituximab) is the most significant driver of their use of this brand, while 26 percent say MabThera's favorable risk-benefit profile is the most significant driver.

31 Aug 2010

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.

25 Aug 2010

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality. REVLIMID was also approved in June 2010 in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy.

20 Aug 2010

Biogen Idec, Knopp Neurosciences enter license agreement for KNS-760704 ALS drug candidate

Biogen Idec and Knopp Neurosciences today announced they have entered into an exclusive, worldwide license agreement under which Biogen Idec will develop and commercialize KNS-760704 (dexpramipexole) for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, and potentially other indications.

18 Aug 2010

Amgen reports top-line results from Vectibix Phase 3 trial for head and neck cancer

Amgen today announced top-line results from a randomized Phase 3 trial evaluating Vectibix as a first-line treatment in patients with recurrent and/or metastatic squamous cell head and neck cancer. The data showed the addition of Vectibix to platinum-based chemotherapy did not result in a statistically significant improvement in overall survival, the primary endpoint, compared to chemotherapy alone.

12 Aug 2010

Genmab reports top-line interim results from ofatumumab Phase II study in Diffuse Large B-Cell Lymphoma

Genmab A/S announced today top-line interim results from an initial Phase II single arm open label study of ofatumumab to evaluate the treatment of relapsed Diffuse Large B-Cell Lymphoma in patients ineligible for or relapsed following a stem cell transplant.

11 Aug 2010

Sanofi-aventis receives FDA approval for new Taxotere Injection Concentrate formulation

Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) has approved a new one-vial formulation of its chemotherapeutic agent Taxotere® (docetaxel) Injection Concentrate. The 1-vial Taxotere is anticipated to become available to cancer treatment clinics and hospitals nationwide in the fall in both 80 mg and 20 mg dosages.

5 Aug 2010

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

$Pivotal PINNACLE trial results of VELCADE in patients with relapsed/refractory MCL released$

Pivotal PINNACLE trial results of VELCADE in patients with relapsed/refractory MCL released

Millennium: The Takeda Oncology Company today reported new correlative science data from the pivotal PINNACLE trial of VELCADE (bortezomib) in patients with relapsed/refractory mantle cell lymphoma. The data, derived from an analysis of archived tumor samples, tested pre-specified biomarkers for their association with time to progression and response to treatment with VELCADE in patients with relapsed MCL.

30 Jul 2010

New Zealand MEDSAFE approves ABRAXANE for metastatic breast cancer

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, and Specialised Therapeutics Ltd. today announced that MEDSAFE, the New Zealand Medicines and Medical Devices Safety Authority, has approved for marketing ABRAXANE® (nanoparticle albumin-bound paclitaxel) for the treatment of metastatic breast cancer after failure of anthracycline therapy.

29 Jul 2010

Allos reports topline results from Phase 2b trial of FOLOTYN vs erlotinib in advanced NSCLC

Allos Therapeutics, Inc. today announced topline results from the Company's randomized Phase 2b investigational trial of FOLOTYN® (pralatrexate injection) versus erlotinib in patients with Stage IIIB/IV (advanced) non-small cell lung cancer (NSCLC) who had received one or two prior systemic treatments including at least one prior platinum-based regimen. The objective of the trial was to estimate the efficacy of FOLOTYN compared to that of erlotinib as assessed by overall survival.

28 Jul 2010

Allos reports net loss of $20.0 million for second-quarter 2010

Allos Therapeutics, Inc. today reported its financial results and business highlights for the quarter and six months ended June 30, 2010.

28 Jul 2010

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus infection to peginterferon alpha-based therapy.

28 Jul 2010

NCCN enters into collaboration to introduce Proventys CDS Oncology system

The National Comprehensive Cancer Network and Proventys, a leader in advanced decision support technologies, have entered into an exclusive collaboration to introduce the Proventys CDS Oncology system, a first-of-its-kind Web platform that arms oncologists with expert recommendations and evidence facilitating the delivery of high-quality, individualized patient care.

27 Jul 2010

Hospira commences EPO Phase I U.S. clinical trial in renal dysfunction patients with anemia

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced the start of a U.S. Phase I clinical trial of its biosimilar erythropoietin (EPO) in patients with renal (kidney) dysfunction who have anemia, an important step on the road toward introducing a biosimilar product in the United States. Erythropoietin is a treatment for anemia associated with chronic renal failure and chemotherapy.

26 Jul 2010

Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

Onyx Pharmaceuticals, Inc. today announced positive top-line results from the Phase 2b 003-A1 study of single-agent carfilzomib, a selective, next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma.

26 Jul 2010

Neutropenia News and Research

Further Reading

Hormone treatment with chemotherapy results in deadly side-effect in neuroblastoma children

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

BARDA awards contract to develop treatment for ionizing radiation exposure

Cellerant Therapeutics signs contract with BARDA to develop CLT-008 therapy for ARS

Roche's MabThera continues to dwarf recently launched monoclonal antibodies: Report

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Biogen Idec, Knopp Neurosciences enter license agreement for KNS-760704 ALS drug candidate

Amgen reports top-line results from Vectibix Phase 3 trial for head and neck cancer

Genmab reports top-line interim results from ofatumumab Phase II study in Diffuse Large B-Cell Lymphoma

Sanofi-aventis receives FDA approval for new Taxotere Injection Concentrate formulation

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Pivotal PINNACLE trial results of VELCADE in patients with relapsed/refractory MCL released

New Zealand MEDSAFE approves ABRAXANE for metastatic breast cancer

Allos reports topline results from Phase 2b trial of FOLOTYN vs erlotinib in advanced NSCLC

Allos reports net loss of $20.0 million for second-quarter 2010

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

NCCN enters into collaboration to introduce Proventys CDS Oncology system

Hospira commences EPO Phase I U.S. clinical trial in renal dysfunction patients with anemia

Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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