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.

Eisai Europe seeks EMA approval of eribulin mesylate for locally advanced or metastatic breast cancer

Eisai Europe Ltd. today announced that it has submitted a marketing authorization application to the European Medicines Agency (EMA) for approval of eribulin mesylate, also known as 'E7389', for the treatment of locally advanced or metastatic breast cancer in Europe. Eribulin mesylate, a non-taxane microtubule dynamics inhibitor, is an investigational chemical compound discovered and developed by Eisai. Regulatory applications for eribulin mesylate have also been submitted in the United States and Japan.

31 Mar 2010

Eisai seeks simultaneous approval of eribulin mesylate in U.S., EU and Japan

Eisai Inc. today announced that it has submitted simultaneous regulatory applications for approval of eribulin mesylate (also known as E7389) for the treatment of locally advanced or metastatic breast cancer to agencies in Japan, the United States and the European Union (EU). Eribulin, a non-taxane microtubule dynamics inhibitor, is an investigational chemical compound discovered and developed by Eisai.

31 Mar 2010

Pregnant breast cancer patients can receive chemotherapy without endangering baby health

Women who discover they have breast cancer while they are pregnant can be treated with chemotherapy without endangering the health of their unborn baby, according to research to be presented at the seventh European Breast Cancer Conference (EBCC7) in Barcelona today (Friday).

26 Mar 2010

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Abraxis BioScience, Inc. today announced that its randomized registrational Phase 3 clinical trial comparing ABRAXANE® (protein-bound paclitaxel) with Taxol® (paclitaxel) injection, both in combination with carboplatin, met the study’s primary endpoint by demonstrating that ABRAXANE showed a significant improvement in overall response rate as compared to Taxol, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), as assessed by independent radiologist review.

17 Mar 2010

Genentech announces topline results from Phase III trial of Avastin

Genentech, Inc., a wholly owned member of the Roche Group, announced today the topline results of a Phase III trial led by the U.S. Cancer and Leukemia Group B (CALGB) and sponsored by the National Cancer Institute investigating the use of Avastin® (bevacizumab) in combination with docetaxel chemotherapy and prednisone in men with late stage prostate cancer (hormone-refractory / HRPC).

12 Mar 2010

Eisai's Dacogen five-day dosing regimen for treatment of MDS receives FDA approval

Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen® (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells.

12 Mar 2010

Fewer injections to treat neutropenia in childhood cancer patients

For patients like 10-year-old Sabrina Jo Spence, new research led by St. Jude Children's Research Hospital investigators meant fewer injections to combat the drop in white blood cells following her recent chemotherapy.

11 Mar 2010

Positive Phase 2 data from Nektar Therapeutics' NKTR-102 study in women with platinum-resistant ovarian cancer

Nektar Therapeutics today announced preliminary progression-free survival data from the first stage of a two-stage Phase 2 clinical study evaluating single-agent treatment with NKTR-102 in women with platinum-resistant ovarian cancer. In the first stage of the study, 39 patients were enrolled with platinum-resistant disease and were evaluable for the secondary endpoint of progression-free survival (PFS).

8 Mar 2010

Poniard Pharmaceuticals' picoplatin Phase 2 study in metastatic CRPC: Positive results

Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative oncology therapies, today announced the presentation of positive final data, including survival data, from the Company's Phase 2 clinical trial of picoplatin as a first-line therapy in men with metastatic castration-resistant (hormone-refractory) prostate cancer (CRPC). The results were presented in a General Poster Session today at the 2010 American Society of Clinical Oncology's Genitourinary Cancers Symposium in San Francisco, CA.

6 Mar 2010

$Phase 3 trial: Cabazitaxel improves survival in patients with metastatic hormone-refractory prostate cancer$

Phase 3 trial: Cabazitaxel improves survival in patients with metastatic hormone-refractory prostate cancer

Sanofi-aventis announced today results from a Phase 3 trial which demonstrated cabazitaxel, an investigational compound, plus prednisone/prednisolone significantly improved overall survival and progression-free survival in patients with metastatic (advanced) hormone-refractory prostate cancer whose disease progressed following treatment with docetaxel-based chemotherapy.

3 Mar 2010

ADMET tester Absorption Systems joins Society of Toxicology as Affiliate

Absorption Systems, a leader in testing drugs for ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity), has joined the Society of Toxicology, the premier global professional association of toxicologists, as an SOT Affiliate. The firm, a contract research organization, has more than a decade of experience assisting pharmaceutical and biotechnology companies in determining which compounds in development should be advanced into clinical testing.

27 Feb 2010

Novartis' Tasigna capsules granted priority review by FDA for treatment of adult patients with Ph+ CML

Novartis announced today that Tasigna® (nilotinib) 200 mg capsules has been granted priority review by the US Food and Drug Administration for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

19 Feb 2010

FDA approves Rituxan-FC combination therapy for CLL

Genentech, Inc., a wholly owned member of the Roche Group, and Biogen Idec announced today the U.S. Food and Drug Administration (FDA) approved Rituxan® (rituximab) in combination with fludarabine and cyclophosphamide (FC) for people with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL).

18 Feb 2010

Gilead Sciences’ “Quad” regimen for HIV exhibits antiretroviral activity comparable to Atripla

Gilead Sciences, Inc. announced Phase II clinical trial results today showing that its investigational fixed-dose single-tablet “Quad” regimen of elvitegravir, GS 9350 (cobicistat) and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection exhibited antiretroviral activity comparable to that of Atripla® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

18 Feb 2010

AstraZeneca, Rigel Pharmaceuticals announce exclusive worldwide license agreement for R788

AstraZeneca and Rigel Pharmaceuticals today announced an exclusive worldwide license agreement for the global development and commercialization of fostamatinib disodium (R788), Rigel's late-stage investigational product for rheumatoid arthritis (RA) and additional indications.

16 Feb 2010

FDA accepts Teva Pharmaceutical Industries' BLA for XM02 G-CSF

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing Teva’s Biologics License Application (BLA) for XM02, a granulocyte colony-stimulating factor (G-CSF) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.

2 Feb 2010

Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours

Patients with gastrointestinal stromal tumours (GIST) can now take action at an earlier stage of this rare form of cancer to reduce the risk of their disease returning following surgery. Novartis Pharmaceuticals Canada announced today that Gleevec* (imatinib mesylate) has received conditional approval by Health Canada for the adjuvant (post-surgical) treatment of adult patients who are at intermediate to high risk of disease recurrence following the surgical removal of GIST.

27 Jan 2010

Neutropenia News and Research

Further Reading

Eisai Europe seeks EMA approval of eribulin mesylate for locally advanced or metastatic breast cancer

Eisai seeks simultaneous approval of eribulin mesylate in U.S., EU and Japan

Pregnant breast cancer patients can receive chemotherapy without endangering baby health

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Genentech announces topline results from Phase III trial of Avastin

Eisai's Dacogen five-day dosing regimen for treatment of MDS receives FDA approval

Fewer injections to treat neutropenia in childhood cancer patients

Positive Phase 2 data from Nektar Therapeutics' NKTR-102 study in women with platinum-resistant ovarian cancer

Poniard Pharmaceuticals' picoplatin Phase 2 study in metastatic CRPC: Positive results

Phase 3 trial: Cabazitaxel improves survival in patients with metastatic hormone-refractory prostate cancer

ADMET tester Absorption Systems joins Society of Toxicology as Affiliate

Novartis' Tasigna capsules granted priority review by FDA for treatment of adult patients with Ph+ CML

FDA approves Rituxan-FC combination therapy for CLL

Gilead Sciences’ “Quad” regimen for HIV exhibits antiretroviral activity comparable to Atripla

AstraZeneca, Rigel Pharmaceuticals announce exclusive worldwide license agreement for R788

FDA accepts Teva Pharmaceutical Industries' BLA for XM02 G-CSF

Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours

Final data from Poniard Pharmaceuticals' randomized Phase 2 trial of picoplatin announced

Pfizer reports final results from randomized Phase 3 trial of Sutent

Bevacizumab drug shows promise to slow tumor growth in lung cancer patients

Industry Focus eBook - Neurology/Neuroscience - 2nd edition eBook

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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