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.

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, today announced that Taiho Pharmaceutical Co., Ltd. has received approval from the Ministry of Health, Labor and Welfare to market ABRAXANE IV Infusion 100 mg, Paclitaxel Injection (Suspension with Albumin), for use in the treatment of breast cancer. The New Drug Application (J-NDA) for ABRAXANE was filed with the Ministry of Health, Labor and Welfare in 2008.

23 Jul 2010

Genentech disappointed with FDA ODAC's recommendation against Avastin

Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one that use of Avastin® (bevacizumab) in combination with paclitaxel for previously untreated (first-line) advanced HER2-negative breast cancer be removed from Avastin's U.S. label.

21 Jul 2010

GCSF administration can reduce side effects of cancer neurobastoma in 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.

21 Jul 2010

Maxygen's option and licensing arrangement with Cangene expires

Maxygen, Inc., a biotechnology company focused on the development of improved protein drugs, today announced that its option and licensing arrangement with Cangene Corporation has expired. Under the agreement, Maxygen had granted Cangene an option to obtain an exclusive license to Maxygen's proprietary MAXY-G34 protein therapeutic for use in treating acute radiation syndrome.

17 Jul 2010

Role of enzyme GSTP1-1 in progression of cancer, other diseases associated with increased cell proliferation

Telik, Inc. today announced the publication of a review in the journal, Cell Death and Differentiation: Glutathione transferases as mediators of signaling pathways involved in cell proliferation and cell death; http://www.nature.com/cdd/journal/vaop/ncurrent/full/cdd201080a.html. This review describes recent advances in the understanding of the important role that the enzyme GSTP1-1 plays in the progression of cancer and other diseases associated with increased cell proliferation.

13 Jul 2010

Study results show no improvement in overall survival for combination of gemcitabine and Amplimexon

AmpliMed Corporation, a cancer therapeutics company, today announced results from AMP-019, a randomized double-blind, placebo-controlled Phase II screening trial designed to determine if a Phase III trial was warranted for the combination of gemcitabine (Gemzar, Eli Lilly) plus Amplimexon (AmpliMed Corporation) in patients with advanced pancreatic ductal adenocarcinoma of the pancreas.

12 Jul 2010

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for SPRYCEL (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase.

12 Jul 2010

ESMO releases revised set of clinical guidelines for cancer patient care

The European Society for Medical Oncology just released an enhanced and revised set of clinical recommendations designed to help oncologists deliver the best quality care to their patients.

8 Jul 2010

Data on activity of Nektar's NKTR-102 in gastrointestinal cancer presented at ESMO 12th World Congress

Nektar Therapeutics announced today that data presented at the European Society for Medical Oncology (ESMO) 12th World Congress on Gastrointestinal Cancer demonstrates that NKTR-102, the company's lead oncology compound, exhibits superior activity compared to irinotecan as part of either a monotherapy or combination regimen in tumor models of gastrointestinal cancers.

7 Jul 2010

Eisai reports preliminary results from Dacogen for Injection Phase III study in AML

Eisai Inc. announced today preliminary results from a randomized Phase III clinical trial of Dacogen® (decitabine) for Injection versus either a low-dose chemotherapy agent or supportive care in elderly patients with acute myeloid leukemia (AML), a life-threatening cancer of the blood that generally occurs in older adults.

1 Jul 2010

SuperGen encouraged by Eisai's intent to file Dacogen sNDA for new indication

SuperGen, Inc., a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced that Eisai Inc. today released information regarding a randomized Phase III clinical trial of Dacogen® (decitabine) for Injection in elderly patients with acute myeloid leukemia (AML). The comparator in this trial was low-dose cytarabine, a chemotherapy agent, or supportive care.

30 Jun 2010

Japan's MHLW grants full marketing authorization to REVLIMID

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy. This marketing authorization represents the first regulatory approval of REVLIMID in Japan.

25 Jun 2010

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.

25 Jun 2010

Nektar commences dosing in Phase 1 study of NKTR-102 in combination with 5-FU/leucovorin

Nektar Therapeutics announced today that the first patients have been dosed in a new Phase 1 dose-escalation clinical study to evaluate NKTR-102, the company's lead oncology compound, in combination with 5-fluorouracil (5-FU)/leucovorin in refractory solid tumor cancers. The study is being conducted at University Hospitals Case Medical Center of the Case Comprehensive Cancer Center in Cleveland, Ohio.

24 Jun 2010

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Merck today announced plans to initiate a Phase II investigational proof-of-concept clinical study to evaluate its oral antifungal agent posaconazole for the treatment of chronic Chagas disease. Chagas disease results from infection with the parasite Trypanosoma cruzi that is spread by biting insects. The disease is estimated to affect approximately eight million people in Latin America, of whom approximately 30-40 percent will develop serious cardiac disease, digestive disease, or both as a result of this infection.

24 Jun 2010

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

Pfizer Inc. announced today that based on discussions with the U.S. Food and Drug Administration (FDA), it will be discontinuing commercial availability of Mylotarg® (gemtuzumab ozogamicin for Injection) (used for the treatment of relapsed acute myeloid leukemia (AML)) in the United States and that it will be voluntarily withdrawing the new drug application (NDA) for Mylotarg effective October 15, 2010.

22 Jun 2010

FDA approves new indication for Tasigna in treatment of rare blood cancer

The U.S. Food and Drug Administration today approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

18 Jun 2010

FDA approves Jevtana to treat men with prostate cancer

The U.S. Food and Drug Administration today approved Jevtana (cabazitaxel), a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.

18 Jun 2010

$FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer$

FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer

Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for Jevtana® (cabazitaxel) Injection in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen.

18 Jun 2010

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

Genzyme Corporation announced today that its alemtuzumab for multiple sclerosis development program has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). This designation covers patients with relapsing-remitting forms of the disease.

15 Jun 2010

Neutropenia News and Research

Further Reading

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

Genentech disappointed with FDA ODAC's recommendation against Avastin

GCSF administration can reduce side effects of cancer neurobastoma in children

Maxygen's option and licensing arrangement with Cangene expires

Role of enzyme GSTP1-1 in progression of cancer, other diseases associated with increased cell proliferation

Study results show no improvement in overall survival for combination of gemcitabine and Amplimexon

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

ESMO releases revised set of clinical guidelines for cancer patient care

Data on activity of Nektar's NKTR-102 in gastrointestinal cancer presented at ESMO 12th World Congress

Eisai reports preliminary results from Dacogen for Injection Phase III study in AML

SuperGen encouraged by Eisai's intent to file Dacogen sNDA for new indication

Japan's MHLW grants full marketing authorization to REVLIMID

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Nektar commences dosing in Phase 1 study of NKTR-102 in combination with 5-FU/leucovorin

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

FDA approves new indication for Tasigna in treatment of rare blood cancer

FDA approves Jevtana to treat men with prostate cancer

FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

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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