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.

FDA gives Priority Review to Celgene's ABRAXANE sNDA for advanced pancreatic cancer

Celgene International Sàrl, a subsidiary of Celgene Corporation today announced that the U.S. Food and Drug Administration has assigned a Priority Review designation to the supplemental New Drug Application for the use of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for the first-line treatment of patients with advanced pancreatic cancer.

23 May 2013

JPIDS releases consensus statement of Sentinel Project on Pediatric Drug-Resistant Tuberculosis

The Journal of the Pediatric Infectious Diseases Society today released its June issue, which includes a consensus statement of the global Sentinel Project on Pediatric Drug-Resistant Tuberculosis.

22 May 2013

Bayer HealthCare to present new data on oncology portfolio at ASCO meeting

Bayer HealthCare announced today that new data on the oncology portfolio, including Nexavar (sorafenib) tablets, Stivarga (regorafenib) tablets and the recently U.S. Food and Drug Administration approved product Xofigo (radium Ra 223 dichloride) injection will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology, May 31 – June 4, in Chicago, IL (USA).

16 May 2013

Prostate cancer drug Xofigo gets FDA approval

The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs.

16 May 2013

Data from MK-5172 Phase II study for treatment of HCV genotype 1 infection to be presented at EASL meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of the latest interim data from a Phase II, multi-center, randomized, dose-ranging clinical trial evaluating the safety and antiviral activity of MK-5172, for the treatment of chronic hepatitis C virus genotype 1 infection.

24 Apr 2013

New data on Merck’s VICTRELIS for chronic HCV to be presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced today that two analyses of VICTRELIS (boceprevir) and data from Phase II studies of two of Merck's investigational medicines for chronic hepatitis C virus (HCV) genotype 1, MK-5172 and vaniprevir (MK-7009), will be presented at the 2013 International Liver Congress (EASL) Annual Meeting.

11 Apr 2013

FDA accepts Merck's NDA for NOXAFIL tablets

Merck, known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational, tablet formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for review by the U.S. Food and Drug Administration.

11 Apr 2013

BIND Therapeutics presents positive Phase 1 clinical study results for BIND-014 at AACR meeting

BIND Therapeutics, a clinical-stage biopharmaceutical company developing a new class of highly selective targeted and programmable therapeutics called AccurinsTM, announced today that positive Phase 1 clinical data for BIND-014, the company's lead drug candidate, were presented today in an oral presentation at the American Association for Cancer Research 2013 Annual Meeting.

10 Apr 2013

Spectrum Pharmaceuticals begins Phase 2 clinical program for SPI-2012

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the Company has initiated a Phase 2 clinical program for SPI-2012 (also referred to as "LAPS-GCSF"), a drug candidate for the treatment of chemotherapy-induced neutropenia that utilizes partner Hanmi Pharmaceutical Company's proprietary LAPSCOVERY™ Technology.

8 Apr 2013

Nektar Therapeutics presents positive results for NKTR-214 at AACR Annual Meeting

Nektar Therapeutics today presented positive preclinical data for NKTR-214, a novel cancer immunotherapy which targets the IL-2 receptor complex, at the 2013 American Association for Cancer Research Annual Meeting.

8 Apr 2013

Phase II study shows effectiveness of Axelar's AXL-003 in treating patients with NSCLC

Axelar AB, part of the Karolinska Development AB portfolio, announced today that preliminary interim results of its Phase II study AXL-003, indicates that AXL1717 is effective in treating patients with non-small cell lung cancer.

2 Apr 2013

European Commission grants conditional marketing authorization for Pfizer's BOSULIF

Pfizer Inc. announced today that the European Commission has granted conditional marketing authorization for BOSULIF (bosutinib) in the European Union for the treatment of adult patients with chronic phase, accelerated phase and blast phase Philadelphia chromosome positive chronic myelogenous leukemia previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

28 Mar 2013

Experience shows in febrile neutropenia treatment

The strongest predictors of guideline-compliant care of cancer patients with febrile neutropenia are the case volumes of the treating physicians and hospitals, a study shows.

8 Mar 2013

Chroma Therapeutics, CTI announce results from tosedostat Phase 2 study on AML

Cell Therapeutics, Inc. (CTI) and Chroma Therapeutics Ltd. announced today that Lancet Oncology has published results from the OPAL Phase 2 study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia (AML).

4 Mar 2013

Otsuka receives FDA approval for ABILIFY MAINTENA to treat schizophrenia

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the U.S. Food and Drug Administration (FDA) has approved ABILIFY MAINTENA (aripiprazole) for extended- release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of schizophrenia.

1 Mar 2013

Taiho Pharmaceutical seeks Japanese approval for TAS-102 to treat colorectal cancer

Taiho Pharmaceutical Co., Ltd. announced on February 27 that it submitted an application on February 26 for approval of the manufacture and marketing of the novel oral nucleoside antitumor agent TAS-102 (combination of trifluorothymidine (FTD) and tipiracil hydrochloride (TPI)) to the Japanese Ministry of Health, Labor and Welfare.

27 Feb 2013

Gamida Cell announces results from NiCord Phase I/II study on hematological malignancies

Gamida Cell announced today the successful results of the Phase I/II study of its second pipeline product NiCord, umbilical cord derived stem cells expanded using the company's proprietary NAM technology.

15 Feb 2013

Celgene's Pomalyst receives FDA approval for treatment of multiple myeloma

The U.S. Food and Drug Administration today approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.

10 Feb 2013

Celgene receives FDA approval for POMALYST to treat multiple myeloma

Celgene Corporation today announced the U.S. Food and Drug Administration (FDA) has approved POMALYST brand therapy (pomalidomide) for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.

10 Feb 2013

Millennium, Seattle Genetics commence ADCETRIS plus chemotherapy phase III trial in MTCL

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced the initiation of a global phase III clinical trial evaluating ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed CD30-positive mature T-cell lymphoma (MTCL) patients, including patients with systemic anaplastic large cell lymphoma (sALCL) and other types of peripheral T-cell lymphomas.

28 Jan 2013

Neutropenia News and Research

Further Reading

FDA gives Priority Review to Celgene's ABRAXANE sNDA for advanced pancreatic cancer

JPIDS releases consensus statement of Sentinel Project on Pediatric Drug-Resistant Tuberculosis

Bayer HealthCare to present new data on oncology portfolio at ASCO meeting

Prostate cancer drug Xofigo gets FDA approval

Data from MK-5172 Phase II study for treatment of HCV genotype 1 infection to be presented at EASL meeting

New data on Merck’s VICTRELIS for chronic HCV to be presented at EASL annual meeting

FDA accepts Merck's NDA for NOXAFIL tablets

BIND Therapeutics presents positive Phase 1 clinical study results for BIND-014 at AACR meeting

Spectrum Pharmaceuticals begins Phase 2 clinical program for SPI-2012

Nektar Therapeutics presents positive results for NKTR-214 at AACR Annual Meeting

Phase II study shows effectiveness of Axelar's AXL-003 in treating patients with NSCLC

European Commission grants conditional marketing authorization for Pfizer's BOSULIF

Experience shows in febrile neutropenia treatment

Chroma Therapeutics, CTI announce results from tosedostat Phase 2 study on AML

Otsuka receives FDA approval for ABILIFY MAINTENA to treat schizophrenia

Taiho Pharmaceutical seeks Japanese approval for TAS-102 to treat colorectal cancer

Gamida Cell announces results from NiCord Phase I/II study on hematological malignancies

Celgene's Pomalyst receives FDA approval for treatment of multiple myeloma

Celgene receives FDA approval for POMALYST to treat multiple myeloma

Millennium, Seattle Genetics commence ADCETRIS plus chemotherapy phase III trial in MTCL

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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