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.

Cubist Pharmaceuticals' SIVEXTRO receives FDA approval for treatment of ABSSSI

Cubist Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration approved SIVEXTRO (tedizolid phosphate) for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI).

21 Jun 2014

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Pharmacyclics, Inc. today announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval.

9 Jun 2014

ARIAD reports data from Iclusig Phase 2 trial in adult patients with gastrointestinal stromal tumors

ARIAD Pharmaceuticals, Inc. today announced, for the first time, data from its Phase 2 trial of Iclusig (ponatinib) in adult patients with refractory metastatic and/or unresectable gastrointestinal stromal tumors (GIST).

2 Jun 2014

$Nektar reports etirinotecan pegol Phase 2 study results in patients with Avastin-refractory high-grade glioma$

Nektar reports etirinotecan pegol Phase 2 study results in patients with Avastin-refractory high-grade glioma

Nektar Therapeutics announced today new data from an investigator-sponsored Phase 2 study of NKTR-102 (etirinotecan pegol) in patients with Avastin-refractory high-grade glioma conducted at Stanford Cancer Institute under the direction of Lawrence Recht, M.D., Professor of Neurology and Neurosurgery, with co-investigator Seema Nagpal, M.D., Clinical Assistant Professor of Neurology and Neurological Sciences, Stanford School of Medicine.

2 Jun 2014

ImmunoGen reports favorable clinical results from STARLYTE Phase II trial of SAR3419 for DLBCL

ImmunoGen, Inc., a biotechnology company that develops novel anticancer therapeutics using its antibody-drug conjugate (ADC) technology, today announced the presentation of favorable clinical findings with SAR3419 (coltuximab ravtansine) from the STARLYTE Phase II trial in diffuse large B-cell lymphoma (DLBCL).

2 Jun 2014

CytRx announces Phase 2b clinical trial results of aldoxorubicin in subjects with metastatic STS

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced updated results from its ongoing multicenter, randomized, open-label global Phase 2b clinical trial investigating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in subjects with metastatic, locally advanced or unresectable soft tissue sarcomas.

28 May 2014

New understanding of toxicity levels of chemotherapy regimens used for early stage breast cancer

Oncologists now have a new understanding of the toxicity levels of specific chemotherapy regimens used for women with early stage breast cancer, according to research from The University of Texas MD Anderson Cancer Center.

28 May 2014

Half-life extension technology: an interview with Dermot Pearson, Novozymes Biopharma

A drug's half-life indicates how long a substance will remain active in the body. It is essentially the period of time that it takes for the concentration of the amount of the drug to be reduced by half, and therefore, determines how frequently a drug needs to be administered to maintain its therapeutic effect.

27 May 2014

Phase I study reveals abemaciclib drug shows evidence of single-agent activity in NSCLC patients

Abemaciclib, an oral drug administered twice daily, currently in development by Eli Lilly and Company (NYSE: LLY), has shown evidence of single-agent activity in patients with advanced non-small cell lung cancer in a Phase I study released ahead of the American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, Ill.

15 May 2014

Ligand's total revenues increase 37% to $16.0 million in first quarter 2014

Ligand Pharmaceuticals Incorporated today reported financial results for the three months ended March 31, 2014, and provided an operating forecast and program updates.

7 May 2014

Teva's SYNRIBO for injection receives FDA approval for home administration

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved SYNRIBO® (omacetaxine mepesuccinate) for injection, for subcutaneous use, to include home administration, and also approved a related Medication Guide and Instructions for Use.

6 May 2014

RDT receives FDA approval for new liquid form of treatment for patients with ALL

Rare Disease Therapeutics, Inc. (RDT), the producer of orphan pharmaceuticals for the treatment of rare diseases, announced today that they have received FDA approval for PURIXAN™ (mercaptopurine) 20 mg/mL oral suspension---a new, easier-to-dose, liquid form of an established treatment for patients with Acute Lymphoblastic Leukemia (ALL).

30 Apr 2014

FDA announces expanded approval of Arzerra in combination with chlorambucil for CLL treatment

The US Food and Drug Administration has announced the expanded approval of Arzerra (ofatumumab) in combination with chlorambucil for the first-line treatment of chronic lymphocytic leukemia (CLL). Arzerra was previously approved by the FDA in October 2009 for the treatment of CLL resistant to other forms of chemotherapy. Diplomat has access to dispense Arzerra.

22 Apr 2014

Amrubicin regimen inferior to irinotecan for extensive SCLC

Irinotecan plus cisplatin remains the gold standard for Japanese patients with extensive small-cell lung cancer, say researchers, after amrubicin plus cisplatin failed to improve survival in their randomised phase III trial.

11 Apr 2014

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc.

8 Apr 2014

Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

Astellas Pharma Inc. and Medivation Inc. today announced the submission of a variation to amend the European Marketing Authorization Application for XTANDI® (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.

4 Apr 2014

EORTC study does not support combination chemotherapy for soft tissue sarcoma

An EORTC study published in The Lancet Oncology does not support administration of intensified doxorubicin and ifosfamide for palliation of advanced soft tissue sarcoma, unless the objective is to shrink the tumor.

27 Mar 2014

European Commission approves Exelixis' COMETRIQ for treatment of progressive, metastatic MTC

Exelixis, Inc. today announced that the European Commission has approved COMETRIQ (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC).

25 Mar 2014

Edison Pharmaceuticals begins EPI-743 clinical trial in children with Pearson syndrome

Edison Pharmaceuticals today announced the initiation of a phase 2 study entitled "A Phase 2 Safety and Efficacy Study of EPI-743 (Vincerinone™) in Children with Pearson Syndrome." The Investigative New Drug application (IND) was approved by the Food and Drug Administration, Office of Hematology and Oncology Products.

17 Mar 2014

Merck's NOXAFIL injection gets FDA approval for intravenous use

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use.

16 Mar 2014

Neutropenia News and Research

Further Reading

Cubist Pharmaceuticals' SIVEXTRO receives FDA approval for treatment of ABSSSI

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

ARIAD reports data from Iclusig Phase 2 trial in adult patients with gastrointestinal stromal tumors

Nektar reports etirinotecan pegol Phase 2 study results in patients with Avastin-refractory high-grade glioma

ImmunoGen reports favorable clinical results from STARLYTE Phase II trial of SAR3419 for DLBCL

CytRx announces Phase 2b clinical trial results of aldoxorubicin in subjects with metastatic STS

New understanding of toxicity levels of chemotherapy regimens used for early stage breast cancer

Half-life extension technology: an interview with Dermot Pearson, Novozymes Biopharma

Phase I study reveals abemaciclib drug shows evidence of single-agent activity in NSCLC patients

Ligand's total revenues increase 37% to $16.0 million in first quarter 2014

Teva's SYNRIBO for injection receives FDA approval for home administration

RDT receives FDA approval for new liquid form of treatment for patients with ALL

FDA announces expanded approval of Arzerra in combination with chlorambucil for CLL treatment

Amrubicin regimen inferior to irinotecan for extensive SCLC

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

EORTC study does not support combination chemotherapy for soft tissue sarcoma

European Commission approves Exelixis' COMETRIQ for treatment of progressive, metastatic MTC

Edison Pharmaceuticals begins EPI-743 clinical trial in children with Pearson syndrome

Merck's NOXAFIL injection gets FDA approval for intravenous use

Industry Focus eBook - Analytical Chemistry (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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