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.

Interim data from Schering-Plough's narlaprevir Phase IIa study

Schering-Plough Corporation reported that interim results from an ongoing Phase IIa study of narlaprevir (SCH 900518), its investigational, once-daily protease inhibitor, demonstrated potent antiviral activity in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1.

3 Nov 2009

Schering-Plough receives FDA complete response letter regarding PEGINTRON

Schering-Plough Corp. announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRON® (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy.

31 Oct 2009

Enrollment for Phase 2 clinical study of NKTR-102 completed ahead of schedule

Nektar Therapeutics today announced that it has completed enrollment ahead of schedule in its Phase 2 clinical study of NKTR-102 in platinum-resistant ovarian cancer. NKTR-102 is Nektar's investigational proprietary compound currently being evaluated in Phase 2 clinical development in ovarian, breast and colorectal cancers.

28 Oct 2009

Amgen to reduce price of Neulasta following Board's orders

The Board issued a Notice of Hearing on March 16, 2009, pertaining to allegations of Board Staff that Neulasta had been, and was being, sold by Amgen Canada Inc. at prices exceeding those indicated by the Board's Excessive Price Guidelines. On October 13, 2009, the Hearing Panel received a Joint Submission by Amgen and Board Staff along with a Voluntary Compliance Undertaking ("VCU") which proposed to resolve the issues raised in the Neulasta proceedings.

28 Oct 2009

Data from Phase II clinical trial of NKTR-118 presented

Data from a phase II study demonstrated that oral NKTR-118 improved lower gastrointestinal dysfunction by increasing the frequency of bowel movements in patients with opioid-induced constipation, while simultaneously preserving opioid-mediated analgesia.

28 Oct 2009

Highlights of Cell Therapeutics' pixantrone study to be presented at the Lymphoma and Myeloma Conference

Cell Therapeutics, Inc. announced that Dr. Richard Van der Jagt of the Ottawa General Hospital will present at the Lymphoma and Myeloma 2009 Conference in New York an overview of CTI's pixantrone phase II and phase III clinical studies that demonstrated high rates of complete remission (CR) in relapsed/refractory aggressive and indolent non-Hodgkin's lymphoma (NHL) patients.

22 Oct 2009

Millennium commences Vc-R-CHOP Phase II trial for diffuse large B-cell lymphoma

Millennium: The Takeda Oncology Company today announced the initiation of a Phase II clinical trial examining rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) with or without VELCADE® (bortezomib) for Injection for patients with a common type of lymphoma. The study will examine previously untreated patients with a genomically defined subtype of lymphoma called non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma.

22 Oct 2009

Novartis' Tasigna capsules meets primary endpoint in comparison trial with Gleevec

Novartis announced today that Tasigna (nilotinib) 200 mg capsules met its primary endpoint in the first head-to-head comparison with the company's groundbreaking drug Gleevec (imatinib mesylate) tablets*. Tasigna produced faster and deeper responses than Gleevec when given as first-line therapy for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Tasigna was well tolerated in the study.

20 Oct 2009

Schering-Plough to present data on boceprevir at the AASLD 2009 Annual Meeting

Schering-Plough announced that data on boceprevir, an investigational hepatitis C virus (HCV) protease inhibitor, will be reported in an oral presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston, Oct. 30-Nov. 3.

19 Oct 2009

Positive data from ZIOPHARM's palifosfamide sarcoma Phase II trial

ZIOPHARM Oncology, Inc. announced today positive top line interim data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma. The analysis evaluated 62 patients treated as of the end of September, with 58 being analyzed.

14 Oct 2009

Vanda Pharmaceuticals announces its agreement with Novartis Pharma AG

Vanda Pharmaceuticals Inc. announced today that it has entered into an agreement with Novartis Pharma AG to commercialize and develop Fanapt(TM) (iloperidone), Vanda's anti-psychotic, in the U.S. and Canada. Fanapt(TM) was approved by the U.S. Food and Drug Administration on May 6, 2009 for the acute treatment of schizophrenia in adults.

14 Oct 2009

Synta Pharmaceuticals updates its Phase 3 SYMMETRY trial results at the Melanoma XIII Conference

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that additional results from its Phase 3 trial (SYMMETRYSM) of elesclomol in combination with paclitaxel in metastatic melanoma was presented at the Perspectives in Melanoma XIII Conference by Steven O’Day, M.D., principal investigator and Chief of Research and Director of the Melanoma Program at the Angeles Clinic in Santa Monica, California.

12 Oct 2009

Nektar Therapeutics presents the results from Phase 2 clinical trial of oral NKTR-118

Nektar Therapeutics presented topline data today from its Phase 2 clinical trial of oral NKTR-118 at the American Academy of Pain Management's (AAPM) 20th Annual Clinical Meeting in Phoenix, Arizona.

12 Oct 2009

New cancer drugs boost drug spending

Cancer treatments are on track to become the biggest driver of specialty pharmacy spending as its contribution to overall drug spending hit five percent for the first time in the first half of 2009, according to Medco Health Solutions, Inc.

8 Oct 2009

Schering-Plough receives FDA recommendation approval for PEGINTRON

Schering-Plough Corp. announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for PEGINTRON® (pegylated interferon alfa-2b) in the adjuvant treatment of patients with Stage III malignant melanoma.

6 Oct 2009

FOLOTYN available for commercial sale in the United States

Allos Therapeutics, Inc. today announced that FOLOTYN (pralatrexate injection) is now available for commercial sale in the United States. The U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) on September 24, 2009. This indication is based on overall response rate.

6 Oct 2009

Promising results from Cell Therapeutics' phase II OPAXIO study for advanced esophageal cancer

Cell Therapeutics, Inc. announced today that, in a study from Brown University to be presented by Howard Safran, M.D., head of the Brown University Oncology Group, in the proffered oral session at the Annual Meeting of the International Society of Gastrointestinal Oncology (ISGIO) in Philadelphia, Pennsylvania patients with cancer of the lower esophagus demonstrated a high rate of complete remission (CR) when given OPAXIO(TM) (paclitaxel poliglumex), a biologically enhanced paclitaxel, when administered in combination with standard cisplatin and concurrent radiation.

1 Oct 2009

Hospira acquires global rights to biogeneric filgrastim from PLIVA

Hospira, Inc. (NYSE: HSP), a global specialty pharmaceutical and medication delivery company, today announced the acquisition of worldwide rights to a biogeneric version of filgrastim and an affiliated European manufacturing facility from PLIVA Hrvatska d.o.o. (Zagreb, Croatia) (ZSE: PLVA-R-A), a move that will help extend Hospira's reach and vertical integration in biogenerics. Financial terms of the agreement were not disclosed.

1 Oct 2009

FDA grants accelerated approval for Allos Therapeutics’ FOLOTYN

Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that last night the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYNTM (pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

28 Sep 2009

Phase 2 trial results of Bayer's Nexavar in combination with capecitabine announced

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the full results from their first collaborative group-sponsored randomized, double-blind, placebo-controlled Phase 2 trial showing that Nexavar(R) (sorafenib) tablets in combination with the oral chemotherapeutic agent, capecitabine, significantly extended progression-free survival in patients with advanced breast cancer.

23 Sep 2009