Oncology News and Research

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Oncology, meaning bulk, mass, or tumor, and the suffix ''-logy'', meaning "study of") is a branch of medicine that deals with tumors (cancer). A medical professional who practices oncology is an ''oncologist''.

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 Advisory Committee recommendation against flibanserin will not affect LibiGel program: BioSante

BioSante Pharmaceuticals, Inc. commented today that the recommendation on June 18, 2010 by the FDA Advisory Committee regarding the safety and efficacy of flibanserin (Boehringer-Ingelheim) will have no impact on its own ongoing development program or approval pathway for LibiGel (testosterone gel), for the treatment of hypoactive sexual desire disorder (HSDD).

22 Jun 2010

APP Pharmaceuticals receives FDA approval to market Ganciclovir for Injection, USP

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration to market Ganciclovir for Injection, USP. Ganciclovir for Injection, USP is therapeutically equivalent to the reference-listed drug Cytovene-IV, which is marketed by Roche Laboratories, Inc.

22 Jun 2010

Ipsen reports top line results from European study of GuidAge for Alzheimer's Dementia

Ipsen today announced top line results of GuidAge®, the longest (5 years) and largest (2,854 subjects) European study in the prevention of Alzheimer's Dementia (AD). This trial was conducted according to the most stringent international standards. The aim of this study was to assess the efficacy of a 5-year treatment with EGb 761® in the prevention of Alzheimer's Dementia in a population of elderly aged 70 or more, with memory complaint spontaneously expressed to their family physician and who lived at home at the inclusion in the study.

22 Jun 2010

Pfizer announces voluntary withdrawal of Mylotarg from U.S. market following FDA request

Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product's safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.

22 Jun 2010

Semafore's SF1126 peptidic prodrug demonstrates clinical activity in chronic lymphocytic leukemia

Semafore Pharmaceuticals today announced the presentation of preliminary clinical data demonstrating that SF1126 has clinical activity in chronic lymphocytic leukemia (CLL). SF1126 is a novel peptidic prodrug that converts to LY294002, one of the most widely studied small molecule inhibitors of both phosphatidylinositol 3-kinase (PI3K) and mammalian target of rapamycin (mTOR). The results were presented at Cambridge Healthtech Institute's 8th Annual Next-Gen Kinase Inhibitors Oncology & Beyond Conference being held June 21-23, 2010, in Cambridge, Massachusetts.

22 Jun 2010

Celator announces expansion of research agreement with Cephalon

Celator Pharmaceuticals today announced that it has expanded its research agreement with Cephalon, Inc.. The research agreement provides for the utilization of Celator's proprietary technology in an ongoing drug development and life-cycle management program at Cephalon.

22 Jun 2010

Al Amal Hospital in Qatar commences treatment with Varian's RapidArc radiotherapy

One of the leading cancer centers in the Middle East has become among the first in the region to introduce fast and efficient RapidArc® radiotherapy treatments from Varian Medical Systems. Al Amal Hospital in Doha, Qatar, has treated nine brain cancer, prostate cancer and head & neck cancer patients with RapidArc since commencing treatments in early May, and it now plans to roll out the technology for many more indications.

21 Jun 2010

Independent DMC recommends continuation of BioSante's ongoing LibiGel CV and Breast Cancer Safety Study

BioSante Pharmaceuticals, Inc., today announced that the independent Data Monitoring Committee (DMC) of the ongoing LibiGel® Cardiovascular (CV) and Breast Cancer Safety Study unanimously recommended study continuation without modifications, after its third review of the study's unblinded safety data. The review was based on data from almost 1,500 women-years of exposure.

21 Jun 2010

BioSante announces $15 million registered direct offering

BioSante Pharmaceuticals, Inc. today announced that it has received commitments from several institutional investors to purchase $15 million of securities in a registered direct offering. The investors are Deerfield Management Company and other institutional investors. BioSante expects to receive net proceeds of approximately $14.2 million after deducting placement agent fees and other offering expenses.

21 Jun 2010

Saladax Biomedical, Bristol-Myers Squibb collaborate to develop clinical diagnostics

Saladax Biomedical, Inc. announced today that it has entered into a multi-year development and commercialization agreement with Bristol-Myers Squibb Company for the development of certain clinical diagnostic tests to be used in conjunction with the development of certain therapeutic compounds in the Bristol-Myers Squibb pipeline.

21 Jun 2010

Families of children with cancer are visiting Capitol Hill to seek more federal funding for cancer research

Today and tomorrow hundreds of families of children with cancer are visiting Capitol Hill to ask Congress one question: Where is the research money that was authorized by the Caroline Pryce Walker Conquer Childhood Cancer Act of 2008?

21 Jun 2010

Positive preclinical data on Aeterna Zentaris' AEZS-130/Ghrelin Receptor Agonist presented at ENDO meeting

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that a poster on its oral synthetic growth hormone secretagogue/ghrelin receptor agonist, AEZS-130, was presented yesterday at the 92nd Annual Endocrine Society (ENDO) Meeting and Expo, which is held through June 22, 2010 at the San Diego Convention Center in San Diego, California.

21 Jun 2010

ZIOPHARM Oncology announces guidance on palifosfamide Phase III trial in metastatic soft tissue sarcoma

ZIOPHARM Oncology, Inc. announced guidance today regarding the Company's planned pivotal Phase III trial for palifosfamide in metastatic soft tissue sarcoma, including details of the proposed study's design, timing and regulatory review.

21 Jun 2010

Dyax signs partnership agreement with Sigma-Tau to develop and commercialize subcutaneous DX-88

Dyax Corp. and Defiante Farmaceutica S.A., a subsidiary of the pharmaceutical company Sigma-Tau SpA, announced today a strategic partnership to develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema and other therapeutic indications throughout Europe, North Africa, Middle East and Russia.

21 Jun 2010

OncoGenex initiates Phase 3 Prostate Cancer SATURN Trial

OncoGenex Pharmaceuticals, Inc. announced today the initiation of a Phase 3 registration trial of custirsen sodium (OGX-011/TV-1011), its lead product candidate being developed for the treatment of castrate-resistant prostate cancer (CRPC). This trial, referred to as the Prostate Cancer SATURN Trial, is the first of three Phase 3 trials to be initiated under a global collaboration and license agreement between OncoGenex and Teva Pharmaceutical Industries to develop and commercialize OGX-011/ TV-1011.

21 Jun 2010

Beyond Moose and Mountains initiative focuses on building Canada's business and regulatory environment

At its 2010 annual general meeting in Montreal yesterday, the national biotechnology association, BIOTECanada, confirmed a national team of industry leaders, whose expertise will ensure Canada keeps growing what today is an $84 billion bio-economy.

21 Jun 2010

APP Pharmaceuticals receives FDA approval to market Aztreonam for Injection, USP

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration to market Aztreonam for Injection, USP in two dosage strengths. Aztreonam is therapeutically equivalent to the reference-listed drug Azactam, which is marketed by Bristol-Myers Squibb.

21 Jun 2010

Exelixis announces regaining of rights to develop and commercialize XL184

Exelixis, Inc. today announced that it has regained full rights to develop and commercialize XL184. Exelixis and Bristol-Myers Squibb Company entered into a global development collaboration for XL184, the clinically most advanced MET inhibitor, in December 2008. Under the agreement, BMS and Exelixis had originally agreed to certain clinical development plans, and Exelixis maintained key rights regarding timing and funding of current and future clinical trials.

21 Jun 2010

Spectrum Pharmaceuticals adjourns Annual Meeting of Shareholders to July 1, 2010

Spectrum Pharmaceuticals, Inc. today announced that it has adjourned its Annual Meeting of Stockholders to 10:30a.m. Pacific Time, Thursday, July 1, 2010, which will be held at the Company's corporate office located at 157 Technology Drive, Irvine, California, 92618.

19 Jun 2010

Oncology News and Research

Further Reading

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

FDA Advisory Committee recommendation against flibanserin will not affect LibiGel program: BioSante

APP Pharmaceuticals receives FDA approval to market Ganciclovir for Injection, USP

Ipsen reports top line results from European study of GuidAge for Alzheimer's Dementia

Pfizer announces voluntary withdrawal of Mylotarg from U.S. market following FDA request

Semafore's SF1126 peptidic prodrug demonstrates clinical activity in chronic lymphocytic leukemia

Celator announces expansion of research agreement with Cephalon

Al Amal Hospital in Qatar commences treatment with Varian's RapidArc radiotherapy

Independent DMC recommends continuation of BioSante's ongoing LibiGel CV and Breast Cancer Safety Study

BioSante announces $15 million registered direct offering

Saladax Biomedical, Bristol-Myers Squibb collaborate to develop clinical diagnostics

Families of children with cancer are visiting Capitol Hill to seek more federal funding for cancer research

Positive preclinical data on Aeterna Zentaris' AEZS-130/Ghrelin Receptor Agonist presented at ENDO meeting

ZIOPHARM Oncology announces guidance on palifosfamide Phase III trial in metastatic soft tissue sarcoma

Dyax signs partnership agreement with Sigma-Tau to develop and commercialize subcutaneous DX-88

OncoGenex initiates Phase 3 Prostate Cancer SATURN Trial

Beyond Moose and Mountains initiative focuses on building Canada's business and regulatory environment

APP Pharmaceuticals receives FDA approval to market Aztreonam for Injection, USP

Exelixis announces regaining of rights to develop and commercialize XL184

Spectrum Pharmaceuticals adjourns Annual Meeting of Shareholders to July 1, 2010

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