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National monitoring essential for preventing emergence of malaria drug resistance

WHO is calling on countries to be increasingly vigilant in monitoring antimalarial drug efficacy in order to allow for early detection of artemisinin resistance.1 This is one among several conclusions of the Global report on antimalarial drug efficacy and drug resistance: 2000-2010, released today. The report is based on 1100 studies conducted by national malaria control programs and research institutes over the ten-year period.

19 Nov 2010

AVEO announces results from tivozanib Phase 1b clinical trial for advanced gastrointestinal cancers

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced results from a Phase 1b clinical trial evaluating the company's lead product candidate, tivozanib, a highly potent and selective inhibitor of VEGF receptors 1, 2, and 3, in combination with FOLFOX6, a standard chemotherapy regimen, in patients with advanced gastrointestinal (GI) cancers.

19 Nov 2010

OXiGENE updates data on FALCON trial for non-small cell lung cancer

OXiGENE, Inc., a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that it presented updated safety and clinical activity data from the FALCON trial, a randomized, controlled Phase 2 study of ZYBRESTAT(TM) (CA4P) in patients with non-small cell lung cancer (NSCLC).

19 Nov 2010

YM BioSciences expands CYT387 Phase I/II clinical trial for myelofibrosis in five sites

YM BioSciences Inc., today reported that the Phase I/II clinical trial for its orally available JAK1/JAK2 inhibitor, CYT387, in patients with myelofibrosis has been expanded to five sites. Of the additional sites, the Stanford Cancer Center (Stanford, California) under Principal Investigator Jason Gotlib, MD has already commenced enrolling patients.

19 Nov 2010

Aastrom announces interim analysis of Phase 2b RESTORE-CLI clinical trial for treatment failure

Aastrom Biosciences, Inc., a leading developer of expanded autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced that an interim analysis of all 86 patients enrolled in the company's Phase 2b RESTORE-CLI clinical trial shows that the study achieved both its primary safety endpoint and primary efficacy endpoint of time to first occurrence of treatment failure.

19 Nov 2010

Impax announces positive top-line results of Phase III IPX066 study for Parkinson's disease

Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc., today announced positive top-line results of the APEX-PD Phase III clinical study with IPX066 in Parkinson's disease (PD). IPX066 is a novel extended release carbidopa-levodopa product.

19 Nov 2010

Ethicon submits BLA to FDA for Fibrin Pad

Ethicon, Inc., a worldwide leader in surgical care, announced today that the company has submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the Fibrin Pad, a novel product candidate that combines Ethicon's biomaterials and plasma-derived biologics (Human Fibrinogen and Human Thrombin), to aid in stopping soft tissue bleeding during surgery.

19 Nov 2010

Elorac announces results of Phase III CPO solution studies for acne at Healthcare Conference in New York

Elorac, Inc., a rapidly growing specialty pharmaceutical company focused on the treatment of dermatological disorders, announced results of two Phase III studies of its patented Carbamide Peroxide (CPO) solution for the treatment of inflammatory acne vulgaris and rosacea at the Lazard Capital Markets 7th Annual Healthcare Conference in New York.

19 Nov 2010

Cerulean presents data on CRLX101, CRLX288 study for cancer at EORTC-NCI-AACR Symposium

Cerulean Pharma Inc., a leader in designing and developing nanopharmaceuticals, today announced that the Company's senior executives presented at the 22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, ongoing in Berlin, Germany.

19 Nov 2010

Aeterna presents data on AEZS-108 Phase 2 study for endometrial cancer at EORTC-NCI-AACR Symposium

Aeterna Zentaris Inc., earlier today, presented Phase 2 positive efficacy and safety data for its compound, AEZS-108, in advanced endometrial cancer.

18 Nov 2010

Circassia announces positive result from phase II T-cell vaccine study for house dust mite allergy

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced successful clinical results from a phase II study of its T-cell vaccine targeting house dust mite allergy.

18 Nov 2010

PAREXEL reaches milestone in early phase studies

PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced that it reached a milestone of completing 200 early phase studies in patient populations during the past three years.

From Parexel 18 Nov 2010

Naurex's antidepressant shares efficacy mechanisms with NMDA receptor antagonist ketamine

Naurex Inc., a company developing innovative treatments to address unmet needs in psychiatry and neurology, today reported that data presented at Neuroscience 2010 show that GLYX-13, its clinical-stage candidate for the treatment of depression, shares key mechanistic features associated with the antidepressant efficacy of the NMDA receptor antagonist ketamine.

18 Nov 2010

New anti-cancer drug targeting vitamin D receptor reduces PSA level in HRPC

A new anti-cancer drug aimed at vitamin D receptors on cancer cells has prompted encouraging responses in the levels of PSA (prostate specific antigen) in men with prostate cancer that has become resistant to hormonal therapies.

18 Nov 2010

Researchers report results from Phase III DEFINE study for coronary heart disease

Researchers today presented results from the Phase III DEFINE (Determining the EFficacy and Tolerability of CETP INhibition with AnacEtrapib) study with Merck's investigational CETP inhibitor, anacetrapib. In the trial of 1,623 patients with coronary heart disease (CHD) or CHD risk equivalents, anacetrapib showed no significant differences from placebo in the primary safety measures studied.

18 Nov 2010

Medivir AB reports positive interim data on Phase 2b ASPIRE study for hepatitis C

Medivir AB, the emerging research-based specialty pharmaceutical company focused on infectious diseases announces today positive top-line 24-week interim data from the Phase 2b ASPIRE (C206) study of TMC435 in treatment-experienced hepatitis C patients.

18 Nov 2010

Merck announces FDA Advisory Committee approval of GARDASIL for anal cancer and AIN treatment

Merck announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee has advised that the data presented support an indication for GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) in both males and females 9 through 26 years of age.

18 Nov 2010

Clinical trial shows dalfampridine tablets improve walking ability in MS patients

Acorda Therapeutics, Inc. today announced that data from the second of two pivotal dalfampridine extended release tablets Phase 3 clinical trials in multiple sclerosis (MS) were published in the October 2010 edition of Annals of Neurology.

18 Nov 2010

Bioniche's achievement of fourth milestone in Urocidin Phase III trial triggers $4.0M payment from Endo

Bioniche Life Sciences Inc., a research-based, technology driven Canadian biopharmaceutical company, today announced achievement of a US$4.0 million milestone payment from its development partner, Endo Pharmaceuticals Inc. This milestone is the fourth achieved by Bioniche subsequent to the parties executing their agreement in July, 2009.

18 Nov 2010

BioSante announces sale of oncolytic virus technology to Cold Genesys

BioSante Pharmaceuticals, Inc., today announced it sold to Cold Genesys, Inc. exclusive, worldwide rights to develop and commercialize its oncolytic virus technology. The technology includes CG0070, a replication-competent adenovirus that has completed a Phase I clinical trial for treatment of superficial bladder cancer. In exchange for the technology, BioSante received a 19.9 percent ownership position in Cold Genesys and a $95,000 upfront cash payment and is eligible to receive future milestone and royalty payments.

18 Nov 2010

Efficacy News and Research

National monitoring essential for preventing emergence of malaria drug resistance

AVEO announces results from tivozanib Phase 1b clinical trial for advanced gastrointestinal cancers

OXiGENE updates data on FALCON trial for non-small cell lung cancer

YM BioSciences expands CYT387 Phase I/II clinical trial for myelofibrosis in five sites

Aastrom announces interim analysis of Phase 2b RESTORE-CLI clinical trial for treatment failure

Impax announces positive top-line results of Phase III IPX066 study for Parkinson's disease

Ethicon submits BLA to FDA for Fibrin Pad

Elorac announces results of Phase III CPO solution studies for acne at Healthcare Conference in New York

Cerulean presents data on CRLX101, CRLX288 study for cancer at EORTC-NCI-AACR Symposium

Aeterna presents data on AEZS-108 Phase 2 study for endometrial cancer at EORTC-NCI-AACR Symposium

Circassia announces positive result from phase II T-cell vaccine study for house dust mite allergy

PAREXEL reaches milestone in early phase studies

Naurex's antidepressant shares efficacy mechanisms with NMDA receptor antagonist ketamine

New anti-cancer drug targeting vitamin D receptor reduces PSA level in HRPC

Researchers report results from Phase III DEFINE study for coronary heart disease

Medivir AB reports positive interim data on Phase 2b ASPIRE study for hepatitis C

Merck announces FDA Advisory Committee approval of GARDASIL for anal cancer and AIN treatment

Clinical trial shows dalfampridine tablets improve walking ability in MS patients

Bioniche's achievement of fourth milestone in Urocidin Phase III trial triggers $4.0M payment from Endo

BioSante announces sale of oncolytic virus technology to Cold Genesys

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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