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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

Selenium secures NIH grant to apply patented antimicrobial technology for ear infections

Selenium, Ltd., a biopharmaceutical company focused on unique solutions to meet antimicrobial coating and therapeutic needs, has been awarded a research grant from the National Institute on Deafness and Other Communication Disorders, one of the National Institutes of Health. With the $155,387 NIH grant the company will apply its proprietary antimicrobial technology to researching the inhibition of biofilms on tympanostomy tubes.

18 Nov 2010

Sangamo presents Phase 2 clinical data in ALS at Society for Neuroscience Meeting

Sangamo BioSciences, Inc. announced today the presentation of Phase 2 clinical data from its ZFP Therapeutic program to develop SB-509, a zinc finger protein transcriptional activator (ZFP-TF) of the vascular endothelial growth factor (VEGF)-A gene as a treatment for ALS.

17 Nov 2010

Aeterna Zentaris presents results of orally active compounds with anti-tumor effects at EORTC-NCI-AACR Symposium

Aeterna Zentaris Inc. today presented posters on encouraging preclinical results for AEZS-129 and AEZS-132, two novel orally active compounds with anti-tumor effects.

17 Nov 2010

Vical enters agreement with GenomIdea to develop DNA vaccine for pandemic influenza

Vical Incorporated today announced that the company has entered into an evaluation and supply agreement with GenomIdea Inc., a subsidiary of AnGes MG, Inc., for the development of a DNA vaccine for livestock against pandemic influenza.

17 Nov 2010

Cardio3 BioSciences announces positive results from C-Cure Phase II clinical trial for heart failure

The Belgian biotechnology company, Cardio3 BioSciences a leader in discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases today announces positive six-month results, including significant functional and clinical benefit, from the Phase II clinical trial of its development programme C-Cure(R), designed as a novel stem cell therapy for heart failure based on breakthrough technology.

17 Nov 2010

Efficacy News and Research

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

Selenium secures NIH grant to apply patented antimicrobial technology for ear infections

Sangamo presents Phase 2 clinical data in ALS at Society for Neuroscience Meeting

Aeterna Zentaris presents results of orally active compounds with anti-tumor effects at EORTC-NCI-AACR Symposium

Vical enters agreement with GenomIdea to develop DNA vaccine for pandemic influenza

Cardio3 BioSciences announces positive results from C-Cure Phase II clinical trial for heart failure

Industry Focus eBook - Cell & Gene Therapy (1st Edition) eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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