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PPACA program provides $733,438 grant to Inovio

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it has received a $733,438 grant under The Patient Protection and Affordable Care Act of 2010 (PPACA).

2 Nov 2010

Positive results from linaclotide Phase 3 trial in patients with IBS-C

Almirall, S.A. and Ironwood Pharmaceuticals, Inc. today announced positive top-line results from a 26-week pivotal Phase 3 clinical trial assessing the efficacy and safety of once-daily dosing of linaclotide 266 mcg in patients with irritable bowel syndrome with constipation (IBS-C).

2 Nov 2010

New findings pave way to improve early detection of ovarian cancer

A drug in testing to treat atherosclerosis significantly inhibited growth of ovarian cancer in both human cell lines and mouse models, the first such report of a peptide being used to fight malignancies, according to a study by researchers at UCLA's Jonsson Comprehensive Cancer Center.

2 Nov 2010

Neogenix Oncology's ensituximab granted FDA orphan drug designation for pancreatic cancer treatment

Neogenix Oncology, Inc. (Neogenix) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company's product candidate ensituximab (monoclonal antibody NPC-1C) for the treatment of pancreatic cancer. The Company initiated in December 2009 a multi-center Phase I clinical trial of ensituximab (NPC-1C) for the treatment of advanced pancreatic and colorectal cancer.

1 Nov 2010

GOG to initiate combination elesclomol-paclitaxel Phase 2 clinical trial for ovarian cancer

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that the Gynecologic Oncology Group (GOG) will initiate a Phase 2 clinical trial of elesclomol in combination with paclitaxel for the treatment of persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer.

1 Nov 2010

Cato Research selects BioClinica's clinical trial management system

BioClinica®, Inc.,, a global provider of clinical trial management solutions, today announced a new agreement with Cato Research Ltd., a full-service contract research organization. Cato Research selected BioClinica's clinical trial management system (CTMS) platform in its search for a best-in-class solution to better serve its growing worldwide client base.

From Clario 1 Nov 2010

Medicago receives Health Canada clearance for Phase II clinical trial of H5N1 Avian Influenza vaccine

Medicago Inc. a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that it has received clearance from Health Canada to commence a Phase II human clinical trial with its H5N1 Avian Influenza vaccine ("H5N1 vaccine"). Enrolment of volunteers is now underway.

1 Nov 2010

Inhibitex announces initiation of INX-189 Phase 1b clinical trial for HCV infection

Inhibitex, Inc. announced today that it has initiated a Phase 1b, multiple ascending dose (MAD) clinical trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic infections caused by hepatitis C virus (HCV).

1 Nov 2010

Acorda reports net income of $12.4 million for third quarter 2010

Acorda Therapeutics, Inc. today announced its financial results for the third quarter of 2010.

1 Nov 2010

Cell Therapeutics announces submission of MAA to European Medicines Agency for Pixuvri

Cell Therapeutics, Inc. announced today that it has submitted a Marketing Authorization Application to the European Medicines Agency for Pixuvri (pixantrone dimaleate) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's lymphoma.

1 Nov 2010

Idera presents IMO-2125 Phase 1 clinical trial data for HCV infection at AASLD Meeting

Idera Pharmaceuticals, Inc. announced today the presentation of data from a Phase 1 clinical trial evaluating IMO-2125, a novel immune modulator, in null-responder patients with chronic hepatitis C virus (HCV) infection.

1 Nov 2010

OptiNose presents sumatriptan Phase II trial results at 2nd European Headache and Migraine Trust International

OptiNose Inc. announced the results from an analysis comparing the Phase II clinical trial obtained with its novel delivery technology to that of other formulations. The analysis suggests rapid absorption rate alone may not explain the efficacy in migraines treated with sumatriptan delivered with the Company's novel bi-directional technology. The results will be presented at the 2nd European Headache and Migraine Trust International on 28th of October 2010.

30 Oct 2010

Presidio to present PPI-461 data for HCV infection at AASLD meeting

Presidio Pharmaceuticals, Inc. announced today that Nathaniel Brown, M.D., Chief Medical Officer, will present a late-breaker poster, "Safety and Pharmacokinetics of PPI-461, a Potent New Hepatitis C virus (HCV) NS5A Inhibitor with Pan-Genotype Activity" at the 61st AASLD meeting in Boston, MA, on November 1, 2010.

30 Oct 2010

HDL and Virginia governor announce $4.2 million investment for expanding operations

Health Diagnostic Laboratory (HDL, Inc.) and Governor Bob McDonnell have announced an investment of $4.2 million in HDL, Inc. operations, resulting in the creation of 213 new jobs in the City of Richmond. HDL, Inc., located in the Virginia BioTechnology Research Park, will expand its clinical laboratory, diagnostics and clinical trial services, as well as its physician/patient consulting.

30 Oct 2010

Alnylam to present data on RNAi therapeutics for fibrotic diseases at The Liver Meeting

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today it will present several poster presentations at the 61st Annual Meeting of the American Association for the Study of Liver Diseases being held in Boston, Mass from October 29 - November 2, 2010.

30 Oct 2010

UB endocrinologist receives Junior Faculty Award to study effects of low testosterone in young men with type 2 diabetes

An endocrinologist in the University at Buffalo's School of Medicine and Biomedical Sciences has received a three-year $400,000 Junior Faculty Award from the American Diabetes Society to study the effects of low testosterone levels in young men with type 2 diabetes.

30 Oct 2010

OHSU to lead next phase of HuCNS-SC trial for NCL in children

Oregon Health & Science University Doernbecher Children's Hospital will lead the next phase of a landmark clinical trial to further assess the safety and preliminary effectiveness of purified human neural stem cells (HuCNS-SC-) as a potential treatment for infantile or late-infantile neuronal ceroid lipofuscinosis (NCL), a rare and currently fatal neurodegenerative disorder that affects infants and children.

30 Oct 2010

BioClinica enters five-year enterprise-wide agreement for Optimizer technology

BioClinica, Inc., a global provider of clinical trial management services, today announced that a Top Ten pharmaceutical company has entered into a five-year enterprise-wide agreement for BioClinica Optimizer to simulate and forecast clinical trial supply scenarios for their worldwide clinical trial operations.

From Clario 29 Oct 2010

KAST trial to assess Kiva vertebral augmentation treatment for painful VCFs due to osteoporosis

Physicians at The Medical College of Wisconsin are conducting the KAST clinical trial at Froedtert Hospital to assess the safety and effectiveness of a new vertebral augmentation treatment (Kiva) for painful vertebral compression fractures (VCFs) due to osteoporosis.

29 Oct 2010

FDA approves Sprycel for treatment of adults with Ph+ CP-CML

The U.S. Food and Drug Administration today approved a new indication for Sprycel (dasatinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

29 Oct 2010

Clinical Trial News and Research

PPACA program provides $733,438 grant to Inovio

Positive results from linaclotide Phase 3 trial in patients with IBS-C

New findings pave way to improve early detection of ovarian cancer

Neogenix Oncology's ensituximab granted FDA orphan drug designation for pancreatic cancer treatment

GOG to initiate combination elesclomol-paclitaxel Phase 2 clinical trial for ovarian cancer

Cato Research selects BioClinica's clinical trial management system

Medicago receives Health Canada clearance for Phase II clinical trial of H5N1 Avian Influenza vaccine

Inhibitex announces initiation of INX-189 Phase 1b clinical trial for HCV infection

Acorda reports net income of $12.4 million for third quarter 2010

Cell Therapeutics announces submission of MAA to European Medicines Agency for Pixuvri

Idera presents IMO-2125 Phase 1 clinical trial data for HCV infection at AASLD Meeting

OptiNose presents sumatriptan Phase II trial results at 2nd European Headache and Migraine Trust International

Presidio to present PPI-461 data for HCV infection at AASLD meeting

HDL and Virginia governor announce $4.2 million investment for expanding operations

Alnylam to present data on RNAi therapeutics for fibrotic diseases at The Liver Meeting

UB endocrinologist receives Junior Faculty Award to study effects of low testosterone in young men with type 2 diabetes

OHSU to lead next phase of HuCNS-SC trial for NCL in children

BioClinica enters five-year enterprise-wide agreement for Optimizer technology

KAST trial to assess Kiva vertebral augmentation treatment for painful VCFs due to osteoporosis

FDA approves Sprycel for treatment of adults with Ph+ CP-CML

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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