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MonoSol Rx receives positive FDA feedback on 505(b)(2) pathway for Montelukast Sodium OSF

MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in proprietary pharmaceutical film products, today announced that it held a pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of Montelukast Sodium Oral Soluble Film (OSF) under a 505(b)(2) pathway.

30 Mar 2011

Amgen announces top-line results from motesanib Phase 3 trial against NSCLC

Amgen, Millennium: The Takeda Oncology Company, and Takeda Pharmaceutical Company Limited today announced top-line results from the MONET1 pivotal Phase 3 trial evaluating motesanib administered in combination with paclitaxel and carboplatin in 1,090 patients with advanced non-squamous non-small cell lung cancer.

30 Mar 2011

BioSante completes patient enrollment in LibiGel Phase III trial against HSDD

BioSante Pharmaceuticals, Inc. today announced that enrollment of subjects in the second of two pivotal Phase III LibiGel safety and efficacy trials has been completed. Enrollment in the first LibiGel efficacy trial was completed in February.

30 Mar 2011

Pharmasset commences PSI-7977 Phase 2b study against HCV

Pharmasset, Inc. announced today that screening has begun in a Phase 2b study of PSI-7977, a nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C.

30 Mar 2011

Columbia Labs' PROCHIEVE Phase III trial results to be published in online medical journal

Columbia Laboratories, Inc. today announced that the Company expects results from the PREGNANT Study, a Phase III clinical trial evaluating PROCHIEVE, will be published in a respected peer-reviewed medical journal online next week, and in the journal's print edition thereafter.

30 Mar 2011

SLN to present Atu027 Phase I study data against solid cancer at ASCO Annual Meeting

Silence Therapeutics plc a leading global RNA interference therapeutics company, announces that interim data from its ongoing Phase I clinical study of Atu027, the Company's lead internal therapeutic candidate, have been accepted for poster presentation at the 2011 American Society of Clinical Oncology Annual Meeting.

30 Mar 2011

Positive preliminary results from Presidio's PPI-461 Phase 1b trial against HCV

Presidio Pharmaceuticals, Inc. announced today positive preliminary results from a Phase 1b clinical trial of PPI-461, a novel HCV NS5A inhibitor for the treatment of patients with chronic hepatitis C.

30 Mar 2011

Positive results from Vertex VX-770 Phase 3 trial against CF

Vertex Pharmaceuticals Incorporated today announced positive results from a 24-week analysis of the ongoing Phase 3 ENVISION study of VX-770, an oral medicine in development that targets the defective protein that causes cystic fibrosis.

30 Mar 2011

Intercept initiates OCA FLINT trial in patients with nonalcoholic steatohepatitis

Intercept Pharmaceuticals, Inc., has been informed by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health that patient enrollment has started in a new clinical trial in patients with nonalcoholic steatohepatitis, which will evaluate Intercept's first-in-class farnesoid X receptor agonist obeticholic acid as a novel therapy for NASH.

30 Mar 2011

Metabolic Solutions initiates MSDC-0602 Phase 2a trial in patients with type 2 diabetes

Metabolic Solutions Development Company, a drug discovery and development company exploiting novel molecular targets to treat metabolic diseases, announced today that it has launched a Phase 2a trial for MSDC-0602, the company's second drug candidate for the treatment of type 2 diabetes.

30 Mar 2011

New lung cancer drug starts human trials

A new drug for lung cancer is being tried by researchers at Oxford. The treatment, which halts the growth of cancer cells, is being trialed on those patients who have stopped responding to chemotherapy. The trial is one of the first to go ahead at the Oxford Cancer Research Centre.

29 Mar 2011

Concert initiates CTP-499 Phase 1 study in patients with diabetic nephropathy

Concert Pharmaceuticals, Inc. today announced it has made significant progress advancing CTP-499, its novel anti-inflammatory, anti-oxidant, and anti-fibrotic agent for diabetic nephropathy and other forms of chronic kidney disease, into clinical development.

29 Mar 2011

Regado to present REG1 Phase 2b trial results against acute coronary syndromes at i2 Summit

Regado Biosciences, Inc., a privately held company pioneering the development of antithrombotic aptamers with active control agents, announced that Thomas J. Povsic, MD, PhD, Assistant Professor of Medicine at Duke University, will present results of the RADAR Phase 2b clinical trial for the Company's lead product, the REG1 anticoagulation system, at the i2 Summit during the American College of Cardiology 2011 60th Annual Scientific Session & Expo.

29 Mar 2011

Keryx KRX-0401 trial data against colorectal cancer, multiple myeloma to be presented at AACR

Keryx Biopharmaceuticals, Inc. today announced that two abstracts on KRX-0401 will be presented at the upcoming 102nd annual meeting of the American Association for Cancer Research to be held in Orlando, Florida, from April 2-6, 2011.

29 Mar 2011

Onyx plans to expand carfilzomib Phase 3 European trial in patients with myeloma

Onyx Pharmaceuticals, Inc. today announced its plans to expand the Phase 3 European clinical trial FOCUS, which is evaluating the efficacy and tolerability of carfilzomib, a selective next-generation proteasome inhibitor.

29 Mar 2011

International Phase II trial to study LY2181308 efficacy in patients with lung cancer

Cancer Research UK scientists in Oxford are trialling an experimental drug to treat lung cancer patients who have stopped responding to initial chemotherapy treatment. The trial will take place at the Oxford Radcliffe Hospitals NHS Trust.

29 Mar 2011

CytRx to present bafetinib preclinical study results at AACR Annual Meeting

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that results from a series of preclinical studies demonstrating that its oncology drug candidate bafetinib inhibits bone destruction in model systems is being presented on April 2, 2011 at the American Academy for Cancer Research 102nd Annual Meeting in Orlando, Florida.

29 Mar 2011

Nordion presents TheraSphere Phase II trial results against liver metastases at SIR meeting

Nordion Inc., a leading provider of products and services to the global health science market, today shared results from the first multi-site, Phase II clinical trial to evaluate TheraSphere® for treatment of metastatic liver cancer.

29 Mar 2011

Dementia & Alzheimer’s drug trial with sleep hormone melatonin

A new drug is in the making that could improve the quality of life for people with dementia. Glasgow-based medical research company CPS Research is conducting a clinical trial using a drug containing the sleep hormone melatonin, which it is hoped will reduce the symptoms associated with the illness.

28 Mar 2011

PHOENIX phase III trial of PHP for distributive shock to continue after positive midpoint recommendation from DMB

The PHOENIX trial is a European, placebo-controlled, Phase III study treating catecholamine-resistant patients in distributive shock with the Nitric Oxide (NO) scavenger Pyridoxalated Haemoglobin Polyoxyethylene Conjugate (PHP). The study was launched by Curacyte AG in Austria, Belgium, Germany, Spain, The Netherlands and in the United Kingdom in 2009.

28 Mar 2011

Drug Trial News

MonoSol Rx receives positive FDA feedback on 505(b)(2) pathway for Montelukast Sodium OSF

Amgen announces top-line results from motesanib Phase 3 trial against NSCLC

BioSante completes patient enrollment in LibiGel Phase III trial against HSDD

Pharmasset commences PSI-7977 Phase 2b study against HCV

Columbia Labs' PROCHIEVE Phase III trial results to be published in online medical journal

SLN to present Atu027 Phase I study data against solid cancer at ASCO Annual Meeting

Positive preliminary results from Presidio's PPI-461 Phase 1b trial against HCV

Positive results from Vertex VX-770 Phase 3 trial against CF

Intercept initiates OCA FLINT trial in patients with nonalcoholic steatohepatitis

Metabolic Solutions initiates MSDC-0602 Phase 2a trial in patients with type 2 diabetes

New lung cancer drug starts human trials

Concert initiates CTP-499 Phase 1 study in patients with diabetic nephropathy

Regado to present REG1 Phase 2b trial results against acute coronary syndromes at i2 Summit

Keryx KRX-0401 trial data against colorectal cancer, multiple myeloma to be presented at AACR

Onyx plans to expand carfilzomib Phase 3 European trial in patients with myeloma

International Phase II trial to study LY2181308 efficacy in patients with lung cancer

CytRx to present bafetinib preclinical study results at AACR Annual Meeting

Nordion presents TheraSphere Phase II trial results against liver metastases at SIR meeting

Dementia & Alzheimer’s drug trial with sleep hormone melatonin

PHOENIX phase III trial of PHP for distributive shock to continue after positive midpoint recommendation from DMB

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