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SIMPONI injection improves inflammation, structural damage in RA patients

Magnetic resonance imaging (MRI) analyses from two Phase 3 clinical trials showed that once every four week subcutaneous injections of SIMPONI (golimumab) 50 mg plus methotrexate resulted in statistically significant improvements in markers of inflammation and structural damage in patients with active rheumatoid arthritis (RA) compared with placebo plus methotrexate.

9 Nov 2010

Merrimack receives $2.44 million under QTDP program to support cancer research

Merrimack Pharmaceuticals was awarded $2.44 million to support research on 10 of its cancer programs through the Qualifying Therapeutic Discovery Project, a grant program created as part of the Patient Protection and Affordable Care Act of 2010 to advance research in areas of unmet medical need.

9 Nov 2010

Dabigatran etexilate benefits AF patients with previous stroke or transient ischemic attack

Today, The Lancet Neurology published positive results from a sub-group analysis of the landmark Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY®) trial - the largest atrial fibrillation (AF) outcomes trial ever completed (18,113 patients in 44 countries worldwide). The new findings fully support the convincing results from the RE-LY® trial and show that AF patients with previous stroke or transient ischemic attack (TIA) may benefit substantially from treatment with dabigatran etexilate.

9 Nov 2010

EpiCept third quarter net loss decreases to $3.2 million

EpiCept Corporation today announced operating and financial results for the three and nine months ended September 30, 2010, and provided an update with respect to the Company's key business initiatives.

9 Nov 2010

BioCryst to present data on BCX4208 for gout at ACR Scientific Meeting

BioCryst Pharmaceuticals, Inc. announced the presentation of new data related to the efficacy and safety of BCX4208 for the treatment of gout at the 74th ACR Scientific Meeting being held in Atlanta, Georgia.

9 Nov 2010

Omthera initiates ECLIPSE study for treatment of high triglycerides

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, today announced the initiation of a randomized, open-label, four-way cross-over pharmacokinetics study to evaluate the bioavailability of Epanova, Omthera's lead compound for the treatment of very high triglycerides, in comparison to Lovaza, the leading prescription Omega-3.

9 Nov 2010

New data on Soliris for PNH treatment to be presented at ASH Annual Meeting

Alexion Pharmaceuticals, Inc. today announced that researchers are scheduled to present new data relating to Soliris (eculizumab) as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) during the 52nd Annual Meeting of the American Society of Hematology (ASH), to be held December 4 - 7, 2010 at the Orange County Convention Center in Orlando.

9 Nov 2010

Denosumab superior to Zometa in preventing SREs in breast cancer patients with bone metastases: Study

Amgen today announced the publication of results from a pivotal Phase 3 study of 2,046 patients which compared denosumab with Zometa® (zoledronic acid) in delaying or preventing skeletal-related events (SREs) in breast cancer patients with bone metastases. An SRE consists of any of the following: a pathologic fracture, the need for radiation or surgery to ameliorate bone pathology secondary to tumor growth, or spinal cord compression.

8 Nov 2010

NUVO announces positive results from WF10 Phase 2 clinical trial for severe allergic rhinitis

Nuvo Research Inc. a specialty pharmaceutical company focused on the research and development of drug products that are delivered into and through the skin using its topical and transdermal drug delivery technologies and on the development of its immune modulating drug candidate WF10, today announced that its European Phase 2 clinical trial evaluating WF10 as a treatment for severe allergic rhinitis met its primary endpoint.

8 Nov 2010

Raptor initiates dosing in DR Cysteamine Phase 2 clinical trial for Huntington's Disease

Raptor Pharmaceutical Corp., today announced that the first patient has been dosed in its Phase 2 clinical trial of DR Cysteamine for the potential treatment of Huntington's Disease. The Phase 2 clinical trial is being conducted under a previously announced collaboration agreement with The Centre Hospitalier Universitaire d'Angers ("CHU d'Angers"), which has commenced enrolling patients at eight clinical sites throughout France.

8 Nov 2010

Positive results from Ardea's RDEA594 combination study with febuxostat or allopurinol for gout

Ardea Biosciences, Inc. announced positive results from two clinical studies of RDEA594 in combination with currently marketed drugs for the treatment of gout patients, febuxostat (Uloric®) and allopurinol.

8 Nov 2010

TB Alliance launches three-drug combination trial for drug-sensitive and multidrug-resistant TB

In advance of the 41st Union World Conference, the Global Alliance for TB Drug Development (TB Alliance) today announced the launch of the first clinical trial to test a novel tuberculosis regimen in a new development paradigm designed to speed new treatments to patients. This novel three-drug combination shows promise to treat both drug-sensitive (DS-TB) and multidrug-resistant TB (MDR-TB), and alter the course of the TB pandemic by shortening and simplifying treatment worldwide.

8 Nov 2010

MAP Pharmaceuticals reports positive results from LEVADEX QT trial for migraine

MAP Pharmaceuticals, Inc. today reported successful results from a thorough QT trial of its investigational LEVADEX™ orally inhaled migraine therapy. The trial evaluated the potential of a supra-therapeutic dose to cause an increase in the QT interval. Results of the trial showed that a supra-therapeutic dose of LEVADEX does not increase QTc intervals. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.

8 Nov 2010

TransTech Pharma, High Point receive $1.96 million grants under QTDP program

TransTech Pharma, Inc. and High Point Pharmaceuticals, LLC. today announced that they have been awarded cash grants totaling $1.96 million under the U.S. Government's Qualifying Therapeutic Discovery Project program.

8 Nov 2010

Santarus's budesonide MMX drug shows positive result for active ulcerative colitis

Santarus, Inc. a specialty biopharmaceutical company, today announced positive top-line results from a second Phase III clinical study evaluating the safety and efficacy of budesonide MMX for the induction of remission of mild or moderate active ulcerative colitis.

8 Nov 2010

bitop includes first patient in Ectoin inhalation solution clinical trial for inflammation and airway obstruction

bitop AG, a biotech company specializing in the development of Ectoin®-containing medical devices, announced the inclusion of the first patient into a clinical trial on the Ectoin inhalation solution in patients with inflammation and airway obstruction.

8 Nov 2010

Plexxikon's PLX4032 shows positive data in patients with metastatic melanoma

Plexxikon today announced positive preliminary data from a pivotal Phase 2 clinical trial of PLX4032 (RG7204) in metastatic melanoma, showing significant tumor shrinkage in the majority of patients.

8 Nov 2010

Pervasis receives $920,000 in grants under QTDP program

Pervasis Therapeutics, Inc. today announced that it has been awarded over $920,000 in grants through the U.S. government's Qualifying Therapeutic Discovery Project, which provides tax credits and grants to projects that show significant potential to produce new therapies, reduce long-term health care costs, or significantly advance the goal of curing cancer within the next 30 years.

8 Nov 2010

Synergy receives $244,479 grant under QTDP program to develop plecanatide for gastrointestinal disorders

Synergy Pharmaceuticals, Inc. a developer of new drugs to treat gastrointestinal disorders (GI) and diseases, announced today that it has been awarded a $244,479 grant under the Qualifying Therapeutic Discovery Project (QTDP) program to aid the Company in its development of plecanatide currently in clinical development to treat gastrointestinal disorders.

8 Nov 2010

SGN-35 drug reduces tumor growth in Hodgkin's lymphoma

An experimental drug for Hodgkin's lymphoma, studied at the University of Alabama at Birmingham, showed beneficial effects in stopping tumor growth with moderate side-effects, according to findings published Thursday in the New England Journal of Medicine.

8 Nov 2010

Drug Trial News

SIMPONI injection improves inflammation, structural damage in RA patients

Merrimack receives $2.44 million under QTDP program to support cancer research

Dabigatran etexilate benefits AF patients with previous stroke or transient ischemic attack

EpiCept third quarter net loss decreases to $3.2 million

BioCryst to present data on BCX4208 for gout at ACR Scientific Meeting

Omthera initiates ECLIPSE study for treatment of high triglycerides

New data on Soliris for PNH treatment to be presented at ASH Annual Meeting

Denosumab superior to Zometa in preventing SREs in breast cancer patients with bone metastases: Study

NUVO announces positive results from WF10 Phase 2 clinical trial for severe allergic rhinitis

Raptor initiates dosing in DR Cysteamine Phase 2 clinical trial for Huntington's Disease

Positive results from Ardea's RDEA594 combination study with febuxostat or allopurinol for gout

TB Alliance launches three-drug combination trial for drug-sensitive and multidrug-resistant TB

MAP Pharmaceuticals reports positive results from LEVADEX QT trial for migraine

TransTech Pharma, High Point receive $1.96 million grants under QTDP program

Santarus's budesonide MMX drug shows positive result for active ulcerative colitis

bitop includes first patient in Ectoin inhalation solution clinical trial for inflammation and airway obstruction

Plexxikon's PLX4032 shows positive data in patients with metastatic melanoma

Pervasis receives $920,000 in grants under QTDP program

Synergy receives $244,479 grant under QTDP program to develop plecanatide for gastrointestinal disorders

SGN-35 drug reduces tumor growth in Hodgkin's lymphoma

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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