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Amgen submits BLA for denosumab subcutaneous RANK Ligand inhibitor

Amgen Inc. today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for denosumab, a subcutaneous RANK Ligand inhibitor. The BLA submission summarizes clinical experience from nearly 6,900 patients across 18 clinical studies, including approximately 5,700 patients with advanced cancer in the three, pivotal, Phase 3, head-to-head trials versus Zometa® (zoledronic acid).

15 May 2010

FDA assigns Cadence Pharmaceuticals' OFIRMEV NDA new PDUFA action date

Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has classified the OFIRMEV™ (acetaminophen) injection New Drug Application (NDA) resubmission as a complete Class 2 response to the FDA's February 10, 2010 action letter and assigned a new Prescription Drug User Fee Act (PDUFA) action date of November 4, 2010.

15 May 2010

BioSante Pharmaceuticals first-quarter net loss increases to $10.5 million

BioSante Pharmaceuticals, Inc. today reported on its recent developments and financial results for the first quarter, and its cash balance as of March 31, 2010.

14 May 2010

Hana Biosciences reports $5.5 million net loss for first-quarter 2010

Hana Biosciences Inc.,, a biopharmaceutical company focused on strengthening the foundation of cancer care, today reported financial results for the first quarter ended March 31, 2010, and provided a corporate update.

14 May 2010

Convergent procedure promising for longstanding persistent atrial fibrillation

nContact Surgical, Inc. announced today the presentation of data collected from 43 patients as a result of a closed chest convergent atrial fibrillation (AF) procedure at the Heart Rhythm Society 2010 Conference in Denver, Colorado.

14 May 2010

SPIROCOR's RSR non-invasively measures presence of significant coronary artery disease

Newly published data confirm a non-invasive Respiratory Stress Response (RSR) can quickly and accurately measure the presence of significant coronary artery disease (sCAD), the leading cause of cardiovascular death worldwide. Patients in the study with sCAD had a lower RSR compared to patients without.

14 May 2010

Inhibitex reports net loss of $4.8M for first-quarter 2010

Inhibitex, Inc. today announced its financial results for the first quarter ended March 31, 2010. The Company also announced that it has initiated a Phase I single ascending dose trial of INX-189, its lead HCV nucleotide polymerase inhibitor, in healthy volunteers under an Investigational New Drug application with the U.S. Food and Drug Administration.

14 May 2010

FREEDOM trial results to be presented at Heart Rhythm 2010

St. Jude Medical, Inc., a global medical device company, today announced results of the FREEDOM trial during the late breaking clinical trial presentations at Heart Rhythm 2010, the Heart Rhythm Society's 31st Annual Scientific Sessions. The trial demonstrated that the QuickOpt optimization feature available in St. Jude Medical cardiac resynchronization therapy devices produces an equivalent response rate in CRT patients as optimization using echocardiography.

14 May 2010

International study to test effectiveness of celecoxib in preventing growth of precancerous polyps

Rush University Medical Center is testing whether celecoxib, known by its brand name Celebrex, can help prevent the growth of precancerous polyps that form in the colon, rectum and small intestine of children with an inheritable genetic disease called familial adenomatous polyposis.

14 May 2010

GRNCM1 do not cause cardiac arrhythmias after transplantation: Preclinical study

Geron Corporation today reported positive preclinical study data showing that GRNCM1, Geron's cardiomyocyte product derived from human embryonic stem cells, does not cause cardiac arrhythmias after transplantation into a model of chronic heart damage designed to test this potential safety concern.

14 May 2010

DMC recommends Celsion to continue enrollment in ThermoDox clinical study for primary liver cancer

Celsion Corporation announced today that after reviewing data from 294 patients including data from 12 Japanese patients enrolled in the pivotal Phase III ThermoDox® clinical study (HEAT Study) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial.

14 May 2010

Neurologix reports lower net loss of $3.5M for first-quarter 2010

Neurologix, Inc., a biotechnology company developing innovative gene therapies for the brain and central nervous system, today announced its financial results for the quarter ended March 31, 2010.

14 May 2010

Immunosuppressive drug sirolimus improves kidney health of patients with ADPKD: Study

The immunosuppressive drug sirolimus considerably improves the kidney health of patients with autosomal dominant polycystic kidney disease, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology.

14 May 2010

caprotec bioanalytics closes EUR 4 million Series B Financing Round

caprotec bioanalytics GmbH today announced the closing of a EUR 4 million ($5.1M) Series B Financing Round with existing investors Creathor Venture, IBB Beteiligungsgesellschaft, ERP Startfonds, and well-known private investors. The proceeds will enable further development and marketing of the Company's proprietary CCMS (Capture Compound Mass Spectrometry) platform technology for analyzing complex protein mixtures.

14 May 2010

Phase IIb trail results of epratuzumab in lupus patients to be presented at EULAR 2010

Immunomedics, Inc., a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that clinical trial results on epratuzumab, the anti-CD22 humanized monoclonal antibody licensed to UCB SA, Brussels, for autoimmune disease indications, from the Phase IIb study in patients with lupus, will be presented in four posters sessions and one published abstract.

14 May 2010

Transdel Pharmaceuticals reports lower net loss of $0.9 million for first-quarter 2010

Transdel Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, today announced financial results for the quarter ended March 31, 2010. The Company also highlighted recent achievements.

14 May 2010

Study results of Cameron Health's S-ICD- System published online in NEJM

Cameron Health, Inc. today announced the publication of study results online in the New England Journal of Medicine highlighting the development and potential benefits of the company's S-ICD- System, the first minimally invasive, subcutaneous implantable cardioverter defibrillator, for the treatment of sudden cardiac arrest.

14 May 2010

Chimerix commences first-in-human study of CMX157 for HIV

Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, announced the commencement of a first-in-human study of CMX157, a novel lipid conjugate of the nucleotide tenofovir with in vitro activity against both tenofovir-sensitive and tenofovir-resistant human immunodeficiency virus (HIV). CMX157 has the potential to increase efficacy and decrease toxicity as compared to tenofovir, and may enable the creation of new 'one pill, once-a-day', fixed-dose combination regimens for the treatment of HIV infection.

14 May 2010

Rexahn Pharmaceuticals announces Phase IIb clinical trial of Zoraxel for ED

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it will initiate a Phase IIb clinical trial for ZoraxelTM in the treatment of erectile dysfunction (ED).

13 May 2010

ARYx Therapeutics decreases first-quarter net loss to $6.4 million

ARYx Therapeutics, Inc. today reported results of operations and provided an update on its business activities for the first quarter ended March 31, 2010.

13 May 2010