|Neurocrine Announces Start of Phase 2B Study of Vmat2 Inhibitor; Eli Lilly Releases Data from Phase 2 Ramucirumab Trials|
|By Staff and Wire Reports|
|Monday, 01 October 2012 19:39|
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced it has initiated a Phase IIb clinical trial (Kinect Study) of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854.
The design of this twelve-week Phase IIb study is a randomized, parallel, double-blind, placebo-controlled, trial of 120 subjects with moderate to severe tardive dyskinesia and underlying schizophrenia or schizoaffective disorder. Topline data is expected in the second quarter of 2013.
Eli Lilly and Company (NYSE: LLY) announced new data from two Phase II ramucirumab (IMC-1121B) trials in patients with non-small cell lung cancer (NSCLC). Results were presented today during the Lung Cancer - Metastatic Poster Session at the ESMO 2012 Congress (European Society for Medical Oncology), 1:00 p.m. - 2:00 p.m. CET, in Vienna, Austria.
Interim data for a study in chemotherapy-näive patients with advanced NSCLC treated with ramucirumab in combination with first-line ALIMTA® (pemetrexed for injection)/platinum-based chemotherapy (Abstract #1245) and final data for a study in patients treated with ramucirumab in combination with paclitaxel/ carboplatinum chemotherapy (Abstract#1287) were presented. The pre-specified interim analysis of progression-free survival (PFS) (Abstract #1245) and final six-month PFS rate (Abstract #1287) support continued development of ramucirumab in lung cancer.
Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today announced that it appointed Sattva S. Neelapu, M.D., Associate Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center to Biovest’s Scientific Advisory Board.
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced that the reductions in stroke or systemic embolism, major bleeding and mortality demonstrated with ELIQUIS® compared to warfarin in the ARISTOTLE trial were consistent across a wide range of stroke and bleeding risk scores in patients with nonvalvular atrial fibrillation.
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the LigaSure™ curved, small jaw, open sealer/divider surgical instrument to be used in ear, nose and throat (ENT) procedures.
DATATRAKInternational, Inc. (OTCQX: DATA), a leader in developing cloud-based, unified eClinical technologies and delivering related services for the clinical trials industry, today announced its participation at several industry events during the month of October.
Durata Therapeutics (NASDAQ: DRTX) today announced results from its QT study of the company’s lead product candidate, dalbavancin. Dalbavancin is currently under investigation in two ongoing, global, Phase 3 clinical trials for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
FONAR Corporation (NASDAQ: FONR), The Inventor of MR Scanning™, reported today its year-end financial results for the year-ended June 30, 2012.
GenMark Diagnostics, Inc., (NASDAQ: GNMK) a leading provider of automated, multiplex molecular diagnostic testing systems, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its eSensor® Respiratory Virus Panel for use on its XT-8 system.
GeoVax Labs, Inc. (OTCQB: GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency Virus (HIV) infections, announced receipt of a $1.9 million award from the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health, supporting the development of a clade C version of the Company's current clade B vaccine products.
Horizon Pharma, Inc. (NASDAQ: HZNP) announced today that it has completed the expansion of its sales force from 80 to 150 representatives.
Integrated Management Information, Inc. (d.b.a. IMI Global) (OTCQB: WFCF), a leading provider of verification and Internet solutions for the agricultural/livestock industry under the Where Food Comes From® brand, today announced that chairman and CEO John Saunders will present at the LD MICRO Summit on Thursday, October 4, 2012, at 12:30 p.m. Pacific Time (3:30 p.m. Eastern).
InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and neurotrauma conditions, today announced that Arthur J. Coury, PhD, has joined the company as an advisor to the CEO.
Life Technologies Corporation (NASDAQ: LIFE) has appointed Carol Cox as senior vice president of the newly created External Affairs & Corporate Communications organization.
Magellan Pharmacy Solutions, a subsidiary of Magellan Health Services Inc. (NASDAQ: MGLN), announced today the launch of Total Drug SolutionsSM, a revolutionary integrated approach to managing all drugs – oral, injectable and infusible – to improve the quality and safety of care while lowering costs for consumers and health plans.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that Company executives will not be presenting at the following investor conferences in order to focus on activities leading to the Lymphoseek NDA resubmission.
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that it has initiated a Phase IIb clinical trial (Kinect Study) of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854.
Pfizer Inc. (NYSE: PFE) announced today that the World Health Organization (WHO) has granted an expansion to the prequalification of Pfizer’s pneumococcal conjugate vaccine, Prevenar 131 (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), to include adults 50 years of age and older against pneumonia and invasive disease caused by the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) contained in the vaccine.
Proteonomix, Inc. (OTCBB:PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, today announced that Numoda Corporation will provide a range of specific clinical trial services for a Proteonomix-sponsored Phase 1 clinical trial with its patent-pending mobilization technology UMK-121 in patients with end-stage liver disease (ESLD).
Puma Biotechnology, Inc. (OTCBB: PBYI), a development stage biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will present an overview of the Company at 10:30 a.m. EDT on Wednesday, September 19, at the UBS Global Life Sciences Conference in New York City.
Sigma-Aldrich Corporation (Nasdaq: SIAL) was recently recognized by the Carbon Disclosure Project (CDP), an independent not-for-profit organization working to drive greenhouse gas emissions reduction and sustainable water use worldwide, for its innovative approach to the disclosure of climate change information.
Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that results of a study in a canine model of OrbeShieldTM (oral beclomethasone 17,21-dipropionate) will be presented at a poster session entitled, "Post-exposure oral 17,21-beclomethasone dipropionate (BDP) improves survival in a canine gastrointestinal acute radiation syndrome (GI ARS) model."
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the appointment of Ken Keller as Executive Vice President, Chief Operating Officer.
Synergetics USA, Inc. (NASDAQ: SURG) ("Synergetics" or the "Company"), a medical device company that designs, manufactures, and markets innovative surgical devices for ophthalmic and neurosurgical applications, today announced results for the fourth quarter and year ended July 31, 2012.