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DARA BioSciences announces the initiation of Phase I clinical study for DB959

DARA BioSciences, Inc. announced that it has initiated a Phase I clinical study for DB959, its PPAR (peroxisome proliferator activated receptor) delta/gamma agonist, an oral drug in development for the treatment of Type 2 Diabetes. The study will enroll approximately 75 volunteers and will be conducted at Quintiles' Overland Park facility.

26 Mar 2010

JCOM receives approval from KFDA to commercialize MuGard in Korea

ACCESS PHARMACEUTICALS, INC. announced that JCOM Co., Ltd., its Korean licensee for both MuGard™ and ProLindac™, has received approval from the Korean Food and Drug Administration of its Registration Dossier for MuGard, an oncology supportive-care treatment for the management of oral mucositis.

26 Mar 2010

Arena Pharmaceuticals initiates patient screening for phase 1 clinical trial of APD916

Arena Pharmaceuticals, Inc. announced today the initiation of patient screening in a Phase 1 clinical trial of APD916, a novel oral drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy and cataplexy.

25 Mar 2010

MediciNova reports net loss of $5.9 million for 2009 fourth quarter

MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced financial results for the fourth quarter and full year ended December 31, 2009.

25 Mar 2010

Evotec AG reports financial results and corporate updates for 2009

Based on the Action Plan 2012, Evotec decided in March 2009 to strengthen its discovery alliances, creating the central vehicle for growth, and to implement strict cost cutting and restructuring measures. The Company reduced headcount in administrative and clinical development functions, reprioritised its R&D activities, concentrated its operations in Europe and closed the former facility of Renovis, Inc. in South San Francisco.

25 Mar 2010

Pernix Therapeutics Holdings acquires oral third-generation cephalosporin, CEDAX

Pernix Therapeutics Holdings, Inc. today announced the acquisition of the antibiotic CEDAX® (ceftibuten) from Shionogi Pharma, Inc.

25 Mar 2010

Æterna Zentaris announces 2009 financial and operating results

Æterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today reported financial and operating results as at and for the fourth quarter and the full year ended December 31, 2009.

24 Mar 2010

Transcept Pharmaceuticals receives second patent for Intermezzo formulation

Transcept Pharmaceuticals, Inc. today announced that the second patent covering the composition and use of Intermezzo® (zolpidem tartrate sublingual tablet), the lead Transcept product candidate, has been issued by the United States Patent and Trademark Office.

24 Mar 2010

Bioalliance Pharma's anti-emetic drug Setofilm receives European approval

BioAlliance Pharma SA, a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announced approval for Setofilm® in 16 European countries.

24 Mar 2010

Portola Pharmaceuticals commences Phase 1 trial of PRT062607 for chronic inflammatory diseases

Portola Pharmaceuticals, Inc. today announced that it has initiated its first in human Phase 1 trial in healthy volunteers of PRT062607, a novel, oral Syk-specific kinase inhibitor in development to treat chronic inflammatory diseases, including rheumatoid arthritis (RA), and certain cancers, including non-Hodgkin's lymphoma and chronic lymphocytic leukemia. In preclinical in vivo models of RA, PRT062607 was shown to reduce inflammation in a dose-dependent manner.

23 Mar 2010

Time-released muco-adhesive patch more effective than oral rinse for xerostomia

A newly developed time-released muco-adhesive patch for treating oral health conditions, including the widespread condition of dry mouth (xerostomia), has been shown to be more effective than a leading oral rinse, according to a newly-published study. As increasing segments of the population consume more medications (one of the leading causes of dry mouth), the results of this study could potentially help provide relief for millions of Americans.

23 Mar 2010

GSK notifies regulatory authorities of the presence of PCV-1 in Rotarix vaccine

GlaxoSmithKline today confirmed that it has notified regulatory authorities of the presence of material from a virus called PCV-1 in its oral rotavirus vaccine, Rotarix™. PCV-1 does not multiply in humans and is not known to cause illness in humans.

23 Mar 2010

Understanding the African mindset may help promote health education in rural areas

Seen through western eyes, beliefs in supernatural forces are common in Ghana and other African countries. Death, suffering and diseases are often attributed to witchcraft. Over thirty per cent of its inhabitants believe such evil forces could be responsible for the spread of HIV/AIDS.

22 Mar 2010

Baxa releases DoseEdge Pharmacy Workflow Management System

Baxa Corporation, a leading provider of medical devices and systems that automate pharmacy operations and increase patient safety, today announced the release of new features for its DoseEdge Pharmacy Workflow Management System. The upgrades extend DoseEdge capabilities to include mobile dose tracking, more pharmacist verification options and enhanced dose status monitoring.

22 Mar 2010

BEMA Granisetron development program: BDSI announces positive meeting with FDA

BioDelivery Sciences International, Inc. announced the positive outcome of a meeting with the FDA on the development program for BEMA Granisetron, the company’s potential treatment for the prevention of nausea and vomiting associated with cancer therapy. FDA concurred with BDSI’s plans to pursue a development program based on clinical pharmacokinetic data for a 505(b)(2) New Drug Application.

22 Mar 2010

ITDS can be effective for screening fever during H1N1 influenza pandemic: UNMC researchers

Researchers at the University of Nebraska Medical Center found an Infrared Thermal Detection System to be a fast and effective fever screening tool in clinical settings during the H1N1 influenza pandemic. The ITDS detected fever in patients through split-second, non-contact skin temperature measurements.

20 Mar 2010

Synergy Pharmaceuticals commences dosing in Phase IIa clinical trial of SP-304 in CC patients

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal disorders and diseases, announced today the initiation of dosing in a Phase IIa clinical trial of SP-304 in patients with chronic constipation (CC). This is a Phase IIa, randomized, double-blind, placebo-controlled, 14-day repeat, oral, dose-escalation study in patients with chronic constipation.

19 Mar 2010

Lifestyle improvements and new treatments for diabetes and cardiovascular disease needed

Treatment with the anti-hypertensive drug valsartan (Diovan) led to a modest reduction in the development of type 2 diabetes but did not significantly reduce cardiovascular events in patients with impaired glucose tolerance, according to researchers at Duke University Medical Center and the University of Oxford. They jointly reported results at the American College of Cardiology meeting today from the world's first study designed to find ways to control the progression to diabetes and cardiovascular disease in people at risk.

19 Mar 2010

European CHMP issues positive opinion for Roche's Tarceva as maintenance therapy for NSCLC

Roche today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for use of Tarceva(R) (erlotinib) as a maintenance therapy for people with advanced non-small cell lung cancer (NSCLC) and stable disease (cancer remains largely unchanged) after initial chemotherapy. The CHMP positive opinion clears the way for European Union approval and means that this group of patients may soon be able to benefit from earlier treatment with Tarceva.

19 Mar 2010

Bactericidal antibiotic with activity against MRSA for treatment of cSSSIs would earn 25% patient share: Report

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a therapy's effect on overall clinical success is the attribute that most influences surveyed infectious disease specialists' prescribing decisions in the treatment of complicated skin and skin structure infections (cSSSIs).

19 Mar 2010

Oral News and Research

DARA BioSciences announces the initiation of Phase I clinical study for DB959

JCOM receives approval from KFDA to commercialize MuGard in Korea

Arena Pharmaceuticals initiates patient screening for phase 1 clinical trial of APD916

MediciNova reports net loss of $5.9 million for 2009 fourth quarter

Evotec AG reports financial results and corporate updates for 2009

Pernix Therapeutics Holdings acquires oral third-generation cephalosporin, CEDAX

Æterna Zentaris announces 2009 financial and operating results

Transcept Pharmaceuticals receives second patent for Intermezzo formulation

Bioalliance Pharma's anti-emetic drug Setofilm receives European approval

Portola Pharmaceuticals commences Phase 1 trial of PRT062607 for chronic inflammatory diseases

Time-released muco-adhesive patch more effective than oral rinse for xerostomia

GSK notifies regulatory authorities of the presence of PCV-1 in Rotarix vaccine

Understanding the African mindset may help promote health education in rural areas

Baxa releases DoseEdge Pharmacy Workflow Management System

BEMA Granisetron development program: BDSI announces positive meeting with FDA

ITDS can be effective for screening fever during H1N1 influenza pandemic: UNMC researchers

Synergy Pharmaceuticals commences dosing in Phase IIa clinical trial of SP-304 in CC patients

Lifestyle improvements and new treatments for diabetes and cardiovascular disease needed

European CHMP issues positive opinion for Roche's Tarceva as maintenance therapy for NSCLC

Bactericidal antibiotic with activity against MRSA for treatment of cSSSIs would earn 25% patient share: Report

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