Argos Therapeutics announced that its Arcelis immunotherapy for renal cell carcinoma (RCC), AGS-003, demonstrated favorable progression-free survival (PFS) and safety in combination with sunitinib, based upon updated results from an ongoing Phase 2 trial. [More]
LSUHSC-S receives $3.9M NIDA grant for development of Embera's EMB-001 for cocaine dependence
Embera NeuroTherapeutics, Inc., a specialty pharmaceutical company developing novel treatments for addiction and obesity, announced today that the Louisiana State University Health Sciences Center (LSUHSC-S) has received a $3.9 million dollar grant from the National Institute on Drug Abuse (NIDA). The grant will support the next stages of development for Embera's drug candidate EMB-001 to treat cocaine dependence, as well as advance EMB-001 into clinical testing. [More]
AcelRx completes ARX-02 End-of-Phase 2 meeting with FDA for cancer breakthrough pain management system
AcelRx Pharmaceuticals, Inc. today announced that it has completed an End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) for ARX-02, a proprietary Sufentanil NanoTab™ Breakthrough Pain Management System for the treatment of cancer breakthrough pain in opioid-tolerant patients. FDA reviewed a package based on the previously announced positive Phase 2 clinical study results to date for ARX-02 and provided AcelRx with guidance on the Phase 3 program design and NDA requirements. [More]
Benicar better than Cozaar in reducing blood pressure: Study
New study results show that patients treated with Benicar® (olmesartan medoxomil) 40 mg once daily had significantly greater reductions in blood pressure and higher rates of goal attainment than patients receiving Cozaar® (losartan potassium) 100 mg once daily at week 8, according to findings of a new head-to-head study presented today at the late breaker session at the 23rd Scientific Meeting of the International Society of Hypertension (ISH) in Vancouver, Canada. [More]
Intra-Cellular Therapies demonstrates ability of ITI-002 to improve motor and non-motor behaviors in PD
Intra-Cellular Therapies, Inc. today announced results from studies demonstrating the anti-Parkinson and other beneficial effects of ITI-002 (IC200214), the Company's novel and selective phosphodiesterase type I (PDE1) inhibitor. [More]
FDA grants Emergent Fast Track Designation for AVP-21D9 anthrax monoclonal antibody development program
Emergent BioSolutions Inc. announced today that its anthrax monoclonal antibody development program investigating AVP-21D9 for the treatment of inhalational anthrax has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). Emergent recently commenced a Phase I clinical trial for AVP-21D9, which is a fully human monoclonal antibody product candidate being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease. [More]
Global phase IV study confirms efficacy of erlotinib in treatment of non-small cell lung cancer
Featured in the October edition of the Journal of Thoracic Oncology (JTO), data from The Tarceva Lung Cancer Survival Treatment (TRUST) confirms the safety and efficacy profile of erlotinib, a highly potent oral active, reversible inhibitor of epidermal growth factor receptor (EGFR) tyrosine-kinase (TK) activity in a large heterogeneous non-small cell lung cancer (NSCLC) population. [More]
Herpevac Trial for Women finds experimental vaccine ineffective in prevention of genital herpes disease
An experimental vaccine intended to prevent genital herpes disease in women, although generally safe and well-tolerated, proved ineffective when tested in the recently concluded clinical study known as the Herpevac Trial for Women. [More]
Achillion initiates ACH-1625 Phase II dosing for HCV infection
Achillion Pharmaceuticals, Inc., a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that the Company has initiated patient dosing in a Phase II clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) infection. ACH-1625 is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication. The drug candidate was discovered and is being advanced by Achillion. [More]
NIH awards Polymedix $986,000 to develop defensin mimetic antimicrobial compounds for oral candidiasis
PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has received a Phase 2 grant in the amount of $986,000 from the National Institute of Health (NIH) to support the development of defensin mimetic antimicrobial compounds for the treatment of oral candidiasis. This grant will fund this research project through August 31, 2012. This award represents the 14th grant or research contract received to date by PolyMedix. [More]
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