Wed, 24/06/09 – 7:42 | No Comment

Amicus Therapeutics (Nasdaq: FOLD) announced it has commenced the U.S. registration Phase 3 trial with its investigational drug, Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease. The Company has reached agreement with the …

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Home » Archive by Month

Article Archive for June 2009

Study Results Present Efficacy And Safety Findings From The PHIRST-1 Study Of Patients With Pulmonary Arterial Hypertension
Wednesday, 10 Jun, 2009 – 2:00 | No Comment

United Therapeutics Corporation (Nasdaq: UTHR) and Eli Lilly and Company (NYSE: LLY) today announced the results of a pivotal 16-week study showing that a once-daily dose of tadalafil was generally well tolerated, improved …

Pharmasset Initiates Phase 1b Multiple Ascending Dose Clinical Trial Of PSI-7851 In Chronic Hepatitis C Patients
Wednesday, 10 Jun, 2009 – 2:00 | No Comment

Pharmasset, Inc. (Nasdaq: VRUS) announced that it had completed the single ascending dose study and begun dosing in a multiple ascending dose trial with PSI-7851, a nucleotide analog polymerase inhibitor for the treatment of …

Drug Benefit Case Studies Needed
Sunday, 7 Jun, 2009 – 1:00 | No Comment

A well-crafted case study is a powerful educational and marketing tool. The Pharmacy Benefit Management Institute’s (PBMI) 15th Anniversary Drug Benefit Conference offers industry experts an opportunity to present case studies that showcase solutions to …

LNA-Based HIF-1 Alpha Inhibitor Shows Early Signs Of Clinical Benefit
Friday, 5 Jun, 2009 – 2:00 | No Comment

Santaris Pharma announced that the cancer drug EZN-2968 - an inhibitor of HIF-1alpha, jointly developed by Enzon Pharmaceuticals and Santaris Pharma A/S - was well tolerated and showed early signs of clinical benefit in previously …

Access Pharmaceuticals Announces Publication Of Thiarabine Combination Data
Friday, 5 Jun, 2009 – 2:00 | No Comment

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), announced that new Thiarabine preclinical efficacy data will shortly be published demonstrating that thiarabine combined with clofarabine provides much greater antitumor activity than achieved by either agent alone. …

ACTEMRA(R) (tocilizumab) Studies To Be Featured At The European League Against Rheumatism (EULAR) Congress
Friday, 5 Jun, 2009 – 2:00 | No Comment

Roche announced that oral and poster presentations highlighting results from the extensive multi-national ACTEMRA(R) (tocilizumab) clinical development program will be presented at the 10th Annual Congress of the European League Against Rheumatism (EULAR), which will …

Novavax And The NIH Agree To Evaluate A Virus-like Particle (VLP) Vaccine Candidate Against The Novel Influenza A (H1N1) Virus
Friday, 5 Jun, 2009 – 2:00 | No Comment

Novavax, Inc. (Nasdaq: NVAX) and the Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) have signed an agreement to cooperate …

Abbott And AstraZeneca Submit New Drug Application To The FDA For CERTRIAD(TM), An Investigational Treatment For Mixed Dyslipidemia
Friday, 5 Jun, 2009 – 2:00 | No Comment

Abbott (NYSE: ABT) and AstraZeneca announced that the companies have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational compound for the treatment of mixed dyslipidemia, …

Elsevier’s PharmaPendium Introduces The FDA Classic Collection
Thursday, 4 Jun, 2009 – 8:36 | No Comment

PharmaPendium, Elsevier’s online resource for authoritative preclinical, clinical and post-marketing drug information, has significantly expanded its coverage of US Food and Drug Administration (FDA) approval documents with the launch of the FDA Classic Collection. This …

TeraMedica Delivers Enterprise Imaging Interchange Technology Contributing To Meaningful Use Of EMRs To Healthcare Facilities With Sun Microsystems
Thursday, 4 Jun, 2009 – 8:36 | No Comment

TeraMedica Healthcare Technology announced, along with partner, Sun Microsystems, that the two companies will be offering a pre-configured solution for viewing and managing clinical images originating from different modalities and providers to bring secure, consistent …

Study Demonstrating Lurasidone Is Effective In Patients With Schizophrenia Published In The Journal Of Clinical Psychiatry
Thursday, 4 Jun, 2009 – 2:00 | No Comment

Dainippon Sumitomo Pharma Co., Ltd., (DSP) announced that positive results from a phase 2 clinical trial for lurasidone in the treatment of patients with schizophrenia have been published in The Journal of Clinical Psychiatry. This …

Advanced Life Sciences Announces Outcome Of FDA’s Anti-Infective Drugs Advisory Committee Review Of Restanza(TM) (cethromycin)
Thursday, 4 Jun, 2009 – 2:00 | No Comment

Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS) announced that the FDA’s Anti-Infective Drugs Advisory Committee voted in the majority that Restanza(TM) (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate community …

Lilly Resubmits Cymbalta(R) Supplemental New Drug Application For Chronic Pain To U.S. Food And Drug Administration
Thursday, 4 Jun, 2009 – 2:00 | No Comment

As projected, Eli Lilly and Company (NYSE: LLY) has resubmitted its supplemental New Drug Application (sNDA) for Cymbalta(R) (duloxetine HCl) for the management of chronic pain to the U.S. Food and Drug Administration (FDA). …

Investigational Cancer Drug BSI-201 Showed Clinical Benefit In 62% Of Patients With Triple-Negative Metastatic Breast Cancer
Thursday, 4 Jun, 2009 – 1:00 | No Comment

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and its fully owned subsidiary, BiPar Sciences, announced results from a randomized Phase 2 clinical trial of BSI-201, a poly ADP-ribose polymerase (PARP) inhibitor, in combination with gemcitabine …

Cordex Receives Special Protocol Assessment Approval From FDA For ATPace(TM)
Wednesday, 3 Jun, 2009 – 1:00 | No Comment

Cordex Pharma, Inc. (OTC Bulletin Board: CDXP) announced that the U.S. Food and Drug Administration (FDA) has approved the design of pivotal, Phase 2b/3 clinical trials evaluating its lead product ATPace(TM) as an antiarrhytmic drug …

AstraZeneca Studies Show Relief Of Nighttime Heartburn And Reduction In GERD-Related Sleep Disturbances
Wednesday, 3 Jun, 2009 – 1:00 | No Comment

Two studies from AstraZeneca (NYSE: AZN) show that symptomatic gastroesophageal reflux disease (GERD) patients treated with NEXIUM(R) (esomeprazole magnesium) 20 mg daily experienced greater relief from nighttime heartburn and GERD-related sleep disturbances compared with …

Hyperion Therapeutics Announces Results Of Phase I Study In Patients With Liver Cirrhosis
Wednesday, 3 Jun, 2009 – 1:00 | No Comment

Hyperion Therapeutics, Inc. announced top-line results from a phase I study of HPN-100 in patients with liver cirrhosis. The data were presented as part of the 2009 Digestive Disease Week meeting. The abstract is titled …

Prometheus Announces New Findings Regarding Patients At Risk For Celiac Disease At DDW
Wednesday, 3 Jun, 2009 – 1:00 | No Comment

Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, announced new findings regarding a correlation between an important serologic marker used in the detection of Crohn’s disease and particular genetic markers in patients at risk …

CuraGen Updates CR011-vcMMAE Data At ASCO
Wednesday, 3 Jun, 2009 – 1:00 | No Comment

CuraGen Corporation (Nasdaq: CRGN) reported three data presentations from its ongoing clinical trials of CR011-vcMMAE, an antibody-drug conjugate that targets GPNMB, in patients with advanced breast cancer and melanoma at the 2009 Annual Meeting …

Arena Pharmaceuticals Announces The Presentation Of Lorcaserin Phase 3 BLOOM Data At The American Diabetes Association’s 69th Scientific Sessions
Wednesday, 3 Jun, 2009 – 1:00 | No Comment

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced that a late-breaking abstract of its lorcaserin Phase 3 BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) trial has been accepted for a poster presentation at …