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Study investigates effectiveness of potential treatment for Non-alcoholic steatohepatitis

Estimates of the prevalence of liver disease suggest that one‐third of the United States population has non‐alcoholic fatty liver disease (NAFLD). NAFLD is now the most common cause for elevated liver function tests in the United States, a trend related to the obesity epidemic in this country. Non-alcoholic steatohepatitis (NASH), the progressive form of NAFLD, can lead to cirrhosis and all its complications.

19 Oct 2010

New research coalition to design first human trial of mosaic HIV vaccine candidate

Duke University Medical Center vaccine experts have assembled an international team of investigators to design and implement the first human trial of a mosaic HIV vaccine candidate, a novel strategy that attempts to counter one of the most daunting challenges in HIV vaccine design: the virus's extensive genetic diversity

19 Oct 2010

Transcept announces Intermezzo tablet preliminary data for insomnia

Transcept Pharmaceuticals, Inc. today announced its preliminary analysis of data from the recently completed Intermezzo 3.5 mg (zolpidem tartrate sublingual tablet) highway driving study.

19 Oct 2010

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

Salix Pharmaceuticals, Ltd. today announced the presentation of two analyses of data from its Phase 3 pivotal clinical trials, TARGET 1 and 2, demonstrating a 14-day course of XIFAXAN 550 mg (rifaximin) taken three times daily achieved adequate relief of symptoms of non-constipation irritable bowel syndrome (non-C IBS) in a significantly greater proportion of patients compared with placebo.

19 Oct 2010

New clinical trial to treat brain cancer launched

Cancer Research UK and Cancer Research Technology the charity's development and commercialisation arm together with immatics biotechnologies have launched the first clinical trial of a promising cancer vaccine to treat glioblastoma, one of the most common forms of brain cancer.

19 Oct 2010

UCB presents P3, P4 clinical trial data for Crohn's disease at ACG Scientific Meeting

Findings from the PRECiSE 3 (P3) open label extension study for Cimzia, demonstrating the longest continuously running maintenance trial for an anti-TNF in Crohn's disease, will be exhibited at the 2010 Annual Scientific Meeting of the American College of Gastroenterology (ACG), taking place in San Antonio from October 15 – 20. Additionally, long-term efficacy data from the PRECiSE 4 (P4) clinical trial also will be presented at the meeting.

19 Oct 2010

Groundbreaking melanoma clinical trial initiated by Patrys

Patrys Limited (ASX: PAB), which is focused on developing revolutionary treatments for cancer, announced today the treatment of the first patient in a human clinical trial to evaluate PAT-SM6 as a therapy for melanoma.

18 Oct 2010

BARACLUDE sNDA receives FDA approval for treatment of CHB patients with decompensated liver disease

Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of BARACLUDE for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease.

18 Oct 2010

Studies explore impact of upper GI conditions on sleep

The impact of upper GI conditions, like gastroesophageal reflux disease (GERD) and functional dyspepsia, on sleep—and treatments aimed at providing relief to heartburn/acid reflux patients who suffer from disordered sleep—were explored in three new studies related to sleep dysfunction presented today at the American College of Gastroenterology's (ACG) 75th Annual Scientific meeting in San Antonio, Texas.

18 Oct 2010

Sequella to develop SQ109 further with EDCTP, LMU, and TB experts in PanACEA

Sequella, Inc., a clinical-stage company focused on commercializing novel drugs for treatment of life-threatening infectious diseases, announced it has signed an agreement with the Ludwig-Maximilians-University (LMU) of Munich to coordinate a European Union grant for Phase 2 clinical trials of SQ109 in adult pulmonary tuberculosis (TB) in seven sites in Africa.

18 Oct 2010

Vertex commences VX-770 and VX-809 combination Phase 2a clinical trial for cystic fibrosis

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 2a clinical trial that will evaluate multiple combinations of VX-770 and VX-809, investigational oral cystic fibrosis transmembrane conductance regulator (CFTR) modulators for the treatment of cystic fibrosis (CF). The trial is designed to evaluate the safety and tolerability of VX-809 dosed alone for 14 days followed by dosing of VX-809 in combination with VX-770 for 7 days.

18 Oct 2010

Fluticasone gets rid of eosinophils in the esophagus, but does not improve symptoms

A group of Mayo Clinic researchers conducted the first controlled trial of swallowed fluticasone nasal spray (also known as Flonase) on people with the allergic esophageal condition called eosinophilic esophagitis. Research showed that the aerosolized swallowed allergy drug helped treat the cause of the throat condition, but symptoms lingered. The researchers' findings were presented today at the Annual Scientific Meeting of the American College of Gastroenterology in San Antonio.

18 Oct 2010

Hyperion's HPN-100 granted FDA Fast Track Designation for urea cycle disorders

Hyperion Therapeutics, Inc. announced today that its investigational compound glycerol phenylbutyrate (HPN-100) has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as adjunctive therapy for the chronic management of urea cycle disorders. Hyperion recently completed its phase III trial which was conducted under a Special Protocol Assessment (SPA) agreement with the FDA. The Company plans to announce results from that trial later this year.

18 Oct 2010

FDA grants fast track designation for Aastrom's CLI cell therapy development program

Aastrom Biosciences, Inc., a leading developer of expanded autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced that the U.S. Food & Drug Administration (FDA) has granted fast track designation for the company's critical limb ischemia (CLI) cell therapy development program. Aastrom plans to initiate Phase 3 clinical testing of its treatment for CLI in early 2011.

18 Oct 2010

14 global studies on osteoporosis medications FORTEO and EVISTA to be presented at ASBMR 2010

Eli Lilly and Company today announced that a total of 14 U.S. and global studies involving its osteoporosis medications, FORTEO® [teriparatide (rDNA origin) injection] and EVISTA® (raloxifene HCl tablets), will be presented at the American Society for Bone and Mineral Research (ASBMR) 2010 Annual Meeting from October 15-19 in Toronto, ON, Canada.

18 Oct 2010

BioSante enrolls 2,500th woman in LibiGel Phase III cardiovascular and breast cancer safety study

BioSante Pharmaceuticals, Inc. today announced enrollment of the 2,500th woman in the LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. This important enrollment milestone triggers the first unblinded statistical analysis of cardiovascular events by the independent Data Monitoring Committee (DMC), which coincides with their fourth unblinded review of all adverse events.

18 Oct 2010

EC grants orphan drug designation to S*BIO's SB1518 for treatment of myelofibrosis

S*BIO Pte Ltd today announced that the European Commission (EC) has granted orphan drug designation to SB1518, its potent and orally active JAK2 inhibitor for the treatment of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis (PET-MF). SB1518 has also received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of the same disorder.

18 Oct 2010

Alcon concludes 'proof of concept' clinical trial of NovaBay's Aganocide for viral conjunctivitis treatment

NovaBay Pharmaceuticals, Inc. announced today that its development partner, Alcon Research, Ltd., has concluded its proof of concept clinical trial of NovaBay's patented lead Aganocide compound, NVC-422 for the treatment of viral conjunctivitis a highly contagious eye infection for which there are currently no marketed products.

18 Oct 2010

Nektar presents data of NKTR-181 mu-opioid analgesic candidate at Pain 2010 Symposium

Nektar Therapeutics presented promising data today from preclinical studies of NKTR-181, a next-generation mu-opioid analgesic candidate with a novel molecular design. NKTR-181 is being developed to effectively treat pain while addressing the abuse liability and serious side effects associated with traditional opioid therapies.

18 Oct 2010

Preliminary Phase 2 data of TZP-102 for diabetic gastroparesis to be presented at ACG annual meeting

Tranzyme Pharma announced today that John Wo, MD, Professor of Medicine and Director, Clinical Research, Division of Gastroenterology, Hepatology and Nutrition, University of Louisville, Louisville, KY, will present preliminary TZP-102 Phase 2 data at this year's ACG annual meeting. The event is being held at the Henry B. Gonzalez Convention Center in San Antonio TX, October 15-20, 2010. Professor Wo is scheduled to speak on Wednesday, October 20th at 8:50am in Ballroom C1.

18 Oct 2010

Drug Trial News

Study investigates effectiveness of potential treatment for Non-alcoholic steatohepatitis

New research coalition to design first human trial of mosaic HIV vaccine candidate

Transcept announces Intermezzo tablet preliminary data for insomnia

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

New clinical trial to treat brain cancer launched

UCB presents P3, P4 clinical trial data for Crohn's disease at ACG Scientific Meeting

Groundbreaking melanoma clinical trial initiated by Patrys

BARACLUDE sNDA receives FDA approval for treatment of CHB patients with decompensated liver disease

Studies explore impact of upper GI conditions on sleep

Sequella to develop SQ109 further with EDCTP, LMU, and TB experts in PanACEA

Vertex commences VX-770 and VX-809 combination Phase 2a clinical trial for cystic fibrosis

Fluticasone gets rid of eosinophils in the esophagus, but does not improve symptoms

Hyperion's HPN-100 granted FDA Fast Track Designation for urea cycle disorders

FDA grants fast track designation for Aastrom's CLI cell therapy development program

14 global studies on osteoporosis medications FORTEO and EVISTA to be presented at ASBMR 2010

BioSante enrolls 2,500th woman in LibiGel Phase III cardiovascular and breast cancer safety study

EC grants orphan drug designation to S*BIO's SB1518 for treatment of myelofibrosis

Alcon concludes 'proof of concept' clinical trial of NovaBay's Aganocide for viral conjunctivitis treatment

Nektar presents data of NKTR-181 mu-opioid analgesic candidate at Pain 2010 Symposium

Preliminary Phase 2 data of TZP-102 for diabetic gastroparesis to be presented at ACG annual meeting

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