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Phase III clinical trial results of DAR-31 published

Gilead Sciences, Inc. today announced the publication of data from DAR-311 (DORADO), a Phase III clinical trial evaluating the company’s once-daily oral endothelin receptor antagonist (ERA) darusentan as an add-on treatment for resistant hypertension, defined as the failure to achieve blood pressure goal while adhering to full doses of an appropriate three (or more) drug antihypertensive regimen that includes a diuretic.

14 Sep 2009

Data from Phase III clinical trial of TYSABRI presented at ECTRIMS

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced data presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) showing the potential of TYSABRI® (natalizumab) to redefine successful multiple sclerosis (MS) therapy.

14 Sep 2009

Naproxcinod clinical study results presented at the 2009 World Congress on Osteoarthritis

NicOx S.A. today announced that it has made three scientific presentations at the 2009 World Congress on Osteoarthritis (annual congress of the Osteoarthritis Research Society International - OARSI), which was held from September 10 to 13 in Montreal, Canada.

14 Sep 2009

Sanofi-aventis and Regeneron Pharmaceuticals discontinue Phase 3 trial of aflibercept

Sanofi-aventis and Regeneron Pharmaceuticals, Inc. today announced the discontinuation of the Phase 3 trial that evaluated aflibercept (VEGF Trap) plus gemcitabine versus placebo plus gemcitabine for the first-line treatment of metastatic pancreatic cancer (VANILLA), based on the recommendations by an Independent Data Monitoring Committee (IDMC).

14 Sep 2009

Oral NKTR-118 has low risk for mediating significant drug-drug interactions

Nektar Therapeutics presented clinical study data today demonstrating that the oral tablet formulation of NKTR-118 has favorable systemic bioavailability and a low risk for mediating significant drug-drug interactions.

14 Sep 2009

Cymbalta maintains reduction in pain for patients with chronic low back pain

New data show patients with chronic low back pain on Cymbalta(R) (duloxetine HCl) maintained reductions in pain for 41 weeks. In patients who initially responded to duloxetine, this maintenance of pain reduction was accompanied by further reduction in pain that was statistically significant as measured by the Brief Pain Inventory (BPI) average pain rating.

11 Sep 2009

Phase 3 trial results of LEVADEX orally inhaled migraine therapy to be presented

MAP Pharmaceuticals, Inc. announced today that it will present analysis of data from the efficacy portion of the first Phase 3 trial of its novel LEVADEX orally inhaled migraine therapy, currently in development, at the 14th Congress of the International Headache Society.

11 Sep 2009

Merck update on the status of telcagepant clinical development programs

Merck & Co., Inc. today updated the status of the clinical development programs for telcagepant (MK-0974) and MK-3207, the Company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the intermittent treatment of acute migraine.

11 Sep 2009

Positive results from Mpex' Phase 2b clinical trial with Aeroquin

Mpex Pharmaceuticals, Inc. today announced positive data from its Phase 2b clinical trial with Aeroquin((R)) (a novel aerosol formulation of levofloxacin, MP-376) in cystic fibrosis (CF). Trial results showed that nebulized Aeroquin met the primary endpoint of reducing bacterial counts of Pseudomonas aeruginosa (P. aeruginosa) in sputum after 28 days of dosing versus placebo.

11 Sep 2009

Phase 3 trial of ataluren commences

PTC Therapeutics, Inc. (PTC) today announced the initiation of a Phase 3 trial of ataluren (formerly PTC124(R)), an investigational protein restoration therapy in patients with nonsense mutation cystic fibrosis (nmCF).

11 Sep 2009

Acceleron's Phase 1 trial of ACE-031 reveals its potential in treating neuromuscular diseases

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including red blood cells, bone, and muscle, today announced preliminary results from the ACE-031 Phase 1 single dose clinical trial demonstrating that ACE-031 increased lean body mass and muscle volume. The results from this randomized, placebo-controlled study were presented at the 14th International Congress of the World Muscle Society in Geneva, Switzerland.

10 Sep 2009

GI Company's Phase II study demonstrates safety of rhITF oral spray formulation

Published today, as an original investigation, in the peer-reviewed Journal of Clinical Oncology, are statistically significant Phase II clinical results of The GI Company's lead clinical compound, rhITF (recombinant human Intestinal Trefoil Factor) oral spray. The article is titled, "A Phase II, Randomized, Double-blind, Placebo-Controlled Study of rhITF Oral Spray for Prevention of Oral Mucositis in Colorectal Cancer Patients Receiving 5-Fluorouracil-based Chemotherapy."

10 Sep 2009

Phase III trial demonstrates rapid efficacy of Zelrix in treating acute migraine

NuPathe Inc., a specialty pharmaceutical company developing innovative products for the treatment of neurological and psychiatric diseases, today announced data from the pivotal Phase III trial of Zelrix™, a novel transdermal patch in clinical development for the treatment of acute migraine. Zelrix combines NuPathe’s proprietary SmartRelief™ iontophoretic transdermal technology with sumatriptan, the most prescribed treatment for acute migraine in the United States.

10 Sep 2009

Quatrx' second phase 3 study of ospemifene tablets provides positive results

QuatRx Pharmaceuticals Company, a privately-held biopharmaceutical company, today announced positive efficacy results from the second of two patient cohorts in the second pivotal Phase 3 study for Ophena(TM) (ospemifene tablets), the company's investigational compound in development for the treatment of postmenopausal vulvovaginal atrophy (VVA).

10 Sep 2009

Protox' Phase 2 study of PRX302 for treating BPH provides positive results

Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced positive 12 month data from its open-label Phase 2 study of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH). The study results indicate that those patients who received an optimal dose of PRX302 continued to demonstrate significant symptomatic relief at 12 months following a single treatment.

10 Sep 2009

Acorda Therapeutics announces Phase 3 Fampridine-SR trial findings

Data from a long-term open-label extension study from the first Phase 3 Fampridine-SR trial, known as MS-F203, showed that 24.9% of extension study participants with multiple sclerosis (MS) met the criteria as Extension Timed Walk Responders (ETWRs) after one year of treatment and demonstrated improved walking speed over a two year period.

10 Sep 2009

Risk of NAFLD lowers with routine physical activities

Researchers from the University of Sydney, Australia determined that patients with a sedentary lifestyle who engage in routine physical activities lower their risk of nonalcoholic fatty liver disease (NAFLD).

10 Sep 2009

Patient enrollment completed in Phase 2b clinical trial for Pyridorin

NephroGenex, Inc., a privately held drug development company focusing on kidney disease, today announced the completion of patient enrollment in its Phase 2b clinical trial (PYR-210) studying the safety and efficacy of its lead drug candidate Pyridorin (pyridoxamine dihydrochloride) in type 2 diabetic patients with overt diabetic nephropathy. Three hundred and seventeen (317) patients have been randomized.

10 Sep 2009

Protox Therapeutics to present TRIUMPH clinical study update

Protox Therapeutics Inc., a leader in the development of receptor targeted fusion proteins, today announced that Dr. Fahar Merchant, President & CEO of Protox Therapeutics, will present at the 11th Annual Rodman & Renshaw Healthcare Conference.

9 Sep 2009

VIVUS' Phase 3 studies find Qnexa effective in tackling obesity

VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from two final, phase 3 pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303), evaluating the safety and efficacy of Qnexa(TM), an investigational drug, in more than 3,750 patients across 93 sites. The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo.

9 Sep 2009