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FDA grants Fast Track designation to Corthera's relaxin for treating acute heart failure

Corthera Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to relaxin, the company's investigational drug for the treatment of acute heart failure (AHF). The Fast Track program facilitates the development and expedites the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

3 Oct 2009

Dapagliflozin with metformin reduces glycosylated hemoglobin level and body weight

Results from a 24-week phase 3 clinical study demonstrated that the investigational drug dapagliflozin, added to metformin, demonstrated significant mean reductions in the primary endpoint, glycosylated hemoglobin level (HbA1c) and in the secondary endpoint, fasting plasma glucose (FPG) in patients with type 2 diabetes inadequately controlled with metformin alone, as compared to placebo plus metformin.

3 Oct 2009

NIH awards Titan $7.6M grant for Probuphine clinical development

Titan Pharmaceuticals, Inc today announced that the National Institutes of Health (NIH) has awarded a Research and Research Infrastructure Grand Opportunities grant to the company through the American Reinvestment and Recovery Act of 2009 (ARRA). The two year grant for Probuphine clinical development is expected to provide approximately $7.6 million, with the first year award of approximately $ 5.6 million now made available to Titan by the NIH.

3 Oct 2009

Nasal spray to improve memory

Good news for procrastinating students: a nasal spray developed by a team of German scientists promises to give late night cram sessions a major boost, if a good night's sleep follows.

3 Oct 2009

New study underscores lack of appropriate government action to ensure safety of vaccines

A new study in the leading scientific journal NeuroToxicology lends further credence to parents and scientists concerned about an increasingly aggressive childhood vaccine schedule and toxic vaccine components.

2 Oct 2009

Array BioPharma to present poster on ARRY-403 glucokinase activator

Array BioPharma Inc. today announced that a poster on ARRY-403, a novel, oral, glucokinase activator (GKA), will be presented at the European Association for the Study of Diabetes annual meeting, on October 2, 2009, in Vienna, Austria.

2 Oct 2009

Aspirin use in seniors study

Researchers at Monash University and the United States-based Berman Center for Outcomes & Clinical Research will lead an international clinical trial to test whether taking aspirin contributes to good health in the elderly.

1 Oct 2009

Mayo study reveals infliximab reduces the need for colectomy

A new study led by Mayo Clinic researchers has found that ulcerative colitis patients had a 41 percent reduction in colectomy after a year when treated with infliximab, according to a study published in the October 2009 issue of Gastroenterology.

1 Oct 2009

Orexigen's Empatic Phase 2b results demonstrate weight loss

Orexigen Therapeutics, Inc. today announced that its 24-week, Phase 2b trial for Empatic(TM) (bupropion SR/zonisamide SR), the Company's second late stage investigational combination drug for the treatment of obesity, met its primary efficacy endpoint by demonstrating statistically significantly greater weight loss for both Empatic doses compared to monotherapies and placebo.

1 Oct 2009

Addrenex submits a sNDA to the FDA for Clonicel

Sciele Pharma, Inc., a Shionogi company, and Addrenex Pharmaceuticals today announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD).

1 Oct 2009

Resverlogix RVX-208 exceeds expectations in Phase 1b/2a clinical trial

Resverlogix Corp. announced today that results from the Company's Phase 1b/2a clinical trial have met and exceeded expectations by successfully concluding the drug, RVX-208, is safe and tolerable. Most importantly RVX-208 has met its primary endpoint to increase the production of plasma ApoA-I, the key cardioprotective protein in high-density lipoprotein (HDL), often referred to as "good" cholesterol.

1 Oct 2009

Antidepressant amitriptyline works just as well as placebo for children with gastrointestinal disorders

When used "off-label," the antidepressant amitriptyline works just as well as placebo in treating pain-predominant gastrointestinal disorders in children, according to a new study in Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute. To view this article's video abstract, go to the AGA's YouTube Channel at www.youtube.com/AmerGastroAssn.

1 Oct 2009

EMD Serono submits NDA for Cladribine Tablets in the U.S.

EMD Serono, Inc. an affiliate of Merck KGaA, Darmstadt, Germany, announced today the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS).

1 Oct 2009

MacuSight's clinical development update on its proprietary ocular sirolimus product

MacuSight, a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, today provided a clinical development update for Perceiva, the company's proprietary ocular sirolimus product.

30 Sep 2009

Non-human primate study results of Restanza released

Advanced Life Sciences Holdings, Inc., today announced positive top-line results from a pivotal, non-human primate study involving its novel, once-a-day, oral antibiotic Restanza(TM) (cethromycin) demonstrating statistical significance at a 90% survival rate against an inhaled lethal dose of plague.

30 Sep 2009

Repros Therapeutics receives further clarification on the Full Clinical Hold status of Proellex

Repros Therapeutics today announced that the Company has received further clarification from the Food and Drug Administration (FDA) on the Full Clinical Hold status of Proellex.

29 Sep 2009

Journal publishes Hythiam's PROMETA treatment program results

Hythiam, Inc. announced today that the results of a double-blind, placebo-controlled study on the impact of the medical component of the PROMETA® Treatment Program on alcohol dependent subjects was accepted and published in the Journal of Clinical Psychopharmacology, a leading scholarly publication in psychopharmacology that features articles reporting on clinical trials and studies.

29 Sep 2009

Hookworms can prevent asthma

A study conducted in Vietnam has added further weight to the view that parasitic gut worms, such as hookworm, could help in the prevention and treatment of asthma and other allergies.

29 Sep 2009

European Commission grants conditional marketing authorization for Gilead's Cayston

Gilead Sciences, Inc. announced today that the European Commission has granted conditional marketing authorization for Cayston® 75 mg powder and solvent for nebuliser solution (aztreonam lysine) for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF) aged 18 years and older.

28 Sep 2009

Investigational vaccine regimen 31% effective in preventing HIV infection

In an encouraging development, an investigational vaccine regimen has been shown to be well-tolerated and to have a modest effect in preventing HIV infection in a clinical trial involving more than 16,000 adult participants in Thailand. Following a final analysis of the trial data, the Surgeon General of the U.S. Army, the trial sponsor, announced today that the prime-boost investigational vaccine regimen was safe and 31 percent effective in preventing HIV infection.

27 Sep 2009