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NAC reduces irritability in children with autism

Autism is a developmental disorder that affects social and communication skills. Irritability is a symptom of autism that can complicate adjustment at home and other settings, and can manifest itself in aggression, tantrums, and self-injurious behavior. These disruptive behaviors are frequently observed in children with autism, which may considerably affect their ability to function at home or in school.

1 Jun 2012

Top-line results from Genzyme’s teriflunomide Phase III trial on MS

Genzyme, a Sanofi company, announced today top-line results from the TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis) trial that assessed the efficacy and safety of once-daily, oral teriflunomide in patients with relapsing forms of multiple sclerosis.

1 Jun 2012

Omeros commences planned PK substudy in Phase 3 clinical program of OMS302

Omeros Corporation today announced the initiation of the planned pharmacokinetic (PK) substudy in its Phase 3 clinical program evaluating OMS302 in patients undergoing intraocular lens replacement (ILR) surgery.

1 Jun 2012

Ketamine reduces suicidal thoughts in patients with bipolar depression

Bipolar disorder is a serious and debilitating condition where individuals experience severe swings in mood between mania and depression. The episodes of low or elevated mood can last days or months, and the risk of suicide is high. Antidepressants are commonly prescribed to treat or prevent the depressive episodes, but they are not universally effective. Many patients still continue to experience periods of depression even while being treated, and many patients must try several different types of antidepressants before finding one that works for them.

31 May 2012

Taiho to initiate TAS-102 Phase III trial in colorectal cancer

Taiho Pharmaceutical Co., Ltd. announced on May 31 that a global Phase III clinical trial (RECOURSE) for the novel combination antimetabolite TAS-102 will start in June this year.

31 May 2012

Top-line data from Flexion‘s FX005 Phase 2 trial on osteoarthritis

Flexion Therapeutics, Inc. today reported that its lead osteoarthritis drug candidate, FX005, demonstrated significant pain relief over placebo at four weeks in a Phase 2 proof-of-concept trial. Top-line data showed FX005, delivered intra-articularly to the knee, was well-tolerated and resulted in prolonged improvement in joint pain and function throughout the 12-week duration of the study.

31 May 2012

Interim data from UCLA and NeuroSigma’s eTNS Phase I trial on PTSD, MDD

Today, at the 52nd annual New Clinical Drug Evaluation Unit (NCDEU) Conference in Arizona, Ian Cook, M.D., Professor of Psychiatry at the University of California, Los Angeles (UCLA) and a Senior Medical Advisor to NeuroSigma, Inc., presented the results from the first 6-subject cohort of a 10-subject Phase I open-label clinical trial studying the effects of external trigeminal nerve stimulation (eTNS) on Post-Traumatic Stress Disorder (PTSD) and depressive symptoms in Major Depressive Disorder (MDD) as an adjunct to pharmacotherapy.

31 May 2012

Wellmune minimizes risk of URTI among marathoners

Marathoners taking Wellmune WGP, a natural immune health ingredient, for four weeks experienced an average reduction of 40% in upper respiratory tract infection symptomatic days that commonly afflict long-distance runners, according to new clinical study results presented today at the American College of Sports Medicine 59th annual meeting.

31 May 2012

Genetics can predict success of smoking cessation and need for medications

Genetics can help determine whether a person is likely to quit smoking on his or her own or need medication to improve the chances of success, according to research published in today's American Journal of Psychiatry. Researchers say the study moves health care providers a step closer to one day providing more individualized treatment plans to help patients quit smoking.

31 May 2012

Top-line results from Alnylam’s ALN-RSV01 Phase IIb trial on RSV infection

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today top-line results from a Phase IIb trial with ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection in lung transplant patients.

31 May 2012

Topline results from Alkermes’ ALKS 37 phase 2b study on opioid-induced constipation

Alkermes plc today announced topline results from a phase 2b dose-ranging clinical study of ALKS 37 in the treatment of opioid-induced constipation. The multicenter, randomized, double-blind, placebo-controlled, repeat-dose study was designed to assess the safety, tolerability, pharmacokinetic profile and efficacy of ALKS 37 in approximately 150 patients.

31 May 2012

Exelixis commences cabozantinib phase 3 pivotal trial in mCRPC

Exelixis, Inc. today announced the initiation of COMET-1, a phase 3 pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer.

31 May 2012

Corrected interim data from Vertex VX-809, KALYDECO combination Phase 2 study for CF

Vertex Pharmaceuticals Incorporated announced today a correction to the previously reported responder analysis, as well as additional data from, the recent interim analysis of an ongoing Phase 2 study of VX-809 and KALYDECO that showed significant improvements in lung function among adults with cystic fibrosis who have two copies of the most common mutation in the cystic fibrosis transmembrane conductance regulator gene, F508del.

30 May 2012

CytRx INNO-206 doxorubicin conjugate shows anti-multiple myeloma effects

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that in animal and in vitro studies, its tumor-targeting doxorubicin conjugate INNO-206 showed anti-multiple myeloma effects and enhanced the anti-tumor effects of bortezomib, which is approved for the treatment of relapsed multiple myeloma.

30 May 2012

Study reveals new evidence of trans-cranial bright light's effect to brain functions

A recent placebo-controlled study reveals new evidence of trans-cranial bright light's effect to brain functions when administered through the ear. Bright light stimulation was found to increase activity in brain areas related to processing of visual sensory information and tactile stimuli. The findings constitute the first ever published scientific article about functional modulation of the brain with bright light delivered to the brain through the ears. The study was published today May 29th, 2012 in the World Journal of Neuroscience.

30 May 2012

Exelixis files NDA with FDA for cabozantinib to treat MTC

Exelixis, Inc. today announced that it has completed the filing of its rolling New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer.

30 May 2012

NAC may be an effective therapy for some features of autism

A specific antioxidant supplement may be an effective therapy for some features of autism, according to a pilot trial from the Stanford University School of Medicine and Lucile Packard Children's Hospital that involved 31 children with the disorder.

30 May 2012

Positive results from Alkermes’ ALKS 5461 phase 1/2 study on MDD

Alkermes plc today presented positive results from the phase 1/2 study of ALKS 5461, a novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression, in an oral session at the 52nd Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting in Phoenix.

30 May 2012

FDA accepts NDA filing for KYNAMRO to treat HoFH

Genzyme, a Sanofi company, and Isis Pharmaceuticals Inc., announced today that the U.S. Food and Drug Administration has accepted for filing the New Drug Application for KYNAMRO (mipomersen sodium) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH).

29 May 2012

Spectrum initiates enrollment in RenaZorb Phase 1 trial in healthy volunteers

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced the initiation of patient enrollment in a Phase 1 clinical trial evaluating the safety and tolerability of RenaZorb in healthy volunteers.

29 May 2012