Efficacy News and Research

RSS

Personalized medicine and the Human Genome Project

It’s nearly a decade since the completion of the Human Genome Project, (1) which aimed to sequence the complete human genome.

1 Jun 2012

Janssen submits canagliflozin NDA with FDA for treatment of type 2 diabetes

Janssen Research & Development, LLC (Janssen), announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of canagliflozin, an investigational, oral, once-daily, selective sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of adult patients with type 2 diabetes.

1 Jun 2012

Scientists succeed in solving first structure of a Wnt protein

The 20 proteins in the Wnt family are some of the most important proteins in controlling how an organism develops and grows, but for 30 years scientists have not known what these vital proteins actually look like. The proteins have eluded standard visualization techniques, in large part because they do not dissolve well in the water-based liquids normally used for biochemical studies.

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

FDA approves RBI’s AppliGel-G for human testing

Royer Biomedical, Inc. (RBI) received FDA approval to proceed with Human Testing of AppliGel-G (Gentamicin) in management of Diabetic Foot Ulcers.

1 Jun 2012

$Vertebroplasty feasible for at least 1 year after fracture$

Vertebroplasty feasible for at least 1 year after fracture

Patients with subacute and chronic osteoporotic vertebral compression fractures can be successfully treated with percutaneous vertebroplasty between 2 and 12 months after symptom onset, say researchers.

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

BHD launches Statin Induced Myopathy Genotype test

Boston Heart Diagnostics (BHD) announced today the commercial launch of the Statin Induced Myopathy (SLCO1B1) Genotype test licensed from the University of Oxford's technology commercialization company Isis Innovation.

31 May 2012

TAU researcher develops new antibodies to target and destroy cancer cells

Because cancer cells grow very quickly, chemotherapy is designed to target cells whose numbers grow rapidly. But this treatment comes with a heavy price - many healthy cells essential for body functions are also targeted and killed by the toxin. This dangerous side-effect has prompted researchers to seek better and more selective ways to kill cancer cells inside the body.

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

Diluent choice affects neuromuscular block times

Anesthesiologists can achieve successful axillary brachial plexus block faster by diluting ropivacaine in dextrose rather than saline, results of a randomized trial show.

30 May 2012

DMARD not superior to oral therapy in long-term treatment of patients with JIA

A retrospective analysis of methotrexate (MTX) safety data found that injection of this disease-modifying anti-rheumatic drug (DMARD) was not superior to oral therapy in long-term treatment of patients with juvenile idiopathic arthritis (JIA). Findings published in Arthritis Care & Research, a peer-reviewed journal of the American College of Rheumatology (ACR), suggest that with similar efficacy and tolerability the more comfortable oral approach may be more suitable to treat pediatric arthritis patients.

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

Endo, Watson reach agreement to resolve two LIDODERM patent infringement lawsuits

Endo announced today that it has reached an agreement with Watson Pharmaceuticals (Watson) resolving two patent infringement lawsuits related to LIDODERM.

30 May 2012

ASCs promising source of cells for use in plastic surgery and regenerative medicine

Adipose stem cells (ASCs)—stem cells derived from fat—are a promising source of cells for use in plastic surgery and regenerative medicine, according to a special review in the June issue of Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons.

30 May 2012

Marshall Edwards initiates ME-344 Phase I trial in solid tumors

Marshall Edwards, Inc., an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today that the first cohort of patients has been dosed in a Phase I clinical trial of ME-344, the Company's lead mitochondrial inhibitor drug candidate, in patients with refractory solid tumors.

30 May 2012