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PD0325901 drug may hold potential to prevent neurofibromatosis 1 in children

A drug originally developed to stop cancerous tumors may hold the potential to prevent abnormal brain cell growth and learning disabilities in some children, if they can be diagnosed early enough, a new animal study suggests.

31 Aug 2012

Enrollment complete in Arrowhead’s CALAA-01 phase 1b trial on solid tumors

Arrowhead Research Corporation, a targeted therapeutics company, today announced that, through its Calando Pharmaceuticals subsidiary, it has completed enrollment of a phase 1b clinical trial of CALAA-01, its RNAi therapeutic candidate targeting solid tumors. All patients participating in the trial have completed dosing with the exception of one patient who is still receiving treatment and will continue to be monitored.

31 Aug 2012

Sosei’s QVA149 Phase III study on COPD meets primary endpoint

Sosei Group Corporation confirms the information released today by Novartis that results from the fifth QVA149 (indacaterol maleate / glycopyrronium bromide) Phase III study, SPARK, met its primary endpoint of a reduced rate of moderate-to-severe COPD exacerbations compared to glycopyrronium bromide.

31 Aug 2012

Heart Rhythm Society, ECAS and EHRA develop 2012 expert consensus statement on AF ablation

The 2012 expert consensus statement on catheter and surgical ablation of atrial fibrillation was developed by the Heart Rhythm Society (HRS), the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC), and the European Cardiac Arrhythmia Society (ECAS) and published in their respective journals: Heart Rhythm, EP Europace and the Journal of Interventional Cardiovascular Electrophysiology (JICE).

30 Aug 2012

FDA grants orphan designation to Aerial BioPharma’s ARL-N05 for treatment of narcolepsy

Aerial BioPharma, a biopharmaceutical company focused on developing biologics and small molecules for conditions in the central nervous system, has received orphan drug designation for its narcolepsy drug in development.

30 Aug 2012

TaiMed, WuXi enter ibalizumab manufacturing agreement

WuXi PharmaTech today announced that it has a contract manufacturing agreement with TaiMed Biologics Inc. for the manufacture of ibalizumab (TMB-355) in support of Phase 2 and Phase 3 clinical trials globally.

29 Aug 2012

Scientists identify genes that underlie growth of primitive leukemia stem cells

University of Rochester Medical Center scientists believe they are the first to identify genes that underlie the growth of primitive leukemia stem cells, and then to use the new genetic signature to identify currently available drugs that selectively target the rogue cells.

29 Aug 2012

Elixir Medical’s DESyne BD Novolimus Eluting Coronary Stent System receives CE Mark approval

Elixir Medical Corporation, a developer of product platforms that combine state-of-the-art medical devices with advanced pharmaceuticals, announced that it has received CE Mark approval for its DESyne BD Novolimus Eluting Coronary Stent System for the treatment of coronary artery disease.

29 Aug 2012

Three Pulmatrix PUR118 clinical studies on COPD, asthma to be presented at ERS Annual Congress

Pulmatrix, Inc., a clinical stage biotechnology company creating novel inhaled therapeutics, announced today that three posters on its lead iCALM therapeutic, the first treatment developed utilizing its iSPERSE inhaled drug platform, will be presented at the European Respiratory Society (ERS) Annual Congress taking place September 1-5, 2012, in Vienna, Austria.

28 Aug 2012

Human Vaccines & Immunotherapeutics Special Focus provides critical view on cancer vaccines

In one of the most comprehensive peer-reviewed discussions on cancer vaccines and immunotherapeutics, a Special Focus in the journal Human Vaccines & Immunotherapeutics provides a critical view on cancer vaccines and a discussion on best approaches for the future.

28 Aug 2012

Positive results from Spinifex’s EMA401 Phase 2 trial on postherpetic neuralgia

Spinifex Pharmaceuticals, an Australian pain drug development company, today announces positive headline results from the Phase 2 clinical trial of its lead product, EMA401, in postherpetic neuralgia (PHN), a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals.

28 Aug 2012

Positive results from CardioKinetix’s Parachute device clinical trial on ischemic heart failure

CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced clinical results showing meaningful and sustained low clinical events for patients with ischemic heart failure three years following Percutaneous Ventricular Restoration (PVR) therapy with the first-of-its-kind catheter-based Parachute™ Ventricular Partitioning Device.

28 Aug 2012

Allegro Diagnostics announces results from BronchoGen genomic test trial on lung cancer

Allegro Diagnostics today announced that results from its AEGIS (Airway Epithelium Gene Expression In the Diagnosis of Lung Cancer) clinical trials, to determine the accuracy of the BronchoGen genomic test, have been accepted for an oral presentation during the late-breaking abstract session at CHEST 2012 on Tuesday, October 23, 2012 at 4:30 p.m. The abstract will also be published in a supplement of the October 2012 issue of CHEST.

28 Aug 2012

Alder’s initiation of ALD518/BMS-945429 Phase 2 trial triggers $3.5M milestone payment

Alder Biopharmaceuticals Inc. today announced it has received a $3.5 million milestone payment from Bristol-Myers Squibb for the initiation of a Phase 2 clinical trial of ALD518/BMS-945429, an investigational antibody therapeutic that blocks interleukin-6 (IL-6), in Crohn's disease.

28 Aug 2012

Leg compressions after stroke appear to trigger natural protective mechanisms that reduce damage

Successive, vigorous bouts of leg compressions following a stroke appear to trigger natural protective mechanisms that reduce damage, researchers report.

28 Aug 2012

America Stem Cell commences ASC-101 Phase I/II study in hematologic malignancies

America Stem Cell, Inc. announced today the initiation of a single-center study at The University of Texas MD Anderson Cancer Center evaluating ASC-101 in dual-umbilical cord transplantation in patients with hematologic malignancies.

28 Aug 2012

Update on Merck's development programs for vorapaxar, ER niacin/laropirprant and anacetrapib

Merck today provided an update on the development programs for vorapaxar, extended release niacin/laropirprant (MK524A, Tredaptive) and anacetrapib in association with the European Society of Cardiology (ESC) meeting in Munich.

27 Aug 2012

Spironolactone should be considered as a treatment option in hypertensive patients with DHF

Mineralocorticoid receptor antagonists should be considered as a treatment option in hypertensive patients with diastolic heart failure, said Professor Burkert Pieske presenting results today of the Aldosterone Receptor Blockade in Diastolic Heart Failure (Aldo-DHF) study at ESC Congress 2012.

27 Aug 2012

Renal denervation safe and effective in patients with treatment resistant hypertension

Renal denervation leads to significant and sustained blood pressure reduction for up to 18 months in patients with treatment resistant hypertension, according to research presented at ESC Congress 2012.

27 Aug 2012

Debiopharm initiates enrollment in triptorelin phase III study for central precocious puberty

Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs and companion diagnostics, today announced that the first patient has been enrolled in an open-label phase III study to investigate the efficacy, safety, and pharmacokinetics of the sustained release triptorelin pamoate 22.5 mg 6-month-formulation in children with central precocious puberty (CPP), a rare disease.

27 Aug 2012

Clinical Trial News and Research

PD0325901 drug may hold potential to prevent neurofibromatosis 1 in children

Enrollment complete in Arrowhead’s CALAA-01 phase 1b trial on solid tumors

Sosei’s QVA149 Phase III study on COPD meets primary endpoint

Heart Rhythm Society, ECAS and EHRA develop 2012 expert consensus statement on AF ablation

FDA grants orphan designation to Aerial BioPharma’s ARL-N05 for treatment of narcolepsy

TaiMed, WuXi enter ibalizumab manufacturing agreement

Scientists identify genes that underlie growth of primitive leukemia stem cells

Elixir Medical’s DESyne BD Novolimus Eluting Coronary Stent System receives CE Mark approval

Three Pulmatrix PUR118 clinical studies on COPD, asthma to be presented at ERS Annual Congress

Human Vaccines & Immunotherapeutics Special Focus provides critical view on cancer vaccines

Positive results from Spinifex’s EMA401 Phase 2 trial on postherpetic neuralgia

Positive results from CardioKinetix’s Parachute device clinical trial on ischemic heart failure

Allegro Diagnostics announces results from BronchoGen genomic test trial on lung cancer

Alder’s initiation of ALD518/BMS-945429 Phase 2 trial triggers $3.5M milestone payment

Leg compressions after stroke appear to trigger natural protective mechanisms that reduce damage

America Stem Cell commences ASC-101 Phase I/II study in hematologic malignancies

Update on Merck's development programs for vorapaxar, ER niacin/laropirprant and anacetrapib

Spironolactone should be considered as a treatment option in hypertensive patients with DHF

Renal denervation safe and effective in patients with treatment resistant hypertension

Debiopharm initiates enrollment in triptorelin phase III study for central precocious puberty

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