Clinical Trial News and Research

RSS

Enrollment commences for Daiichi Sankyo's ENSURE-AF multinational phase 3 study in NVAF patients

Daiichi Sankyo Company, Limited today announced that it has started enrolling patients into the ENSURE-AF multinational phase 3 study, which will evaluate the efficacy and safety of its investigational oral, once-daily direct factor Xa-inhibitor edoxaban compared to enoxaparin/warfarin for the prevention of stroke and other blood clot complications in patients with non-valvular atrial fibrillation (NVAF) undergoing electrical cardioversion (low-energy shocks to trigger normal heart rhythm).

31 Mar 2014

ICON agrees to acquire Aptiv Solutions for $143.5 million

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has agreed, subject to certain closing conditions, to acquire Aptiv Solutions for a cash consideration of $143.5 million. Aptiv Solutions is owned by The Halifax Group, SV Life Sciences, Comvest Partners and Management.

31 Mar 2014

Amgen reports positive findings from AMG 145 Phase 3 studies in patients at risk for cardiovascular disease

Amgen (NASDAQ: AMGN) today announced new detailed data from three Phase 3 studies that showed treatment with its novel investigational cholesterol-lowering medication, evolocumab (AMG 145), resulted in a statistically significant reduction of 55-66 percent in low-density lipoprotein cholesterol (LDL-C) compared to placebo in patients with high cholesterol.

31 Mar 2014

New FDA Roadmap App helps sponsors improve clinical research

The new FDA Roadmap App from PHT Corporation helps sponsors navigate the Roadmap to Patient-Focused Outcome Measurement in Clinical Trials released by the FDA with their Clinical Outcome Assessment Qualification Program.

31 Mar 2014

Cheap drug holds promise of treating heart attack patients

The initial results of this trial were published a few months ago (Circulation. 2013;128:1495-1503), and showed that patients who received this treatment during emergency transit to hospital had much smaller amounts of dead heart muscle than those randomly assigned to receive no treatment.

31 Mar 2014

Mechanical circulatory assist device may have untapped potential in heart surgery patients, say physicians

The most frequently used mechanical circulatory assist device in the world may have untapped potential, physicians say.

31 Mar 2014

Poor blood pressure control increases stroke risk in patients with atrial fibrillation

Poor blood pressure control among patients with atrial fibrillation is associated with a 50-percent increased risk of stroke, according to an analysis presented by Duke Medicine researchers.

31 Mar 2014

Device to improve blood flow implanted in muscular dystrophy patient

"Today, we're going to make history," said 18-year-old Eric Ramos on the day UT Southwestern Medical Center doctors operated on his ailing heart.

29 Mar 2014

Experts in brain and spinal cord injuries to discuss treatment approaches at 23rd Annual Meeting of AMSSM

Post-concussion syndrome (PCS) and spinal cord injuries are complex problems that can present with a variety of symptoms or sequelae.

29 Mar 2014

ATHENA develops surrogate organ system for toxicity testing

Creating surrogate human organs, coupled with insights from highly sensitive mass spectrometry technologies, a new project is on the brink of revolutionizing the way we screen new drugs and toxic agents.

29 Mar 2014

RXi Pharmaceuticals provides business update, reports Q4 and full year 2013 financial results

RXi Pharmaceuticals Corporation, a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today reported its financial results for the full year 2013, and provided a business update.

29 Mar 2014

Two doses of HPV-16/18 AS04-adjuvanted vaccine Cervarix non-inferior to three-doses

A recent study in the journal Human Vaccines & Immunotherapeutics, showed that two doses of the HPV-16/18 AS04-adjuvanted vaccine Cervarix (GlaxoSmithKline) are non-inferior to three-doses in the current schedule.

29 Mar 2014

Idera Pharmaceuticals reports positive top-line results from Phase 2 trial of IMO-8400

Idera Pharmaceuticals, Inc. today announced positive top-line data from its randomized, double-blind, placebo controlled Phase 2 trial of IMO-8400 in 32 patients with moderate-to-severe plaque psoriasis.

28 Mar 2014

ADMA Biologics reports consolidated net loss of $15.5M in 2013

ADMA Biologics, Inc., a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, today announced its financial results for the year ended December 31, 2013 and provided recent company developments as well as anticipated milestones for 2014.

28 Mar 2014

American College of Cardiology honors two Cedars-Sinai Heart Institute researchers

Two Cedars-Sinai Heart Institute physician-researchers have been named recipients of prestigious awards from the American College of Cardiology.

28 Mar 2014

Takeda to present results from global EXAMINE CV safety outcomes trial at ACC 2014

Takeda Pharmaceuticals Company Limited will present sub-analyses from the global EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) cardiovascular (CV) safety outcomes trial in a poster session at the American College of Cardiology’s 63rd Annual Scientific Session in Washington, DC.

28 Mar 2014

$Patrys reports final results from PAT-SM6 Phase I/IIa study in patients with refractory or relapsed MM$

Patrys reports final results from PAT-SM6 Phase I/IIa study in patients with refractory or relapsed MM

Patrys Limited, a clinical stage biotechnology company, is pleased to announce the final results from its Phase I/IIa, open-label study in patients with refractory or relapsed multiple myeloma (MM).

28 Mar 2014

Novartis’ investigational compound achieves overall response rate of 58% in patients with ALK+ NSCLC

Novartis today announced that The New England Journal of Medicine (NEJM) published clinical trial results showing the investigational compound LDK378 (ceritinib) achieved an overall response rate (ORR, including complete response [CR] and partial response [PR]) of 58% and a median progression-free survival (PFS) of seven months in adults with advanced anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) who received 400 mg or higher of LDK378 per day.

28 Mar 2014

FDA accepts AVP-825 NDA for acute treatment of migraine

The U.S. Food and Drug Administration has accepted the New Drug Application (NDA) for AVP-825, an innovative closed-palate Breath Powered investigational drug-device combination product for the acute treatment of migraine.

27 Mar 2014

Cytrx releases statement in response to two recent lawsuits

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today issued the following statement in response to two recent lawsuits filed in the name of CytRx shareholders:

27 Mar 2014

Clinical Trial News and Research

Enrollment commences for Daiichi Sankyo's ENSURE-AF multinational phase 3 study in NVAF patients

ICON agrees to acquire Aptiv Solutions for $143.5 million

Amgen reports positive findings from AMG 145 Phase 3 studies in patients at risk for cardiovascular disease

New FDA Roadmap App helps sponsors improve clinical research

Cheap drug holds promise of treating heart attack patients

Mechanical circulatory assist device may have untapped potential in heart surgery patients, say physicians

Poor blood pressure control increases stroke risk in patients with atrial fibrillation

Device to improve blood flow implanted in muscular dystrophy patient

Experts in brain and spinal cord injuries to discuss treatment approaches at 23rd Annual Meeting of AMSSM

ATHENA develops surrogate organ system for toxicity testing

RXi Pharmaceuticals provides business update, reports Q4 and full year 2013 financial results

Two doses of HPV-16/18 AS04-adjuvanted vaccine Cervarix non-inferior to three-doses

Idera Pharmaceuticals reports positive top-line results from Phase 2 trial of IMO-8400

ADMA Biologics reports consolidated net loss of $15.5M in 2013

American College of Cardiology honors two Cedars-Sinai Heart Institute researchers

Takeda to present results from global EXAMINE CV safety outcomes trial at ACC 2014

Patrys reports final results from PAT-SM6 Phase I/IIa study in patients with refractory or relapsed MM

Novartis’ investigational compound achieves overall response rate of 58% in patients with ALK+ NSCLC

FDA accepts AVP-825 NDA for acute treatment of migraine

Cytrx releases statement in response to two recent lawsuits

Event guide: 15th World Clinical Biomarkers & CDx Europe eBook

Latest eBooks

Editorial Focus eBook - Proteomics (2nd Edition)

Industry Focus eBook - Life Science Microscopy (2nd Edition)

Biologics stability screening toolkit: Three practical workflows for accelerating formulation development

Event guide: 2nd World RNA-Based Therapeutics & Vaccines Summit Korea

Advancing Neuroscience Research Through Collaboration and Patient-Centered Innovation

The impact of vibration on microscopy

How Omics Technologies Are Transforming Biological Research and Drug Discovery