CRO selection is a challenge for every company outsourcing clinical trials. When the trial you are about to launch is for a rare genetic disease and has 30 patients spread across multiple countries and continents, the challenges are multiplied. This was the situation for Cerenis Therapeutics, which recently launched a Phase 3 trial for patients having very low levels of high-density lipoprotein.
The extraordinary advances in cardiovascular medicine over the past decades have extended and improved countless lives. Drugs for heart-related disease make up one of the biggest selling areas, with hypertension medications alone expected to reach over $24 billion in global sales in 2015. Real successes in reducing the death rate from myocardial infarction and controlling blood pressure and cholesterol are some of the true successes of modern medicine.
PRA Health Sciences (PRA) provides comprehensive clinical development and consultative services to support our clients’ cardio-metabolic studies.
A global real world safety study program, mandated by various regulatory bodies, to confirm risk/benefit profile for a novel oral anticoagulant.
Clinical development involving rare diseases poses a unique set of medical, scientific, and operational challenges.
For many years it has been almost universally accepted that there are various sources that may impact or cause disease among which biological, social, and environmental differences have all been investigated. Many clinical trials have been conducted to assess the impact of the environment on outcomes e.g., the effect of the environment on the outcome of studies assessing the efficacy of drugs for patients with dry-eye syndrome, the impact of diet on obesity and cardiovascular disease, and the impact of the environment on autoimmune diseases have all been studied, as have many other interactions.
Sanofi is a multinational pharmaceutical company engaged in the research and development, manufacturing, and marketing of prescription drugs, vaccines, and over-the-counter healthcare products.
New data on Novartis’ investigational medicine, LCZ696, for patients with heart failure with reduced ejection fraction (HFrEF) shows it has the potential to change the course of the disease for patients.1,2 In August 2014, Novartis presented topline results from the landmark PARADIGM-HF study showing LCZ696 was superior to ACE inhibitor enalapril on key endpoints, including significantly reducing the risk of cardiovascular (CV) death or heart failure hospitalization.5
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that it has initiated a Phase 1 clinical study for ISIS-APOARx, an antisense drug targeting apolipoprotein(a) for the treatment of atherosclerosis.
Catabasis Pharmaceuticals Inc., today announced the initiation of a Phase 1 study to investigate the safety and tolerability of CAT-2003 in healthy volunteers and in adults with mildly elevated lipids. CAT-2003 is a conjugate of niacin and eicosapentaenoic acid (EPA), an omega-3 fatty acid, covalently linked using the company's proprietary SMART Linker technology to create a new chemical entity and is being developed for patients with severe hypertriglyceridemia.
Piramal Enterprises’ diagnostic division recently announced the launch of “QDx Instacheck” Right-here-Right-now.
CeQur SA, a company focused on the development and commercialization of simple insulin delivery devices, announced that initial data from a study of the company's PaQ® Insulin Delivery Device were presented today at the 6th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Paris, France.
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 2 study evaluating ISIS-CRPRx in patients with paroxysmal atrial fibrillation.
The rising incidence of lifestyle diseases such as diabetes and obesity, an ageing population and the prevalence of cardiovascular diseases such as arrhythmia, heart failure and atrial fibrillation, have expanded the patient pool for cardiac rhythm management (CRM) devices in both Europe and the United States.
Portola Pharmaceuticals, Inc. and Lee's Pharmaceutical (HK) Ltd. (
DiaMedica (TSX VENTURE:DMA) has successfully completed cGMP manufacturing of DM-199 to be utilized in upcoming clinical trials.
ActiGraph, a leading provider of objective patient monitoring solutions for the global research community, recently announced the release of a new mobile app for researchers.
Manufacturers to focus on innovative, easy-to-use and patient-friendly products due to a shift in the adoption pattern for imaging modalities.
Zafgen, Inc., a leading biopharmaceutical company dedicated to addressing the unmet needs of severely obese patients, today announced that it has initiated Phase 2a clinical testing of beloranib.
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced positive, top-line data from a recently completed Phase 2 study in carcinoid syndrome with telotristat etiprate.
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the initiation of dosing in a Phase 1 multiple dose clinical trial of APD811, a novel oral drug candidate discovered by Arena that targets the prostacyclin (IP) receptor for the treatment of pulmonary arterial hypertension (PAH).