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Alirocumab drug significantly improves cholesterol levels compared to ezetimibe

The investigational drug alirocumab significantly improved cholesterol levels compared to ezetimibe, when added to regular statin therapy in patients with high cholesterol and elevated risk of cardiovascular disease (CVD), according to the ODYSSEY COMBO II trial, presented as a Hot Line today at ESC Congress 2014.

1 Sep 2014

Intravenous iron supplement can improve quality of life for iron deficient heart failure patients

Heart failure patients with iron deficiency can experience significant and sustainable improvements in functional capacity and quality of life as well as reduced risk of hospital admission for worsening heart failure by receiving just one to two intravenous doses of an iron supplement, according to the results of a study presented today at ESC Congress 2014.

30 Aug 2014

Investigational LCZ696 drug: A real breakthrough for patients with heart failure

An investigational new heart failure drug could be poised to change the face of cardiology based on Hot Line results presented today at ESC Congress 2014.

30 Aug 2014

Review of clinical trials based on administering antidepressants for chronic postsurgical pain

After a systematic review of clinical trials based on administering antidepressants for acute and chronic postsurgical pain, researchers have concluded that more trials are needed to determine whether these drugs should be prescribed for postsurgical pain on a regular basis.

30 Aug 2014

Researchers receive encouraging results from two historic pediatric HIV vaccine trials

Applying the benefit of hindsight, researchers at Duke Medicine have reanalyzed the findings of two historic pediatric HIV vaccine trials with encouraging results. The vaccines had in fact triggered an antibody response -- now known to be associated with protection in adults -- that was previously unrecognized in the infants studied in the 1990s.

29 Aug 2014

Janssen, Bayer announce expansion of EXPLORER global cardiovascular research program for XARELTO

Janssen Research & Development, LLC and its development partner, Bayer HealthCare, announced today the expansion of the EXPLORER global cardiovascular research program for XARELTO (rivaroxaban) to include additional high-risk patient populations.

29 Aug 2014

International consortium to accelerate collaborative multi-site trials of potential Ebola vaccine

A candidate Ebola vaccine could be given to healthy volunteers in the UK, The Gambia and Mali as early as September, as part of an series of safety trials of potential vaccines aimed at preventing the disease that has killed more than 1,400 people in the current outbreak in West Africa.

29 Aug 2014

NIH to start initial human testing of investigational Ebola vaccine next week

Initial human testing of an investigational vaccine to prevent Ebola virus disease will begin next week by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

29 Aug 2014

TGen to lead first-in-patient clinical trial studies to test novel drugs for glioblastoma

SIn 2012, The Ben & Catherine Ivy Foundation awarded $10 million in grants for two groundbreaking brain cancer research projects at the Translational Genomics Research Institute. One of those projects has officially received the final regulatory approval from University of California, San Francisco, which means patient enrollment for the trial can begin.

29 Aug 2014

Amgen seeks FDA approval for evolocumab to treat patients with high cholesterol

Amgen today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration for evolocumab seeking approval for the treatment of high cholesterol.

28 Aug 2014

Isis Pharmaceuticals begins ISIS-APOCIIIRx Phase 3 study in FCS patients

Isis Pharmaceuticals, Inc. announced the initiation of a Phase 3 study evaluating ISIS-APOCIIIRx in patients with familial chylomicronemia syndrome (FCS). FCS is a rare orphan disease, characterized by extremely high triglyceride levels, that affects an estimated 3,000 to 5,000 patients worldwide.

28 Aug 2014

New MS treatment found safe, tolerable in phase I clinical trials

A new treatment under investigation for multiple sclerosis (MS) is safe and tolerable in phase I clinical trials, according to a study published August 27, 2014, in Neurology Neuroimmunology & Neuroinflammation, a new online-only, freely accessible, specialty medical journal.

28 Aug 2014

Experimental drug shows promise as viable treatment for anemia of inflammation

An experimental drug designed to help regulate the blood's iron supply shows promise as a viable first treatment for anemia of inflammation, according to results from the first human study of the treatment published online today in Blood, the Journal of the American Society of Hematology.

28 Aug 2014

Asterias receives clearance from FDA to initiate Phase 1/2a clinical trial of AST-OPC1

Asterias Biotherapeutics Inc. has received clearance from the U.S. Food and Drug Administration to initiate a Phase 1/2a clinical trial of its product, AST-OPC1, in patients with complete cervical spinal cord injury.

27 Aug 2014

Ruthigen gets DMC recommendation to begin RUT58-60 Phase 1/2 clinical trial

Ruthigen Inc., a biopharmaceutical company focused on improving patient outcomes and reducing healthcare costs in invasive procedures, has announced that its lead drug candidate, RUT58-60, has received a recommendation from the Data Monitoring Committee to begin enrolling patients in the Company's planned Phase 1/2 clinical trial.

26 Aug 2014

Sanofi, Regeneron present alirocumab Phase 3 trial results at ESC Congress 2014

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that details from four pivotal trials in the alirocumab ODYSSEY clinical program will be presented on Sunday, August 31, during a Hot Line session at ESC Congress 2014 in Barcelona, Spain, the world's largest cardiology meeting.

25 Aug 2014

Actavis files ANDA for generic version of Neupro

Actavis plc today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Rotigotine Extended-release Transdermal Film, 1 mg/24 hr, 2mg/24 hr, 3 mg/24hr, 4 mg/24 hr, 6mg/24hr, and 8 mg/24 hr.

25 Aug 2014

Lilly’s ixekizumab superior to placebo, etanercept on all skin clearance measures in Phase 3 studies

Eli Lilly and Company's investigational medicine ixekizumab was statistically superior to etanercept and placebo on all skin clearance measures in Phase 3 studies, the company said today in disclosing top-line results from its pivotal UNCOVER studies in moderate-to-severe plaque psoriasis.

22 Aug 2014

Baxter reports positive results from BAX 855 Phase 3 trial for hemophilia A

Nektar Therapeutics reports Baxter International Inc. today announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)], which met its primary endpoint in reducing annualized bleed rates (ABR) in the prophylaxis arm compared to the on-demand arm.

From Baxter International Inc. 22 Aug 2014

Auxilium Pharmaceuticals' CCH drug effective against cellulite in Phase 2a study

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced positive results from a randomized, double-blind Phase 2a study of collagenase clostridium histolyticum (or CCH) for the treatment of edematous fibrosclerotic panniculopathy (EFP), commonly known as cellulite.

21 Aug 2014

Drug Trial News

Alirocumab drug significantly improves cholesterol levels compared to ezetimibe

Intravenous iron supplement can improve quality of life for iron deficient heart failure patients

Investigational LCZ696 drug: A real breakthrough for patients with heart failure

Review of clinical trials based on administering antidepressants for chronic postsurgical pain

Researchers receive encouraging results from two historic pediatric HIV vaccine trials

Janssen, Bayer announce expansion of EXPLORER global cardiovascular research program for XARELTO

International consortium to accelerate collaborative multi-site trials of potential Ebola vaccine

NIH to start initial human testing of investigational Ebola vaccine next week

TGen to lead first-in-patient clinical trial studies to test novel drugs for glioblastoma

Amgen seeks FDA approval for evolocumab to treat patients with high cholesterol

Isis Pharmaceuticals begins ISIS-APOCIIIRx Phase 3 study in FCS patients

New MS treatment found safe, tolerable in phase I clinical trials

Experimental drug shows promise as viable treatment for anemia of inflammation

Asterias receives clearance from FDA to initiate Phase 1/2a clinical trial of AST-OPC1

Ruthigen gets DMC recommendation to begin RUT58-60 Phase 1/2 clinical trial

Sanofi, Regeneron present alirocumab Phase 3 trial results at ESC Congress 2014

Actavis files ANDA for generic version of Neupro

Lilly’s ixekizumab superior to placebo, etanercept on all skin clearance measures in Phase 3 studies

Baxter reports positive results from BAX 855 Phase 3 trial for hemophilia A

Auxilium Pharmaceuticals' CCH drug effective against cellulite in Phase 2a study

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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