Clinical Trial News and Research

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FDA convenes Advisory Committee meeting to discuss safety of LABA's

On Wednesday, March 10 and Thursday, March 11, the FDA is convening an Advisory Committee meeting on the clinical trial design for long acting beta-2 adrenergic agonists.

22 Mar 2010

Nanotechnology weapons for cancer

US Researchers have come up with new nanoparticle robots that are essentially a tiny army that can travel in the blood till they reach the cancers and then tweak some important cancer causing genes that can cure the cancer.

22 Mar 2010

Caltech-led trial demonstrates feasibility of nanoparticles and RNAi-based therapeutics for treating cancer

A California Institute of Technology -led team of researchers and clinicians has published the first proof that a targeted nanoparticle-used as an experimental therapeutic and injected directly into a patient's bloodstream-can traffic into tumors, deliver double-stranded small interfering RNAs (siRNAs), and turn off an important cancer gene using a mechanism known as RNA interference (RNAi).

22 Mar 2010

Sorin Group reports consolidated revenues of € 689.0M for 2009

“The final 2009 financial statements confirm the full achievement of our targets; this solid financial basis will be the foundation for future growth. The 2010-2014 Plan confirms the strategic guidelines previously communicated, based on profitability and cash flow expansion and prepares for accelerated growth in the future” said André-Michel Ballester, Chief Executive Officer, Sorin Group.

20 Mar 2010

Cedars-Sinai Neurovascular Center's clinical trial of minimally invasive stenting procedure for TIA

Individuals between 30 and 80 years of age, who have had a transient ischemic attack (TIA) or non-severe stroke within the past 30 days, and who cannot be treated surgically, may be eligible to participate in a Phase III clinical trial of a minimally invasive stenting procedure at the Cedars-Sinai Neurovascular Center. The study will focus specifically on patients who have had an intracranial artery narrowed by at least 70 percent and who are experiencing recurrent strokes or TIAs despite being on anti-clotting medication.

19 Mar 2010

CPEX Pharmaceuticals' Phase 2a Nasulin trial fails, Arcadia Capital Advisors issues statement

Richard S. Rofe, who serves as Managing Director for Arcadia Capital Advisors, LLC, and is part of a shareholder group that includes Arcadia with a 9.97 percent ownership interest in CPEX Pharmaceuticals, Inc.,, commented on CPEX's recent announcement of failed Phase 2a Nasulin study results.

19 Mar 2010

Synergy Pharmaceuticals commences dosing in Phase IIa clinical trial of SP-304 in CC patients

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal disorders and diseases, announced today the initiation of dosing in a Phase IIa clinical trial of SP-304 in patients with chronic constipation (CC). This is a Phase IIa, randomized, double-blind, placebo-controlled, 14-day repeat, oral, dose-escalation study in patients with chronic constipation.

19 Mar 2010

A.P. Pharma's NDA for APF530 in prevention of CINV: FDA issues Complete Response Letter

A.P. Pharma, Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for APF530 in the prevention of both acute and delayed onset chemotherapy-induced nausea and vomiting.

19 Mar 2010

Noscapine can be used as prophylactic treatment for prostate cancer: Study

New research has revealed a major breakthrough in the use of cough medicine ingredient noscapine as a prophylactic treatment for prostate cancer.

19 Mar 2010

Stemedica files IND for trial using allogeneic mesenchymal bone marrow cells in patients with ischemic stroke

Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that it has filed an Investigative New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a clinical trial. The trial will assess the safety, tolerability and efficacy of Stemedica's high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke.

19 Mar 2010

Robertson Foundation commits $10.2M for Duke Medicine's cell therapy research

A $10.2 million commitment from the Robertson Foundation to create a state-of-the-art Translational Cell Therapy Center (TCTC) will advance Duke Medicine's pioneering cell therapy research and treatment programs for children and adults with cancer, cerebral palsy, stroke and brain injuries suffered at birth.

19 Mar 2010

FDA approves expanded indication for Boston Scientific's CRT-Ds

Boston Scientific Corporation today announced that the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) has unanimously recommended approval of an expanded indication for its cardiac resynchronization therapy defibrillators (CRT-Ds), including the COGNIS® CRT-D. The panel recommended the expansion include the majority of the studied population of the landmark MADIT-CRT clinical trial, which evaluated the ability of these devices to slow the progression of heart failure in patients with asymptomatic or mild heart failure.

19 Mar 2010

Atritech to initiate confirmatory study of WATCHMAN LAA Closure Device

Atritech, Inc., an emerging medical device company, announced today that it has obtained clarity from the U.S. Food and Drug Agency on the regulatory path towards full approval of its WATCHMAN® Left Atrial Appendage Closure Technology in the United States.

19 Mar 2010

GSK's 2009 Corporate Responsibility Report published online

In its 2009 Corporate Responsibility Report published online today, GSK reiterated its commitment to running its business responsibly and to making the company more responsive, more flexible and more open to the expectations of society.

19 Mar 2010

Cedars-Sinai Medical Center announces clinical trial of minimally invasive procedure for opening carotid arteries

Patients who suffer from plaque-related narrowing of a carotid artery but are not good candidates for open surgery may be eligible to participate in a clinical trial at Cedars-Sinai Medical Center of a minimally invasive procedure designed to open carotid arteries the way angioplasty and stenting clear arteries of the heart.

19 Mar 2010

Three scientists receive 2010 Discoverers Award for developing new class of HIV drug

Three scientists who led the 11-year quest to develop a groundbreaking HIV drug today received the 2010 Discoverers Award -- the highest honor given to scientists by the Pharmaceutical Research and Manufacturers of America. The honorees are Tony Wood, Ph.D., Elna van der Ryst, M.D., Ph.D. and Manos Perros, Ph.D.

19 Mar 2010

FDA approves Somaxon Pharmaceuticals' Silenor for treatment of insomnia

Somaxon Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance.

19 Mar 2010

Cameron Health initiates clinical trial of minimally invasive S-ICD System for patients at risk of SCA

Cameron Health, Inc. today announced the commencement of the company's pivotal clinical trial to gain U.S. approval of its Subcutaneous Implantable Defibrillator (S-ICD®) System. The minimally invasive S-ICD System is prescribed for use in patients at risk of Sudden Cardiac Arrest (SCA). The S-ICD System is unique in that the implantation of the system is entirely subcutaneous; no leads are in or on the heart.

19 Mar 2010

U.S.-based CRO licenses NewCardio's QTinno software solution for automating cardiac safety analysis

NewCardio, Inc., a cardiac diagnostic technology provider, announced today that a U.S.-based CRO that provides early phase and specialty clinical drug development services to the pharmaceutical industry, has signed an MSA, licensing NewCardio's QTinno™ software solution in order to deliver fully automated cardiac safety analysis in early phase QT studies.

18 Mar 2010

Scientific revelations discovered during Retina Implant’s first human clinical trial

Retina Implant, AG, a leading developer of subretinal implants for the visually impaired, today announced scientific revelations discovered during the company’s first human clinical trial. The results achieved in the 11 patients that were involved in the trial exceeded the company’s expectations for their first trial.

18 Mar 2010

Clinical Trial News and Research

FDA convenes Advisory Committee meeting to discuss safety of LABA's

Nanotechnology weapons for cancer

Caltech-led trial demonstrates feasibility of nanoparticles and RNAi-based therapeutics for treating cancer

Sorin Group reports consolidated revenues of € 689.0M for 2009

Cedars-Sinai Neurovascular Center's clinical trial of minimally invasive stenting procedure for TIA

CPEX Pharmaceuticals' Phase 2a Nasulin trial fails, Arcadia Capital Advisors issues statement

Synergy Pharmaceuticals commences dosing in Phase IIa clinical trial of SP-304 in CC patients

A.P. Pharma's NDA for APF530 in prevention of CINV: FDA issues Complete Response Letter

Noscapine can be used as prophylactic treatment for prostate cancer: Study

Stemedica files IND for trial using allogeneic mesenchymal bone marrow cells in patients with ischemic stroke

Robertson Foundation commits $10.2M for Duke Medicine's cell therapy research

FDA approves expanded indication for Boston Scientific's CRT-Ds

Atritech to initiate confirmatory study of WATCHMAN LAA Closure Device

GSK's 2009 Corporate Responsibility Report published online

Cedars-Sinai Medical Center announces clinical trial of minimally invasive procedure for opening carotid arteries

Three scientists receive 2010 Discoverers Award for developing new class of HIV drug

FDA approves Somaxon Pharmaceuticals' Silenor for treatment of insomnia

Cameron Health initiates clinical trial of minimally invasive S-ICD System for patients at risk of SCA

U.S.-based CRO licenses NewCardio's QTinno software solution for automating cardiac safety analysis

Scientific revelations discovered during Retina Implant’s first human clinical trial

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