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NIH awards $12.8 million renewal grant for Louisville adult stem cell research project

At the time when Dr. Roberto Bolli received word that he was awarded a $12.8 million grant renewal from the National Institutes of Health for one research project, five patients in another of his clinical trials at the University of Louisville have reached the successful endpoint of their participation.

9 Sep 2011

Cardiovascular and Renal Drugs Advisory Committee recommends FDA approval of J&JPRD's rivaroxaban

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) announced today that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended approval of rivaroxaban, a novel, once-daily, oral anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

9 Sep 2011

Weight Watchers more effective alternative to primary care for obese adults

A new, one-year global study published today in The Lancet indicates that overweight and obese adults referred to Weight Watchers, a community based provider of weight-loss services, lost more than twice as much weight when compared with those who received standard care.

9 Sep 2011

Positive results from Sanaria PfSPZ Vaccine initial Phase 1 trial on malaria

Positive results from the initial Phase 1 clinical trial in 80 healthy volunteers and complementary pre-clinical studies of the Sanaria PfSPZ Vaccine are published today in the online issue of Science.

9 Sep 2011

University of Maryland surgeons transplant first lungs treated with experimental repair process

Surgeons at the University of Maryland Medical Center have transplanted the first lungs treated in the United States with an experimental repair process before transplantation. The procedure is part of a five-center national clinical research trial to evaluate the efficacy of repairing, before transplant, lungs that might otherwise have been passed over as unsuitable for organ donation.

8 Sep 2011

Aggressive medical management better than stenting for prevention of recurrent stroke

Patients at a high risk for a second stroke who received intensive medical treatment had fewer strokes and deaths than patients who received a brain stent in addition to the medical treatment, a large nationwide clinical trial has shown. The investigators published the results in today's online first edition of the New England Journal of Medicine.

8 Sep 2011

Enrollment complete in Concentric Medical's Stentriever trial for acute ischemic stroke

Concentric Medical, Inc., a global leader in acute ischemic stroke intervention, today announced completion of enrollment of the TREVO Study.

8 Sep 2011

Microvascular compression syndrome may cause Parkinson's

A potentially treatable blood vessel abnormality in the brain may be the cause of Parkinson's Disease in some patients, according to a study published today in the journal Neurology International by a team of leading physicians and neuroscientists at Pittsburgh's Allegheny General Hospital.

8 Sep 2011

OptiNose chooses BioClinica's advanced imaging and IWR solutions for clinical trials

BioClinica, Inc., a global provider of clinical trial management solutions, today announced that OptiNose, Inc. selected BioClinica Trident IWR, Optimizer clinical supplies forecasting, and Imaging Core Lab services for use in a series of clinical trials including several pivotal Phase III studies.

From Clario 8 Sep 2011

Aggressive medical treatment without stenting better for high-risk stroke patients

An article appearing in the Sept. 7 New England Journal of Medicine, reporting on National Institutes of Health research on brain stents, says aggressive medical treatment without stenting is better for high-risk stroke patients.

8 Sep 2011

AOI Medical receives ISO 13485 Certification and CE marking approval for two VCF devices

AOI Medical, Inc. has received ISO 13485 Certification and CE marking approval for its Ascendx VCF Repair System and its Ascendx Acu-Cut Vertebral Augmentation System to treat vertebral compression fractures (VCF).

8 Sep 2011

Researchers rethink fenretinide for prevention of oral cancer

Scientists on the cutting edge of biomedical research know that research is a process - a combination of successes and failures that inform the next step forward. However, for some researchers at The Ohio State University progress means taking a step back. Supported by the Ohio State University Center for Clinical and Translational Science (CCTS), these scientists are using failed and forgotten research to uncover future treatments for major health conditions as diverse as oral cancer and stroke.

7 Sep 2011

Top-line results from Auxilium XIAFLEX palpable cord study in Dupuytren's contracture subjects

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced positive top-line results from a pilot clinical study to assess safety, tolerability, and multiple-dose pharmacokinetics of XIAFLEX (collagenase clostridium histolyticum) in adult Dupuytren's contracture subjects with multiple palpable cords.

7 Sep 2011

Cancer Research UK opens olaparib-temozolomide combination Phase I trial in glioblastoma

Cancer Research UK's Drug Development Office has opened a trial of a new combination of drugs for the treatment of patients with brain cancer.

7 Sep 2011

ImmunoCellular provides update on ICT-107 Phase II trial for glioblastoma multiforme

ImmunoCellular Therapeutics, Ltd., a biotechnology company focused on the development of novel immune-based cancer therapies, provided an update today on clinical trial site activity and patient enrollment for its Phase II clinical trial of ICT-107, the Company's dendritic cell based cancer vaccine candidate targeting multiple tumor antigens for the treatment of glioblastoma multiforme.

7 Sep 2011

New bone marrow-derived stem cell therapy can benefit patients with degenerative disc disease

Neurosurgery researchers at UC Davis Health System have used a new, leading-edge stem cell therapy to promote the growth of bone tissue following the removal of cervical discs -- the cushions between the bones in the neck -- to relieve chronic, debilitating pain.

7 Sep 2011

St. Jude Medical's Genesis neurostimulation device receives European CE Mark approval

St. Jude Medical, Inc., a global medical device company, today announced it has received the industry's first and only regulatory approval for the use of an implanted neurostimulation device for patients with intractable chronic migraine.

7 Sep 2011

Leading cancer journals publish OncoGenex's custirsen pre-clinical and Phase II study data

OncoGenex Pharmaceuticals, Inc. announced today that data from two studies, a Phase II clinical study and a pre-clinical study, evaluating the investigational compound custirsen, were published in the September issues of the journals Clinical Cancer Research and Cancer Research.

7 Sep 2011

FDA stalls the blood-thinner Xarelto’s approval citing inadequate evidence

The Food and Drug Administration (FDA) said in a staff report released today that “there is insufficient information about the drug to determine whether it is safe for use with its proposed labeling.” Their report questions its safety and effectiveness, saying a new study is needed.

6 Sep 2011

Discovery Labs files Complete Response to FDA for SURFAXIN to treat RDS in premature infants

Discovery Labs, Inc. today announced that, on September 2, 2011, it submitted its Complete Response to the 2009 Complete Response Letter issued by the U.S. Food and Drug Administration (FDA) for SURFAXIN(lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants.

6 Sep 2011

Clinical Trial News and Research

NIH awards $12.8 million renewal grant for Louisville adult stem cell research project

Cardiovascular and Renal Drugs Advisory Committee recommends FDA approval of J&JPRD's rivaroxaban

Weight Watchers more effective alternative to primary care for obese adults

Positive results from Sanaria PfSPZ Vaccine initial Phase 1 trial on malaria

University of Maryland surgeons transplant first lungs treated with experimental repair process

Aggressive medical management better than stenting for prevention of recurrent stroke

Enrollment complete in Concentric Medical's Stentriever trial for acute ischemic stroke

Microvascular compression syndrome may cause Parkinson's

OptiNose chooses BioClinica's advanced imaging and IWR solutions for clinical trials

Aggressive medical treatment without stenting better for high-risk stroke patients

AOI Medical receives ISO 13485 Certification and CE marking approval for two VCF devices

Researchers rethink fenretinide for prevention of oral cancer

Top-line results from Auxilium XIAFLEX palpable cord study in Dupuytren's contracture subjects

Cancer Research UK opens olaparib-temozolomide combination Phase I trial in glioblastoma

ImmunoCellular provides update on ICT-107 Phase II trial for glioblastoma multiforme

New bone marrow-derived stem cell therapy can benefit patients with degenerative disc disease

St. Jude Medical's Genesis neurostimulation device receives European CE Mark approval

Leading cancer journals publish OncoGenex's custirsen pre-clinical and Phase II study data

FDA stalls the blood-thinner Xarelto’s approval citing inadequate evidence

Discovery Labs files Complete Response to FDA for SURFAXIN to treat RDS in premature infants

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