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Janssen receives complete response letter from FDA for XARELTO sNDA

Janssen Research & Development, LLC today announced the U.S. Food and Drug Administration has issued a complete response letter for the supplemental New Drug Application for XARELTO (rivaroxaban) to reduce the risk of stent thrombosis in patients with acute coronary syndrome.

28 Jun 2013

Hospira receives positive opinion from EMA's CHMP for EC approval of Inflectra

Hospira, the world's leading provider of injectable drugs and infusion technologies, today received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use, recommending the European Commission approval of Inflectra (infliximab) for rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis.

28 Jun 2013

Eleven Biotherapeutics reports positive results from EBI-005 Phase 1b/2a study in patients with DED

Eleven Biotherapeutics, a biopharmaceutical company designing and engineering novel and differentiated protein-based biotherapeutics for ocular diseases, announced today positive topline clinical results from a 6-week randomized, double-masked, placebo-controlled Phase 1b/2a study of EBI-005 in patients with dry eye disease.

28 Jun 2013

Curing type 1 diabetes: an interview with Dr. Habib Zaghouani, MU School of Medicine

Type 1 diabetes is an attack by the immune system of the islet of Langerhans within the pancreas. Basically, the islet of Langerhans harbor beta cells, which produce insulin and when the islets are attacked, the beta cells destruct and there is no more insulin. When the insulin level goes low, blood glucose levels go high and that creates a problem.

28 Jun 2013

Researchers create culturally targeted educational materials to help patients make health care decisions

Hispanic cancer patients rarely participate in clinical trials, but researchers want to tailor a Spanish DVD to help change this. To create a relevant educational tool, Moffitt Cancer Center researchers investigated why awareness of and participation in trials are so low in this population.

28 Jun 2013

Edge Therapeutics announces positive preliminary results from EG-1962 study for prevention of DCI

Edge Therapeutics announced today positive preliminary results from the first human use of EG-1962, the Company's novel bioabsorbable nimodipine microparticle formulation for the prevention of delayed cerebral ischemia, a life-threatening complication of subarachnoid hemorrhage, typically resulting from a ruptured brain aneurysm or traumatic brain injury.

27 Jun 2013

Researchers study possible alternative medications to treat cancer-related pain

Researchers at the Brain and Spine Institute at John Theurer Cancer Center at HackensackUMC, one of the nation's 50 best hospitals for cancer, are studying a possible alternative to side effect-ridden opioid-based medications to treat cancer-related pain.

27 Jun 2013

Ambit Biosciences presents data from Phase 2 ACE study of quizartinib for treatment of AML

Ambit Biosciences Corporation announced today data from the Phase 2 ACE study of quizartinib (AC220), a FLT3 inhibitor, were featured in multiple presentations at the 18th Congress of the European Hematology Association in Stockholm, Sweden.

27 Jun 2013

FDA grants fast track designation to Genervon Biopharmaceuticals for ALS drug GM604

In a huge victory for ALS sufferers, FDA granted Genervon Biopharmaceuticals a fast track designation for its first in class highly effective multi-target master regulator biotechnology drug GM604 for ALS. FDA said it met the necessary criteria.

27 Jun 2013

Sprout Pharmaceuticals resubmits flibanserin NDA for treating HSDD in pre-menopausal women

Sprout Pharmaceuticals, the Raleigh-based pharmaceutical company developing flibanserin, a treatment being evaluated for Hypoactive Sexual Desire Disorder in pre-menopausal women, confirmed today that the company has resubmitted the New Drug Application for flibanserin earlier this year and expects US Food and Drug Agency action before the end of 2013.

27 Jun 2013

Researchers develop breakthrough approach to reduce harmful effects from blood transfusions

Researchers from Case Western Reserve University School of Medicine have developed an unprecedented approach to restore nitric oxide to donated blood, a breakthrough that could dramatically reduce harmful effects from transfusions.

26 Jun 2013

New streamlined method harnesses tumor-infiltrating lymphocytes to improve outcomes

Jamie K. Teer, Ph.D., assistant member of the Cancer Biology and Evolution Program at Moffitt Cancer Center, and colleagues have developed a new streamlined method to rapidly identify the genetic changes in small protein fragments unique to melanoma cancer cells.

26 Jun 2013

Researchers discover promising new way to treat HIV-related blood cancer

Researchers at the USC Norris Comprehensive Cancer Center have discovered a promising new way to treat a rare and aggressive blood cancer most commonly found in people infected with HIV.

26 Jun 2013

AtheroNova starts AHRO-001 Phase 1 clinical trial for treatment of atherosclerosis

AtheroNova Inc., a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announces achievement of a major milestone with the initiation of a Phase 1 clinical trial with its lead compound, AHRO-001. The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of AHRO-001 in healthy volunteers.

25 Jun 2013

Highland Therapeutics subsidiary reports positive HLD-200 Phase-1 results in ADHD patients

Highland Therapeutics, Inc., a specialty pharmaceutical company based in the MaRS Discovery District in Toronto, today announced that its wholly owned subsidiary has generated positive Phase-1 results for HLD-200 - a novel formulation of methylphenidate being developed to treat the symptoms associated with Attention-Deficit/Hyperactivity Disorder.

25 Jun 2013

Weight loss does not reduce heart disease risks among Type 2 diabetes patients: Study

A landmark study investigating the long-term effects of weight loss on the risks of cardiovascular disease among patients with Type 2 diabetes has now concluded, with significant results to be published today in the New England Journal of Medicine.

25 Jun 2013

CytRx reaches targeted enrollment in aldoxorubicin Phase 2b study for treatment of soft tissue sarcoma

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, announced that it has reached the targeted enrollment of 105 evaluable patients in its international Phase 2b clinical trial with aldoxorubicin as a first-line treatment for soft tissue sarcoma.

25 Jun 2013

Researchers test modified dendritic cells in patients with melanoma

In this issue of the Journal of Clinical Investigation, researchers led by Scott Pruitt at Duke University and Merck Research Laboratories report on a human clinical trial in which modified dendritic cells, a component of the immune system, were tested in patients with melanoma.

25 Jun 2013

Elcelyx's study shows NewMet has better glucose-lowering effects than metformin in type2 diabetic patients

Elcelyx Therapeutics announced today that clinical study results confirm that the primary site of action of Type 2 diabetes medicine metformin is in the lower bowel rather than in the circulation.

24 Jun 2013

Boehringer submits application to EMA for use of Pradaxa for treatment of acute DVT, PE

Boehringer Ingelheim today announced the submission of an application to the European Medicines Agency (EMA) for use of Pradaxa (dabigatran etexilate) for the treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE.

24 Jun 2013

Clinical Trial News and Research

Janssen receives complete response letter from FDA for XARELTO sNDA

Hospira receives positive opinion from EMA's CHMP for EC approval of Inflectra

Eleven Biotherapeutics reports positive results from EBI-005 Phase 1b/2a study in patients with DED

Curing type 1 diabetes: an interview with Dr. Habib Zaghouani, MU School of Medicine

Researchers create culturally targeted educational materials to help patients make health care decisions

Edge Therapeutics announces positive preliminary results from EG-1962 study for prevention of DCI

Researchers study possible alternative medications to treat cancer-related pain

Ambit Biosciences presents data from Phase 2 ACE study of quizartinib for treatment of AML

FDA grants fast track designation to Genervon Biopharmaceuticals for ALS drug GM604

Sprout Pharmaceuticals resubmits flibanserin NDA for treating HSDD in pre-menopausal women

Researchers develop breakthrough approach to reduce harmful effects from blood transfusions

New streamlined method harnesses tumor-infiltrating lymphocytes to improve outcomes

Researchers discover promising new way to treat HIV-related blood cancer

AtheroNova starts AHRO-001 Phase 1 clinical trial for treatment of atherosclerosis

Highland Therapeutics subsidiary reports positive HLD-200 Phase-1 results in ADHD patients

Weight loss does not reduce heart disease risks among Type 2 diabetes patients: Study

CytRx reaches targeted enrollment in aldoxorubicin Phase 2b study for treatment of soft tissue sarcoma

Researchers test modified dendritic cells in patients with melanoma

Elcelyx's study shows NewMet has better glucose-lowering effects than metformin in type2 diabetic patients

Boehringer submits application to EMA for use of Pradaxa for treatment of acute DVT, PE

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