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Romidepsin drug shows surprising benefit in preclinical studies of inflammatory breast cancer

A drug now used to treat a type of lymphoma has shown surprising benefit in preclinical studies of inflammatory breast cancer, according to a researcher at Thomas Jefferson University's Kimmel Cancer Center.

11 Dec 2013

New drug combination therapy effective for patients with HER2-positive breast cancer

Combining the chemotherapy drugs docetaxel and carboplatin with the HER2-targeted therapy trastuzumab was identified to be an ideal postsurgery treatment option for patients with HER2-positive breast cancer, regardless of tumor size and whether or not disease has spread to the lymph nodes, according to results from the BETH study presented here at the 2013 San Antonio Breast Cancer Symposium, held Dec. 10-14.

11 Dec 2013

Researchers awarded $25 million NIH grant to study critical limb ischemia treatment

A team of researchers from Brigham and Women's Hospital, Boston Medical Center and Massachusetts General Hospital has been awarded $25 million by the National Institutes of Health to conduct a four-year, randomized clinical trial-the BEST-CLI Trial (Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia). The trial will compare traditional bypass surgery with the less invasive alternative of endovascular treatment for patients with critical limb ischemia.

11 Dec 2013

AP, Kaiser Permanente initiate clinical trial to evaluate the efficacy of Promescent lidocaine spray

Absorption Pharmaceuticals LLC in collaboration with Kaiser Permanente announced today the initiation of a clinical trial to evaluate the efficacy of Promescent lidocaine spray for men with premature ejaculation. This Phase III, double blind, placebo-controlled, randomized study will measure the intravaginal ejaculatory latency time for subjects aged 18 and older.

11 Dec 2013

Schizophrenia treatment responses follow distinct trajectories

The positive and negative symptoms of schizophrenia generally change in parallel with each other, shows research, supporting the notion that the different symptom domains of the condition have a shared underlying pathology.

11 Dec 2013

First patient enrolled in Otonomy's pivotal Phase 2b study of OTO-104 for Meniere's disease

Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced enrollment of the first patient in its pivotal Phase 2b study of OTO-104 for the reduction of vertigo in patients with unilateral Meniere's disease.

11 Dec 2013

Queen's University heads key European study to find new treatments for bowel cancer

Queen's University has announced it is to lead a €6 million European study to find new treatments for bowel cancer.

11 Dec 2013

Surefire Medical enrolls patients in COSY clinical trial to investigate benefits of SIRT in liver metastasis

Surefire Medical, Inc. today announced that it has completed enrollment in the Coiling vs. Surefire Infusion System in Y90 (COSY) clinical trial.

11 Dec 2013

Researchers personalizing cancer treatments for young patients

The aim of personalizing cancer treatments by targeting genomic mutations in the cancer has seen rapid advances in recent years. However, many of these targeted cancer therapies have been more frequently identified for adult patients. Recognizing a need to further explore genomic profiling in pediatric malignancies, the Hugs for Brady Foundation has committed $300,000 to the precision medicine initiative at Rutgers Cancer Institute of New Jersey.

11 Dec 2013

Study shows children with ALL can safely receive intravenous infusions of chemotherapy

Children with acute lymphoblastic leukemia (ALL), the most common form of pediatric cancer, can safely receive intravenous infusions of a reformulated mainstay of chemotherapy that has been delivered via painful intramuscular injection for more than 40 years, research suggests.

11 Dec 2013

Pharmacyclics presents ibrutinib trial data for B-cell malignancies at ASH meeting

Pharmacyclics, Inc. today announced results of 40 clinical, non-clinical and pre-clinical presentations on ibrutinib (IMBRUVICA™) at the 55TH Annual meeting of the American Society of Hematology (ASH) held in New Orleans, Dec 7 - 10, 2013.

11 Dec 2013

Navidea receives Fast Track designation for Lymphoseek injection

Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer.

11 Dec 2013

Baxter seeks FDA approval of OBI-1 for adults with acquired hemophilia A

Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of OBI-1, a recombinant antihemophilic porcine sequence factor VIII, in patients with acquired hemophilia A.

From Baxter International Inc. 11 Dec 2013

Avanir Pharmaceuticals' AVP-923 phase II trial fails to meet primary efficacy endpoint

Avanir Pharmaceuticals, Inc. today announced that PRIME, its phase II clinical trial of the investigational drug AVP-923 (dextromethorphan / quinidine) for the treatment of central neuropathic pain in patients with multiple sclerosis did not meet the primary efficacy endpoint.

10 Dec 2013

UTHealth starts clinical trial to study two forms of stem cell treatments for children with CP

A first-of-its-kind clinical trial studying two forms of stem cell treatments for children with cerebral palsy has begun at The University of Texas Health Science Center at Houston Medical School.

10 Dec 2013

Sanofi US launches second PiPH innovation challenge to improve drug development process

Today, Sanofi US launched its second Partners in Patient Health Innovation Challenge: Collaborate | Innovate, which will award $100,000 to the winning team. This year's theme is "Co-Creating for Breakthroughs: Moving toward a collaborative research and development ecosystem."

10 Dec 2013

electroCore’s non-invasive VNS therapy for headaches reviewed at AHS and NANS meetings

electroCore’s non invasive vagus nerve stimulation therapy for the prevention and treatment of cluster headache and migraine was reviewed at both the AHS Annual Scottsdale Headache Symposium (Nov 21st to 24th) and the NANS meeting this weekend (Dec 5th to 8th).

10 Dec 2013

Epilepsy experts discuss on new NTI definition, bioequivalence guidelines at AES annual meeting

For several years, epilepsy practitioners have questioned the U.S. Food and Drug Administration's definition of bioequivalence as it applies to narrow therapeutic index drugs, such as those used for epilepsy. In response to these concerns, the FDA has sponsored 3 studies of antiepileptic drugs and also convened an advisory board to help determine which drugs are NTI.

10 Dec 2013

Alnylam presents new pre-clinical data with ALN-AT3 for treatment of hemophilia and RBD

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has presented new pre-clinical data with ALN-AT3, a subcutaneously administered RNAi therapeutic targeting antithrombin (AT) for the treatment of hemophilia and rare bleeding disorders (RBD), at the 55th Annual Meeting of the American Society of Hematology (ASH) held December 7 - 10, 2013 in New Orleans.

10 Dec 2013

European study investigates high blood pressure drug for treating Alzheimer's patients

An extensive European study is currently investigating whether a drug used to treat high blood pressure may also help patients with Alzheimer's disease. The EU is investing almost 6 million euros on the project, in which Sahlgrenska Academy and Sahlgrenska University Hospital are responsible for Sweden's contribution.

10 Dec 2013

Clinical Trial News and Research

Romidepsin drug shows surprising benefit in preclinical studies of inflammatory breast cancer

New drug combination therapy effective for patients with HER2-positive breast cancer

Researchers awarded $25 million NIH grant to study critical limb ischemia treatment

AP, Kaiser Permanente initiate clinical trial to evaluate the efficacy of Promescent lidocaine spray

Schizophrenia treatment responses follow distinct trajectories

First patient enrolled in Otonomy's pivotal Phase 2b study of OTO-104 for Meniere's disease

Queen's University heads key European study to find new treatments for bowel cancer

Surefire Medical enrolls patients in COSY clinical trial to investigate benefits of SIRT in liver metastasis

Researchers personalizing cancer treatments for young patients

Study shows children with ALL can safely receive intravenous infusions of chemotherapy

Pharmacyclics presents ibrutinib trial data for B-cell malignancies at ASH meeting

Navidea receives Fast Track designation for Lymphoseek injection

Baxter seeks FDA approval of OBI-1 for adults with acquired hemophilia A

Avanir Pharmaceuticals' AVP-923 phase II trial fails to meet primary efficacy endpoint

UTHealth starts clinical trial to study two forms of stem cell treatments for children with CP

Sanofi US launches second PiPH innovation challenge to improve drug development process

electroCore’s non-invasive VNS therapy for headaches reviewed at AHS and NANS meetings

Epilepsy experts discuss on new NTI definition, bioequivalence guidelines at AES annual meeting

Alnylam presents new pre-clinical data with ALN-AT3 for treatment of hemophilia and RBD

European study investigates high blood pressure drug for treating Alzheimer's patients

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