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Daiichi Sankyo submits LIXIANA supplemental NDA for review in Japan

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has submitted a supplemental New Drug Application for its oral, once-daily direct factor Xa-inhibitor LIXIANA® (Edoxaban Tosilate Hydrate) for review by the Japanese Ministry of Health, Labour and Welfare. Daiichi Sankyo is seeking approval in Japan for edoxaban in new indications for non-valvular atrial fibrillation and symptomatic venous thromboembolism.

19 Dec 2013

Tryton Medical launches Bifurcation Institute to advance care for bifurcated coronary artery disease

Tryton Medical, Inc., the leading developer of stents designed to treat bifurcation lesions, today announced the launch of the Bifurcation Institute. The Bifurcation Institute is a comprehensive education resource established to advance the standard of care for bifurcated coronary artery disease, a common, and often untreated, clinical need.

19 Dec 2013

Sanofi and Regeneron Pharmaceuticals team up with ACC to enhance clinical research with alirocumab

Sanofi and Regeneron Pharmaceuticals, Inc. today announced an innovative collaboration with the American College of Cardiology focused on enhancing clinical research with alirocumab, an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). PCSK9 is known to contribute to circulating low-density lipoprotein cholesterol (LDL-C) levels. Alirocumab is being co-developed by Sanofi and Regeneron.

19 Dec 2013

Robotic surgery more expensive than laparoscopic surgery, but have similar outcomes

In a study of national data on colon surgery, Johns Hopkins researchers found that while patients who undergo either minimally invasive laparoscopic surgery or the high-tech robotic approach have similar outcomes, robotic surgery is significantly more expensive.

19 Dec 2013

New guideline to help doctors treat patients with hypertension

A new guideline developed by evidence gathered from randomized clinical trials for the management of high blood pressure contains nine recommendations and a treatment algorithm to help doctors treat patients with hypertension.

19 Dec 2013

Merck initiates clinical trial to evaluate MK-3475 and pazopanib in advanced renal cell carcinoma

Merck, known as MSD outside the United States and Canada, today announced the initiation of a clinical trial to evaluate the combination of the company's investigational anti-PD-1 immunotherapy, MK-3475, and GlaxoSmithKline's orally administered kinase inhibitor, pazopanib, in advanced renal cell carcinoma.

18 Dec 2013

Octapharma enrolls first patients in GAM-27 Phase II/III clinical trial for relapsing multiple sclerosis

Octapharma AG, one of the largest global manufacturers of human proteins, today announced the enrolment of the first two patients in its GAM-27 Phase II/III clinical trial for the treatment of relapsing multiple sclerosis. Through intravenous administration of immunoglobulin (Octagam 5%), the study seeks to support the overall clinical benefit of a lower annualised relapse rate in patients where first-line treatment is not suitable.

18 Dec 2013

New projects advance treatments for radiation syndrome, cardiac arrest-induced brain injury and rare blood disorder

The National Institutes of Health today has launched three pre-clinical projects to advance potential new treatments for acute radiation syndrome, brain injury following cardiac arrest and a rare blood disorder called beta thalassemia.

17 Dec 2013

MTN receives $70M to develop and test products that aim to reduce spread of HIV

With funding of $70 million to support its effort into 2021, the Microbicide Trials Network (MTN) will continue to develop and test products that aim to reduce the spread of HIV, the virus that causes AIDS, federal officials announced yesterday.

17 Dec 2013

Genetically targeted drugs used for lung cancer may also have applications in colorectal cancer patients

A University of Colorado Cancer Center study published online ahead of print in the journal Molecular Cancer Research shows that ALK and ROS1 gene rearrangements known to drive subsets of lung cancer are also present in some colorectal cancers. These results imply that drugs used to target ALK and ROS1 in lung cancer may also have applications in this subset of colorectal cancer patients.

17 Dec 2013

UCLA scientists receive $21M grant to conduct groundbreaking clinical trials on stem cell science

Scientists from UCLA are now bringing their groundbreaking stem cell science directly to patients in two exciting new clinical trials scheduled to begin in early 2014, thanks to funding from California's stem cell agency.

17 Dec 2013

Navidea seeks FDA approval for marketing Lymphoseek Injection for SLN detection

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that it has submitted a Supplemental New Drug Application with the U.S. Food and Drug Administration seeking approval for the marketing and sale of Lymphoseek (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer, an indication for which Lymphoseek was also granted Fast Track designation earlier this month.

17 Dec 2013

Preclinical data shows BGB324 as potential treatment option for Chronic Myeloid Leukemia

BerGenBio AS, an oncology biopharmaceutical company, announces that preclinical data demonstrating that BGB324 has potential application as a novel treatment for Chronic Myeloid Leukemia, was presented in a poster at the Annual Meeting of the American Society of Hematology, which took place on December 7-10, 2013.

17 Dec 2013

Norgine signs exclusive licensing agreement with Innovacell for ICEF15

Norgine B.V. and Innovacell today announced they have entered into an exclusive licensing agreement for Europe, SADAC and MENA for ICEF15. Innovacell and Norgine will co-develop ICEF15 and Norgine will commercialise the product. The start of the ICEF15 phase IIb clinical trial is imminent and it is anticipated that the first patient will be dosed in Q1 2014.

17 Dec 2013

Investigators, CTUs chosen to lead five HIV/AIDS clinical trials networks through 2021

Principal investigators and clinical trials units have been chosen to lead and conduct the research of five HIV/AIDS clinical trials networks through 2021. The effort is directed and funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Total funding for the networks' leadership and the CTUs is expected to reach $225 million in 2014, the first year of operation.

17 Dec 2013

Targacept reports top-line results from TC-5619 Phase 2b trial for negative symptoms in schizophrenia

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, today announced top-line results from a Phase 2b clinical trial of TC-5619 as an augmentation therapy for the treatment of negative symptoms of schizophrenia.

17 Dec 2013

Scientists continue work to end chemotherapy pain

With this year's $600,000 grant from the Leukemia & Lymphoma Society and $1.5 million grant from the NIH, a Saint Louis University investigator is continuing her work to end chemotherapy pain. Noted pain researcher Daniela Salvemini, Ph.D., is using the funding to capitalize on her recent finding published in Pain, a breakthrough that helps scientists understand a molecular pathway by which pain occurs with certain anti-cancer drugs.

17 Dec 2013

BWH receives $140M grant from NIAID to support ongoing research led by AIDS Clinical Trial Group

The National Institute of Allergy and Infectious Diseases has awarded two seven-year grants to Brigham and Women's Hospital to fund the AIDS Clinical Trial Group Network.

16 Dec 2013

BioLineRx reports promising initial results from Phase 2 trial of BL-8040 in AML patients

BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today promising initial results for its BL-8040 drug candidate in a Phase 2 clinical trial for patients with relapsed or refractory acute myeloid leukemia (AML).

16 Dec 2013

Stem cell technology: an interview with Professor Igor Slukvin, University of Wisconsin-Madison and scientific founder of CDI and Cynata

Stem cells have a potential to develop into multiple cell types and divide without limit to replenish cells in human body throughout the life of individual.

16 Dec 2013

Clinical Trial News and Research

Daiichi Sankyo submits LIXIANA supplemental NDA for review in Japan

Tryton Medical launches Bifurcation Institute to advance care for bifurcated coronary artery disease

Sanofi and Regeneron Pharmaceuticals team up with ACC to enhance clinical research with alirocumab

Robotic surgery more expensive than laparoscopic surgery, but have similar outcomes

New guideline to help doctors treat patients with hypertension

Merck initiates clinical trial to evaluate MK-3475 and pazopanib in advanced renal cell carcinoma

Octapharma enrolls first patients in GAM-27 Phase II/III clinical trial for relapsing multiple sclerosis

New projects advance treatments for radiation syndrome, cardiac arrest-induced brain injury and rare blood disorder

MTN receives $70M to develop and test products that aim to reduce spread of HIV

Genetically targeted drugs used for lung cancer may also have applications in colorectal cancer patients

UCLA scientists receive $21M grant to conduct groundbreaking clinical trials on stem cell science

Navidea seeks FDA approval for marketing Lymphoseek Injection for SLN detection

Preclinical data shows BGB324 as potential treatment option for Chronic Myeloid Leukemia

Norgine signs exclusive licensing agreement with Innovacell for ICEF15

Investigators, CTUs chosen to lead five HIV/AIDS clinical trials networks through 2021

Targacept reports top-line results from TC-5619 Phase 2b trial for negative symptoms in schizophrenia

Scientists continue work to end chemotherapy pain

BWH receives $140M grant from NIAID to support ongoing research led by AIDS Clinical Trial Group

BioLineRx reports promising initial results from Phase 2 trial of BL-8040 in AML patients

Stem cell technology: an interview with Professor Igor Slukvin, University of Wisconsin-Madison and scientific founder of CDI and Cynata

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