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Bayer's gadobutrol injection for CNS imaging receives FDA Advisory Committee approval

Bayer HealthCare Pharmaceuticals Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration voted unanimously that clinical trial and postmarketing data for gadobutrol injection, a macrocyclic 1.0 molar gadolinium-based contrast agent (GBCA), support approval of the product for proposed use in diagnostic magnetic resonance imaging (MRI) in adults and children.

24 Jan 2011

SuppreMol completes successful pre-IND meeting with U.S. FDA

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases, today announced that it has successfully completed a pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead compound SM101, which is being developed for the treatment of Primary Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE).

24 Jan 2011

Scientists ignore relevant drug clinical trials when conducting new research on same topic

The vast majority of already published and relevant clinical trials of a given drug, device or procedure are routinely ignored by scientists conducting new research on the same topic, a new Johns Hopkins study suggests.

24 Jan 2011

CRI, Oncovir sign new investment agreement to produce immunological stimulant

Cancer Research Institute, a U.S. nonprofit organization founded in 1953 to advance the science of tumor immunology and foster the discovery and development of new cancer immunotherapies, announced today that its Cancer Vaccine Acceleration Fund, a joint initiative with the Ludwig Institute for Cancer Research, has completed a new investment agreement with Oncovir, a biotechnology company based in Washington, D.C., to enable the production of the immunological stimulant Hiltonol- (Poly-ICLC).

24 Jan 2011

CVAF completes new investment agreement with Oncovir for production of Hiltonol

Cancer Research Institute, Inc. (CRI), a U.S. nonprofit organization founded in 1953 to advance the science of tumor immunology and foster the discovery and development of new cancer immunotherapies, announced today that its Cancer Vaccine Acceleration Fund (CVAF), a joint initiative with the Ludwig Institute for Cancer Research (LICR), has completed a new investment agreement with Oncovir, Inc., a biotechnology company based in Washington, D.C., to enable the production of the immunological stimulant Hiltonol® (Poly-ICLC).

21 Jan 2011

Additional data from HyperAcute Pancreas cancer immunotherapy Phase 2 trial to be presented at ASCO 2011

NewLink Genetics Corporation today announced that additional data from its Phase 2 clinical trial of the company's investigational HyperAcute® Pancreas cancer immunotherapy will be presented during a poster session at the American Society of Clinical Oncology 2011 Gastrointestinal Cancers Symposium in San Francisco, California.

21 Jan 2011

Scientist receives RO1 research grant to improve blood, marrow transplantation in myeloma patients

Thea Friedman, M.D., associate scientist and director of oncology basic research at the John Theurer Cancer Center at Hackensack University Medical Center was recently awarded a National Cancer Institutes of Health-National Cancer Institute RO1 research grant to improve allogeneic blood and marrow transplantation for multiple myeloma patients.

21 Jan 2011

Major breakthrough: Genome-based medicine for treatment of alcoholism

For the first time in alcohol addiction research, UVA investigators have successfully treated alcohol-dependent individuals with medication that is tailored specifically to match their genetic profile.

21 Jan 2011

Positive results from nimotuzumab Phase II study for gastric cancer

YM BioSciences, a life sciences product development company advancing a diverse portfolio of promising hematology and cancer-related products at various stages of development, today announced that results were reported from a randomized Phase II gastric cancer study of nimotuzumab being conducted by its licensees, Daiichi Sankyo Co., Ltd. in Japan and Kuhnil Pharma Co. Ltd., in Korea.

21 Jan 2011

ACT Biotech releases telatinib Phase 2 trial data for metastatic stomach cancer

ACT Biotech, a biopharmaceutical company focused on the development of highly targeted, oral therapeutics for the treatment of cancer, today released data on additional analysis of the Phase 2 clinical trial of telatinib in patients with metastatic stomach cancer that further supports the highly-potent nature of the antiangiogenic agent.

21 Jan 2011

New gene test can predict tumor spread in bladder cancer patients

Cancer scientists have designed the first molecular test to predict which bladder cancer patients may have cancer involvement in their lymph nodes at the time of surgery-which could help doctors determine which patients are good candidates for pre-surgical, or neo-adjuvant, chemotherapy.

21 Jan 2011

PROSPECT trial results shed new light on plaque types that cause unexpected heart attacks

Results from the PROSPECT clinical trial shed new light on the types of vulnerable plaque that are most likely to cause sudden, unexpected adverse cardiac events, and on the ability to identify them through imaging techniques before they occur.

21 Jan 2011

Archimedes, FDA collaborate to develop computer model of clinical trials evaluating weight loss medications

Archimedes Inc., a healthcare modeling company, announced today that it has entered into a Research Collaboration Agreement with the U.S. Food and Drug Administration (FDA) to develop a computer model of clinical trials evaluating weight loss medications. The model will be used to obtain a better understanding of the benefits of weight loss against the long-term risks of cardiovascular outcomes in patients treated with weight loss drugs.

20 Jan 2011

FDA grants Soligenix Orphan Drug Designation to RiVax for prevention of ricin intoxication

Soligenix, Inc., a late-stage biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to RiVax™ for the prevention of ricin intoxication. RiVax™ is a proprietary vaccine that contains a recombinant subunit of the A chain of ricin toxin which induces ricin neutralizing antibodies in humans and animals.

20 Jan 2011

ACD CPR performed with combination of ResQPump and ResQPOD could save lives of cardiac arrest patients

A combination of two devices could save the lives of thousands of cardiac arrest patients each year if implemented nationwide, suggests clinical trial results published in today's online edition of The Lancet.

20 Jan 2011

UnitedHealth Group reports net earnings of $4.10 per share for 2010

UnitedHealth Group today reported fourth quarter and full year 2010 financial results, including strong revenue growth from both its Health Benefits and Health Services business platforms. Full year and fourth quarter 2010 net earnings were $4.10 per share and $0.94 per share, respectively.

20 Jan 2011

Ingenix announces formation of new Life Sciences division

Ingenix, a leading provider of health care information, technology and consulting services, today announced the formation of Ingenix Life Sciences, a newly-organized division that focuses Ingenix's capabilities in assisting life sciences clients to identify, analyze and measure the value of their products.

20 Jan 2011

Medidata extends Grants Manager web-based budgeting application with new Contracting module

Medidata Solutions, a leading global provider of SaaS-based clinical development solutions, today extended the Grants Manager® web-based budgeting application with a new Contracting module, enabling sites and sponsors to negotiate clinical trial site budgets directly online, eliminating the burden of managing hundreds of email messages and reducing budgeting cycle times.

20 Jan 2011

Pervasis pursues matrix-embedded endothelial cell-based therapy to target and regulate cell stroma

Pervasis Therapeutics, Inc. today announced that the company is pursuing a matrix-embedded endothelial cell-based therapy (PVS-30200) to target and regulate cell stroma (the tumor environment or "ecosystem" that is comprised of various supporting cell types distinct from cancer cells) in order to prevent key processes that play a role in advancing solid tumor growth and metastasis.

20 Jan 2011

Koronis' KP-1461 drug causes extra mutations to occur in HIV genome in HIV-infected patients

Recently published Phase 2a clinical trial results show that the frequency of specific, drug-induced mutations in the HIV genome can be significantly increased by administering KP-1461, a drug being developed by Koronis Pharmaceuticals based on its novel Viral Decay Acceleration (VDA) drug mechanism.

20 Jan 2011

Clinical Trial News and Research

Bayer's gadobutrol injection for CNS imaging receives FDA Advisory Committee approval

SuppreMol completes successful pre-IND meeting with U.S. FDA

Scientists ignore relevant drug clinical trials when conducting new research on same topic

CRI, Oncovir sign new investment agreement to produce immunological stimulant

CVAF completes new investment agreement with Oncovir for production of Hiltonol

Additional data from HyperAcute Pancreas cancer immunotherapy Phase 2 trial to be presented at ASCO 2011

Scientist receives RO1 research grant to improve blood, marrow transplantation in myeloma patients

Major breakthrough: Genome-based medicine for treatment of alcoholism

Positive results from nimotuzumab Phase II study for gastric cancer

ACT Biotech releases telatinib Phase 2 trial data for metastatic stomach cancer

New gene test can predict tumor spread in bladder cancer patients

PROSPECT trial results shed new light on plaque types that cause unexpected heart attacks

Archimedes, FDA collaborate to develop computer model of clinical trials evaluating weight loss medications

FDA grants Soligenix Orphan Drug Designation to RiVax for prevention of ricin intoxication

ACD CPR performed with combination of ResQPump and ResQPOD could save lives of cardiac arrest patients

UnitedHealth Group reports net earnings of $4.10 per share for 2010

Ingenix announces formation of new Life Sciences division

Medidata extends Grants Manager web-based budgeting application with new Contracting module

Pervasis pursues matrix-embedded endothelial cell-based therapy to target and regulate cell stroma

Koronis' KP-1461 drug causes extra mutations to occur in HIV genome in HIV-infected patients

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