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FDA clears Omeros' OMS721 IND for inhibition of complement‑mediated TMAs

FDA clears Omeros' OMS721 IND for inhibition of complement‑mediated TMAs

Omeros Corporation today announced that its Investigational New Drug Application (IND) to evaluate OMS721 for the inhibition of complement‑mediated thrombotic microangiopathies (TMAs) has been cleared by the U.S. Food and Drug Administration. [More]
Amgen reports positive findings from AMG 145 Phase 3 studies in patients at risk for cardiovascular disease

Amgen reports positive findings from AMG 145 Phase 3 studies in patients at risk for cardiovascular disease

Amgen (NASDAQ: AMGN) today announced new detailed data from three Phase 3 studies that showed treatment with its novel investigational cholesterol-lowering medication, evolocumab (AMG 145), resulted in a statistically significant reduction of 55-66 percent in low-density lipoprotein cholesterol (LDL-C) compared to placebo in patients with high cholesterol. [More]

RuiYi declares $15M Series B financing to advance monoclonal antibodies targeting GPCR receptors

RuiYi, Inc. announced today a $15 million Series B financing by existing investors: 5AM Ventures, Versant Ventures, Apposite Capital, SR One, the independent corporate healthcare venture capital fund of GlaxoSmithKline, Merck Serono Ventures, the strategic corporate venture fund of Merck Serono, and Aravis SA. [More]
Research report on China's bevacizumab market

Research report on China's bevacizumab market

Research and Markets has announced the addition of the "Investigation Report on China Bevacizumab Market, 2009-2018" report to their offering. [More]
Concise analysis of China’s rituximab drug market

Concise analysis of China’s rituximab drug market

Research and Markets has announced the addition of the "Investigation Report on China Rituximab Market, 2009-2018" report to their offering. [More]
Brazil's ANVISA approves Genzyme's Lemtrada for multiple sclerosis treatment

Brazil's ANVISA approves Genzyme's Lemtrada for multiple sclerosis treatment

Genzyme, a Sanofi company, announced today that Brazil's national health surveillance agency, ANVISA, has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations. [More]
New treatment could halt progression of dementia

New treatment could halt progression of dementia

Researchers at the University of Texas Medical Branch at Galveston have discovered a way to potentially halt the progression of dementia caused by accumulation of a protein known as tau. [More]

Added benefit of ipilimumab in advanced melanoma not proven for non-pretreated patients

The German Institute for Quality and Efficiency in Health Care already assessed the added benefit of ipilimumab in advanced melanoma in 2012. A considerable added benefit was found for patients who had already received previous treatment. In the new dossier compiled by the drug manufacturer, the drug was now compared with the appropriate comparator therapy dacarbazine specified by the Federal Joint Committee (G-BA) also for non-pretreated patients. [More]
Amgen announces results from Phase 3 TESLA Trial of evolocumab in patients with HoFH

Amgen announces results from Phase 3 TESLA Trial of evolocumab in patients with HoFH

Amgen (NASDAQ: AMGN) today announced that the Phase 3 TESLA (Trial Evaluating PCSK9 Antibody in Subjects with LDL Receptor Abnormalities) trial evaluating evolocumab met its primary endpoint of the percent reduction from baseline at week 12 in low-density lipoprotein cholesterol (LDL-C). [More]
Igenica Biotherapeutics doses first patient in Phase 1 clinical trial of IGN523 in patients with AML

Igenica Biotherapeutics doses first patient in Phase 1 clinical trial of IGN523 in patients with AML

Igenica Biotherapeutics, a company focused on the discovery and development of innovative antibodies and antibody-drug conjugates (ADCs) for the treatment of cancer, announced today that the first patient has been dosed in a Phase 1 clinical trial of IGN523 in patients with relapsed or refractory acute myeloid leukemia (AML). [More]

Glycoprofiling test could halve number of false-positives in diagnosis of ovarian cancer

The world's most widespread test for ovarian cancer reports false-positives in 94 of 100 diagnosed cases. Now, chemists at the University of Copenhagen working with clinical researchers at University College London have developed a method able to halve the number of false-positives. [More]
Scientists discover new protein that drive metastasis of cancer cells

Scientists discover new protein that drive metastasis of cancer cells

An international team of researchers led by scientists at The Wistar Institute have discovered and defined LIMD2, a protein that can drive metastasis, the process where tumors spread throughout the body. [More]

New sugar-test may reduce false-positive ovarian cancer screening tests

The world's most widespread test for ovarian cancer reports false-positives in 94 of 100 diagnosed cases. Now, chemists at the University of Copenhagen working with clinical researchers at University College London have developed a method able to halve the number of false-positives. When fully developed, the new test will spare a significant number of women from unnecessary worry and further testing. Furthermore, global health care providers stand to save substantial sums - just by including a test on a certain sugar molecule in tandem with the currently prevailing diagnostic test. [More]
Eisai collaborates with Biogen Idec to develop and commercialize treatment options for AD

Eisai collaborates with Biogen Idec to develop and commercialize treatment options for AD

Eisai Co., Ltd. and Biogen Idec announced today that they have entered into a collaboration to develop and commercialize two of Eisai's clinical candidates for Alzheimer's disease (AD), E2609 and BAN2401. [More]
Researchers find antibody that may be used in future treatments for recurrent small-cell lung cancer

Researchers find antibody that may be used in future treatments for recurrent small-cell lung cancer

Researchers at Norris Cotton Cancer Center have found an antibody that may be used in future treatments for recurrent small-cell lung cancer, which currently has no effective therapy. [More]
Omeros submits investigational new drug to initiate OMS721 Phase 2 clinical program

Omeros submits investigational new drug to initiate OMS721 Phase 2 clinical program

Omeros Corporation today announced that it has submitted to the U.S. Food and Drug Administration (FDA) an investigational new drug (IND) application to initiate the Phase 2 clinical program for OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin‑associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system. [More]

Dyax reports total revenues of $16.9 million for fourth quarter 2013

Dyax Corp. today announced financial results for the fourth quarter and year ended December 31, 2013. [More]
Infliximab drug shows promising results in treating children with Kawasaki Disease

Infliximab drug shows promising results in treating children with Kawasaki Disease

Kawasaki Disease (KD) is a severe childhood disease that many parents, even some doctors, mistake for an inconsequential viral infection. If not diagnosed or treated in time, it can lead to irreversible heart damage. [More]

Bevacizumab offers no benefit for patients newly diagnosed with glioblastoma

Adding bevacizumab (Avastin) to standard chemotherapy and radiation treatment does not improve survival for patients newly diagnosed with the often deadly brain cancer glioblastoma, researchers report in the Feb. 20 issue of the New England Journal of Medicine. [More]
CytoDyn submits PRO 140 Phase 2b trial protocol to FDA for treatment substitution in HIV patients

CytoDyn submits PRO 140 Phase 2b trial protocol to FDA for treatment substitution in HIV patients

CytoDyn Inc., a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, announced today that the Company has submitted a Phase 2b clinical trial protocol, for its lead product candidate, PRO 140, to the U.S. Food and Drug Administration for treatment substitution in patients with Human Immunodeficiency Virus (HIV). [More]