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Scientists chemically synthesize ECA-derived oligosaccharides relevant for immunotherapy

Scientists chemically synthesize ECA-derived oligosaccharides relevant for immunotherapy

Immunotherapy using monoclonal antibodies is a promising treatment strategy, and it might now be within reach: American scientists have successfully prepared an oligosaccharide enterobacterial antigen for which a monoclonal antibody has been developed. The study is published in the journal Angewandte Chemie. [More]
CMC Biologics, River Vision sign manufacturing agreement for Teprotumumab to treat Grave's Orbitopathy

CMC Biologics, River Vision sign manufacturing agreement for Teprotumumab to treat Grave's Orbitopathy

CMC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, and River Vision Development Corporation (River Vision), a private company focused on ophthalmology, announced today that they have entered into an agreement for the process transfer and cGMP production of RV001 (Teprotumumab) – a recombinant monoclonal antibody targeting insulin-like growth factor 1 that is in development for treatment of Grave's Orbitopathy and other indications. [More]
FDA approves Praluent (alirocumab) Injection for treatment of patients with high LDL cholesterol

FDA approves Praluent (alirocumab) Injection for treatment of patients with high LDL cholesterol

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration approved Praluent (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. [More]
EMA's CHMP recommends approval of Praluent (alirocumab) for use in patients with hypercholesterolemia

EMA's CHMP recommends approval of Praluent (alirocumab) for use in patients with hypercholesterolemia

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent (alirocumab), recommending its approval for use in certain adult patients with hypercholesterolemia. [More]
3SBio purchases entire equity interest in Zhejiang Wansheng

3SBio purchases entire equity interest in Zhejiang Wansheng

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that it has acquired the entire equity interest in Zhejiang Wansheng Pharmaceutical Co., Ltd a limited liability company incorporated in the PRC for an aggregate consideration of RMB 528 million. [More]
Omeros' OMS721 granted FDA Fast Track designation for treatment of atypical hemolytic uremic syndrome

Omeros' OMS721 granted FDA Fast Track designation for treatment of atypical hemolytic uremic syndrome

Omeros Corporation today announced that the U.S. Food and Drug Administration granted Fast Track designation to OMS721 for the treatment of patients with atypical hemolytic uremic syndrome (aHUS). OMS721 is 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]
New monoclonal antibodies may provide blueprint for effective Alzheimer's disease treatments

New monoclonal antibodies may provide blueprint for effective Alzheimer's disease treatments

Scientists at NYU Langone Medical Center's Center for Cognitive Neurology have evidence that monoclonal antibodies they developed may provide the blueprint for effective treatments for Alzheimer's disease and other neurodegenerative diseases, such as Parkinson's disease. [More]
ZEVALIN drug now available to non-Hodgkin's lymphoma patients in Hong Kong

ZEVALIN drug now available to non-Hodgkin's lymphoma patients in Hong Kong

CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announces that ZEVALIN is now available at hospitals in Hong Kong to patients with indicated non-Hodgkin's lymphoma (NHL), including at Hong Kong Sanatorium & Hospital. [More]
New research offers potential for early intervention to prevent neurodegenerative diseases

New research offers potential for early intervention to prevent neurodegenerative diseases

New research led by investigators at Beth Israel Deaconess Medical Center provides the first direct evidence linking traumatic brain injury to Alzheimer's disease and chronic traumatic encephalopathy (CTE) -- and offers the potential for early intervention to prevent the development of these debilitating neurodegenerative diseases. [More]
Study examines how low-methionine diet may help improve outcomes in triple-negative breast cancer patients

Study examines how low-methionine diet may help improve outcomes in triple-negative breast cancer patients

A diet that starves triple-negative breast cancer cells of an essential nutrient primes the cancer cells to be more easily killed by a targeted antibody treatment, UW Carbone Cancer Center scientists report in a recent publication. [More]
Janssen-sponsored Phase 2b trial shows guselkumab effective in treating moderate to severe plaque psoriasis

Janssen-sponsored Phase 2b trial shows guselkumab effective in treating moderate to severe plaque psoriasis

Results published today in The New England Journal of Medicine from a Janssen Research & Development, LLC (Janssen)-sponsored Phase 2b trial showed up to 86 percent of patients with moderate to severe plaque psoriasis receiving guselkumab (CNTO 1959) achieved a Physician's Global Assessment (PGA) score of cleared psoriasis or minimal psoriasis at week 16, the study's primary endpoint. [More]
Phase 3 ODYSSEY JAPAN trial of Praluent injection meets primary endpoint

Phase 3 ODYSSEY JAPAN trial of Praluent injection meets primary endpoint

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the Phase 3 ODYSSEY JAPAN trial of the investigational therapy Praluent® (alirocumab) Injection met its primary endpoint. [More]
Ludwig, CRI launch clinical trials to evaluate immunotherapies for treatment of GBM and solid tumors

Ludwig, CRI launch clinical trials to evaluate immunotherapies for treatment of GBM and solid tumors

Ludwig Cancer Research and the Cancer Research Institute have launched clinical trials evaluating an immunotherapy for the treatment of the brain cancer glioblastoma multiforme (GBM), and a combination of immunotherapies for a variety of solid tumors. [More]
Aridis expands, accelerates current AR-301 Phase 2a study for treatment of acute pneumonia in the U.S.

Aridis expands, accelerates current AR-301 Phase 2a study for treatment of acute pneumonia in the U.S.

Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel anti-infectives and immunotherapies for infectious diseases, announced today that the U.S. Food and Drug Administration has accepted its Investigational New Drug (IND) application for AR-301, also referred to as Salvecin, the company's fully human anti-Staphylococcal α-toxin IgG1 monoclonal antibody being developed for the treatment of hospital-acquired and ventilator-associated pneumonia (HAP and VAP) caused by Staphylococcus aureus, including multi-drug resistant 'MRSA' strains. [More]
Aytu BioScience now trading under new symbol following its corporate name change

Aytu BioScience now trading under new symbol following its corporate name change

Aytu BioScience, Inc., a specialty healthcare company focused on developing treatments for urological and related conditions, announced today that the company is now trading under the new symbol "AYTU," following its corporate name change, which became effective June 8, 2015. [More]
New treatment option available for CLL patients in Manitoba and Saskatchewan

New treatment option available for CLL patients in Manitoba and Saskatchewan

People in Manitoba and Saskatchewan living with Chronic Lymphocytic Leukemia (CLL) will now be able to access a new treatment option through the prescription drug insurance plans in both provinces. Earlier this week, GAZYVA (obinutuzumab) in combination with chlorambucil chemotherapy was added to benefits formularies of the Provincial Oncology Drug Programs at CancerCare Manitoba and the Saskatchewan Cancer Agency. [More]
Research finding could lead to first effective therapies, vaccines against dengue virus

Research finding could lead to first effective therapies, vaccines against dengue virus

Researchers at Vanderbilt University and the National University of Singapore have determined the structure of a human monoclonal antibody which, in an animal model, strongly neutralizes a type of the potentially lethal dengue virus. [More]
Aridis' Aerucin gets FDA Fast Track Designation for treatment of hospital-acquired and ventilator-associated pneumonia

Aridis' Aerucin gets FDA Fast Track Designation for treatment of hospital-acquired and ventilator-associated pneumonia

Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel therapies for infectious diseases, announced today that the U.S. Food and Drug Administration granted Fast Track Designation to its fully human monoclonal antibody Aerucin for the treatment of hospital-acquired and ventilator-associated pneumonia caused by Pseudomonas aeruginosa. [More]
American Journal of Respiratory and Critical Care Medicine publishes overview of MERS-CoV outbreak in Korea

American Journal of Respiratory and Critical Care Medicine publishes overview of MERS-CoV outbreak in Korea

An overview and analysis of the factors underlying the recent Middle East Respiratory Syndrome coronavirus (MERS-CoV) outbreak in Korea has been published online ahead of print in the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine. [More]
Synthetic Biologics announces initiation of SYN-010 Phase 2 clinical trial for treatment of IBS-C

Synthetic Biologics announces initiation of SYN-010 Phase 2 clinical trial for treatment of IBS-C

Synthetic Biologics, Inc., a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, reported the initiation of a Phase 2 clinical trial of its proprietary SYN-010 for the treatment of irritable bowel syndrome with constipation (IBS-C). [More]
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