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SARIL-RA-TARGET trial: Sarilumab meets co-primary efficacy endpoints in RA patients

SARIL-RA-TARGET trial: Sarilumab meets co-primary efficacy endpoints in RA patients

Regeneron Pharmaceuticals, Inc. and Sanofi announced today that a Phase 3 study of sarilumab, an investigational, fully human IL-6 receptor antibody, met its co-primary efficacy endpoints of a greater improvement in signs and symptoms of rheumatoid arthritis (RA) at 24 weeks and physical function at 12 weeks, compared to placebo. [More]
New data shows safety and efficacy of biosimilar infliximab treatment in IBD patients

New data shows safety and efficacy of biosimilar infliximab treatment in IBD patients

Clinical experience of biosimilar infliximab in 78 inflammatory bowel disease (IBD) patients presented at Digestive Diseases Week (DDW) 2015 in Washington D.C. showed that the treatment is comparable to the reference medicinal product (RMP) in terms of efficacy and safety. [More]
Immune Pharmaceuticals announces Q1 2015 financial results; files Quarterly Report on Form 10-Q

Immune Pharmaceuticals announces Q1 2015 financial results; files Quarterly Report on Form 10-Q

Immune Pharmaceuticals Inc. announced financial results for the first quarter ended March 31, 2015. Immune filed its Quarterly Report on Form 10-Q for the first quarter of 2015 on Friday, May 15, 2015. [More]
Results from four major studies on cancer treatments to be presented at ASCO Annual Meeting

Results from four major studies on cancer treatments to be presented at ASCO Annual Meeting

The American Society of Clinical Oncology today announced results from four major studies to be presented at ASCO's 51st Annual Meeting, May 29-June 2, in Chicago. Findings showed that use of a widely available vitamin pill reduces the risk of non-melanoma skin cancers; that early chemotherapy extends the lives of men with advanced prostate cancers; and that new therapies can improve outcomes for children with a rare form of kidney cancer and adults with relapsed multiple myeloma. [More]
TSRI researchers find interferon beta protein as prime suspect in persistent viral infections

TSRI researchers find interferon beta protein as prime suspect in persistent viral infections

Interferon proteins are normally considered virus-fighters, but scientists at The Scripps Research Institute have found evidence that one of them, interferon beta (IFN╬▓), has an immune-suppressing effect that can help some viruses establish persistent infections. [More]
Stanford University professor named recipient of 2015 ECOG-ACRIN Young Investigator Award

Stanford University professor named recipient of 2015 ECOG-ACRIN Young Investigator Award

Heather Wakelee, MD, is the recipient of the 2015 ECOG-ACRIN Young Investigator Award, the ECOG-ACRIN Cancer Research Group announced today. Dr. Wakelee is associate professor of medicine in the Division of Oncology at the Stanford University School of Medicine in Stanford, Calif. [More]
Preclinical data from Synthetic Biologics' SYN-005 for Pertussis treatment presented at ECCMID 2015

Preclinical data from Synthetic Biologics' SYN-005 for Pertussis treatment presented at ECCMID 2015

Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, announced that preclinical data from its novel SYN-005 program for the treatment of Pertussis were presented in two posters at ECCMID 2015 (European Congress of Clinical Microbiology and Infectious Diseases), on April 25, 2015, in Copenhagen, Denmark. [More]
Study: Extending natalizumab treatment effective in preventing MS symptoms

Study: Extending natalizumab treatment effective in preventing MS symptoms

In a study of 1,964 patients with multiple sclerosis (MS) led by researchers at the NYU Langone Multiple Sclerosis Comprehensive Care Center, extending the dose of natalizumab from 4 weeks up to 8 weeks was shown to be well-tolerated and effective in patients, and resulted in no cases of the potentially fatal side effect progressive multifocal leukoencephalopathy (PML). [More]
New drug combination shows promise in patients with metastatic melanoma

New drug combination shows promise in patients with metastatic melanoma

Once again, researchers at Penn's Abramson Cancer Center have extended the reach of the immune system in the fight against metastatic melanoma, this time by combining the checkpoint inhibitor tremelimumab with an anti-CD40 monoclonal antibody drug. [More]
Researchers explore benefits and risks of biosimilar antibodies

Researchers explore benefits and risks of biosimilar antibodies

In the emerging biosimilar market, biosimilar antibodies are being developed to treat conditions currently addressed by their original, targeted biological therapy. Only a few biosimilars are approved by the EMA, and just one has been approved by the FDA. In a review article, researchers used the clinical development data from one drug to explore the broader benefits and risks of these cost-effective, but as yet unfamiliar treatment options. [More]
NIST researchers develop new 2D NMR fingerprinting method to measure monoclonal antibodies

NIST researchers develop new 2D NMR fingerprinting method to measure monoclonal antibodies

National Institute of Standards and Technology researchers at the Institute for Bioscience and Biotechnology Research have demonstrated the most precise method yet to measure the structural configuration of monoclonal antibodies (mAbs), an important factor in determining the safety and efficacy of these biomolecules as medicines. [More]

New longer-term data on Genzyme's relapsing MS treatments to be presented at AAN 2015

Genzyme, a Sanofi company, announced today that new longer-term data on its relapsing multiple sclerosis treatments, Aubagio (teriflunomide) and Lemtrada (alemtuzumab), will be featured during the 67th annual meeting of the American Academy of Neurology being held in Washington, D.C. April 18-25. [More]
Vanderbilt researchers join multi-center effort to accelerate development of potential Ebola therapy

Vanderbilt researchers join multi-center effort to accelerate development of potential Ebola therapy

Vanderbilt University researchers have joined a multi-center effort led by Pennsylvania-based Inovio Pharmaceuticals Inc. to accelerate development of potential antibody therapies against the often-lethal Ebola virus. [More]
MabVax closes $11.6 million in private placement

MabVax closes $11.6 million in private placement

MabVax Therapeutics Holdings, Inc., a clinical-stage cancer immunotherapy company, is pleased to announce that it has closed on gross proceeds of approximately $11.6 million in a private placement (the "Private Placement") led by OPKO Health, Inc. and Dr. Phillip Frost, CEO and Chairman of OPKO Health. [More]
Astellas Pharma, MD Anderson sign option agreement to research and develop new treatment for AML

Astellas Pharma, MD Anderson sign option agreement to research and develop new treatment for AML

Astellas Pharma Inc. and The University of Texas MD Anderson Cancer Center today announced the signing of an option agreement to research and develop a new treatment for patients with acute myeloid leukemia (AML). [More]
World-first human clinical trials for Hendra virus to begin this month

World-first human clinical trials for Hendra virus to begin this month

An antibody manufactured at The University of Queensland will be used in world-first human Hendra virus clinical trials starting this month. [More]
Hospira announces availability of INFLECTRA (infliximab) in Canada

Hospira announces availability of INFLECTRA (infliximab) in Canada

Hospira, Inc., a global leader in biosimilars and the world's leading provider of injectable drugs and infusion technologies, announces the availability of INFLECTRA (infliximab) in Canada, the country's first subsequent entry biologic (SEB) monoclonal antibody (mAb) therapy. [More]
Synthetic Biologics begins SYN-004 Phase 2a clinical trial to prevent C. difficile infection

Synthetic Biologics begins SYN-004 Phase 2a clinical trial to prevent C. difficile infection

Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced the initiation of a Phase 2a clinical trial to evaluate the gastrointestinal (GI) antibiotic-degrading effects and the safety of SYN-004, the Company's investigational oral beta-lactamase enzyme designed to protect the microbiome and prevent C. difficile infection (CDI). [More]

CFDA accepts WuXi MedImmune's novel anti-IL6 monoclonal antibody IND application for review

WuXi PharmaTech (Cayman) Inc., a leading open-access R&D capability and technology platform company serving the global pharmaceutical, biotechnology, and medical device industries, announced today that an Investigational New Drug (IND) application for WuXi MedImmune's novel anti-IL6 monoclonal antibody for rheumatoid arthritis has been accepted for review by the China Food and Drug Administration. [More]
Aridis Pharmaceuticals begins Aerucin Phase 1 clinical study for treatment of acute pneumonia

Aridis Pharmaceuticals begins Aerucin Phase 1 clinical study for treatment of acute pneumonia

Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel therapies for infectious diseases, announced today the initiation of a Phase 1 clinical study of Aerucin, the Company's fully human IgG1 monoclonal antibody (mAb) against Pseudomonas aeruginosa bacteria, which is being developed as an adjunctive treatment for acute pneumonia. [More]
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