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

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]
Amgen seeks marketing approval of Repatha (evolocumab) in Japan for treatment of high cholesterol

Amgen seeks marketing approval of Repatha (evolocumab) in Japan for treatment of high cholesterol

Amgen today announced that an application seeking marketing approval of Repatha (evolocumab) for the treatment of high cholesterol has been submitted for review to the Ministry of Health, Labour and Welfare in Japan. [More]
Eli Lilly, Innovent Biologics announce biotech drug development collaborations in China

Eli Lilly, Innovent Biologics announce biotech drug development collaborations in China

Eli Lilly and Company and Innovent Biologics, Inc. today announced one of the largest biotech drug development collaborations in China to date between a multi-national and domestic company. [More]
Cosentyx (secukinumab) safe, effective for treating psoriasis patients

Cosentyx (secukinumab) safe, effective for treating psoriasis patients

Novartis today announced new two-year results demonstrating sustained efficacy with Cosentyx (secukinumab) with an acceptable safety profile for the treatment of psoriasis patients. The data comes from the extension study of the pivotal Phase III FIXTURE and ERASURE trials. [More]
New range of purified, soluble immunoreceptors announced by AMSBIO

New range of purified, soluble immunoreceptors announced by AMSBIO

AMSBIO has announced a new range of purified, soluble immunoreceptors involved in key signalling pathways. Together with new indoleamine 2,3-dioxygenase (IDO) assay kits these products that can be used to screen for inhibitors of protein-protein interaction, as well as neutralizing antibodies that serve as positive controls for inhibition. [More]
Novimmune tests NI-0501 as first-line treatment for hemophagocytic lymphohistiocytosis

Novimmune tests NI-0501 as first-line treatment for hemophagocytic lymphohistiocytosis

Novimmune SA announces that patients diagnosed with hemophagocytic lymphohistiocytosis (HLH), and who are participating in the company's ongoing clinical trial of its NI-0501 monoclonal antibody, will now be able to be treated with the drug without having to first fail conventional treatments. [More]
United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics Corporation announced today that the United States Food and Drug Administration has approved Unituxin (dinutuximab) Injection (formerly called ch14.18), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. [More]
Chronic heart failure patients with decreased calcitriol may benefit from aggressive supplementation

Chronic heart failure patients with decreased calcitriol may benefit from aggressive supplementation

In patients with chronic heart failure, the vitamin D metabolite 1,25-dihydroxyvitamin D (1,25(OH)2D), also called calcitriol, and its ratio to parathyroid hormone (PTH 1-84) may help predict cardiovascular death; and patients with decreased calcitriol and decreased ratio of calcitriol to PTH might benefit from more aggressive supplementation, a new study finds. [More]
Diplomat Pharmacy selected to distribute Novartis' COSENTYX (secukinumab)

Diplomat Pharmacy selected to distribute Novartis' COSENTYX (secukinumab)

Diplomat Pharmacy, Inc. has been selected to the Novartis limited-distribution panel to distribute COSENTYX (secukinumab), a drug approved in January by the U.S. Food and Drug Administration to treat adults with moderate-to-severe plaque psoriasis. [More]
Celimmune licenses anti-IL-15 monoclonal antibody from Amgen

Celimmune licenses anti-IL-15 monoclonal antibody from Amgen

Celimmune LLC, a clinical development-stage immunotherapy company focused on treating and preventing autoimmune diseases, announced today that it has licensed a Phase 2-stage, anti-IL-15 monoclonal antibody (AMG 714) from Amgen. [More]
Mundipharma launches Remsima® (infliximab), a new-generation value-based monoclonal antibody, in six European markets

Mundipharma launches Remsima® (infliximab), a new-generation value-based monoclonal antibody, in six European markets

Mundipharma International Limited’s network of independent associated companies are launching Remsima® (infliximab) this month in Germany, Italy, UK, Netherlands, Belgium and Luxembourg following expiry of the relevant patents and Supplementary Protection Certificates, having secured distribution rights from Celltrion Healthcare Hungary Kft for Remsima in these markets. [More]
WuXi applauds TaiMed for receiving FDA breakthrough therapy designation for ibalizumab

WuXi applauds TaiMed for receiving FDA breakthrough therapy designation for ibalizumab

WuXi PharmaTech (Cayman) Inc., a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology, and medical device industries with operations in China and the United States, congratulates our partner TaiMed Biologics for receiving breakthrough therapy designation from the U.S. FDA for ibalizumab (TMB355). [More]
Hospira launches first biosimilar monoclonal antibody (mAb) InflectraTM (infliximab) in the UK

Hospira launches first biosimilar monoclonal antibody (mAb) InflectraTM (infliximab) in the UK

Inflectra is licensed for the treatment of inflammatory conditions including rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, adult and paediatric ulcerative colitis and plaque psoriasis. [More]
Remsima (infliximab) now available in Europe for treatment of autoimmune diseases

Remsima (infliximab) now available in Europe for treatment of autoimmune diseases

Celltrion Healthcare has today announced the launch of Remsima (infliximab) in 12 European markets: Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain, Sweden and the UK. [More]
Reslizumab drug appears to reduce risk of severe asthma attacks

Reslizumab drug appears to reduce risk of severe asthma attacks

An investigational drug appears to cut the risk of severe asthma attacks in half for patients who have difficulty controlling the disorder with standard medications, according to results from two multicenter clinical trials. [More]
Clinical data demonstrates safety, efficacy of vedolizumab for treatment of adults with UC and CD

Clinical data demonstrates safety, efficacy of vedolizumab for treatment of adults with UC and CD

Takeda Pharmaceuticals International GmbH today announced the presentation of data further demonstrating the efficacy and safety of vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). [More]
InflectraTM (infliximab) patient registry reports interim results in the treatment of inflammatory bowel disease

InflectraTM (infliximab) patient registry reports interim results in the treatment of inflammatory bowel disease

Data have been presented today on the use of Hospira’s Inflectra (infliximab), the world’s first approved biosimilar monoclonal antibody (mAb), at the European Crohn’s and Colitis Organisation Inflammatory Bowel Diseases (ECCO-ibd) conference. [More]
Hospira announces launch of first biosimilar monoclonal antibody in Europe

Hospira announces launch of first biosimilar monoclonal antibody in Europe

Hospira, Inc., a world leader in the development of biosimilar therapies, today announced the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets. [More]

Retinal venular calibre predicts ranibizumab vision improvement

Retinal venular calibre may predict visual outcome in diabetic macular oedema patients given the anti-vascular endothelial growth factor monoclonal antibody ranibizumab, a pilot study suggests. [More]
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