Monoclonal Antibody News and Research

RSS

Monoclonal antibodies (MAbs) are produced from a single B cell clone and can bind to a single type of antigen binding site. MAbs are homogenous antibodies that cannot form lattices with monomeric proteins as they can bind to only a single epitope on the antigen. Developed in the 1970s, MAbs can be produced against any given substance. Thus they can be used to detect and purify any substance of interest. This has made MAbs a powerful tool of molecular biology, biochemistry, and medicine.

Final data from Symphogen's rozrolimupab Phase 2 trial on primary immune thrombocytopenia

The hematology journal BLOOD published today a full-length article describing final Phase 2 data for Symphogen's rozrolimupab, a novel human recombinant mixture of 25 antibodies which all are manufactured simultaneously from a single batch.

22 Aug 2012

FDA extends action date for Pfizer’s tofacitinib NDA review

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the New Drug Application (NDA) for tofacitinib, an investigational oral treatment for adults with moderately to severely active rheumatoid arthritis (RA).

22 Aug 2012

FSH-specific polyclonal antibody might offer more effective way to prevent osteoporosis

A new study suggests that a polyclonal antibody that blocks follicle-stimulating hormone (FSH) in mice without ovaries might offer a more effective way to prevent or arrest osteoporosis than currently available treatments.

21 Aug 2012

Mepolizumab almost halves exacerbations in severe asthma patients

The largest study of patients with severe asthma to date, published in The Lancet special issue on respiratory medicine, shows that those treated with the monoclonal antibody mepolizumab experienced an almost 50% reduction in severe exacerbations, emergency room visits, and hospitalisations compared with patients given placebo.

17 Aug 2012

3SBio files APX001 IND application with SFDA in China

Apexigen, Inc., an emerging biopharmaceutical company focused on the discovery and development of monoclonal antibody therapeutics, announced today that its partner, 3SBio [SSRX] of Shenyang, China, filed an Investigational New Drug (IND) application for APX001, also known as SSS07, with the State Food and Drug Administration (SFDA) in China.

16 Aug 2012

Positive results from Acorda post-marketing commitment study of dalfampridine-ER for MS

Acorda Therapeutics, Inc. today announced top line results from a post-marketing commitment study evaluating a 5mg dose of dalfampridine-ER to improve walking in people with multiple sclerosis. The study failed to confirm efficacy of the 5mg dose.

13 Aug 2012

Genentech receives FDA approval for Lucentis to treat diabetic macular edema

Genentech, a member of the Roche Group, today announced that Lucentis (ranibizumab injection) was approved by the U.S. Food & Drug Administration (FDA) for treatment of diabetic macular edema (DME), an eye condition in people with diabetes that causes blurred vision, severe vision loss and sometimes blindness

12 Aug 2012

PharmAthene receives clinical hold order from FDA for SparVax rPA anthrax vaccine program

PharmAthene, Inc., a biodefense company developing medical countermeasures against biological and chemical threats, announced today it has received notification from the U.S. Food and Drug Administration (FDA) that its SparVax rPA anthrax vaccine program has been placed on clinical hold.

12 Aug 2012

University of Nevada researcher to optimize new rapid test for melioidosis

A new rapid test to diagnose melioidosis, a difficult infection to treat - and classified as a biothreat by the Centers for Disease Control and Prevention - is being optimized and tested by University of Nevada School of Medicine researcher David AuCoin.

9 Aug 2012

Amgen announces decision to stop ganitumab Phase 3 trial in advanced pancreatic cancer

Amgen today announced a decision to stop the ganitumab (AMG 479) Phase 3 GAMMA (Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas) trial following the recommendation of an independent Data Monitoring Committee (DMC) overseeing the trial.

9 Aug 2012

UMass Medical, Serum Institute of India partner on anti-rabies monoclonal antibody pivotal trial

A pivotal clinical trial for an anti-rabies human monoclonal antibody (RMAb) being developed through a collaborative partnership between MassBiologics of the University of Massachusetts Medical School and the Serum Institute of India, Ltd., is starting to enroll patients.

8 Aug 2012

Curcumin emerges as prime candidate for less expensive AD treatment

The spice compound that gives curry dishes their yellow color and pungent flavor is emerging as a prime candidate for a less expensive treatment for Alzheimer's disease (AD), according to an article in the current edition of Chemical & Engineering News. C&EN is the weekly newsmagazine of the American Chemical Society, the world's largest scientific society.

2 Aug 2012

FibroGen receives FDA Orphan Drug Designation for FG-3019 to treat IPF

FibroGen, Inc., today announced that FG-3019, the Company's human monoclonal antibody against connective tissue growth factor (CTGF), has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF).

31 Jul 2012

Rituximab aids remission in idiopathic membranous nephropathy

Rituximab achieves good rates of remission in patients with persistent idiopathic membranous nephropathy, with few serious adverse events, study results show.

31 Jul 2012

Progress with GSK in advancing VaxiRNA technology earns Alnylam $3.2M milestone payment

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has earned a development milestone payment from GlaxoSmithKline, totaling $3.2 million. The milestone payment is related to progress in the companies' collaboration on the use of VaxiRNA technology for the production of GSK influenza vaccine.

30 Jul 2012

Regeneron reports total revenues of $304 million for second quarter 2012

Regeneron Pharmaceuticals, Inc. announced financial and operating results for the second quarter of 2012 and provided an update on development programs.

25 Jul 2012

Anti-IL-3 monoclonal antibodies to treat early stage Rheumatoid Arthritis in development

SuppreMol GmbH, an autoimmune disease specialist, today announced a licensing agreement with the University Hospital of Regensburg to develop SM401, a humanized anti-IL-3 monoclonal antibody for early diagnosis and treatment of Rheumatoid Arthritis (RA). SuppreMol will advance preclinical development of SM401 for treatment of RA. Simultaneously, the Company will further validate a highly sensitive human IL-3 diagnostic assay for patient stratification.

24 Jul 2012

EMA CHMP issues positive opinion for conditional approval of brentuximab vedotin for lymphoma

Millennium: The Takeda Oncology Company and, Takeda Pharmaceutical Company Limited today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for conditional approval of brentuximab vedotin for two indications.

21 Jul 2012

New antibody can be used as early diagnostic tool for Parkinson's

Conditions such as Parkinson's disease are a result of pathogenic changes to proteins. In the neurodegenerative condition of Parkinson's disease, which is currently incurable, the alpha-synuclein protein changes and becomes pathological. Until now, there have not been any antibodies that could help to demonstrate the change in alpha-synuclein associated with the disease. An international team of experts led by Gabor G. Kovacs from the Clinical Institute of Neurology at the MedUni Vienna has now discovered a new antibody that actually possesses this ability.

21 Jul 2012

Regeneron, Sanofi initiate enrollment in SAR236553/REGN727 Phase 3 program

Sanofi and Regeneron Pharmaceuticals, Inc. announced today that several trials within ODYSSEY, the Phase 3 clinical program of SAR236553/REGN727, have initiated patient enrollment.

21 Jul 2012

Monoclonal Antibody News and Research

Further Reading

Final data from Symphogen's rozrolimupab Phase 2 trial on primary immune thrombocytopenia

FDA extends action date for Pfizer’s tofacitinib NDA review

FSH-specific polyclonal antibody might offer more effective way to prevent osteoporosis

Mepolizumab almost halves exacerbations in severe asthma patients

3SBio files APX001 IND application with SFDA in China

Positive results from Acorda post-marketing commitment study of dalfampridine-ER for MS

Genentech receives FDA approval for Lucentis to treat diabetic macular edema

PharmAthene receives clinical hold order from FDA for SparVax rPA anthrax vaccine program

University of Nevada researcher to optimize new rapid test for melioidosis

Amgen announces decision to stop ganitumab Phase 3 trial in advanced pancreatic cancer

UMass Medical, Serum Institute of India partner on anti-rabies monoclonal antibody pivotal trial

Curcumin emerges as prime candidate for less expensive AD treatment

FibroGen receives FDA Orphan Drug Designation for FG-3019 to treat IPF

Rituximab aids remission in idiopathic membranous nephropathy

Progress with GSK in advancing VaxiRNA technology earns Alnylam $3.2M milestone payment

Regeneron reports total revenues of $304 million for second quarter 2012

Anti-IL-3 monoclonal antibodies to treat early stage Rheumatoid Arthritis in development

EMA CHMP issues positive opinion for conditional approval of brentuximab vedotin for lymphoma

New antibody can be used as early diagnostic tool for Parkinson's

Regeneron, Sanofi initiate enrollment in SAR236553/REGN727 Phase 3 program

Antibodies eBook

Latest eBooks

Industry Focus eBook - Analytical Chemistry (3rd edition)

Industry Focus eBook - Microbiome (1st edition)

Industry Focus eBook - Cell biology (5th edition)

Advancing degrader and proximity-based drug development

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®