Antibody News and Research

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An antibody is a blood protein that is produced in response to and counteracts an antigen. Antibodies are produced in response to disease and help the body fight against the particular disease. In this way, antibodies help the body develop an immunity to disease.

Cellerant Therapeutics signs contract with BARDA to develop CLT-008 therapy for ARS

Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has signed a contract valued at up to $153 million over five years with the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response of the Department of Health and Human Services, to develop CLT-008, a cellular therapy for the treatment of Acute Radiation Syndrome (ARS).

2 Sep 2010

Nabi Biopharmaceuticals, Diosynth sign long-term commercial manufacturing agreement

Nabi Biopharmaceuticals announced today that it has entered into a long-term commercial manufacturing agreement with Diosynth RTP, Inc. for the manufacture of Drug Substance integral to the production of NicVAX, Nabi's innovative and proprietary investigational vaccine for the treatment of nicotine addiction and prevention of smoking relapse.

2 Sep 2010

ThromboGenics second microplasmin Phase III trial for non-surgical treatment of VMA meets primary endpoint

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer announces that its second Phase III trial evaluating microplasmin for the non-surgical treatment of vitreomacular adhesion (VMA) has met its primary endpoint.

2 Sep 2010

Agensys commences AGS-16M8F ADC Phase I clinical trial for renal cancer

Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a Phase I clinical trial of AGS-16M8F an antibody-drug conjugate (ADC) that is being developed for the treatment of metastatic renal cancer. An ADC uses the specific binding properties of an antibody to target a toxin in tumor cells, resulting in selective tumor cell killing.

2 Sep 2010

Neutralizing key toxin associated with Staph aureus bacteria reduces severity of skin and soft-tissue damage

Scientists from the National Institutes of Health and University of Chicago have found a promising treatment method that in laboratory mice reduces the severity of skin and soft-tissue damage caused by USA300, the leading cause of community-associated Staphylococcus aureus infections in the United States.

2 Sep 2010

Quidel's RapidVue hCG lateral flow pregnancy immunoassay granted FDA 510(k) clearance

Quidel Corporation, a leading provider of rapid diagnostic testing solutions, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of Quidel's RapidVue® hCG test, a lateral flow pregnancy immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG).

2 Sep 2010

PDL BioPharma reports revenue guidance of $86 million for 2010 third quarter

PDL BioPharma, Inc. today announced revenue guidance for the third quarter ended September 30, 2010 of approximately $86 million, as compared with actual results of $71.4 million for the third quarter of 2009, a 20 percent year-over-year increase.

2 Sep 2010

Stromedix's STX-100 receives orphan drug status from FDA for treatment of IPF

Stromedix, Inc., a biotechnology company focused on innovative therapies for fibrosis and fibrotic organ failure, announced today that its lead clinical candidate STX-100 has been granted orphan drug status by the U.S. Food and Drug Administration for the treatment of idiopathic pulmonary fibrosis, a debilitating and almost uniformly fatal disease in which patients experience progressive difficulty breathing due to fibrosis (scarring) of the lung.

31 Aug 2010

MGH scientists develop new microfluidic tool for accurate isolation of neutrophils

A team led by Massachusetts General Hospital (MGH) scientists has developed a new microfluidic tool for quickly and accurately isolating neutrophils - the most abundant type of white blood cell - from small blood samples, an accomplishment that could provide information essential to better understanding the immune system's response to traumatic injury. The system, described in a Nature Medicine paper that received advance online release, also can be adapted to isolate almost any type of cell.

31 Aug 2010

Roche's MabThera continues to dwarf recently launched monoclonal antibodies: Report

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia, 41 percent of surveyed European hematologist-oncologists say that the favorable efficacy profile of Roche's MabThera (rituximab) is the most significant driver of their use of this brand, while 26 percent say MabThera's favorable risk-benefit profile is the most significant driver.

31 Aug 2010

Eisai receives new action date for FDA priority review of eribulin mesylate NDA for metastatic breast cancer

Eisai Inc. announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency expects to complete priority review of the eribulin mesylate New Drug Application (NDA) for locally advanced or metastatic breast cancer on or before December 30, 2010, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date of September 30, 2010.

30 Aug 2010

New methodologies for protein measurement needed to address adulteration in infant formula and pet food

Recent incidents of adulteration involving infant formula, other milk products and pet food with the industrial chemical melamine revealed the weaknesses of current methods widely used across the domestic and global food industry for determining protein content in foods. The possible utility of alternative existing and emerging methods is the subject of a new paper published in Comprehensive Reviews in Food Science and Food Safety, a peer-reviewed journal of the Institute of Food Technologists (IFT).

27 Aug 2010

Genentech receives FDA Refuse to File letter for accelerated approval of trastuzumab-DM1 BLA

ImmunoGen, Inc., a biotechnology company that develops antibody-based targeted anticancer products, today announced that Genentech, a member of the Roche Group, today announced its receipt of a Refuse to File (RTF) letter from the US Food and Drug Administration (FDA) for the accelerated approval of the Biologic License Application (BLA) for trastuzumab-DM1, or T-DM1, submitted in July 2010.

27 Aug 2010

Athera Biotechnologies, Electra-Box Diagnostica sign distribution agreement for 'CVDefine' kit

Athera Biotechnologies and Electra-Box Diagnostica, announced today that they have signed an agreement for distribution of "CVDefine" kit. CVDefine measures a new biomarker in blood, a specific anti-body, that has been linked to increased risk for cardiovascular disease. Athera Biotechnologies is part of the Karolinska Development portfolio.

27 Aug 2010

Immunomedics 2010 fourth quarter revenue decreases to $0.7 million

Immunomedics, Inc., a biopharmaceutical company primarily focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today reported financial results for the fourth quarter and fiscal year ended June 30, 2010.

27 Aug 2010

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

In its review of the BLA, the FDA stated the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population.

27 Aug 2010

Octapharma completes clinical development of Uniplas human pooled plasma

Octapharma AG, one of the largest private manufacturers of plasma products in the world, announced today that the clinical development for Uniplas® has been successfully completed. The product has been filed for registration in Europe and will be submitted later in the USA.

26 Aug 2010

FDA grants LFB's recombinant anti-CD20 monoclonal antibody orphan drug status for CLL

The recombinant anti-CD20 monoclonal antibody produced by LFB Biotechnologies received orphan drug status for the treatment of Chronic Lymphocytic Leukemia (CLL). This approval from the FDA Office of Orphan Products Development was granted on August 6th, 2010.

26 Aug 2010

Nabi receives US patent for treatment and prevention of nicotine addiction with NicVAX conjugate vaccines

Nabi Biopharmaceuticals announced the receipt of a patent for treating and preventing nicotine addiction with NicVAX® and related nicotine conjugate vaccines. The United States Patent and Trademark office issued U.S. Patent No. 7,776,620 entitled "Hapten-carrier conjugates for treating and preventing nicotine addiction" for the exclusive use of methods for treating and preventing nicotine addiction with NicVAX and related nicotine vaccines. This patent runs through December 2018.

26 Aug 2010

Biogen to publish data on two-step assay for anti-JC virus antibody detection

Biogen Idec and Elan Corporation, plc today announced data has been published in the Annals of Neurology on an investigational, two-step assay to detect anti-JC virus (JCV) antibodies in human serum and plasma

26 Aug 2010

Antibody News and Research

Further Reading

Cellerant Therapeutics signs contract with BARDA to develop CLT-008 therapy for ARS

Nabi Biopharmaceuticals, Diosynth sign long-term commercial manufacturing agreement

ThromboGenics second microplasmin Phase III trial for non-surgical treatment of VMA meets primary endpoint

Agensys commences AGS-16M8F ADC Phase I clinical trial for renal cancer

Neutralizing key toxin associated with Staph aureus bacteria reduces severity of skin and soft-tissue damage

Quidel's RapidVue hCG lateral flow pregnancy immunoassay granted FDA 510(k) clearance

PDL BioPharma reports revenue guidance of $86 million for 2010 third quarter

Stromedix's STX-100 receives orphan drug status from FDA for treatment of IPF

MGH scientists develop new microfluidic tool for accurate isolation of neutrophils

Roche's MabThera continues to dwarf recently launched monoclonal antibodies: Report

Eisai receives new action date for FDA priority review of eribulin mesylate NDA for metastatic breast cancer

New methodologies for protein measurement needed to address adulteration in infant formula and pet food

Genentech receives FDA Refuse to File letter for accelerated approval of trastuzumab-DM1 BLA

Athera Biotechnologies, Electra-Box Diagnostica sign distribution agreement for 'CVDefine' kit

Immunomedics 2010 fourth quarter revenue decreases to $0.7 million

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

Octapharma completes clinical development of Uniplas human pooled plasma

FDA grants LFB's recombinant anti-CD20 monoclonal antibody orphan drug status for CLL

Nabi receives US patent for treatment and prevention of nicotine addiction with NicVAX conjugate vaccines

Biogen to publish data on two-step assay for anti-JC virus antibody detection

Immunology eBook

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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