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.

FDA confirms Advisory Committee meeting date for lorcaserin NDA review

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that the US Food and Drug Administration (FDA) has notified the company of the confirmed scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 16, 2010, for the review of the lorcaserin New Drug Application (NDA). Lorcaserin, which Arena discovered and has developed for weight management, is intended for obese patients as well as overweight patients who have at least one weight-related co-morbid condition.

7 Aug 2010

Progenics announces EMA CHMP positive opinion for RELISTOR in pre-filled syringes

Progenics Pharmaceuticals, Inc. today announced that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has issued a positive opinion for RELISTOR (methylnaltrexone bromide) subcutaneous injection in pre-filled syringes.

7 Aug 2010

BioMimetic Therapeutics reports net loss of $7.7M for second-quarter 2010

BioMimetic Therapeutics, Inc. today reported its financial results as of and for the three and six months ended June 30, 2010. For the three months ended June 30, 2010, the Company reported a net loss of $7.7 million, or $0.35 per diluted share, compared to a net loss of $6.3 million, or $0.32 per diluted share, for the same period in 2009. For the six months ended June 30, 2010, the Company reported a net loss of $16.2 million, or $0.73 per diluted share, compared to a net loss of $14.3 million, or $0.75 per diluted share, for the same period in 2009.

6 Aug 2010

Dyax announces first Phase 3 trial results of KALBITOR for acute HAE

Dyax Corp. announced today that results from EDEMA3, the Company's first Phase 3 trial evaluating KALBITOR (ecallantide) for the treatment of acute attacks of hereditary angioedema, were published in the August issue of The New England Journal of Medicine. KALBITOR, discovered and developed by Dyax, is available in the United States for the treatment of acute attacks of HAE in patients 16 years of age and older.

6 Aug 2010

Studies show biological agents play important role in maintaining remission in Crohn's disease

Biological agents may play an important role in maintaining remission in Crohn's disease, according to two new studies in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association Institute.

6 Aug 2010

YM concludes dose-escalation in CYT387 Phase I/II clinical trial for myelofibrosis

YM BioSciences Inc., announced the conclusion of dose-escalation in the Phase I portion of its Phase I/II clinical trial of CYT387 at Mayo Clinic in patients with myelofibrosis. In total, 21 patients were treated in Phase I, with no voluntary withdrawals reported. CYT387 has shown significant activity in reducing spleen size and controlling constitutional symptoms in these patients.

5 Aug 2010

Repligen total revenue for first-quarter fiscal 2011 increases 39% to $7.01 million

Repligen Corporation today reported results for the first quarter of fiscal year 2011, ended June 30, 2010. Total revenue for the first quarter was $7,010,000 compared to total revenue of $5,061,000 for the first quarter of fiscal year 2010, an increase of $1,949,000 or 39%. Bioprocessing product revenue for the first quarter was $4,269,000 compared to $2,473,000 for the first quarter of fiscal 2010, an increase of $1,796,000 or 73%.

5 Aug 2010

Micromet second-quarter 2010 total revenues increase to $6.5 million

Micromet, Inc., a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of cancer, today announced its financial results for the second quarter and six months ended June 30, 2010.

5 Aug 2010

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

Elusys awarded second contract to develop Anthim for treatment of anthrax infection

Elusys Therapeutics, Inc., a privately-held biopharmaceutical company, announced today that it has been awarded a second contract year of funding valued at $40.6 million for the advanced development of Anthim for the prevention and treatment of anthrax infection following a biowarfare attack. This funding is in addition to $16.8 million already received under this contract and is part of a potential five year contract award totaling up to $143 million if all options are exercised by the Government.

5 Aug 2010

ImmunoGen fourth-quarter 2010 net loss increases to $13.4 million

ImmunoGen, Inc., a biotechnology company that develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced financial results for the three-month period and fiscal year ended June 30, 2010.

5 Aug 2010

Sigma-Aldrich, NHLBI and BU collaborate in atherosclerotic cardiovascular disease research

Sigma-Aldrich® today announced it has entered into an agreement with the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health, and Boston University (BU) to develop methods to measure several potential biomarkers of atherosclerotic cardiovascular disease (CVD) using plasma samples from the NHLBI's Framingham Heart Study (FHS), one of the most prestigious clinical studies in medicine. Funding for the project is provided by the NHLBI to Sigma-Aldrich under a research subaward agreement with BU.

5 Aug 2010

Scientist invents new approach to boost body's response to vaccinations

As the medical community searches for better vaccines and ways to deliver them, a University of Rochester scientist believes he has discovered a new approach to boosting the body's response to vaccinations.Richard P. Phipps, Ph.D., found that the same molecules used in drugs that treat diabetes also stimulate B cells in the immune system, pushing them to make antibodies for protection against invading microorganisms.

5 Aug 2010

FDA designates XOMA 052 orphan drug for Behcet's disease

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, announced that the U.S. Food and Drug Administration has designated XOMA 052, an antibody to interleukin-1 beta, an orphan drug for the treatment of Behcet's disease. As previously announced, the Committee for Orphan Medical Products of the European Medicines Agency has recommended the granting of orphan medicinal product designation for XOMA 052 for the same indication in the European Union.

5 Aug 2010

Acceleron's ACE-031 protein therapeutic for DMD receives FDA Fast Track designation

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including muscle, bone, fat, red blood cells and the vasculature, today announced it received FDA Fast Track designation for ACE-031 for the treatment of Duchenne Muscular Dystrophy (DMD), a fatal neuromuscular disease in which patients suffer from the progressive loss of muscle mass and strength. ACE-031 is an investigational protein therapeutic being developed to increase muscle mass and strength.

5 Aug 2010

New article published in Journal of Surgical Research highlights PACE technology

SANUWAVE Health, Inc., an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in regenerative medicine, today announced that an article titled "Microvascular Response to Shock Wave Application in Striated Skin Muscle" was recently published in the on-line edition of the Journal of Surgical Research.

4 Aug 2010

MabCure files provisional patent application for ovarian cancer diagnostic antibodies

Biotechnology company MabCure, Inc. today announced the company has filed a provisional patent application for its ovarian cancer diagnostic antibodies with the U.S. Patent and Trademark Office. The filing was based on positive results of a recent study that showed MabCure's tumor-specific monoclonal antibodies (MAbs) successfully identified ovarian cancer in blood (94 percent) and distinguished it from benign tumors of the ovaries or healthy blood obtained from men and women.

4 Aug 2010

IL releases new HemosIL HIT-Ab(PF4-H) assay

Instrumentation Laboratory (IL) today announced the release of the new HemosIL HIT-Ab(PF4-H) assay as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Delivering results in minutes, the HemosIL HIT-Ab(PF4-H) assay detects total immunoglobulin against Platelet Factor 4-Heparin complexes, the antibodies associated with the pathology of HIT.

4 Aug 2010

Researchers identify TACI; MyD88 activates immune system against infection

Researchers from Mount Sinai School of Medicine have found a new mechanism that explains how certain immune cells are activated to create protective antibodies against infections or pathological antibodies such as those present in autoimmune diseases like lupus and rheumatoid arthritis. The research is published online in the September issue of Nature Immunology.

4 Aug 2010

Periodontal disease may increase risk of cognitive dysfunction: Researchers

NYU dental researchers have found the first long-term evidence that periodontal (gum) disease may increase the risk of cognitive dysfunction associated with Alzheimer's disease in healthy individuals as well as in those who already are cognitively impaired.

4 Aug 2010

Antibody News and Research

Further Reading

FDA confirms Advisory Committee meeting date for lorcaserin NDA review

Progenics announces EMA CHMP positive opinion for RELISTOR in pre-filled syringes

BioMimetic Therapeutics reports net loss of $7.7M for second-quarter 2010

Dyax announces first Phase 3 trial results of KALBITOR for acute HAE

Studies show biological agents play important role in maintaining remission in Crohn's disease

YM concludes dose-escalation in CYT387 Phase I/II clinical trial for myelofibrosis

Repligen total revenue for first-quarter fiscal 2011 increases 39% to $7.01 million

Micromet second-quarter 2010 total revenues increase to $6.5 million

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Elusys awarded second contract to develop Anthim for treatment of anthrax infection

ImmunoGen fourth-quarter 2010 net loss increases to $13.4 million

Sigma-Aldrich, NHLBI and BU collaborate in atherosclerotic cardiovascular disease research

Scientist invents new approach to boost body's response to vaccinations

FDA designates XOMA 052 orphan drug for Behcet's disease

Acceleron's ACE-031 protein therapeutic for DMD receives FDA Fast Track designation

New article published in Journal of Surgical Research highlights PACE technology

MabCure files provisional patent application for ovarian cancer diagnostic antibodies

IL releases new HemosIL HIT-Ab(PF4-H) assay

Researchers identify TACI; MyD88 activates immune system against infection

Periodontal disease may increase risk of cognitive dysfunction: Researchers

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