Monoclonal Antibody News and Research

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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.

Genmab reports top-line interim results from ofatumumab Phase II study in Diffuse Large B-Cell Lymphoma

Genmab A/S announced today top-line interim results from an initial Phase II single arm open label study of ofatumumab to evaluate the treatment of relapsed Diffuse Large B-Cell Lymphoma in patients ineligible for or relapsed following a stem cell transplant.

11 Aug 2010

FDA grants Orphan Drug Designation to YM BioSciences' JAK1/2 inhibitor

YM BioSciences Inc., announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration has granted Orphan Drug Designation to the Company's highly-selective JAK1/2 inhibitor, CYT387, for the treatment of myelofibrosis, a chronic debilitating unmet medical need, in which a patient's bone marrow is replaced by scar tissue, and for which treatment options are limited or unsatisfactory.

10 Aug 2010

Cancer Research Technology grants Scancell licence to use 105AD7 human antibody

Scancell Holdings Plc,, the developer of therapeutic cancer vaccines, and Cancer Research Technology Ltd - Cancer Research UK's commercialisation and development arm - today announce that they have signed an agreement under which Scancell has been granted a licence to use a human antibody known as 105AD7.

10 Aug 2010

Epitomics launches EP Clone Rabbit Monoclonal Antibodies

Epitomics, Inc., the rabbit monoclonal antibody company, announces today the launch of EP Clone™ Rabbit Monoclonal Antibodies and their detection systems for pathology applications. These diagnostic immunohistochemistry (IHC) products are manufactured by the In Vitro Diagnostic (IVD) Division of the Company. This new line of products are developed in compliance with regulation for IHC antibodies and detection systems in the United States, these products are manufactured under FDA's Quality System Regulation (21 CFR, Part 820).

9 Aug 2010

FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Pfizer Inc. announced today that the U.S. Food and Drug Administration has granted approval of the use of a Prefilled Dual-Chamber Syringe for administration of XYNTHA® Antihemophilic Factor (Recombinant) Plasma/Albumin-Free to hemophilia A patients. XYNTHA is a recombinant factor VIII product indicated for both the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A.

9 Aug 2010

Progenics second-quarter total revenue decreases to $2.3 million

Progenics Pharmaceuticals, Inc. today announced its results of operations for the second quarter and six months ended June 30, 2010.

9 Aug 2010

Intellect Neurosciences receives Notice of Allowance for new OXIGON patent in Canada

Intellect Neurosciences, Inc announced that it has received a Notice of Allowance from the Canadian Patent and Trademark Office for a new patent related to OX1 (OXIGON™), the Company's clinical-stage drug candidate that has disease-modifying potential for Alzheimer's and other neurodegenerative disorders. OX1 is an orally-administered, brain-penetrating, naturally-occurring, copper-binding small molecule targeting multiple mechanisms that contribute significantly to the underlying pathology of Alzheimer's disease.

9 Aug 2010

Dr Reddy’s launches first generic darbepoetin alfa

Dr. Reddy's Laboratories Ltd. announced today the launch of Cresp® - the first generic darbepoetin alfa in the world, and the only darbepoetin alfa in India. Cresp® has been approved in India for the treatment of anemia due to chronic kidney disease and anemia due to chemotherapy.

9 Aug 2010

Health Canada approves first targeted biological therapy to show survival benefit in stomach cancer

Roche announced today that after priority review, Health Canada has approved HERCEPTIN(R) (trastuzumab), in combination with XELODA(R) (capecitabine) or intravenous 5-fluorouracil and cisplatin, for the first-line treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach (gastric cancer) or gastro-esophageal cancer.

9 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

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

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

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

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

ZymoGenetics second-quarter net loss declines to $3.8 million

ZymoGenetics, Inc. today reported substantially improved financial results for the quarter ended June 30, 2010. For the second quarter of 2010, the company's net loss declined to $3.8 million, or $0.04 per share, a $23.2 million improvement from the $27.0 million loss, or $0.39 per share, reported for the second quarter of 2009. The improvement resulted from higher revenues as well as reduced operating expenses.

4 Aug 2010

FDA approves N30 Pharma's NDA for N6022 GSNOR

N30 Pharmaceuticals, LLC today announced the approval of its Investigational New Drug Application for N6022 by the U.S. Food and Drug Administration. N6022, a first-in-class inhibitor of s-nitrosoglutathione reductase (GSNOR), has the potential to be an important new treatment for acute exacerbations of asthma, chronic obstructive pulmonary disease (COPD) and inflammatory bowel disease (IBD).

3 Aug 2010

Repligen receives three additional grants to develop HDAC inhibitors for neurodegenerative diseases

Repligen Corporation today announced that the Company has received three additional grants to support its research program to develop HDAC inhibitors for neurodegenerative diseases. Repligen has received $436,000 in research funding to support the ongoing development of histone deacetylase inhibitors for Friedreich's ataxia.

2 Aug 2010

Formatech selects Femta's FM101 therapeutic candidate for Fillanthropy program

Today, Formatech, Inc. announced that it has selected Femta's FM101 therapeutic candidate to be enrolled in its Fillanthropy Program. Under this program, Formatech will donate the services required to aseptically fill and finish one lot of the drug candidate for use in support of Femta's upcoming clinical trials.

31 Jul 2010

Monoclonal Antibody News and Research

Further Reading

Genmab reports top-line interim results from ofatumumab Phase II study in Diffuse Large B-Cell Lymphoma

FDA grants Orphan Drug Designation to YM BioSciences' JAK1/2 inhibitor

Cancer Research Technology grants Scancell licence to use 105AD7 human antibody

Epitomics launches EP Clone Rabbit Monoclonal Antibodies

FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Progenics second-quarter total revenue decreases to $2.3 million

Intellect Neurosciences receives Notice of Allowance for new OXIGON patent in Canada

Dr Reddy’s launches first generic darbepoetin alfa

Health Canada approves first targeted biological therapy to show survival benefit in stomach cancer

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

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

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

FDA designates XOMA 052 orphan drug for Behcet's disease

MabCure files provisional patent application for ovarian cancer diagnostic antibodies

ZymoGenetics second-quarter net loss declines to $3.8 million

FDA approves N30 Pharma's NDA for N6022 GSNOR

Repligen receives three additional grants to develop HDAC inhibitors for neurodegenerative diseases

Formatech selects Femta's FM101 therapeutic candidate for Fillanthropy program

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