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.

Amgen receives Complete Response Letter for the Biologic License Applications for Prolia from FDA

Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Applications (BLA) for Prolia(TM) (denosumab) in the treatment and prevention of postmenopausal osteoporosis.

19 Oct 2009

FDA approves Quotient Biodiagnostics' BLA for transfusion diagnostic monoclonal antibodies

Quotient Biodiagnostics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved its biologics license application (BLA) for the first 15 monoclonal antibodies in its proprietary line of transfusion diagnostics. These products are for use by blood donor centers, reference laboratories, and hospitals to type and screen blood.

19 Oct 2009

Genentech reports results of ACTEMRA Phase III study for rheumatoid arthritis

Genentech, Inc., a wholly-owned member of the Roche Group, today announced two-year results from a Phase III study, which showed that people with rheumatoid arthritis (RA) who received either a 4 mg/kg or 8 mg/kg dose of ACTEMRA® (tocilizumab), in combination with methotrexate, had no progression of joint damage, (75 and 83 percent, respectively, as assessed by radiograph) compared with people who received methotrexate alone (66 percent).

19 Oct 2009

Access Pharmaceuticals' update on its European commercial launch of Mugard

ACCESS PHARMACEUTICALS, INC. today provided an update on its European commercial launch of MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy.

15 Oct 2009

PIKAMAB obtains U.S. patent rights to develop theragnostic product

PIKAMAB, a stratified medicine biopharmaceutical company, announced today that it has secured exclusive rights to two issued U.S. patents from Hospital for Special Surgery, New York. PIKAMAB is developing Lupus TherasightTM, a novel theragnostic product that will eventually help guide the drug development process and patient treatment protocols in the areas of lupus and lupus nephritis.

15 Oct 2009

Progenics Pharmaceuticals and Wyeth Pharmaceuticals sign license agreement

Progenics Pharmaceuticals, Inc. today announced that it has entered into an agreement with Wyeth Pharmaceuticals, a division of Wyeth under which Progenics is regaining all worldwide rights to the RELISTOR® franchise from Wyeth Pharmaceuticals, which Progenics had previously licensed to Wyeth Pharmaceuticals.

14 Oct 2009

Study: Animals are not essential for human cancer research

A recently released paper published in the journal Alternatives to Laboratory Animals (ATLA 37, 399-416), presents a serious challenge to long-standing claims that animals are an important part of human cancer research.

14 Oct 2009

AVANIR Pharmaceuticals announces results of Zenvia double-blind Phase III STAR trial

AVANIR Pharmaceuticals, Inc. today announced detailed results from the confirmatory double-blind Phase III STAR trial evaluating two doses of the investigational drug Zenvia™ (dextromethorphan/quinidine) compared to placebo in the treatment of pseudobulbar affect (PBA) in patients with underlying multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS).

14 Oct 2009

Sanofi-aventis collaborates with Merrimack Pharmaceuticals for rights to human monoclonal antibody MM-121

Dyax Corp. announced today new developments involving drug candidates identified using the Company’s proprietary phage display technology as a result of two deals recently announced by sanofi-aventis.

13 Oct 2009

Johnson & Johnson announces financial results for the third quarter of 2009

Johnson & Johnson today announced sales of $15.1 billion for the third quarter of 2009, a decrease of 5.3% as compared to the third quarter of 2008. Operational results declined 2.8% and the negative impact of currency was 2.5%. Domestic sales declined 8.1%, while international sales declined 2.5%, reflecting operational growth of 2.4% and a negative currency impact of 4.9%.

13 Oct 2009

Compugen, Bayer Schering Pharma sign collaboration agreement for tumor research

Compugen Ltd. announced today that they have signed a collaboration agreement with Bayer Schering Pharma AG, Germany covering the further evaluation of a Compugen discovered tumor target and its splice variants.

13 Oct 2009

Selexis and Irvine Scientificti to jointly present results of recent collaborative effort

Selexis SA and Irvine Scientific Inc. announced today plans to jointly present results of a recent collaborative effort combining the Selexis SURE Cell Line Development Programs(TM) and the Irvine IS CHO Culture System, demonstrating the rapid production of gram quantities of monoclonal antibodies from stable CHO production cell lines.

12 Oct 2009

World’s first engineered T cell receptor trial opens with new cellular therapy for HIV

Researchers at Adaptimmune Limited and the University of Pennsylvania School of Medicine, have announced the approval of an Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) and opening for enrolment of the first ever study using patients’ cells carrying an engineered T cell receptor to treat HIV (SL9 HA-GAG-TCR). The trial may have important implications in the development of new treatments for HIV potentially slowing – or even preventing – the onset of AIDS.

11 Oct 2009

Additional Zenvia Phase III results in multiple sclerosis announced by AVANIR

AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR) today announced additional detailed results from the confirmatory double-blind Phase III STAR trial evaluating two doses of the investigational drug Zenvia™ (dextromethorphan/quinidine) compared to placebo in the treatment of pseudobulbar affect (PBA) among patients with underlying multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS). Over the course of the 12-week study in the MS patient subset, Zenvia 30/10 mg met the primary efficacy endpoint by reducing PBA episode rates by an incremental 11.9% beyond placebo

9 Oct 2009

CytoDyn to conduct a study on Cytolin at Massachusetts General Hospital

In response to new economic and regulatory realities, CytoDyn, Inc. has made a sea change in its strategy for developing Cytolin®, the Company’s unique immune therapy for treating HIV/AIDS.

9 Oct 2009

Hospira and Celltrion agree to develop and market eight biogeneric products

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today signed a Business Cooperation Agreement with South Korea-based Celltrion, Inc. and Celltrion Healthcare, Inc. ("Celltrion"), which outlines the business terms of a future distribution agreement for the United States, Europe, Australia, New Zealand and Canada for eight biogeneric products that are currently under development by Celltrion, five of which are incremental to Hospira's pipeline.

9 Oct 2009

Lpath reports positive Phase 1 clinical trial results of iSONEP in wet-AMD patients

Lpath, Inc., the category leader in lipidomics-based therapeutics, reported positive summary results of its single-dose Phase 1 clinical trial of iSONEP™ in wet-AMD patients.

8 Oct 2009

New cancer drugs boost drug spending

Cancer treatments are on track to become the biggest driver of specialty pharmacy spending as its contribution to overall drug spending hit five percent for the first time in the first half of 2009, according to Medco Health Solutions, Inc.

8 Oct 2009

Zenvia patent application: AVANIR Pharmaceuticals receives USPTO "Notice of Allowance"

AVANIR Pharmaceuticals, Inc. today announced that it has received a “Notice of Allowance” from the United States Patent and Trademark Office (USPTO) announcing that it intends to grant the Company a new patent, extending the period of commercial exclusivity for its lead drug candidate Zenvia™ well into 2025.

8 Oct 2009

AVANIR's STAR trial Phase III data to be presented at the World Congress on Controversies in Neurology

AVANIR Pharmaceuticals, Inc. today announced it will present detailed data from the Phase III confirmatory STAR trial in the treatment of pseudobulbar affect (PBA) at the 3rd World Congress on Controversies in Neurology (CONy) in Prague, Czech Republic on October 8 - 11, 2009 and the American Neurological Association (ANA) 134th Annual Meeting in Baltimore, MD on October 11 - 14, 2009.

6 Oct 2009

Monoclonal Antibody News and Research

Further Reading

Amgen receives Complete Response Letter for the Biologic License Applications for Prolia from FDA

FDA approves Quotient Biodiagnostics' BLA for transfusion diagnostic monoclonal antibodies

Genentech reports results of ACTEMRA Phase III study for rheumatoid arthritis

Access Pharmaceuticals' update on its European commercial launch of Mugard

PIKAMAB obtains U.S. patent rights to develop theragnostic product

Progenics Pharmaceuticals and Wyeth Pharmaceuticals sign license agreement

Study: Animals are not essential for human cancer research

AVANIR Pharmaceuticals announces results of Zenvia double-blind Phase III STAR trial

Sanofi-aventis collaborates with Merrimack Pharmaceuticals for rights to human monoclonal antibody MM-121

Johnson & Johnson announces financial results for the third quarter of 2009

Compugen, Bayer Schering Pharma sign collaboration agreement for tumor research

Selexis and Irvine Scientificti to jointly present results of recent collaborative effort

World’s first engineered T cell receptor trial opens with new cellular therapy for HIV

Additional Zenvia Phase III results in multiple sclerosis announced by AVANIR

CytoDyn to conduct a study on Cytolin at Massachusetts General Hospital

Hospira and Celltrion agree to develop and market eight biogeneric products

Lpath reports positive Phase 1 clinical trial results of iSONEP in wet-AMD patients

New cancer drugs boost drug spending

Zenvia patent application: AVANIR Pharmaceuticals receives USPTO "Notice of Allowance"

AVANIR's STAR trial Phase III data to be presented at the World Congress on Controversies in Neurology

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