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.

Fluarix seasonal influenza vaccine approved by the FDA

The U.S. Food and Drug Administration today approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older.

20 Oct 2009

Origene Technologies' acquisition of Marligen Biosciences reinforces its leading position in the bio-medical research industry

OriGene Technologies, Inc. today announced the acquisition of Marligen Biosciences, Inc., a provider of cutting-edge multiplex assays for the Luminex xMAP(R) platform for protein and gene expression profiling assays and testing services, and DNA and RNA purification kits.

20 Oct 2009

Human Genome Sciences and GlaxoSmithKline to present Phase 3 trial results of BENLYSTA

Human Genome Sciences, Inc. and GlaxoSmithKline PLC (GSK) today announced the full presentation of results from BLISS-52, the first of two pivotal Phase 3 trials of BENLYSTA™ (belimumab) in seropositive patients with systemic lupus erythematosus (SLE).

20 Oct 2009

UT student receives fellowship grant for pre-eclampsia research

Roxanna Irani, a M.D./Ph.D. student at The University of Texas Graduate School of Biomedical Sciences at Houston (GSBS), has received a $10,000 fellowship for her efforts to better understand a condition known as pre-eclampsia that threatens the lives of expectant women and their unborn children.

20 Oct 2009

UCB reports on the outcome of Cimzia and MTX treatment for rheumatoid arthritis

UCB today announced data that showed rapid and sustained improvements in ACR20, physical function, pain and fatigue of rheumatoid arthritis (RA) as early as the first week, and inhibition of progression of structural joint damage (seen at week 24) following treatment with Cimzia (certolizumab pegol), together with methotrexate (MTX), was sustained up to 100 weeks.

19 Oct 2009

New data on Phase 3 SIMPONI clinical trials for rheumatoid arthritis

New long-term data from two pivotal, Phase 3 clinical trials showed that patients with active rheumatoid arthritis (RA) receiving SIMPONI(TM) (golimumab) every four weeks achieved sustained improvements in signs and symptoms and physical function response through one year. These new data were presented today at the 2009 American College of Rheumatology (ACR) Annual Scientific Meeting.

19 Oct 2009

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

Talecris Biotherapeutics' PROLASTIN-C receives FDA approval

Talecris Biotherapeutics (Nasdaq: TLCR) today received approval from the U.S. Food and Drug Administration for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more concentrated version of PROLASTIN® produced using advances in manufacturing technology.

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

Angiochem reports Phase 1/2 efficacy study results of ANG1005 for treating brain cancer

Angiochem, Inc. a clinical-stage biotechnology company developing drugs that are uniquely capable of crossing the blood-brain barrier to treat brain diseases, announced today that its lead drug candidate, ANG1005, has demonstrated a favorable safety and efficacy profile in more than 100 patients with brain cancer from two separate Phase 1 /2 clinical studies in patients with progressive gliomas, including recurrent glioblastoma, and in patients with progressive brain metastases.

19 Oct 2009

Human Genome Sciences completes Phase 3 development program, earns $75 million from Novartis

Human Genome Sciences, Inc. today announced that it has earned a $75 million milestone payment from Novartis, related to successful completion of the Phase 3 development program and the decision to submit applications seeking regulatory approval to market ZALBIN™ (albinterferon alfa-2b) for the treatment of chronic hepatitis C.

19 Oct 2009

Angiochem announces results of Phase 1 /2 clinical trials of ANG1005

19 Oct 2009

Rituxan's sBLA receives a Complete Response from the FDA

Genentech, Inc. a wholly-owned member of the Roche Group, and Biogen Idec announced today that the companies received a Complete Response from the U.S. Food and Drug Administration (FDA) for a supplemental Biologics License Application (sBLA) for Rituxan (rituximab) plus methotrexate (MTX) in patients with moderately-to-severely active rheumatoid arthritis (RA) who no longer respond to treatment with a disease modifying antirheumatic drug (DMARD), including MTX.

19 Oct 2009

Cardium Therapeutics reports positive findings from Excellarate Phase 1/2 clinical study

Cardium Therapeutics today announced the publication of positive findings from the open label multi-center Phase 1/2 clinical study of Excellarate(TM) (GAM501, Ad5PDGF-B / 2.6% collagen), its product candidate for the potential treatment of non-healing diabetic foot ulcers.

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

Arrayit announces collaboration with European Space Agency for mission-critical contribution

Arrayit Corporation (OTCBB: ARYC), a proprietary life sciences technology leader, announces a collaboration with the European Space Agency.

15 Oct 2009

Baxter International announces financial results for third quarter 2009; updates full-year financial outlook

Baxter International Inc. today reported solid financial results for the third quarter of 2009, and provided its fourth quarter and updated full-year 2009 financial outlook.

From Baxter International Inc. 15 Oct 2009

Positive results from Protalix BioTherapeutics Phase III UPLYSO clinical trial

Protalix BioTherapeutics, Inc., announced today positive top-line results from the Company's pivotal Phase III clinical trial of UPLYSO (taliglucerase alfa, previously referred to as prGCD) in treatment naive patients diagnosed with Gaucher disease.

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

Antibody News and Research

Further Reading

Fluarix seasonal influenza vaccine approved by the FDA

Origene Technologies' acquisition of Marligen Biosciences reinforces its leading position in the bio-medical research industry

Human Genome Sciences and GlaxoSmithKline to present Phase 3 trial results of BENLYSTA

UT student receives fellowship grant for pre-eclampsia research

UCB reports on the outcome of Cimzia and MTX treatment for rheumatoid arthritis

New data on Phase 3 SIMPONI clinical trials for rheumatoid arthritis

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

FDA approves Quotient Biodiagnostics' BLA for transfusion diagnostic monoclonal antibodies

Talecris Biotherapeutics' PROLASTIN-C receives FDA approval

Genentech reports results of ACTEMRA Phase III study for rheumatoid arthritis

Angiochem reports Phase 1/2 efficacy study results of ANG1005 for treating brain cancer

Human Genome Sciences completes Phase 3 development program, earns $75 million from Novartis

Angiochem announces results of Phase 1 /2 clinical trials of ANG1005

Rituxan's sBLA receives a Complete Response from the FDA

Cardium Therapeutics reports positive findings from Excellarate Phase 1/2 clinical study

Access Pharmaceuticals' update on its European commercial launch of Mugard

Arrayit announces collaboration with European Space Agency for mission-critical contribution

Baxter International announces financial results for third quarter 2009; updates full-year financial outlook

Positive results from Protalix BioTherapeutics Phase III UPLYSO clinical trial

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

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