Biologics Drug / Agent News and Research

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Discovery of genes that regulate glucose levels

In an effort to understand how genes work, a collaborative study which includes the University of Southern California (USC) has identified a gene that regulates glucose levels. The results, which will be published in the July issue of the Journal of Clinical Investigation and is currently available online, may provide further understanding of the underlying causes of diabetes.

3 Jun 2008

CSL Behring study shows extended half-life recombinant VIIa leads to longer biologic activity

CSL Behring today presented results of a pre-clinical study that not only demonstrates the feasibility of genetically fusing factor VIIa to human albumin, but that this therapeutic protein with a prolonged half-life can lead to a longer biologic effect.

3 Jun 2008

First patient enrolled in phase III study of Bevacizumab and Trastuzumab in early breast cancer

A new international study for women with HER2-positive breast cancer is open for enrollment. The pivotal BETH (BEvacizumab and Trastuzumab Adjuvant Therapy in HER2-positive Breast Cancer) study is a Phase III clinical research trial that is investigating the benefits of combining two monoclonal antibodies, the anti-angiogenic, bevacizumab (Avastin) and the targeted therapy trastuzumab (Herceptin), together with chemotherapy for the treatment of patients with early stage HER2-positive breast cancer.

27 May 2008

New blood test reveals risk for metabolic syndrome

University of Minnesota researchers have discovered that people with high oxidation levels of the low-density lipoprotein (LDL) particle that carries cholesterol throughout the blood are much more likely to develop metabolic syndrome - which can lead to a considerably increased risk of developing heart disease.

20 May 2008

CQ's Carey looks at Bush Administration SCHIP directive, privacy protections in health IT bill, request for increased FDA funding

Mary Agnes Carey, associate editor of CQ HealthBeat, discusses testimony by Government Accountability Office officials about SCHIP expansion guidelines, compromise on a Senate health information technology bill and a request for increased funding from FDA's top official in this week's "Health on the Hill from kaisernetwork.org and CQ."

19 May 2008

Industry group letter indicates qualified aupport for bill to allow approval of generic biotechnology medications

The Biotechnology Industry Organization has issued a letter to Reps. Anna Eshoo (D-Calif.) and Joe Barton (R-Texas) to indicate qualified support for a bill (HR 5629) that they have introduced to allow FDA to approve generic biotech medications, CQ HealthBeat reports (McCarthy, CQ HealthBeat, 5/16).

19 May 2008

Black patients face higher death rates in early stages of kidney disease

Black patients are more likely to die in the early stages of chronic kidney disease than whites, according to a new study by a Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed) researcher and his team that will be published in the July issue of the Journal of the American Society of Nephrology.

19 May 2008

U.S. patent office grants re-examination of RNA splicing microarray patent on behalf of Jivan

Jivan Biologics, Inc. announced today that the United States Patent and Trademark Office has ordered the re-examination of U.S. Patent No. 6,881,571. The serial number for the reexamination is 90/009,017.

19 May 2008

FDA approves new formulation of genetically engineered version of Factor VIIa plasma protein

The U.S. Food and Drug Administration today approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.

9 May 2008

Study affirms effectiveness of medication for juvenile rheumatoid arthritis

Juvenile rheumatoid arthritis (JRA) is a chronic autoimmune disease that strikes children between the ages of newborn to 16 years. All children with JRA have joint pain, stiffness, and swelling and some also have fever and skin rashes.

9 May 2008

FDA begins multi-year hiring initiative

Biologists, chemists, medical officers, mathematical statisticians and investigators are among the experts in demand as the U.S. Food and Drug Administration begins a multi-year hiring initiative.

30 Apr 2008

MaxCyte introduces large scale transfection technology - accelerates cell-based assay development

MaxCyte has announced the introduction of its ITF Inline Transfection System, a validated platform for preparative transfection, based on unique flow electroporation technology.

21 Apr 2008

Study details cost-effectiveness of rheumatoid arthritis treatments for Medicare recipients

For elderly and disabled rheumatoid arthritis (RA) sufferers, the Medicare Prescription Drug Improvement and Modernization Act (MMA) brought the promise of better disease management with "biologic" drugs.

15 Apr 2008

Variation in CHI3L1 gene increases risk of asthma

A tiny variation in a gene known as CHI3L1 increases susceptibility to asthma, bronchial hyperresponsiveness and decline in lung function, researchers report early online in the New England Journal of Medicine.

10 Apr 2008

FDA approves Rotarix

The U.S. Food and Drug Administration has announced the approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children.

4 Apr 2008

Proteolix's Carfilzomib granted orphan drug designation

Proteolix, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to carfilzomib, a selective blocker of proteasome activity for the treatment of multiple myeloma.

3 Apr 2008

U.S. Patent Office confirms validity of Osteotech's U.S. patent on mixtures of a radiolucent material

Osteotech, Inc. ( NASDAQ:OSTE ) , a leader in the emerging field of biologic solutions for regenerative medicine, announced today that the United States Patent and Trademark Office has confirmed the validity of its U.S. Patent No. 5,676,146.

25 Mar 2008

PharmAthene signs agreement to acquire biodefense vaccines business from Avecia

PharmAthene, Inc., a biodefense company specializing in the development and commercialization of medical countermeasures against biological and chemical threats, and Avecia Biologics Limited, a contract manufacturer of biopharmaceuticals, has announced that the companies have entered into a definitive sale and purchase agreement under which PharmAthene will acquire all of the assets and intellectual property related to Avecia's biodefense vaccines business.

24 Mar 2008

New medical adhesive

The U.S. Food and Drug Administration today approved a new medical adhesive (a fibrin sealant) called Artiss for use in attaching skin grafts onto burn patients.

20 Mar 2008

Blood test for Parkinson's shows promise

A test that profiles molecular biomarkers in blood could become the first accurate diagnostic test for Parkinson's disease, new research shows.

12 Mar 2008

Biologics Drug / Agent News and Research

Discovery of genes that regulate glucose levels

CSL Behring study shows extended half-life recombinant VIIa leads to longer biologic activity

First patient enrolled in phase III study of Bevacizumab and Trastuzumab in early breast cancer

New blood test reveals risk for metabolic syndrome

CQ's Carey looks at Bush Administration SCHIP directive, privacy protections in health IT bill, request for increased FDA funding

Industry group letter indicates qualified aupport for bill to allow approval of generic biotechnology medications

Black patients face higher death rates in early stages of kidney disease

U.S. patent office grants re-examination of RNA splicing microarray patent on behalf of Jivan

FDA approves new formulation of genetically engineered version of Factor VIIa plasma protein

Study affirms effectiveness of medication for juvenile rheumatoid arthritis

FDA begins multi-year hiring initiative

MaxCyte introduces large scale transfection technology - accelerates cell-based assay development

Study details cost-effectiveness of rheumatoid arthritis treatments for Medicare recipients

Variation in CHI3L1 gene increases risk of asthma

FDA approves Rotarix

Proteolix's Carfilzomib granted orphan drug designation

U.S. Patent Office confirms validity of Osteotech's U.S. patent on mixtures of a radiolucent material

PharmAthene signs agreement to acquire biodefense vaccines business from Avecia

New medical adhesive

Blood test for Parkinson's shows promise

Pittcon Highlights: Pharmaceutical & Biologic eBook

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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