Biologics Drug / Agent News and Research

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FDA clears for marketing rapid test to screen for bacterial contamination in blood platelets

The U.S. Food and Drug Administration has cleared for marketing the first rapid test to detect bacterial contamination in blood platelets prior to transfusion.

18 Sep 2007

FDA licenses 15 new blood typing tests

The U.S. Food and Drug Administration today licensed 15 new blood typing tests that were previously unavailable in the United States.

17 Sep 2007

NASA and NIH to use International Space Station to answer questions about health and diseases

A Sept. 12 signing of a memorandum of understanding marked a key milestone for NASA and the National Institutes of Health in their long partnership to advance scientific discovery.

13 Sep 2007

Two drugs equally effective for heart patients undergoing angioplasty

In lifesaving procedures to open blocked heart arteries a key question has persisted for years: Is use of the more expensive drug, abciximab, justified over use of the less-expensive eptifibatide

11 Sep 2007

Biologic treatment for rheumatoid arthritis and the risk of cancer

The relationship between rheumatoid arthritis (RA), an autoimmune disease marked by chronic inflammation of the joints and tissue surrounding vital organs, and the incidence of cancer is complicated.

30 Aug 2007

FDA approves cobas TaqScreen WNV test for West Nile virus

The U.S. Food and Drug Administration has announced approval of a second test for the detection of West Nile virus (WNV) in blood and organs.

29 Aug 2007

FDA approves new Roche direct detection of West Nile Virus in donated human blood

Roche Diagnostics announced that the US Food & Drug Administration (FDA) has approved its biologics license application for the company's test for direct detection of West Nile Virus in donated human blood and plasma.

From Roche Sequencing and Life Science 29 Aug 2007

FDA approves Evithrom (human thrombin)

The U.S. Food and Drug Administration has approved Evithrom (human thrombin), a blood-clotting protein used to help control bleeding during surgery.

28 Aug 2007

Rotarix accepted for review by FDA

GlaxoSmithKline has announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for Rotarix, an oral candidate vaccine for infants to prevent rotavirus gastroenteritis.

16 Aug 2007

Diets high in the nutrient choline may increase risk for colorectal polyps

Contrary to expectations, diets high in the nutrient choline were associated with an increased risk of some colorectal polyps, which can, but do not always, lead to colorectal cancer, according to a study published online in the August 7 Journal of the National Cancer Institute.

8 Aug 2007

Unlocking proteins from their cellular shell

Applying physical stress to cells, researchers at the University of Pennsylvania have demonstrated that everyday forces can alter the structure of proteins tucked within cells, unfold them and expose new targets in the fight against disease.

3 Aug 2007

FDA, DoD collaborate on regulated drugs, biologics, and medical devices

Data from the U.S. Military Health System will soon help the U.S. Food and Drug Administration make decisions affecting the safety and use of FDA-regulated products for all Americans.

3 Aug 2007

BioMedical Enterprises announces patent infringement lawsuit stay ordered

BioMedical Enterprises, Inc. (BME), has announced that on July 20th the Honorable Judge Laura Taylor Swain ordered that all proceedings in the patent infringement lawsuit between BME and InteliFUSE, Inc. be stayed pending the Court's disposition of a motion for summary judgment brought by BME.

27 Jul 2007

Medtronic receives FDA approval for first artificial disc for the neck

Millennium Research Group (MRG) has conducted a detailed analysis of the US spinal implant market in its US Markets for Spinal Implants report.

26 Jul 2007

Biologic agents valuable treatment option for patients with inflammatory bowel disease

The use of biologic agents for the treatment of inflammatory bowel disease (IBD) may benefit patients, but doctors need to consider the potential associated side effects in determining treatment course, according to a consensus paper published in this month's issue of Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute.

26 Jul 2007

GSK's Cervarix receives positive opinion in Europe

GlaxoSmithKline has announced that its cervical cancer candidate vaccine received a positive opinion from the European Committee for Human Medicinal Products (CHMP) for the prevention of precancerous lesions (high grade cervical intraepithelial neoplasia - CIN grades 2 and 3) and cervical cancer causally related to human papillomavirus types 16 and 18.

19 Jul 2007

Leading-edge treatment for Crohn's disease at Pediatric Infusion Center

Seventeen-year-old Eliot Drieband explains what it's like to have Crohn's disease - a type of inflammatory bowel disease - in the same matter-of-fact way she describes preparing for an advanced placement exam, working on the school newspaper, starting an organ donor awareness club for teens and being a peer counselor for other kids facing chronic, life-altering illnesses.

9 Jul 2007

Trial shows CERVARIX cervical cancer candidate vaccine effective

Results from an interim analysis of a Phase III study show that CERVARIX, the GlaxoSmithKline (GSK) cervical cancer candidate vaccine, provides up to 100 percent protection against advanced precancerous lesions caused by the most common types of human papillomavirus, types 16 and 18.

28 Jun 2007

Alogliptin for type 2 diabetes shows promise in early trial

Alogliptin, a highly selective dipeptidyl peptidase-IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes, demonstrated efficacy in reducing glucose levels throughout the day, in an early phase clinical study.

26 Jun 2007

Researchers use 'genomic pathway' to predict Parkinson's

A new Mayo Clinic study provides strong evidence that the joint effects of common DNA variations in several genes that encode proteins within a well-defined biological pathway largely explain why some persons get Parkinson's disease while others don't, and even predict with great accuracy at what age people might develop their first symptoms.

17 Jun 2007