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FDA grants Tarix's TXA127 Orphan Drug designation for stem cell engraftment and treatment of MDS

Tarix Pharmaceuticals today announced that it's drug, TXA127, has been granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA) as a treatment to enhance engraftment in patients receiving a stem cell transplant. TXA127 has also received Orphan Drug designation for the treatment of Myelodysplastic Syndrome (MDS).

28 Jun 2010

FDA grants Abbott 510(k) clearance to market molecular diagnostic test for detection of chlamydia, gonorrhea

Abbott announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market a new, sensitive molecular diagnostic test and instrument to simultaneously detect two of the nation's most prevalent sexually transmitted diseases (STDs), gonorrhea and chlamydia, including a new variant strain of chlamydia recently discovered in Sweden.

28 Jun 2010

Boston Therapeutics submits structure, function claims of SUGARDOWN to FDA

Boston Therapeutics, Inc. has announced that it has submitted structure and function claims of its SUGARDOWN™ to the US Food and Drug Administration on June 21, 2010.

28 Jun 2010

Clinical study results show no increased risk of CV events associated with SYMLIN injection

Amylin Pharmaceuticals, Inc. today announced results from an analysis of an integrated database of clinical studies that showed no increased risk of cardiovascular events associated with SYMLIN (pramlintide acetate) injection use compared to a pooled comparator group treated with either placebo or rapid-acting insulin. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla.

28 Jun 2010

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA (exenatide) injection added to Lantus (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla.

28 Jun 2010

Tolerx initiates confirmatory Phase 3 clinical trial to evaluate otelixizumab in new-onset type 1 diabetes

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today announced the initiation of a confirmatory Phase 3 clinical trial to further evaluate otelixizumab in autoimmune new-onset type 1 diabetes. The confirmatory Phase 3 clinical trial is called DEFEND-2 (Durable-Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes) and immediately follows successful completion of enrollment in the initial Phase 3 clinical trial, DEFEND-1, with results from DEFEND-1 expected in the first half of 2011.

28 Jun 2010

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Raptor Pharmaceutical Corp. announced that it has enrolled the first patient in a pivotal Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

28 Jun 2010

Final results of VIAject vs. RHI Phase 3 study in type 2 diabetes patients presented at 70th ADA

The final results of a six-month, multi-center, open-label Phase 3 study of VIAject® (more-rapid-acting injectable human insulin) versus regular human insulin (RHI) in 471 patients with type 2 diabetes were presented today by Helena Rodbard, M.D., at the 70th Scientific Sessions of the American Diabetes Association. Dr. Rodbard was a principal investigator of this study, which was designed to evaluate the safety and efficacy of VIAject® versus regular human insulin when used in combination with insulin glargine.

28 Jun 2010

Medtronic initiates enrollment in ASPIRE study of MiniMed Paradigm x54 Low Glucose Suspend integrated system

Demonstrating its dedication to close the loop for diabetes management, Medtronic, Inc. today announced that the first patient has been enrolled as part of the ASPIRE study of the MiniMed Paradigm x54 System featuring Low Glucose Suspend automation. Low Glucose Suspend works by automatically suspending insulin delivery temporarily if blood glucose levels become too low as defined by the patient and his or her healthcare provider and is a feature available commercially in Medtronic's Paradigm® Veo™ System in more than 35 countries outside of United States.

28 Jun 2010

In-school education programs can reduce obesity, other risk factors for type 2 diabetes: HEALTHY

Healthier cafeteria choices, longer and more intense periods of physical activity and robust in-school education programs can lower rates of obesity and other risk factors for type 2 diabetes, according to a national study called HEALTHY.

28 Jun 2010

WellPoint research leads to limits on use of Boniva; FDA spars with tobacco company

"WellPoint Inc. (WLP), the largest U.S. managed-care concern by membership, made it harder last year for its members to gain approval for use of the Boniva osteoporosis drug after internal research linked it to higher fracture rates, lower patient compliance and higher total costs of care than two other drugs, a WellPoint executive said Thursday," Dow Jones Newswires/The Wall Street Journal reports.

28 Jun 2010

FDA grants orphan drug designation for Chiasma's Octreolin

Chiasma, Inc., a privately held biopharma company, announced that the Food and Drug Administration has granted orphan drug designation for Chiasma's investigational new drug, Octreolin, an oral form of octreotide acetate that uses the Company's proprietary Transient Permeability Enhancer technology for the oral treatment of acromegaly, a hormonal disorder that results from an excess of growth hormone.

28 Jun 2010

G8 leaders to discuss economic policy, developing world, maternal and child health, Haitian rebuilding

Ahead of the G8 summit, which begins Friday in Canada, "leaders engaged in a series of dueling letters and interviews that exposed their conflicts" in how to foster global economic recovery, the Associated Press reports.

28 Jun 2010

Data on MetAP2 inhibitors for treatment of obesity presented at ADA 2010

Zafgen, Inc., a pharmaceutical company pioneering novel obesity therapeutics to help the body regain and sustain a lean, healthy state by targeting imbalances in fat metabolism, today announced data on ZGN-201, a prototype methionine aminopeptidase 2 inhibitor, for the treatment of obesity. Preclinical studies demonstrate MetAP2 inhibition eliminates excess body weight through the regulation of fat metabolism and food intake, and normalizes glucose tolerance in animal models.

28 Jun 2010

Senate fails to pass 'extenders' bill, state Medicaid funding

After a bill to extend jobs and economic relief programs failed for the third time in the Senate Thursday, Majority Leader Harry Reid announced he would withdraw the bill, Politico reports. The legislation included financial relief for states, including billions to support Medicaid programs.

28 Jun 2010

FDA approves OraSure Technologies' OraQuick HCV Rapid Antibody Test

OraSure Technologies, Inc. announced today that its OraQuick Hepatitis C Rapid Antibody Test has been approved by the U.S. Food and Drug Administration for use in detecting HCV antibodies in venous whole blood specimens, making it the first rapid HCV test approved by the FDA for use in the United States.

28 Jun 2010

Pennsylvania reports drop in hospital infections, other patient care issues include CT scans

The Pennsylvania Department of Health found that 12.5 percent fewer patients contracted infections in the state's hospitals in 2009 than a year earlier, according to the Pittsburgh Post-Gazette. But the reports shows that there were 25,914 infections in 2009. "'Though the report seems to show we're making progress, 25,914 is still a very large number and shows we still have our work cut out for us in bringing that number down,' Stephen Ostroff, the state's acting physician general, said Thursday.

25 Jun 2010

FDA approves OraQuick HCV Rapid Antibody Test for HCV

The U.S. Food and Drug Administration today announced approval of the first rapid blood test for antibodies to the hepatitis C virus for individuals 15 years and older.

25 Jun 2010

Research provides hope and encouragement to people living with lupus

Research presented during the 9th International Lupus Congress held in Vancouver, Canada from June 24-27, 2010 should give hope and encouragement for the future of the treatment and management of lupus to the 1.5 million Americans and 5 million people worldwide living with lupus. In recent years, there have been significant advances made in many areas of lupus research including the development of new treatments, adult stem cell transplantation, genetics, lupus-related cardiovascular disease, and quality of life issues for people with lupus.

25 Jun 2010

Patient enrollment completed in pilot study of CyPath labeling solution for early detection of lung cancer

Cancer diagnostics company Biomoda, Inc. today announced it completed patient enrollment and sample collection in a pilot study to determine the clinical sensitivity and specificity of its CyPath labeling solution for the early detection of lung cancer. Top-line data and results will be released when available.

25 Jun 2010

Food News and Research

FDA grants Tarix's TXA127 Orphan Drug designation for stem cell engraftment and treatment of MDS

FDA grants Abbott 510(k) clearance to market molecular diagnostic test for detection of chlamydia, gonorrhea

Boston Therapeutics submits structure, function claims of SUGARDOWN to FDA

Clinical study results show no increased risk of CV events associated with SYMLIN injection

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Tolerx initiates confirmatory Phase 3 clinical trial to evaluate otelixizumab in new-onset type 1 diabetes

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Final results of VIAject vs. RHI Phase 3 study in type 2 diabetes patients presented at 70th ADA

Medtronic initiates enrollment in ASPIRE study of MiniMed Paradigm x54 Low Glucose Suspend integrated system

In-school education programs can reduce obesity, other risk factors for type 2 diabetes: HEALTHY

WellPoint research leads to limits on use of Boniva; FDA spars with tobacco company

FDA grants orphan drug designation for Chiasma's Octreolin

G8 leaders to discuss economic policy, developing world, maternal and child health, Haitian rebuilding

Data on MetAP2 inhibitors for treatment of obesity presented at ADA 2010

Senate fails to pass 'extenders' bill, state Medicaid funding

FDA approves OraSure Technologies' OraQuick HCV Rapid Antibody Test

Pennsylvania reports drop in hospital infections, other patient care issues include CT scans

FDA approves OraQuick HCV Rapid Antibody Test for HCV

Research provides hope and encouragement to people living with lupus

Patient enrollment completed in pilot study of CyPath labeling solution for early detection of lung cancer

The future is bioengineered: Synthetic biology and global sustainability eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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