|Novavax Initiates Phase 2 Trial of RSV Vaccine; FDA Approves the Dexcom G4 PLATINUM|
|By Staff and Wire Reports|
|Monday, 08 October 2012 19:03|
Novavax, Inc. (Nasdaq: NVAX) announced enrollment has begun in a Phase 2 dose-ranging clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age.
The study is being conducted in collaboration with PATH, an international nonprofit organization that transforms global health through innovation, which is providing approximately $2 million in funding to support the trial.
Dexcom (NASDAQ: DXCM), a leader in continuous glucose monitoring, announced the U.S. FDA has approved its eagerly anticipated new continuous glucose monitoring system, the Dexcom G4™ PLATINUM.
Clinical trials report up to approximately 19 percent improvement in overall accuracy for the Dexcom G4 PLATINUM compared to the Seven Plus, and approximately a 30 percent improvement in accuracy in the hypoglycemia range (i.e., when blood glucose is less than 70mg/dl). The overall accuracy and ease of use for the Dexcom G4 PLATINUM sets a new standard for commercially available CGMs, making the Dexcom G4 PLATINUM the most-advanced CGM system available.
“Improved accuracy in the critical hypoglycemic range is most important from a life-saving point of view,” said Terrance H. Gregg, Dexcom CEO. “The Dexcom G4 PLATINUM fulfills the promise of CGM for people with diabetes by providing accurate and reliable real-time performance.”
Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40 years. The traditional standard-of-care for glucose (blood sugar) measurement has been a finger stick meter. Although they remain an essential part of a comprehensive diabetes management program, finger stick meters are inherently limited by the fact that, like a photograph, it only provides data for the specific moment in which the measurement is completed; it doesn't show whether glucose is going up or down – or how fast.
By contrast, CGM provides an in-motion picture that shows not only glucose levels, but also the speed and direction in which it is moving, and alerts the user to sudden changes so they can take action.
Boston Scientific Corporation (NYSE: BSX) has entered into a definitive agreement to acquire privately-held Rhythmia Medical, Inc., a developer of next-generation mapping and navigation solutions for use in cardiac catheter ablations and other electrophysiology procedures, including atrial fibrillation and atrial flutter.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced today that based on preliminary financial data, the Company estimates total sales of $448 million for the quarter ended September 30, 2012.
Genetic Immunity (OTCBB: PWRV) is pleased to announce the GMP approval of its manufacturing facility.
Life Technologies (NASDAQ: LIFE) today announced the acquisition of Compendia Bioscience, a preeminent cancer bioinformatics company widely used by the pharmaceutical industry to identify novel gene targets for drug discovery and development.
Luminex Corporation (Nasdaq: LMNX) today announced that it expects to report results for the third quarter of 2012 on Monday, October 29, 2012.
Organovo Holdings, Inc. (OTCQX: ONVO), a developer and manufacturer of functional human tissues using a novel three-dimensional bioprinting technology, announced today that it will begin trading on the highest OTC marketplace, OTCQX®.
Response Genetics, Inc. (Nasdaq: RGDX), a company focused on the development and commercialization of molecular diagnostic tests for cancer, announced today that on October 5, 2012, the Company was notified that it has regained compliance with the NASDAQ Capital Market and its minimum market value of listed securities requirement.
Revolutions Medical Corporation (OTCQB: RMCP) announced today that it has signed a sales and marketing agreement with MedPro Associates ("MedPro") to expand U.S. sales of its flagship product, the RevVac™ vacuum auto-retractable safety syringe.
Verenium Corporation (Nasdaq: VRNM), a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes, today announced that it has entered into an agreement with Comerica Bank for a two-year, $10 million revolving credit facility.