FDA Accepts NDA For Type 2 Diabetes Drug. Radient Pharma Confirms Study For Its Onko-Sure. Print E-mail
By Staff and Wire Reports   
Tuesday, 08 March 2011 19:04
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 08, 2011.

FDA Accepts NDA For Type 2 Diabetes Drug Compound Dapagliflozin - The U.S. Food and Drug Administration has accepted its New Drug Application for dapagliflozin, an investigational compound for the treatment of adults with type 2 diabetes mellitus per Bristol-Myers Squibb Co. (NYSE:BMY).

The European Medicines Agency or EMA also has validated a Marketing Authorisation Application or MAA for dapagliflozin which is a product of a diabetes collaboration, formed in January 2007 between Bristol-Myers and UK-based healthcare company AstraZeneca Plc (NYSE:AZN).

The collaboration is intended to enable the companies to research, develop and commercialize select investigational drugs for type 2 diabetes.  The companies filed both the New Drug Application (NDA) and Marketing Authorisation Application (MAA) in December 2010.


Radient Pharma Confirms Study For Its Onko-Sure In Vitro Diagnostic Cancer Test - As part of a collaboration agreement with Mayo Validation Support Services, MVSS,  Radient Pharmaceuticals Corp. (AMEX:RPC) confirmed its post-launch trial "Evaluation of AMDL-ELISA DR-70" or RPC's Onko-Sure in vitro diagnostic cancer test is on track. The project is designed to further validate the efficiency of Onko-Sure relative to the Carcinoembryonic Antigen marker in colorectal cancer patients.  976 biospecimens and annotations were provided to Radiant Pharmaceuticals which were tested by Mayo with the standard CEA cancer streening test.  Radiant Pharmaceuticals completed the testing on March 4, 2011 of the biospecimens using its Onko-Sure IVD cancer screening test and would submit the data from it's Onko-Sure tests along with the CEA tests performed on the same samples by MVSS, to a third party statistical analysis service for sample decoding.

Specifically, RPC's study compares the effectiveness of RPC's Onko-Sure IVD cancer test to the CEA marker in a large population of patients, including non-cancer patients and patients in stages I through IV with colorectal cancer.

The final study results would be part of RPC's clinical post-launch validation of Onko-Sure. Under the agreement, the final RPC study data and corresponding results would be returned to MVSS.


Also Tuesday:


Astro-Med, Inc. (NASDAQ: ALOT), a manufacturer of high tech specialty printers, test and measurement systems, and electronic medical instrumentation, will announce its financial results for the Fourth Quarter and the Fiscal Year ended January 31, 2011 on Tuesday, March 15, 2011 at 4:00 pm Eastern Daylight Savings Time (3 pm Central Daylight Savings Time).

Connectyx Technologies Holdings Group, Inc. (PINKSHEETS: CTYX) ("Connectyx"), www.connectyx.com, manufacturer and distributor of the MedFlash®, the nation's premier Personal Health and Wellness Management System (ePHM) for maintaining personal health records (PHR), announced today that the company will be exhibiting at the 7th NEYEPA NationalEYEPA Coalition March 10th - 12that Bahia Mar Beach Resort in Fort Lauderdale, Florida.

Cytori (NASDAQ: CYTX) received US Patent No. 7,901,672 ('the 672 patent) today from the United States Patent and Trademark Office for a method of enriching a patient's own fat with their own adipose derived stem and regenerative cells (ADRCs) to create a cell-enriched fat graft.

Healthnostics, Inc. (PINKSHEETS: HNSS) provided guidance for 2011 sales and earnings based upon (a) prior year's results, (b) acquisitions and joint ventures, and (c) current business activity.

MMRGlobal, Inc. (OTCBB: MMRF) today announced that it has begun the process of forming a wholly-owned subsidiary called MMR Life Sciences Group, Inc.

Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) responded today as its stock has been halted by the New York Stock Exchange (NYSE) due to unusual trading activity believed to be caused by an inaccurate article published on 'TheStreet.com' on March 7, 2011 regarding RPC's collaboration with a nonprofit worldwide leader in medical care, research and education and its study to compare the effectiveness of RPC's Onko-Sure® In Vitro diagnostic (IVD) cancer test to the Carcino-Embryonic Antigen (CEA) marker in a large population of patients (N=976) with all stages of colorectal cancer.

Stellar Biotechnologies, Inc. (PINKSHEETS:SBOTF) (TSX-V: KLH) has appointed Michael R. McClurg to VP, Business Development & Marketing.

Telkonet, Inc. (OTCQB: TKOI), developer of the revolutionary energy management platform EcoSmart, which incorporates its patented Recovery Time™ technology, has taken a key step in management's strategic restructuring.



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