Clinical Hold Removed for Helix's Alpha-2b Application; Thermo Fisher to Buy Back its Common Stock Print E-mail
By Staff and Wire Reports   
Friday, 11 November 2011 19:57
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 11, 2011.

Helix BioPharma Corp. (NYSE:HBP), a biopharmaceutical company developing drug candidates for the prevention and treatment of cancer, announced the "clinical hold" on its investigational new drug ("IND") application for its Topical Interferon Alpha-2b, Phase II/III, low-grade cervical lesion efficacy trial has been removed by the United States Food and Drug Administration ("FDA").

The FDA completed its review of Helix's "clinical hold" complete response submission, which Helix filed as announced in its news release of October 12, 2011, and granted Helix approval to perform the planned clinical trial.

The Company is still in need of additional funding as well as strategic partner support before commencing this trial. As such, it does not currently have an estimated timeline for commencement or completion of this trial. The Company hopes, however, that this FDA approval will be helpful in generating the support it requires.

Interferon alpha-2b is a potent cytokine that possesses antiviral, immunomodulatory and antiproliferative activities with activity against HPV.

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Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, announced that its board of directors has authorized the repurchase of an additional $750 million of shares of its own common stock in the open market or in negotiated transactions. The new repurchase authorization will remain in effect through November 9, 2012.

As of today, the company has $25 million remaining under its existing share repurchase authorization, which expires February 22, 2012.


Also Friday:


Affymax, Inc. (Nasdaq: AFFY) and Takeda Global Research & Development Center, Inc., U.S., today announced results from additional analyses of the EMERALD Phase 3 studies that evaluated the investigational agent peginesatide in dialysis patients with anemia due to chronic kidney disease (CKD).

ARCA biopharma, Inc. (Nasdaq: ABIO)
, a biopharmaceutical company developing genetically-targeted therapies for atrial fibrillation and other cardiovascular diseases, announced today that two Gencaro (bucindolol hydrochloride) abstracts have been selected for oral presentation at the American Heart Association’s Scientific Sessions 2011, being held November 12-16, 2011 in Orlando, Florida.

Bio-Reference Laboratories, Inc. (NASDAQ: BRLI) announced today that its board of directors has approved a Stock Repurchase Program authorizing the repurchase of up to 1,000,000 shares of its Common Stock in the over-the-counter market at prevailing market prices through October 31, 2012.

Bristol-Myers Squibb Company (NYSE: BMY) today announced a technology transfer agreement with the Brazilian Ministry of Health to expand access to Reyataz® (atazanavir sulfate) in Brazil.

CNS Response, Inc. (OTCBB: CNSO) today announced its acquisition of a neurometric platform, and other intellectual property, which may help physicians better understand positive or negative patient response to Transcranial Magnetic Stimulation (TMS).

Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today reported financial and operating results for the three and nine months ended September 30, 2011.

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible catheter robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced the world's first uses of the Magellan™ Robotic System in the treatment of Peripheral Vascular Disease (PVD).

Opexa Therapeutics, Inc. (NASDAQ:OPXA)
, a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today announced that Neil K. Warma, President and Chief Executive Officer, will present at the Lazard Capital Markets 8th Annual Healthcare Conference on Wednesday, November 16, 2011, at 10:30 a.m. EST.

SDIX™ (NASDAQ: SDIX)
, today announced that it has entered into an agreement to sell the assets of its water quality division to Modern Water plc for $4.5 million. Modern Water is acquiring the division’s intellectual property, its current inventory and commercial contracts, as well as its equipment and staff.

Spherix Incorporated (NASDAQ: SPEX) -- Spherix, an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis, and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies -- today reported financial results for the three and nine months ended September 30, 2011.

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that its board of directors has authorized the repurchase of an additional $750 million of shares of its own common stock in the open market or in negotiated transactions. The new repurchase authorization will remain in effect through November 9, 2012.

YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM), a drug development company advancing a diverse portfolio of hematology and cancer-related products, today reported operational and financial results for its first quarter of fiscal 2012, ended September 30, 2011.



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