FDA approves Hologic 3-D mammography device. Inhibitex Hep C drug gets Fast Track Print E-mail
By BioMedReports.com Staff   
Friday, 11 February 2011 20:28
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 11, 2011.

Shares of Hologic, Inc. (Nasdaq:HOLX), moved higher today after the company announced that they had received approval from the FDA for its Selenia Dimensions digital breast tomosynthesis system, the first mammography device that generates 3-D images of the breast. The device provides both 2-D and 3-D X-ray images, giving doctors additional viewpoints of the breast, potentially helping them spot more cancerous tumors.

"We are extremely proud to be the first company to receive FDA approval of a 3-D digital mammography system and to offer women this ground-breaking , superior imaging technology," said Rob Cascella, President and Chief Executive Officer. "Our Dimensions 3-D takes advantage of all of the benefits of digital mammography and quite simply makes it better with the combination of fast, high quality 3-D breast imaging. We believe tomosynthesis has the potential to change how screening and diagnostic mammography is performed, and over time will prove invaluable to the earliest possible detection of breast cancer and in the reduction of unnecessary diagnostic interventions."

Hologic is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women.

Inhibitex, Inc. (Nasdaq:INHX) today reported that the FDA has designated the investigation of INX-08189, for the treatment of chronic hepatitis C viral infection, as a Fast Track development program. The company said that the characteristics of INX-08189 that contributed to the Fast Track status include a high genetic barrier to resistance, its pan-genotypic activity, and once-daily oral dosing. Inhibitex reported interim data from its ongoing Phase 1b clinical trial in January and anticipates completing this trial by the end of the first quarter of 2011.

Celsion Corporation (NASDAQ:CLSN), a leading oncology drug development company, today announced that after reviewing data from 482 randomized patients in its multinational, randomized, double-blind, placebo-controlled, pivotal Phase III clinical study of ThermoDox in combination with radio frequency ablation for primary liver cancer (the HEAT study), the study's Data Monitoring Committee (DMC) has unanimously recommended that the trial continue enrollment. The HEAT study has enrolled over 86% of the 600 patients necessary to ensure that its primary end point, progression free survival, can be achieved with statistical significance.

"The DMC's recommendation to continue enrollment in the HEAT study marks an important milestone for Celsion and ThermoDox, as it is its final scheduled evaluation ahead of enrollment completion," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "We remain optimistic and encouraged by this progress and by the potential for ThermoDox to establish an effective standard of care for the enduring unmet need of patients with primary liver cancer."

The board of directors for Biogen Idec, Inc., (NASDAQ:BIBB), has authoried the buyback of 20 million shares to offset common stock issuances under it's share-based compensationplans. Shares of Biogen Idec were unchanged after hours. The buyback has no expiration date. As of January 31, 2011, there were 240.9 million outstanding shares.

Thermo Fisher Scientific Inc's (NYSE:TMO) test, which could help prevent organ damage in kidney transplant patients, has been approved by the FDA to monitor levels of the immunosuppressant everolimus. Shares closed up 1.5% on Friday.

Also Friday:

Abaxis, Inc. (Nasdaq:ABAX), a medical products company manufacturing point-of-care blood analysis instruments for the medical, research and veterinary markets, announced today a $2.8 million equity investment in Scandinavian Micro Biodevices APS, ("SMB"), a privately-held developer and manufacturer of point-of-care diagnostic products for veterinary use.

Caliper Life Sciences, Inc. (Nasdaq:CALP) will conduct a conference call discussing the company's fourth quarter and fiscal year 2010 financial results at 5:00 pm Eastern (2:00 pm Pacific) on Wednesday, February 23, 2011.

Genesis Biopharma, Inc. (OTC Bulletin Board:GNBP), a biotechnology company developing targeted cancer therapies, today announced that Anthony J. Cataldo has been named President and Chief Executive Officer.

Hypertension Diagnostics, Inc. (OTCBB: HDII), today announced financial results for the second quarter of fiscal year 2011 ("Q2 2011") ended December 31, 2010.

Corporate Profile, LLC announced today that NeoStem, Inc. (NYSE Amex: NBS) CEO, Dr. Robin Smith, was interviewed on CorporateProfile.com.

Neuro-Biotech Corp. (PINKSHEET: MRES) (OTCQB: MRES). The offer the Company received yesterday was a surprise, as we did not consider the reception of such an offer at this stage of our business plan.

Nutrition 21, Inc. (OTCBB: NXXI), the developer and marketer of clinically substantiated nutritional ingredients for dietary supplements, foods and beverages,and animal nutrition, today announced financial results for the second fiscal quarter ended December 31, 2010.

Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) today announced the pricing of a previously announced underwritten public offering of 6,000,000 shares of its common stock, offered at a price to the public of $11.25 per share.

PPJ Enterprise (PPJ) (PINKSHEETS:PPJE) , a leader in proprietary automated health care reimbursement cycle (all specialties), online health information digital systems and practice information management digital system software for health care and general businesses worldwide, has announced that it has retained DME Capital LLC, a New York based Investor Relations firm to expand the Company's strategic investor relations program.

SeraCare Life Sciences, Inc. (Nasdaq:SRLS), a global life sciences company providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics, today reported operational and financial results for its first quarter of fiscal year 2011, ended December 31, 2010.

ViroPharma Incorporated (Nasdaq:VPHM) today announced that Vincent Milano, president and chief executive officer of ViroPharma, will present at the Leerink Swann Hot Topics in Therapeutics Roundtable Conference at 2:40 P.M. ET on Thursday, February 17, 2011.



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