|FDA approves Hologic 3-D mammography device. Inhibitex Hep C drug gets Fast Track|
|By BioMedReports.com Staff|
|Friday, 11 February 2011 20:28|
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.