Irritable Bowel Syndrome :: IBS drug Zelmac banned from sale in Australia
Australian health authorities have removed a medicine Zelmac for irritable bowel syndrome (IBS) from sale because of safety concerns.
Company
Head and Neck Cancer :: Erbitux with chemotherapy increases overall survival of head and neck cancer patients
ImClone Systems Incorporated (NASDAQ: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) announced that a first line Phase III study of ERBITUX(R) (Cetuximab) combined with platinum-based chemotherapy met the primary endpoint of increasing overall survival in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
Suppository :: FDA to stop marketing suppository products containing trimethobenzamide
As part of the Food and Drug Administration’s (FDA) on-going initiative to ensure that all marketed U.S. drugs have required marketing approval, the agency announced that companies must stop manufacturing and distributing unapproved suppository drug products containing trimethobenzamide hydrochloride.
Mammography :: iCAD comments on recent article evaluating computer-aided detection and mammography
iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of Computer-Aided Detection (CAD) solutions for the early identification of cancer, commented on an article published in the New England Journal of Medicine entitled, “Influence of Computer Aided Detection on Performance of Screening.” CAD uses sophisticated algorithms to identify areas of interest on a mammography film, acting as a “second set of eyes” for the radiologist.
Heart :: Approval to start US BTT pivotal trial
Ventracor has received approval from the US Food & Drug Administration to begin enrolment in the US Bridge To Transplant (BTT) Pivotal Trial of the VentrAssist Left Ventricular Assist Device (LVAD).
MRI :: New technology offers hope of safe MRI exams
As the diagnostic capability of MRI continues to advance, and as the availability of MRI machines increases worldwide, so should the availability of implantable devices that are MRI safe. This advance is urgently needed says one executive.
Head and Neck Cancer :: Study of Erbitux for Advanced Head and Neck Cancer
First large, randomized Phase III study of ERBITUX with chemotherapy in recurrent and/or metastatic head and neck cancer meets primary endpoint of improving overall survival.
Medicare :: Kinetic Concepts responds to Medicare Bidding Rule
Kinetic Concepts, Inc. (NYSE:KCI), a global medical technology company with leadership positions in advanced wound care and therapeutic surfaces, issued a statement on the recently-released final competitive bidding rule by the Centers for Medicare and Medicaid Services (“CMS”).
Sleep :: Cephalon’s Nuvigil approved for new drug application by FDA
Cephalon, Inc. (Nasdaq: CEPH) announced that it has received an approvable letter, together with draft labeling, from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for NUVIGIL(TM) (armodafinil) Tablets [C-IV] for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift work sleep disorder (SWSD).
Prostate Cancer :: Cell Genesys released data of GVAX Immunotherapy for Prostate Cancer
Cell Genesys, Inc. (Nasdaq: CEGE) announced final, updated results from its second multi-center Phase 2 trial of GVAX immunotherapy for prostate cancer which evaluated escalating doses of the immunotherapy in 80 patients with metastatic hormone-refractory prostate cancer (HRPC).