For-Profit Hospitals Most Likely to Overtreat Dementia Patients (CME/CE, with video)

Tube-feeding patients with advanced dementia (MedPage Today) — a practice whose effectiveness has been questioned by two widely cited literature reviews — is most common in larger hospitals and those run for profit, researchers said.

FDA Unveils New Safety Plan for Medical Imaging

WASHINGTON (MedPage Today) — The Food and Drug Administration (FDA) announced it plans to issue new safety requirements for manufacturers of CT and fluoroscopic devices to reduce unnecessary radiation from exposure to medical imaging.

IV Systems Recalled Due to Leakage, Embolism Concerns

WASHINGTON (MedPage Today) — The FDA recalled a number of intravenous infusion and closed catheter systems due to a risk of air embolism, blood or fluid leakage, and potentially fatal injury.

Raptor Pharmaceutical to present DR Cysteamine trial data at Lysosomal Disease Network Symposium

Raptor Pharmaceutical Corp., today announced the presentation of cystinosis data at the Annual Lysosomal Disease Network WORLD Symposium 2010, being held February 10-12 in Miami, Florida. Biomarker data from a Phase IIb pilot study of Raptor’s proprietary delayed-release cysteamine bitartrate (”DR Cysteamine”) will be the subject of a poster titled, “Correlation of Plasma Cysteamine and [...]

DMC recommends Celsion to continue its Phase III ThermoDox clinical trial for primary liver cancer

Celsion Corporation announced today that after reviewing safety data from 120 patients enrolled in the pivotal Phase III ThermoDox® clinical trial (”HEAT” trial) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial.

Genzyme and Isis Pharmaceuticals: Phase 3 mipomersen study in heFH patients meets primary endpoint

Genzyme Corp. and Isis Pharmaceuticals Inc. today announced that the phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH) met its primary endpoint with a highly statistically significant 28 percent reduction in LDL-cholesterol after 26 weeks of treatment, compared with an increase of 5 percent for placebo.

Positive results from Naurex’s Phase I clinical trial of GLYX-13 reported

Naurex Inc., a clinical stage company developing innovative treatments for depression and other CNS disorders based on its novel glycine site functional partial agonist (GFPA) NMDA receptor modulators, today reported positive top-line results from its Phase I clinical trial of lead compound GLYX-13.

Alexza Pharmaceuticals announces development and commercialization collaboration with Biovail Laboratories International

Alexza Pharmaceuticals, Inc. announced today that it has established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation, to develop and commercialize AZ-004 (Staccato® loxapine) in the U.S. and Canada. AZ-004 is Alexza’s lead program, based on the company’s proprietary technology, the Staccato system. Alexza submitted its New Drug Application [...]

DMC recommends JV to continue enrolling patients in Phase III clinical trial of StemEx

The Gamida Cell-Teva Joint Venture (JV) announced today that the Data Monitoring Committee (DMC) has independently reviewed preliminary data from the pivotal registration, Phase III clinical trial of StemEx (called ExCell) and has recommended that the JV continue to enroll patients in this study.

QR Pharma commences clinical trial of Posiphen in early stage AD patients

QR Pharma, Inc. (QR), a developer of novel drugs to treat Alzheimer’s disease (AD), announced today that it began a clinical trial of its lead compound, Posiphen, in early stage AD patients.