U.S. pharmaceutical companies will begin offering 50 percent discounts on covered brand-name prescription drug costs for Medicare Part D beneficiaries who have reached the coverage gap, or donut hole, beginning in 2011, according to the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services.

WASHINGTON, D.C.--BIOrest LABR-312, an IV anti-inflammatory drug, reduced the rates of late loss in diabetic patients and those with high counts of monocyte, and exhibited no safety concerns or signs of overall in-stent lumen loss in stenosis patients, according to the results of the late-breaking BLAST trial presented Sept. 24 at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific meeting.

The FDA has conditionally approved the first of two planned U.S. cohorts of the randomized, controlled PARTNER II trial, which will evaluate the next-generation Sapien XT transcatheter aortic valve from Edwards Lifesciences.

The FDA announced Sept. 23 that the controversial diabetes drug Avandia (rosiglitazone, GlaxoSmithKline) will remain on the market, but with significant restrictions associated with its use. In contrast, the European Medicines Agency recommended that Avandia (as well as the rosiglitazone-containing Avandamet and Avaglim) be taken off the market.

Cardiac Science announced today it will combine microvolt T-wave alternans (MTWA) testing technology from Cambridge Heart with its Quinton Q-Stress cardiac stress systems.

Overall, there were no significant differences in outcomes in patients suffering out-of-hospital cardiac arrest when initially given either chest compressions or defibrillation. However, subgroup analyses showed a trend toward superiority of chest compressions when emergency response time was greater than five minutes, according to a meta-analysis published Sept. 9 in BMC Medicine.

The FDA has begun a safety review of the diabetes drug Actos (pioglitazone, Takeda), after receiving preliminary results from a long-term observational study designed to evaluate the risk of bladder cancer associated with use of this drug.

Transition Therapeutics has announced that a clinical study of gastrin analogue TT-223, in combination with Eli Lillys proprietary GLP-1 analogue, in patients with type 2 diabetes did not meet its efficacy endpoints. Given these findings, the companies decided to end any further development of TT-223.