Bayer has temporarily suspended worldwide marketing of heart surgery drug Trasylol (aprotinin injection). The move comes after requests from the German Federal Institute for Drugs and Medical Devices and the US Food and Drug Administration (FDA) and other regulators that Bayer suspend marketing until final results from the Canadian BART trial were complied and evaluated. The BART study is an independent randomised, controlled trial being conducted in high-risk cardiac surgery patients, but it was recently halted after data showed an increase in all-cause mortality for patients in the aprotinin treatment arm. Once the BART data is available the marketing suspension will be re-evaluated. Meanwhile, following Bayer's announcement several lawsuits have been filed against the company. Napoli Bern & Associates announced the filing of two suits seeking damages for the deaths of two heart patients. Stora Enso has launched a new Pharma DDS packaging solution and Pharma DDSi. The specially developed carton aims to increase patient drug-taking compliance. The design includes a locking mechanism and unit dose packaging. The Pharma DDSi solution includes a microchip which is embedded in the carton. The microchip, developed by Cypak, records the precise time, date and which pill is removed from the package. By pressing an answer key embedded in the carton, the patient can record how he or she feels and responds to the drugs. Direvo Biotech has acquired AC Biotech in an acquisition which will help Direvo to expand its capabilities and offerings to customers in the biotechnology and pharmaceutical markets. AC Biotech will continue as an independent, fully-owned subsidiary of Direvo. AC Biotech is a provider of bioprocess development and contract manufacturing services including fermentation and downstream processes using microbial and plant-based systems. Details of the transaction were not disclosed. The FDA has awarded a multi-year contract to healthcare alliance Premier to provide data for post-marketing drug surveillance. This contract will support the FDA's Office of Surveillance and Epidemiology and the Office of New Drugs, Paediatric and Maternal Health staff as they evaluate drug risks.
The FDA will have access to Premier's Perspective database, the largest integrated clinical, financial, and operational comparative database in the nation, which will compliment and strengthen the utility of passive reporting systems currently in place. Perspective is used by approximately 600 hospitals for benchmarking and quality improvement activities and comprises more than 130 million patient visit records. Hospitals submit data to Premier which validates, analyses and formats the data to make it meaningful for hospitals. Merck has received FDA approval of easypod, the company's delivery system for administering Saizen (somatropin (rDNA origin) for injection), used to treat growth hormone deficiency. The device was designed to help patients administer a subcutaneous daily injection, reliably in three steps and is already available in the UK, Australia, Canada and several European and South American countries. Nitec Pharma has signed an agreement with PAZ GmbH for the exclusive worldwide rights to Tarenflurbil, PAZ's anti-inflammatory drug, for the treatment of chronic inflammation and pain. Tarenflurbil is a novel inhibitor of the transcription regulator NF-kB and the transcription factor AP-1, both of which have a role in inflammation. "This licensing deal is a significant step in expanding the Nitec portfolio of development compounds," Nitec chief executive Anders Harfstrand said. The terms of the contract were not disclosed.