September 5, - September 11, 2005

September 9: Slumping TAXUS Sales Lead to Earnings Warning for Boston Scientific

Sales of Boston Scientific's flagship Taxus stent are continuing to erode, prompting the company to issue a warning this week that its third-quarter earnings would likely be lower than expected.

Speaking at a healthcare conference in Boston Sept. 7, Boston Scientific Chief Financial Officer Larry Best said the company was unlikely to meet its previous forecast for the third quarter, which was projected at per-share earnings between 44 cents and 49 cents, and sales of between $1.56 billion and $1.63 billion. Best, who called the firm's performance "surprisingly soft," didn't provide updated projections for the quarter.

September 9: Applied Neurosolutions Files Pre-IDE for Diagnostic Alzheimer’s Test

Applied NeuroSolutions has submitted a pre-IDE (Investigational Device Exemption) application with the FDA, the first step in the process of commercializing its cerebrospinal fluid (CSF) diagnostic Alzheimer's disease (AD) test.

In partnership with Peter Davies and a scientific team at Albert Einstein College of Medicine, Applied NeuroSolutions has developed a CSF test to detect Alzheimer's at a very early stage with 85 percent to 95 percent accuracy in more than 3,000 patient samples. There are approximately 2 million new patients annually worldwide who are candidates for a CSF diagnostic test, according to market research firm Datamonitor.

September 8: MVIT Announces new 'SMART' drug delivery systems

Vancouver, British Columbia-based MIV Therapeutics (MIVT), which develops next-generation biocompatible stent coatings and drug delivery technologies for the treatment of cardiovascular disease, recently announced the development of a new drug-delivery system incorporating "smart" drug-eluting coating technologies. The new delivery system is specifically designed to benefit patients who require the controlled, gradual release of drugs from implanted medical devices.

According to MIVT, this new "smart" drug eluting system is designed to improve the overall biocompatibility of polymer composites and to increase the control of drug-delivery characteristics. Engineering specifications used in this system provide considerably improved drug release flexibility, including the option of releasing a wide variety of drugs to address the various needs of a patient's particular pathological condition over extended periods of time. This "smart" coating technology carries with it the promise of providing highly personalized and optimal therapeutic benefits to patients who require implantable medical devices.

September 8: Andrx’s ANDAs Put on Hold by FDA

The FDA's Florida District office has placed Andrx's pending abbreviated new drug applications (ANDAs) on hold due to manufacturing problems - a move that could potentially threaten the generic firm's portfolio of previously approved drugs.

The drugmaker's problems stem from a May inspection in which the FDA discovered possible current good manufacturing practice (cGMP) violations at one of Andrx's facilities. At the close of the inspection, the FDA investigator issued Andrx a Form 483. According to Andrx's website, the company is awaiting approval of 35 ANDAs.

September 8: Glaxosmithkline to Buy Canada’s ID Biomedical for 1.7 Bln CAD plus Debt

GlaxoSmithKline PLC said it has agreed to buy Canadian vaccine company ID Biomedical for 35 cad per share, or 1.7 bln cad (1.4 bln usd) plus the assumption of 77 mln usd in debt. Glaxo will also loan ID Biomedical up to 120 mln usd to repay term debt and finance its cash requirements up to the expected closing date for the deal. Glaxo said the price represents a premium of 13 pct over the closing price of ID Biomedical shares yesterday, and a premium of 30 pct over the 20-day average.

September 7: Cryolife Announces First Biodisc Implants

CryoLife - a biomaterials and biosurgical device company based in Atlanta - announced that its BioDisc Spinal Disc Repair System, a nucleus pulposus repair device, was successfully implanted in two patients. The patients underwent a discectomy approximately six weeks ago to treat herniated discs in the lumbar spinal area.

September 6: St. Jude Gets Japanese Approval to Market ICDs

St. Jude Medical announced regulatory and reimbursement approvals from the Ministry of Health, Labor and Welfare in Japan for its Epic+ and Atlas+ implantable cardioverter-defibrillator (ICD) product families.

The ICDs will be immediately available in Japan through Getz Brothers, a St. Jude Medical Company, and Fukuda Denshi. The devices are the first St. Jude ICDs available in Japan.

September 6: Judge Sides with Drugmakers in Antitrust Importation Lawsuit

A federal judge has dismissed a Minnesota class action lawsuit that contends nine large drugmakers, including Pfizer, Eli Lilly and GlaxoSmithKline (GSK), violated antitrust laws in their efforts to suppress the importation of prescription drugs from Canada.

In dismissing the case, Judge Joan Ericksen of the U.S. District Court for the District of Minnesota ruled that the plaintiffs lack standing to challenge the alleged anticompetitive behavior. The importation of these drugs "is unlawful and, therefore, not the type of activity which federal antitrust laws were designed to protect," according to her recent decision.