September 5, - September 11, 2005
Sept
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.
Sept 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.
Sept
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.
Sept
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.
Sept
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.
Sept
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.
Sept
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.
Sept
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.
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