September 12, - September 19, 2005
Sept 16th: Industry
Guide Predicts RFID Market at $8.8 Billion By 2010
The market for radio-frequency
identification (RFID) in hospitals will increase to $8.8 billion
by 2010, according to an industry guide published by Research
and Markets.
According to the research firm's "RFID
& Emerging Technologies Guide to Healthcare," the RFID growth
will be segmented into three categories: RFID-driven revenue,
with hardware and software integration, accounting for $1.3
billion; infrastructure support, including wireless networks and
enterprise-related software, accounting for $2.7 billion; and
hospital connectivity, accounting for $4.8 billion.
Sept 16th: FDA Issues
Approvable Letter for Hip Device
Biomet has received an approvable
letter from the FDA for its ceramic-on-ceramic hip system, used
as a hip replacement.
The firm said it expects to
introduce the Biomet C2a-Taper Acetabular System immediately
following the receipt of a final approval order, which Biomet
projects will be issued by the end of the year. Biomet is
sourcing the C2a ceramic head and ceramic liner from CeramTec
AG.
Sept 16th: Lawsuit
against FDA Intended To Force Decision on Omnitrope
Sandoz has filed a lawsuit against
the FDA accusing the agency of unlawfully delaying a decision on
the firm's application to market generic human growth hormone —
a move that ramps up pressure on the FDA to issue guidelines for
follow-on biologics.
The FDA's "unreasonable delay" has
left Sandoz's application "frozen in perpetual limbo subject to
some as-yet unidentified consideration," Sandoz says in a recent
complaint filed in the U.S. District Court for the District of
Columbia. The lawsuit accuses the agency of arbitrarily and
illegally delaying its decision on Sandoz's drug application
despite having all the necessary data.
Sept 15th: FDA
Finalizes Third-Party Inspection Guidance
The FDA issued the final guidance
for third-party device inspections today clarifying what
standards companies must meet to be qualified to inspect
products instead of the FDA. These inspections by so-called
Accredited Persons (AP) are used to ensure that these products
qualify for sale in foreign markets.
According to the FDA, the new
program helps manufacturers by giving them greater control over
the timing of inspections. And because other countries may
already recognize some of the APs accredited by the FDA, it is
possible that one inspection could satisfy the requirements of
more than one regulatory authority, saving the time needed for
multiple inspections.
Sept 15th: Angioscore
Receives FDA Clearance to Market Angiosculpt Scoring Balloon
Catheter
AngioScore Inc. announced yesterday
that the company has received U.S. Food and Drug Administration
(FDA) 510(K) clearance to market the AngioSculpt Scoring Balloon
Catheter (AngioSculpt®) for the treatment of infrapopliteal
peripheral arterial disease. The AngioSculpt joins a new class
of specialty medical devices aimed at treating peripheral
arterial disease (PAD), one of the fastest-growing segments in
the worldwide interventional marketplace. An estimated 10
million patients suffer from PAD in the U.S. alone, of whom only
approximately 800,000 undergo a revascularization or amputation
procedure each year.
Sept 15th: Corgenix
Launches Next Generation Predictive Cardiovascular Diagnostic
Line
Corgenix Medical Corporation, a
worldwide marketer of diagnostic test kits, announces the launch
of AtherOx™, a next generation product line utilizing patented
technology to identify individuals at risk for developing
atherosclerotic cardiovascular disease. The AtherOx™ technology
is a novel diagnostic product that measures oxidized Low-Density
Lipoprotein (oxLDL) complexed with a plasma protein known as
B2GP1, which combined functions as a specific marker of
potential cardiovascular disease.
Sept 15th: Teva, Barr
Partner to Market Generic Allegra
Rivals Barr Pharmaceuticals and Teva
Pharmaceutical have partnered to market a generic version of
sanofi-aventis' blockbuster allergy drug Allegra, the companies
said recently. Barr received final FDA approval to market its
version of the drug last week
.
Barr said the partnership will help mitigate potential losses
from Barr's at-risk launch of generic Allegra (fexofenadine HCl),
used to treat symptoms of seasonal allergic rhinitis. Allegra
sales totaled approximately $1.4 billion for the 12 months
ending in June.
The news surprised analysts, who had
assumed Barr was unlikely to attempt a launch before all patent
litigation was resolved. To date, the U.S. District Court in New
Jersey has granted Barr summary judgment of non-infringement on
three Allegra patents, but decisions are still pending on five
other patents relating to Allegra tablet and capsule products.
Barr said it expects litigation on the remaining patents to
begin sometime in 2006.
Sept 15th: Chiron
Rejects Novartis' $45 Billion Offer
Chiron has rejected Novartis' recent
offer to acquire the biopharmaceutical company, saying the $40
per share cash offer from its largest stockholder is
"inadequate."
Novartis, which already owns roughly 42 percent of the
California-based vaccine manufacturer, recently made the $4.5
billion offer for the remaining 112 million shares.
Novartis made its offer one day
after Chiron announced it had made progress on alleviating
manufacturing problems at its Liverpool, England, plant, which
has been inactive for nearly a year. The UK's Medicines and
Healthcare products Regulatory Agency (MHRA) last October
required Chiron to suspend operations at the plant because the
company violated UK good manufacturing practice regulations. The
suspension reduced the U.S. supply of flu vaccine by nearly 50
percent last winter. Widespread shortages prompted some
facilities to provide vaccinations to only at-risk patients such
as the elderly, the young and those with chronic illnesses.
Sept 14th:
Watson Pharmaceuticals Announces Completion of $300 Million
Share Repurchase Program
Watson Pharmaceuticals, Inc., a
leading specialty pharmaceutical company, today announced that
the company has completed its $300 million share repurchase
program. The share repurchase program was announced in February
2005 and authorized the repurchase of up to $300 million of the
company's common stock over a one year period. Watson has
repurchased a total of approximately 9.4 million shares, or $300
million of its common stock, under the share repurchase program.
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