September 19, - September 25, 2005
Sept 23rd: Breakthrough in Medical
Imaging May Be Only a Fingertip Away
Former Soviet Scientists Publish Findings on
Technique for Capturing Internal Images Using a Person's Fingertips.
The High Accuracy and Cost-Effectiveness of This Technology May
Revolutionize Medical Imaging.
PHIS, Inc. announced today that two peer-reviewed international
journals, Kybernetes and Functional Diagnostics, published articles
that may signal the beginning of a new era in medical imaging. The
discoveries announced in the two papers ("Secondary
holodiffractional radiation of biological systems" in Kybernetics,
Vol. 5, 2005 and "Integrative functional system of living systems"
in Functional Diagnostics, Vol. 1, 2005) were made by Marina Shaduri,
Ph.D., founder of the Bioholography Center and senior researcher at
the Institute of Molecular Biology and Biological Physics of the
Georgian Academy of Sciences.
Shaduri, along with her late partner Dr. George Tshitshinadze,
proved it is possible to acquire diagnostic-quality visual
information about a living organism's structure and disease
processes via painless body surface assessments. They claim that
living organisms function like a dynamic three-dimensional hologram
-- called a "biohologram." Over eight thousand patients have been
diagnosed using the patented method called BEO-Tomography.
Subsequent verification was performed in four thousand cases,
demonstrating the method's high sensitivity, particularly, in
detecting cancer (greater than 85% accuracy). BEO-Tomography's
non-invasive and benign nature makes it a safe diagnostic
alternative for adults, children, and animals.
With this technology, pathologic areas are displayed on a larger
scale while the normally functioning organs are not as readily
discernable on the fingertips' coronas. This unique feature of
living systems enables the acquisition of precise images of
extremely small tumors, e.g., 2 mm in diameter, with high
resolution. The development of more sophisticated devices and
software will improve the quality of visualization, thus providing
replicas of microscopic structures and detection of infectious
diseases.
Sept 23rd: Crawford Steps Down As FDA Chief
FDA Commissioner Lester Crawford stunned the industry with the
announcement late Friday that he was stepping down from the post he
had fought to gain just two months before. Crawford, 67, whose
nomination was delayed by an anonymous allegation of personal
misconduct and political opposition to the agency's decision not to
approve the Plan B contraceptive, gave no specific reason for his
resignation. He was confirmed by the Senate on July 18, after having
served as acting commissioner and deputy commissioner. The White
House reportedly named Andrew von Eschenbach, the head of the
National Cancer Institute, as acting commissioner.
Sept 23rd: FDA to Review Device Ad Requirements
The FDA is considering whether device manufacturers must submit
their promotional materials for review and whether they should face
penalties for misleading or false materials. In November, the FDA
will hold a two-day public meeting with patients, doctors,
manufacturers and others to discuss possible changes to its
marketing requirements for materials aimed at individuals, known as
direct-to-consumer advertising. Currently most medical devices are
not subject to FDA promotional regulations, but that might change.
"I would encourage device companies to take seriously the issues,"
said Deborah Wolf, a lawyer for FDA's device division.
Sept 23rd: Boston Scientific Faces Securities Class
Action Suit
Boston Scientific is facing a class action suit by securities
purchasers, who allege the company provided false and misleading
information about its ability to satisfy the FDA regulations
governing device product quality and representations about its
knowledge and expertise regarding medical devices. These statements
artificially inflated the value of the company's stock, Scott+Scott
alleges. The firm also alleges over $400 million in insider trading.
On August 23, investors learned of these alleged violations,
causing Boston Scientific's stock to drop 4.5 percent to $25.92. The
plaintiff seeks to recover damages on behalf of all purchasers of
the company's securities between March 31, 2003, and August 23,
2005.
Sept 23rd: Guidant Faces Class Action Suit over
ICD Flaws
Guidant is facing a class action lawsuit based on problems with
its implantable cardioverter-defibrillators (ICD). Viles & Beckman
recently filed a claim alleging that Guidant knew of potentially
fatal flaws with its device well in advance of notifying physicians
and the public.
On June 17, Guidant announced that it would recall nearly 50,000
ICDs distributed worldwide due to faulty insulation in the wiring.
Faulty insulation has the potential to cause short circuits and
prevent the device from shocking the heart during a cardiac event.
Sept 22nd: FDA Calls for Recall of Baxter
Healthcare's Infusion Pump
The FDA has issued a Class I recall of Baxter Healthcare's
COLLEAGUE Volumetric Infusion Pump because of reports of damage to
the pump's batteries. Specifically, there have been reports of
swelling and excessive discharge from the batteries, possibly
leading to interruption or prevention of life-sustaining therapy.
These problems have been associated with four deaths and 10 serious
injuries. However, there is no requirement that the pumps be
returned.
Sept 22nd: Generic of Allegra to Be Launched
Aiming to hang on to some of the highly profitable Allegra
market, sanofi-aventis is launching an authorized generic of the
allergy drug through Prasco Laboratories.
Ohio-based Prasco will make generic Allegra in 30-, 60-, and
180-mg dosage strengths. The move follows Barr Pharmaceuticals' and
Teva Pharmaceutical's at-risk launch of generic Allegra (fexofenadine
HCl) in the same three formulations. The two generic firms are
embroiled in ongoing patent litigation with sanofi-aventis over
rights to the drug.
Barr, Teva and fellow generic drugmaker Impax Laboratories could
further cut into sanofi-aventis's Allegra franchise if they elect to
pursue an at-risk launch of Allegra-D — Allegra plus decongestant.
Authorized generics maker Prasco said it believes consumers will
prefer the "brand sameness" of its Allegra equivalent to standard
generic versions of the drug. "We are optimistic we will capture
significant market share," Prasco CEO E. Thomas Arington said.
Sept 22nd: Pfizer's Osteoporosis Treatment Not
Approvable, Says FDA
Pfizer's highly anticipated osteoporosis treatment Oporia has
been deemed "non-approvable" by the FDA. The New York-based
drugmaker didn't disclose why its new drug application (NDA) for
Oporia (lasofoxifene) was rejected, saying only that it recently
received a non-approvable letter from the FDA regarding the drug, a
second-generation selective estrogen receptor modulator (SERM). The
company added "it will be reviewing its submission with the FDA and
considering various courses of action."
Pfizer submitted its NDA for Oporia in August 2004. The FDA was
originally supposed to rule on the application in June, but the
deadline was extended for three months after the agency determined
it needed more time to review the NDA, which sought an indication
for the prevention of osteoporosis.
Sept 20th: FDA Approves Wireless Medical Device
The FDA recently approved a wireless in-home medical monitoring
device that will allow physicians to remotely monitor patient
health. Guidant's LATITUDE Communicator allows doctors to read
implantable device information, including blood pressure and weight,
in order to help patients at risk of heart failure and sudden
cardiac death.
The device transmits the data to a secure Internet server, from
which the physician can access this medical information at any time.
In addition to wireless, automatic device data uploads, the
Communicator enables LATITUDE Active Monitoring, a daily
confirmation of the patient's device status.
Sept 20th: Boston Scientific Wins Approval for New
Coronary Device
Boston Scientific Corp. has gained federal regulatory clearance
to market a new device to treat coronary artery blockages. The
Natick, Mass., company received U.S. Food and Drug Administration
clearance to market its new Flextome Cutting Balloon Dilatation
Device. It's set to be used to treat coronary artery blockages
resistant to regular balloon angioplasties. U.S. sales of the
product will start immediately. European marketing approval for the
product came through in January. Doctors use balloon angioplasty to
open blocked coronary arteries before they implant stents to help
stop them from closing again. Boston Scientific says its new product
uses microsurgical blades to score artery lesions to enable balloons
to push through.
Sept 20th: Study: Counterfeit Drug Sales to Reach
$75 Billion By 2010
Sales of counterfeit prescription drugs are expected to reach $75
billion by the end of the decade, nearly doubling current levels and
outpacing the annual growth rate of legitimate pharmaceutical sales,
according to a new study.
Counterfeit drug sales are estimated to grow 13 percent annually
through 2010, compared to 7.5 percent estimated annual growth for
global pharmaceutical commerce, says the report from the Center for
Medicines in the Public Interest (CMPI), which is part of Pacific
Research Institute, a free-market think tank. CMPI based its growth
projections on current estimates of counterfeits from the FDA and
World Health Organization.
Global pharmaceutical sales are expected to grow to $530 billion
by 2010, CMPI said.
Sept 19th: ICD Malfunctions on the Rise, According To FDA
Analysis
Implantable cardioverter defibrillators (ICDs) are malfunctioning
at an alarmingly high rate, according to a new FDA analysis. The
analysis, conducted by Harvard University medical professor William
Maisel, indicates that ICD malfunctions requiring surgical
replacement increased from 7.9 per 1,000 devices in 1998 to 38.6 in
2001, before falling to the mid-20s by 2002, the last year examined.
Of the approximately 416,000 ICDs implanted in the U.S. from 1990 to
2002, roughly 8,500 were removed from patients due to confirmed
device malfunction, the data shows.
Sept 19th: Abbott's Xact Carotid Stents System Wins FDA
Approval
Abbott Laboratories last week became the second firm approved to
sell a carotid stent in the U.S., putting it into a market that
analysts say could reach $1 billion in annual sales.
The FDA approved Abbott's Xact Carotid and its Emboshield Embolic
Protection System to treat patients at risk of stroke who aren't
favorable candidates for surgery. Guidant received FDA approval last
year for a similar carotid stent. Abbott hopes to capture 25 percent
of the U.S. market in the product's first full year on the market
and sustain that share as the market expands, the company said.
Sept 19th: Boston Scientific Receives European Approval to
Market Precision Spinal Cord Stimulation System
Boston Scientific recently announced that it has received CE Mark
for the Precision Spinal Cord Stimulation (SCS) system, Europe's
smallest neuromodulation system for the treatment of chronic pain.
The company plans to begin introducing the product in Europe this
year, with a full launch in 2006. The Precision SCS system has
received approval from the FDA and was launched in the U.S. in March
of this year.
Sept 19th: Barr Will Meet With FDA to Discuss Plan B
Barr Pharmaceuticals will meet with the FDA in the next few weeks
to discuss its controversial oral contraceptive Plan B, which
remains in limbo after the FDA delayed its decision whether to allow
the drug to be sold OTC.
Barr has been seeking dual status for Plan B since it bought the
drug from the Women's Capital Corporation (WCC) in October 2003. In
April 2003, the WCC petitioned the FDA to give OTC status to Plan B.
In May 2004, the FDA rejected Barr's original application, on
grounds it lacked scientific data for the product's OTC use among
adolescents younger than 16, according to Steven Galson, acting
director of the FDA's Center for Drug Evaluation and Research. In
July 2004, Barr resubmitted an application seeking approval for an
OTC version of Plan B.
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