September 26, - October 2, 2005
Sept 30th
Cordis Corporation Acquires Lumend, Inc.
Cordis, a Johnson & Johnson company, recently announced the
acquisition of LuMend, a privately held company focused on the
development of chronic total occlusion (CTO) devices to treat
peripheral vascular disease. A CTO is a complete or partial blockage
of an artery that can lead to surgery or lower extremity amputation.
Medtronic Seeks FDA Approval For Spinal Device
Medtronic recently submitted a premarket approval (PMA)
application to the FDA for its rhBMP-2 device for posterior lumbar
spinal fusion surgery.
The company based its PMA on a randomized, prospective clinical
study involving more than 460 patients. The device is a bone
morphogenetic protein that stimulates new bone growth or bone
regeneration, and is the active component in Medtronic's Infuse Bone
Graft. The FDA previously approved its use for anterior lumbar
interbody fusion procedures and for certain tibial fractures.
The company says that Infuse will be the only bone graft
replacement to receive PMA. More than 250,000 lumbar spinal fusions
are performed each year to stabilize the vertebrae and help
eliminate pain caused by degenerative disc disease in the spine
GSK: Paxil May Cause Increased Risk Of Birth Defects
A new epidemiologic study of GlaxoSmithKline's (GSK) top-selling
antidepressant Paxil suggests the drug may be associated with an
increased risk of birth defects compared to other antidepressants,
GSK states in a recently issued "Dear Healthcare Professional"
letter.
GSK's letter, which was recently posted to the FDA's website,
warns that pregnant women exposed to Paxil (paroxetine HCl) or Paxil
CR (paroxetine HCl controlled-release tablets) during the first
trimester were more than twice as likely to have a child with birth
defects than women taking other antidepressants. The warning was
based on preliminary data from a GSK-led retrospective epidemiologic
study involving nearly 3,600 pregnant women, according to the
letter.
Sept 29th
Heart Devices Market May Reach $25 Billion By 2014
The U.S. market for heart devices is likely to grow by nearly 15
percent over the next 10 years, surpassing the $25 billion mark by
2014, a recent study finds.
According to a Sept. 1 report by Kalorama Information, The U.S.
Market for Cardiovascular Devices, devices such as pacemakers,
implantable cardioverter-defibrillators and heart stents are
increasingly gaining clinical and reimbursement acceptance for a
wide range of heart diseases, including congestive heart failure,
arrhythmias and heart valve disease.
Boston Scientific Suspends Sales Of Acid Reflux Kit
Boston Scientific has suspended sales of the acid reflux disease
treatment Enteryx after more than two-dozen reports of problems
because of incorrect use of Enteryx injection kits.
The company's recall notice says that some doctors accidentally
punctured the wall of the esophagus while injecting the substance,
causing "adverse events." According to reports filed with the FDA,
patients have suffered leakage, swelling and ulcers in the
esophagus. An elderly patient died last year after a doctor
accidentally hit the wall of the patient's aorta, the body's largest
artery.
About 3,800 patients have been treated with Enteryx, which was
approved in 2003 by the FDA. The treatment is a liquid polymer
injected directly into the walls of the esophagus. It thickens into
a permanent spongy lump that is supposed to help block acid from
flowing from the stomach toward the throat.
Tysabri Submission Includes Label Revisions, Risk Management
Plan
Biogen Idec and Elan's plan to revive its withdrawn multiple
sclerosis (MS) drug Tysabri includes revisions to the product's
label, as well as the establishment of a risk management plan for
the drug.
The firms recently announced they had filed a supplemental
biologics license application (sBLA) with the FDA, seeking
permission to return the drug to the market as a treatment for MS.
The filing comes roughly seven months after Biogen and Elan
voluntarily suspended marketing and clinical use of Tysabri (natalizumab),
following reports that three patients taking the drug in a clinical
trial contracted progressive multifocal leukoencephalopathy (PML), a
rare and frequently fatal demyelinating disease of the central
nervous system.
Although the companies are still negotiating the label changes
with the FDA, they indicated that a black box warning for PML would
be included in the new label. However, the companies are not
expected to remove existing label information regarding Tysabri's
use in combination with Biogen's older MS treatment Avonex
(interferon beta-1a) — a move that caught some observers by
surprise.
Sept 28th
Medtronic Challenges Stent Licensing Agreement
Medtronic is challenging a FTC recommendation giving Johnson &
Johnson permission to grant Abbott Laboratories an exclusive license
to a patented system for implanting stents. Medtronic either wants
J&J to give it an exclusive license or access to the technology in
addition to Abbott.
The system in question, which allows stents to be inserted by a
physician without the help of an assistant, is known as
rapid-exchange stent delivery.
Medtronic has enlisted doctors to lobby the FTC, urging the
agency to allow Medtronic to use the technology in order to remain
competitive in the drug-coated stent market — a market that analysts
predict will reach $3.5 billion by 2008.
Beth Israel Medical Center Investigating Unique Treatment For
Heart Failure
Cardiologists at Beth Israel Medical Center are currently
enrolling patients in an investigational study that is looking at
the safety and efficacy of a new treatment for moderate to severe
heart failure, in which a pacemaker-like device helps strengthen the
heart's pumping power. The FIX-HF-5 (Fix Heart Failure 5) study
involves a pulse generator, the Optimizer System, that delivers
electrical signals to the heart muscle in the midst of its pumping
action, "fooling" it into producing more intracellular calcium and
thus increasing the heart's ability to pump and contract.
Promising Diagnostic Tools For Multiple Sclerosis Developed At
Yale
Yale School of Medicine researchers have identified three rapid
diagnostic methods that can target antibodies commonly found in
multiple sclerosis patients, greatly improving potential diagnosis
and treatment. The team reports their findings in this week's
Proceedings of the National Academies of Science.
Sept 27th
Study Finds Way To Prevent Device-Related Infections
A new type of chemical bond between antibiotics and titanium, a
material used in devices, may be the first step toward eliminating
device-related infections, according to a recent report in the
journal Chemistry and Biology.
Researchers at Jefferson Medical College in Philadelphia found
that by fastening the antibiotic vancomycin to titanium powder they
were able to immediately kill bacteria sensitive to the antibiotic.
The scientists developed a bonding method to ensure that the
antibiotic stays attached to metal.
Infections associated with orthopedic implants are one of the
major causes of implant failure because when bacteria grow on an
implant it cannot knit properly with the bone. "The biggest benefit
of this work is to keep the infection from ever starting," Eric
Wickstrom, one of the developers of the bonding method, says.
Prices For Brand Drugs Increasing Faster Than Those For
Generics, Says GAO
Retail prices for frequently used brand drugs have increased
roughly three times faster than those of commonly used generic
drugs, according to a Government Accountability Office (GAO) report,
which predicts public and private insurers will turn to generics to
reduce costs.
"With brand drug prices increasing three times as fast as generic
drug prices, public and private health insurance sponsors will
likely continue to focus on strategies to encourage increased use of
generic drugs when available," says the report, requested by Sens.
Olympia Snowe (R-Maine) and Ron Wyden (D-Ore.).
From January 2000-December 2004, the average retail price paid by
patients without prescription drug coverage for 96 frequently used
drugs increased 24.5 percent. Twenty drugs — 19 brand and one
generic — accounted for 64 percent of the total retail price
increase, the report shows.
Sept 26th
FDA Approves Early End To Study Of Essure Birth Control
Procedure
The FDA recently approved early termination of a postapproval
study of Conceptus' Essure birth control procedure because of the
positive data obtained so far. The purpose of the study was to
determine the success rate in placing the device. The Essure
procedure deploys a soft micro-insert into the fallopian tube
through the cervix using a minimally invasive transcervical tubal
access catheter. Once in place, the device is designed to block the
fallopian tube.
Although the treatment of the number of patients usually required
by the FDA has not been completed, the positive results thus far
convinced the agency to end the study. The FDA's decision moves the
agency one step closer to approving a supplemental label for
bilateral placement rates.
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.
FDA Issues Proposed Rule On cGMPs For PET Drugs
The FDA has issued a proposed rule on current good manufacturing
practices (cGMPs) for positron emission tomography (PET) drugs.
The proposed rule will establish minimum standards for the
production and testing of PET drugs, the FDA said. The agency has
also concurrently published a draft guidance, titled "PET Drug
Products — Current Good Manufacturing Practice." The guidance
describes acceptable approaches for PET drug producers to meet the
requirements of the proposed regulation.
PET is a medical diagnostic tool in which a radioactive drug is
administered to a patient, most commonly by intravenous injection,
and the distribution and uptake of the radioactive drug to various
bodily organs is imaged using a scanner. The image helps physicians
diagnose diseases such as cancer and heart disease.
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