CONTENTS:
- Medical Devices
- Drugs & Biologics
- Food & Dietary
Medical Devices
IDS seeks FDA clearance for mammography
system
Imaging Diagnostic Systems has filed an application with the FDA
seeking 510(k) clearance for its CT laser mammography technology,
which can generate 3D images using continuous wave-laser technology
and could help diagnose cancer in dense breasts. The device already
is approved in Europe, Canada and Australia.
Report: Firms test high-risk devices on
"training patients"
Companies developing pacemakers, stents and other high-risk devices
are allowing clinical trial physicians to practice implanting such
devices on "training patients," without reporting much
information about these patients to the FDA, a new study finds. The
practice lacks regulatory oversight, according to the study.
Sonova plans to recall cochlear implants made by
Advanced Bionics
Sonova Holding said it plans to pull from the market its HiRes 90K,
a cochlear implant developed by its Advanced Bionics unit, after
receiving reports of adverse events from two patients. Sonova said
its division "is working closely with the FDA to identify the
problem and institute changes to the product to ensure that the
HiRes 90K has the highest quality for patients who use the
device."
FDA issues approvable letter to Hologic for 3D
mammography
The FDA has issued an approvable letter to Hologic for its Selenia
Dimensions 3D digital mammography tomosynthesis device.
"Hologic is fortunate to be in a position where we are ahead
of everybody else in getting this technology to this point in
development," said the company's marketing director.
FDA's failure to inspect sites during clinical
stage raises concerns
A substantial number of patients involved in a clinical trial of
Aptus Endosystems' Aptus AAA Endovascular Repair System, a
stent graft designed to treat aortic aneurysms, developed blood
clots that might have been caused by faulty manufacturing
processes, according to the company and physicians involved in the
trial. The FDA doesn't generally conduct manufacturing site
inspections for devices in the clinical phase, which can raise
risks for patients, according to doctors.
Sphere Medical's propofol monitoring tool gets
CE Mark approval
Sphere Medical has been granted approval in Europe to sell the
Pelorus 1000 monitoring system, which can monitor the dosage levels
of sedative propofol, as a research instrument. The company is
testing the device as an in vitro diagnostic tool.
Health Canada asks PWB Health to pull Breast Light
from market
Health Canada has asked PWB Health to recall its Breast Light after
finding that the device lacks sufficient clinical data to support
its effectiveness in spotting signs of breast cancer. The agency
also ordered pharmacies and distributors to immediately stop
selling the device.
Genzyme licenses a lung cancer test to
Roche
Roche Holding has secured worldwide rights from Genzyme to develop
a test that can rapidly pinpoint epidermal growth-factor receptor
mutations, which are linked to lung cancer, and predict a
patient's response to its lung cancer drug Tarceva. Roche also
has agreed to team up with OSI Pharmaceuticals to create a
companion test that can identify those with nonsmall-cell lung
cancer.
DIRAmed seeks $2M in funding for blood sugar
monitor
DIRAmed hopes to obtain $2 million in investment capital to hire
more workers, analyze clinical trial data and complete the
development of a prototype of its noninvasive blood glucose
monitor. The company's blood-sugar meter is based on Raman
spectroscopy, which quantifies the scattering of light to analyze
molecules.
SEC filing: HyperBranch Medical gets $2.07M in
stock offering
HyperBranch Medical Technology disclosed in a regulatory filing
that it secured $2.07 million in a stock offering. The company
specializes in developing polymer-based products used to seal
wounds.
Jury rules in favor of B. Braun in patent dispute
with Terumo
A federal jury in Delaware ruled that Terumo infringed on a patent
held by B. Braun Melsungen for a catheter system that features a
safety clip designed to reduce the risk of accidental sticks.
Teams of researchers work to develop XMRV
test
Various institutions and companies are developing tests to identify
the XMRV retrovirus in the blood supply. Researchers at Abbott,
Cleveland Clinic and Emory University have created tests that can
determine the presence of antibodies to three XMRV proteins. One
researcher working with the National Cancer Institute has made an
XMRV antibody test using blood samples from patients with chronic
fatigue syndrome, while an NCI researcher modified an HIV test
called X-SCA to be able to detect XMRV.
BG Medicine gets FDA clearance for cardiac
test
The FDA has cleared BG Medicine's Galectin-3 test, which can
detect heart failure by measuring levels of the protein galectin-3
in blood. BG Medicine is collaborating with LabCorp to launch the
product, and is working to develop an automated version with Abbott
Laboratories and two other firms.
Democrats question Republicans' stand on
health reform
Sixty Democrats, led by Rep. Joseph Crowley, D-N.Y., on Tuesday
sent a letter to Republicans, calling those who want to repeal the
health reform law but accept government-based health plans as
hypocrites. The Democrats said that Republicans should "walk
that walk" and stop denying the same coverage "to
Americans who don't happen to be Members of Congress."
Medtronic has $800 million deal for
Ardian
Medtronic has agreed to pay $800 million in cash to acquire Ardian,
a maker of a catheter-based system that treats hypertension by
killing nerves near the kidneys. The deal also calls for Medtronic
to pay additional fees if Ardian meets revenue-based milestones
through 2015.
Stryker, hospitals team up to fund S.C. medical
innovation project
Stryker has agreed to provide discounts to six South Carolina
hospitals to help them generate savings that will be used to fund
the S.C. Medical Translational Technology Program. The SC
MedTransTech project aims to support the development and
commercialization of medical technology, as well as boost the
state's competitiveness in the field of biomedical
engineering.
Invacare announces planned resignation of
CEO
Invacare said A. Malachi Mixon III, who went on medical leave in
April because of a mild stroke, will resign as its chief executive,
effective Jan. 1. Mixon will continue to serve as chairman and
concentrate on the company's research-and-development and
government-related operations. Gerald Blouch, Invacare's acting
CEO since April, will succeed Mixon with a mission to redirect the
focus of the company's four units from regional to global
operations.
Philips unveils Web-based monitoring service for
pacemaker patients
Electronics has introduced a service that could allow its
cardiographic technicians to remotely monitor and detect
abnormalities in patients implanted with pacemakers.
"Web-based remote pacemaker monitoring helps cardiology
practices to streamline workflow, improve patient compliance, and
enhance practice economics," said Paul Bromberg, Philips
Remote Patient Monitoring's general manager.
Protein-coated stent could reduce risk of heart
attack
Australian scientists said they have developed a stent coated with
an artificial human protein, called elastin, that could
significantly reduce the risk of heart attacks and blood clots in
patients who have had heart attacks. The lead researcher said he
thinks the device could be tested in humans in two years.
Siemens unveils Biograph mMR
Siemens has launched the Biograph mMR, the first clinical device
that merges the capabilities of MRI and PET. The device would
reduce scanning time for patients by about 50% by allowing doctors
to detect tumors and determine malignancy at the same time.
HHS issues new insurance spending rules
The HHS on Monday released the final rules on medical loss ratio,
requiring large insurers to spend 85 cents per premium dollar on
medical care, not administrative costs or profit. The new rules
also give states a three-year period to loosen their spending
thresholds and exempt small health policies, mini-medical plans and
new insurance plans.
Hologic to distribute SuperSonic's ultrasound
system in the U.S.
Hologic has agreed to exclusively market and install SuperSonic
Imagine's Aixplorer MultiWave ultrasound system in the U.S. for
an undisclosed amount. SuperSonic's device detects breast
cancer by looking for changes in the elasticity of breast tissues
using the company's ShearWave Elastography technology.
Angiotech faces lawsuit over deal
termination
Rex Medical said it sued Angiotech Pharmaceuticals claiming that
the latter failed to honor a licensing deal that calls for it to
exclusively distribute Rex Medical's Option inferior vena cava
filter, which is designed to prevent pulmonary embolisms. Angiotech
said it couldn't fulfill its obligations under the agreement
because of its financial situation and recently announced
recapitalization plan.
Medicare's regional carrier to cover
Uroplasty's device
Uroplasty announced that one of Medicare's regional carriers,
Palmetto GBA, has agreed to cover its Urgent PC Neuromodulation
System for use in treating overactive bladder. "We believe the
strong clinical data that supports PTNS led the regional Medicare
carriers to determine that PTNS treatments meet the criteria for
medical necessity," said David Kaysen, Uroplasty's chief
executive.
Access Scientific obtains $2M in equity
financing
Access Scientific has secured $2 million in a round of equity
financing from seven investors. The funding comes after the San
Diego-based firm introduced its Picc Wand Peelable Safety
Introducer, an FDA-cleared device designed to insert sheaths and
catheters.
REVA Medical hopes to obtain up to $85M in stock
offering
San Diego-based REVA Medical is looking to secure as much as $85
million in an offering on the Australian stock exchange, according
to a prospectus filed with the U.S. Securities and Exchange
Commission. The company will use the proceeds to market its
next-generate stent used for treating cardiac diseases.
European Parliament: Revised RoHS directive to
cover medical devices
The European Parliament has decided to require makers of medical
devices to comply with the revised version of the RoHS directive,
which limits the use of hazardous materials in electronic systems.
Device makers have been given a transition period of eight years to
adopt the revised directive, which is expected to take effect in
2011.
Stem cell-based spray holds promise for healing
wounds
Physicians at the University of Utah have combined thrombin and
calcium with platelets and progenitor cells derived from patients
to develop a topical spray designed to heal wounds and burns. The
treatment, which takes about 15 minutes to apply, is being tested
by university researchers in patients with burns and chronic
wounds.
Mobisante develops smartphone-based ultrasound
system
Mobisante has developed an ultrasound device that can be linked to
a smartphone, allowing health providers to detect internal
hemorrhage in patients during emergencies or monitor pregnant women
at home, among other uses. The startup is seeking FDA clearance for
the portable device and hopes to start commercialization in
2011.
Drugs & Biologics
Report: Quality flaws still plague J&J
unit's Puerto Rican plant
FDA inspectors have published a report indicating that Johnson
& Johnson subsidiary McNeil Consumer Healthcare has failed to
correct some of the manufacturing flaws at its Puerto Rican
facility that were cited in a warning letter earlier this year. The
report "shows that the company continues to have serious
quality control issues at its plant and that it is not in
compliance with current good manufacturing practices required by
federal law," an FDA spokeswoman said.
Sun Pharma's generic Cymbalta gets tentative
approval from FDA
The FDA has issued tentative marketing approval for Sun
Pharmaceutical Industries' duloxetine hydrochloride, a copy of
Eli Lilly and Co.'s Cymbalta. The drug is used for treating
generalized anxiety disorder, diabetic peripheral neuropathic pain
and major depressive disorder. Sun will launch the generic product
in 20-, 30- and 60-milligram capsules.
Ranbaxy gains FDA approval to launch a generic
Aricept, sources say
Ranbaxy Laboratories reportedly received marketing approval from
the FDA for donepezil hydrochloride, a generic version of
Eisai's Alzheimer's medicine Aricept. The brand-name
drug's patent expired Thursday, and Ranbaxy expects to launch
its product this week, sources said.
FDA delays a decision on MS pill cladribine until
February
Merck KGaA said the FDA has extended for three months a priority
review of cladribine, an oral treatment for relapsing multiple
sclerosis. The announcement comes two months after the company
failed to obtain European approval for the drug.
NICE refuses to endorse Novartis' kidney
cancer drug Afinitor
The U.K. National Institute for Health and Clinical Excellence has
refused to recommend Novartis' Afinitor as second-line therapy
for kidney cancer, saying there is "still too much
uncertainty" about the drug's cost-effectiveness. The
agency has "to ensure that the money available to the
[National Health Service] ... is used to best effect, particularly
when funds, like the rest of the public sector, is under
considerable financial pressure," said NICE CEO Andrew Dillon.
Novartis said it intends to appeal the decision.
J&J receives good news in Risperdal, pain
patch case
Citing FDA warning letters, the attorney general for West Virginia
had sued Johnson & Johnson six years ago over allegations that
the drugmaker, along with its Janssen unit, illegally claimed that
the Duragesic pain patch and another product, Risperdal, were safer
than other similar products. In the latest on the case, the Supreme
Court of Appeals of West Virginia last week reversed a previous
judgment against J&J and granted the company a new trial.
"We are pleased that the West Virginia Supreme Court has
reversed and remanded this case," said a spokesman for
Ortho-McNeil Janssen.
FDA approves CNS' generic of spasticity drug
Lioresal
The FDA has granted CNS Therapeutics approval to market gablofen, a
treatment for severe spasticity. The medicine, a copy of
Novartis' Lioresal, is administered intrathecally using an
implantable infusion pump developed by Medtronic.
Vertex files for FDA approval of hepatitis C drug
telaprevir
Vertex Pharmaceuticals has finished filing a new-drug application
with the FDA for telaprevir, a drug candidate for hepatitis C.
Vertex said it asked the agency to cut the review period from 10
months to six months.
U.S. needs clear policy on stem cell research,
expert says
Congress needs to craft clear, comprehensive policy on research
that uses stem cells derived from human embryos to end legal
ambiguity surrounding such research, said John Gearhart, a stem
cell pioneer and head of the University of Pennsylvania's
Institute for Regenerative Medicine. An appeals court will conduct
a hearing in December to discuss the legality of providing federal
funding for embryonic stem cell research.
J&J pulls children's Benadryl and Motrin
from distribution
Johnson & Johnson is removing about 4 million packages of
allergy tablet Children's Benadryl in cherry and grape flavors
and about 800,000 bottles of Motrin's junior-strength caplet
from wholesale and retail establishments because of
"insufficiencies in the development of the manufacturing
process," a spokeswoman said. "Consumers can continue to
use the product; they don't have to take any action," she
said.
Justice Dept. sees record settlements from pharma
this year
Of the $3 billion that the Justice Department recently announced it
collected in settlements under the False Claims Act this year, $2.5
billion of it came from the drug industry, including $669 million
from Pfizer, $302 million from Astra Zeneca and $192 million from
Novartis. "We're going to hold both companies and
individuals accountable," said Assistant Attorney General Tony
West.
Cornerstone voluntarily withdraws 3 drugs
containing propoxyphene
Cornerstone Therapeutics said it will voluntarily stop selling
three painkillers that contain propoxyphene, after the FDA asked
for the market removal of such medicines because of increased heart
risk. "Cornerstone is committed to complying fully with the
FDA's request and will react accordingly as our top priority is
always the safety ... of our patients," said President and CEO
Craig Collard.
Research institute in Boston joins fight against
stem cell ruling
The Boston Biomedical Research Institute has joined several groups
in opposing a federal judge's initial decision to block
government funding for embryonic stem cell research. "A
university and a foundation have offered to provide BBRI with human
embryonic stem cells with mutations conferring muscular dystrophy
for its research, but BBRI has not accepted these materials as a
result of the injunction," BBRI said in a court filing. BBRI
is the employer of Dr. James L. Sherley, one of the scientists who
sued the NIH for funding studies involving human embryonic stem
cells.
India bans obesity pill sibutramine because of
adverse effects
The Drug Controller General of India has banned production and sale
of weight-loss drug sibutramine and its variants because they can
cause adverse reactions, including heart attack. The move follows a
recommendation from an expert panel, which looked into the issue
after Abbott Laboratories pulled its branded version off the U.S.
market last month.
Food & Dietary
Food safety bill, up for vote today, draws support
from food companies
Cargill, Campbell Soup and a number of other food manufacturers
that at some point in the past two years conducted product recalls
are supporting a $1.4 billion bill aimed at improving food safety,
despite stricter rules in the legislation. The Senate is expected
to hold a vote today on the bill, which would provide the FDA more
authority to mandate recalls.
Food safety law raises concerns for smaller
farms
Advocates for small farms and sustainable agriculture are speaking
against a proposed law aimed at improving food safety, saying it
could unfairly burden small farms. "Blanket legislation for
large farmers does not really work the same for small
farmers," said a farmers' market expert, while Dave
Murphy, founder of food advocacy group Food Democracy Now!, said,
"There is the general feeling that the majority of these food
safety outbreaks actually occur in larger facilities."
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
