CONTENTS:
Medical Devices
AdvaMed stands by FDA's device approval
process
David Nexon, senior executive vice president at AdvaMed, defended
the FDA's 510(k) process for medical devices after the process
was recently criticized by Public Citizen, a consumer advocacy
group. Nexon also noted that adopting a "one-size-fits
all" strategy in device evaluations "would be a
tremendous disservice to patients."
FDA classifies recall of Hospira's infusion
pumps as Class I
The FDA ordered a Class I recall of Hospira's Symbiq
One-Channel and Two-Channel Infusers because of a defect that may
affect the ability of the devices to identify in-line air during
infusions. The company said there have been no reports of adverse
events linked to the device failure.
NuOrtho Surgical gets FDA clearance for
electrosurgical probe
The FDA has granted NuOrtho Surgical 510(k) clearance for Ceruleau,
an electrosurgical probe designed for treating unhealthy cartilage
tissue. The company said it has entered deals with several other
businesses for the distribution of the device in the U.S.
Consumer group criticizes FDA's medical device
approval process
Researchers at consumer group Public Citizen have raised concerns
about the FDA's process for approving medical devices,
including regulators' interpretation of requirements for the
510(k) process. Researches say the new-device process is being
bypassed. The authors urged a combination of legislation and
regulatory changes.
Philips faces patent-infringement suit from Zoll
Medical
Zoll Medical has filed a lawsuit in the U.S. District Court for
Massachusetts against Philips Electronics alleging infringement of
five patents for defibrillator technology. The case comes a month
after Philips filed its own suit against Zoll regarding the alleged
violation of 15 patents covering automated external
defibrillators.
FDA: Baxter has 2 years to recall drug-infusion
pump Colleague
The FDA is allowing Baxter International to pull from the market
about 200,000 units of drug-infusion pump Colleague during the next
two years and offer either a refund or a replacement. A spokeswoman
for Baxter said the company is collaborating with Sigma
International to ramp up production of a replacement pump.
Meridian Bioscience gets clearance for C.
difficile test
Meridian Bioscience has obtained FDA approval for its Illumigene
molecular test designed to detect Clostridium difficile bacteria,
which can cause severe colon inflammation. The company said the
test can generate results in less than 60 minutes.
Roche gets FDA approval for MRSA test
Roche Molecular Systems has gained FDA clearance for its
LightCycler MRSA Advanced test. The company said the test can
determine methicillin-resistant Staphylococcus aureus nasal
colonization and yields results in two hours.
FDA device center to meet with international
agencies
The FDA's Center for Devices and Radiological Health will
conduct a forum Sept. 13 to 15 to discuss regulatory issues with
international regulatory agencies. Participants have been requested
to read several learning modules to prepare for the event,
including an overview of the 510(k) process.
FDA asks for additional tests of liver diagnostic
device
The FDA has rejected Exalenz Bioscience's application for
approval of its BreathID device for use in liver disease diagnosis
and asked the company to perform additional trials based on
predetermined goals. The Israel-based company said it will continue
to conduct studies of the device.
SurModics licenses implant technology to
Australian company
SurModics Pharmaceuticals, a SurModics unit, has agreed to license
its SCENESSE implant formula, a biodegradable polymer implant
technology designed to treat sun-related skin disorders, to
Australian firm Clinuvel Pharmaceuticals.
New guidelines back use of MRI in stroke
diagnosis
The American Academy of Neurology has released its new guidelines,
saying MRI proved to be more effective than CT scans in detecting
ischemic stroke damage. "Specific types of MRI scans can help
reveal how severe some types of stroke are. These scans also may
help find lesions early," said Dr. Peter Schellinger, the lead
author of the guidelines.
Artificial heart could benefit patients in
end-stage failure
Carmat used synthetic and animal tissues to develop a total
artificial heart designed to replace a diseased heart in patients
with end-stage cardiac failure. The France-based startup, which is
conducting the last phase of preclinical trials, hopes to launch
human trials by the end of 2011 and commercialize the device in
Europe in 2013, said Carmat CEO Marcello Conviti.
U.K. agency approves 2 treatments for
Barrett's esophagus
The U.K. National Institute for Clinical Excellence has approved
the use of photodynamic therapy and radiofrequency ablation in the
treatment of Barrett's esophagus in patients with high-grade
dysplasia. The agency issued the decision after finding that the
two techniques proved to be safe and effective in treating the
disorder.
Canadian firm's implant controls glucose in
diabetic pigs
Diabetic pigs treated with Sernova's Cell Pouch System showed
long-term normal glucose levels without experiencing adverse
events, according to preclinical trials. The implantable device
uses insulin-producing tissues, or islets, derived from the
pancreas of the animals to enable the therapeutic cells to thrive
and function in a natural environment.
Device analyzes sounds from joints to detect
osteoarthritis
U.K. scientists have launched a prototype of a device that can
detect knee osteoarthritis at an early stage by listening and
analyzing patterns of sounds coming from knee joints. "We
imagine that it would be a piece of a portable equipment a bit like
an ECG machine. This could be used by the doctor or the nurse to
make a regular assessment of change within the knee joint,"
said a professor who is working on the device.
NuOrtho Surgical gets FDA clearance for
electrosurgical probe
The FDA has granted NuOrtho Surgical 510(k) clearance for Ceruleau,
an electrosurgical probe designed for treating unhealthy cartilage
tissue. The company said it has entered deals with several other
businesses for the distribution of the device in the U.S.
Stentys completes enrollment for trial of
self-expanding stent
Stentys has finished enrolling patients in a clinical trial
designed to compare the efficacy of its self-expanding stent with a
traditional balloon-expandable stent in people with acute
myocardial infarction. Results of the APPOSITION II study will be
released in September.
Chip holds promise for precise electrical brain
stimulation
An international group of scientists has developed the
Rehabilitation Nano Chip, a biomimetic chip that can control the
delivery of electrical stimulation to diseased brain areas by
monitoring and analyzing brain activity. They plan to complete the
experiments on the device within six months and hope to start
testing its ability in treating Parkinson's disease and other
neurological conditions in a few years.
Dune Medical reports positive trial results for
surgical tool
Dune Medical Devices said interim results from a European study
showed that the use of its MarginProbe system in removing breast
tumors resulted in a 50% reduction in the need for additional
surgeries. The company finished a clinical study of the device this
year that will be used in seeking marketing approval in the
U.S.
National Cardio to settle fraud claim for
$3.6M
Government officials said California-based National Cardio Labs,
which analyzes diagnostic data from cardiac monitors and other
devices, has agreed to settle for $3.6 million allegations of
fraud. The company and two of its managers were accused of
submitting false claims to Medicare and other health insurers for
certain diagnostic testing for six years.
AAMI working group to focus on bioabsorbable
vascular implants
The Association for the Advancement of Medical Instrumentation has
set up a working group focused on bioabsorbable vascular implants
in an effort to complement the functions of a proposed
International Organization for Standardization group.
Biomet plans to expand in Indiana
Biomet plans to spend $26 million on an expansion in Warsaw, Ind.,
according to officials from the state's Kosciusko County
Council. The orthopedic device firm is expected to generate 280
jobs in the state as part of its plan. The company could receive
tax reductions on the project after the council approved its
request for an economic development area designation.
Ximedica plans expansion, introduces group for
providers
Ximedica has hired 30 employees over the past 15 months and plans
to expand its facilities for research and development and
manufacturing operations at its headquarters in Providence, R.I.
The company also equipped its medical R&D services with medical
simulation systems and launched a Human Centered Healthcare
Services group that will focus on helping health care providers
improve the delivery of care.
Vivorte secures $200K in funding for implantable
device
Vivorte has obtained $200,000 in equity investment from the
Kentucky Science and Technology Corp. The Louisville, Ky.-based
company will use the funding to develop and commercialize a tiny,
implantable device designed to prevent hip fractures during
falls.
Cardio monitoring company to settle federal
claim
The U.S. attorney's office said California-based National
Cardio Labs, which analyzes diagnostic data from cardiac monitors
and other medical devices, has agreed to pay $3.6 million to settle
a lawsuit over health care claims. In the lawsuit, the company and
its executives were accused of submitting false claims to Medicare
and other health insurers for heart and blood pressure diagnostic
testing from January 1998 to February 2004.
Delphi Medical to sell unit's assets to
Sparton
Sparton, an electromechanical device firm, said it plans to broaden
its presence in the therapeutic device market by buying some assets
of Delphi Medical Systems' contract manufacturing unit for
about $8 million in cash. Sparton said it will carry out the deal
through its division, Sparton Medical Systems Colorado, using
existing cash reserves.
Minnetronix secures more space for HQ,
production
Minnetronix will lease an additional 11,800 square feet of space as
part of its plan to expand its headquarters and production facility
in St. Paul, Minn. The company will use the additional space to
accommodate product design, training and administrative operations,
among others.
Devicor buys breast cancer unit of J&J's
Ethicon Endo-Surgery
Devicor Medical Products said it closed on its purchase of a breast
cancer unit owned by Johnson & Johnson's Ethicon
Endo-Surgery. The division sells the Mammotome Breast Biopsy System
and other products used in the diagnosis and treatment of breast
cancer. Devicor said it plans to employ the unit's 300 workers
and create up to 150 new jobs.
Investment will let Accuri Cytometers reach new
market
Accuri Cytometers has landed $6 million in venture capital
financing from Arboretum Ventures and other investors. Accuri Chief
Executive Jeff Williams said the funding will allow the firm
"to respond to a rising number of requests for an Accuri flow
cytometer for clinical diagnostic applications, providing the same
benefits of high performance, cost-effectiveness and ease-of-use
experienced by our life science research customers."
Medical-device firm gets $10.5M investment from
Endeavour
Providien has received a $10.5 million investment from private
equity firm Endeavour Capital, according to a regulatory filing.
The medical-device company focuses on buying smaller firms that
offer contract medical device manufacturing services, said a
managing partner at Endeavour.
Neuros names industry veteran as independent
director
Neuros Medical has appointed Scott Drees, who held executive posts
at St. Jude Medical, Boston Scientific and Johnson & Johnson,
to its board of directors. The company is working on a
neurostimulation tool that electrically stimulates the nerves to
inhibit pain from amputations.
Mobisante tells investors about ultrasound
system
Five early-stage companies attended the Technology Alliance's
Innovation Showcase in Washington state to promote their
technologies to investors. Among the firms was Mobisante, which is
working on a mobile phone-based ultrasound system that can be used
in primary care, obstetrics and emergency care settings.
Report: European monitoring market to hit $161M by
2013
Affordability and the need to handle large volumes of information
will help the European market for electrocardiograms, respiratory
systems and other patient monitoring data management devices to
reach about $161.4 million by 2013, according to a report by Frost
& Sullivan. The report, however, noted that the prevalence of
obsolete systems that are unsuitable for the latest versions of
data management systems could hamper the market's growth in the
region.
Stryker division to sell Etex's bone graft
products
Etex has signed a nonexclusive agreement that calls for
Stryker's spine unit to distribute its bone graft substitute
products, Bio MatrX Structure and Bio MatrX Generate. In March, the
FDA approved Etex's porous bone graft substitute CarriGen.
MicroLumen picks Florida to accommodate
headquarters
MicroLumen is constructing a 60,000-square-foot facility in
Oldsmar, Fla., that will serve as its headquarters and create about
100 jobs in the area. The company manufactures medical tubing
products used in medical devices, such as stents and catheters.
Masimo acquires brain-monitor
manufacturer
Masimo has purchased SEDLine, a developer of an
electroencephalography-based monitor that can track brain activity
in sedated patients, for an undisclosed amount. Masimo said it
would give health providers in the U.S. and abroad more access to
SEDLine's brain-monitoring technology.
Kinetic Concepts sets up research and technology
center
Kinetic Concepts has formed the Advanced Research and Technology
center to focus on the development of new technologies in the field
of wound healing, regenerative medicine and treatment support.
David J. McQuillan, the company's senior vice president, will
lead the new research unit.
Private-equity firms acquire SterilMed
Private equity firms Great Hill Partners and Primus Capital Funds
have acquired SterilMed, a Minnesota-based firm that reprocesses
catheters and other single-use medical devices, for an undisclosed
amount. The transaction will allow SterilMed to "continue on
its current path," said Brian Sullivan, the company's
chairman.
IBM to spend $100M to develop health care
technologies
IBM is tapping more than 100 of its researchers and hiring health
providers and other experts to develop health care tools and
processes for the medical industry as part of a three-year, $100
million program. The company's initiative aims to develop
personalized treatment methodologies, streamline delivery of health
care services and create new incentives and models so that the
health care system rewards medical staff based on patient
outcomes.
TriVascular obtains $60M in venture
financing
TriVascular has secured $60 million in venture financing led by
Pinnacle Ventures. The Santa Rosa, Calif.-based company said it
plans to launch in Europe its Ovation Abdominal Stent Graft used to
treat abdominal aortic aneurysms, as well as fund future studies
and product development efforts.
AAMI working group to focus on bioabsorbable
vascular implants
The Association for the Advancement of Medical Instrumentation has
set up a working group focused on bioabsorbable vascular implants
in an effort to complement the functions of a proposed
International Organization for Standardization group. The AAMI
panel will be tasked with addressing gaps in implant standards and
assessing any standards developed by the ISO.
EU drug regulators consider devices in 5-year
strategy
In its proposed 2011-2015 strategy, the European Heads of Medicines
Agencies is seeking comments on the possible incorporation of
medical device regulation into the regulatory network for drugs.
The agency has set a July 30 deadline for feedback on the draft
strategy.
PET/CT shows promise in detecting breast cancer
bone metastases
PET/CT was able to detect 12 cases of bone metastases of breast
cancer that were either negative or equivocal on bone scintigraphy,
a study showed. PET/CT also was able to determine nonbone
metastases, suggesting that additional imaging tests might no
longer be required when using this method.
Axelrod defends CMS chief appointee
Berwick
Dr. Donald Berwick's recess appointment as CMS administrator
will not lead to the implementation of a British form of health
care system, White House Senior Adviser David Axelrod said in
response to criticism from Republicans. "What we don't
want in this midst of an election is to ... let this be drawn out
in a long kind of political circus while the job that needs to be
done is not getting done or not getting done with the man who
should be doing it," Axelrod said in a television
interview.
U.S. to name free preventive services under health
law
Health plans acquired after Sept. 23 will provide free coverage for
several preventive health services, including immunizations, cancer
screenings and obesity prevention services, under the new rules of
the health reform law, the White House is scheduled to announce
today. The rules seek to encourage people to use preventive
services more often and reduce the country's spending on
treatments for preventable chronic diseases.
FDA is urged to adopt current standards for home
use
AdvaMed is calling on the agency to refrain from introducing
conflicting requirements and adopt existing standards instead to
ensure the safe use of medical devices at home. Among the standards
that device firms want the FDA to recognize for its home-use
program are AAMI HE75:2009 Human Factors Engineering -- Design of
Medical Devices and IEC 60601-1-11 Medical electrical
equipment.
Medical device experts say exports' strength
is threatened
The U.S. medical-device industry continues to "enjoy a
positive balance of trade," in which more products are
exported than imported, said Brett Loper, AdvaMed's chief
lobbyist. However, the health reform law's industry taxes and
the slow pace of regulatory process could force medical device
firms to move manufacturing operations to Europe, according to
industry representatives.
Drugs & Biologics
FDA investigates the cancer risk of
angiotensin-receptor blockers
FDA officials are investigating angiotensin-receptor blockers, a
class of blood pressure drugs, after clinical data suggested that
they might increase the risk of cancer. However, the agency thinks
"the benefits of ARBs continue to outweigh their potential
risks."
FDA advisers won't endorse Vivus' Qnexa
because of safety concerns
An FDA advisory panel voted 10-6 against recommending the approval
of Vivus' obesity treatment Qnexa, saying its potential adverse
effects are a concern. The FDA is scheduled to decide by Oct. 28
whether to approve the drug.
Court dismisses Taro's complaint regarding a
Sun unit's tender offer
A U.S. district court dismissed litigation filed by Taro
Pharmaceutical Industries that seeks to stall a takeover bid from
Sun Pharmaceutical Industries' Alkaloida Chemical to acquire
all of Taro's outstanding shares. "The court also
dismissed Taro's other claims, including breach of contract and
misappropriation of trade secrets, for lack of subject matter
jurisdiction," Sun said in a statement.
FDA advisers: Avandia should stay on the market,
with more warnings
An FDA advisory panel voted 20-12 for continued marketing of
GlaxoSmithKline's Avandia, concluding that research data that
link the diabetes drug to heart risks are not enough to warrant its
withdrawal. Half of the experts who voted to keep the product on
the market called for additional warnings and restrictions for its
use.
Novartis will settle a class-action discrimination
suit for $175M
Novartis agreed to pay $175 million to end a class-action lawsuit
claiming that it discriminated against female employees. The
settlement allows "for full compensation of both former and
current female field force employees, ensuring that every woman who
worked at Novartis over the past eight years has been compensated
fairly," David Sanford, lead counsel for the plaintiffs, said
in a statement.
Glenmark's generic version of asthma drug
Uniphyl gains FDA approval
Glenmark Generics obtained FDA approval to market theophylline, a
copy of Purdue Pharmaceutical Products' Uniphyl, which is a
treatment for asthma and other respiratory illnesses. The approval
covers 400- and 600-milligram doses of the extended-release
tablet.
Gilead files a patent suit to prevent a generic
Ranexa from Lupin
Gilead Sciences filed a lawsuit against Indian generic-drug maker
Lupin for allegedly infringing on its patents for angina treatment
Ranexa. The biopharmaceutical firm said Lupin sought FDA approval
to manufacture and sell a copy of the drug before patent
expiration.
ChemGenex plans to submit leukemia drug Omapro to
the FDA
After a discussion with the FDA, biotech firm ChemGenex
Pharmaceuticals plans to submit a new-drug application for leukemia
treatment Omapro based on the combined data of two studies. The
application is for patients with chronic myeloid leukemia who have
not responded to standard treatment. The company could forward the
application by the end of the year.
Sources: GSK will settle a majority of Avandia
lawsuits for $460M
Sources said GlaxoSmithKline agreed to pay about $460 million to
settle about 10,000 lawsuits concerning diabetes drug Avandia,
which allegedly can cause strokes and heart attacks. The report
comes as FDA advisers meet to decide whether the drug should be
pulled from the market.
KV partner Hologic resubmits Gestiva for FDA
approval
KV Pharmaceutical said partner Hologic resubmitted Gestiva, a drug
to prevent preterm birth, for marketing approval by the FDA.
Hologic received a complete-response letter for the treatment in
January 2009.
Shareholder blames Pfizer execs for illegal
marketing practices
A Pfizer shareholder said in a lawsuit that the drugmaker's
board and senior management should be held liable for improper drug
promotion, which resulted in a fine of $2.3 billion. Inaction by
Pfizer directors hurt the value of investors' stakes in the
company, said the shareholder's lawyers.
Bristol and Otsuka will get priority review for
Sprycel's expanded use
Bristol-Myers Squibb and partner Otsuka Pharmaceutical obtained
priority-review status from the FDA for cancer drug Sprycel as
first-line treatment for adults with newly diagnosed chronic
myeloid leukemia. Sprycel is approved to treat those who do not
benefit from Novartis' Gleevec.
Consumers who bought recalled children's drugs
sue J&J unit McNeil
Consumers filed lawsuits accusing Johnson & Johnson's
McNeil Consumer Healthcare of fraud and racketeering related to a
recall of children's products. The complaints state that
coupons offered by the company to those who purchased recalled
drugs are "worthless" and "wrongly assumes that all
consumers will want to purchase the company's children's
products at some uncertain future date."
California high court reinstates a price-fixing
suit against drugmakers
The California Supreme Court reversed a lower-court ruling and
reinstated a price-fixing lawsuit that accuses major drugmakers of
conspiring to overcharge pharmacies, which passed increases on to
their customers. The decision means that in the state, "no
price-fixer is going to get off on the basis that the victim might
have passed on to its customers the amount of the price fix,"
said a lawyer representing pharmacies.
FDA to decide on Gaucher drug taliglucerase alfa
by February
The FDA plans to make an approval decision on Protalix
Biotherapeutics' Gaucher disease drug, taliglucerase alfa, by
Feb. 25, four months later than expected. If approved,
taliglucerase alfa will compete with Genzyme's Cerezyme, which
is in short supply because of a manufacturing problem.
Biotech
Study: Genes carried by 30% of African-Americans
raise kidney risk
Scientists analyzed data from the 1000 Genomes Project DNA data
bank and identified two variants, G1 and G2, in the APOL1 gene that
may help explain the greater rates of kidney disease among
African-Americans. The genes raise the risk for focal segmental
glomerulosclerosis and hypertension-attributed end-stage kidney
disease. "We found that the APOL1 risk genes for renal disease
occur in more than 30 percent of African-American
chromosomes," said the co-senior author of the study.
Lung made of cells grown in lab shows promise in
rats
Scientists at Massachusetts General Hospital and Harvard Medical
School said they have developed an artificial lung that enabled
rats to breathe for about six hours when transplanted into the
animals. They created the synthetic lung by removing all cells from
the rats' lungs and putting the organ's scaffolding inside
a bioreactor to grow with several types of human lung cells.
U.K. study to focus on stem cell treatment for
osteoarthritis
A U.K. study will enroll up to 70 patients to test the efficacy of
stem cells derived from bone marrow in treating knee
osteoarthritis. The charity group Arthritis Research UK is funding
the clinical trial, which is set to begin before the end of the
year.
Scientists call for federal oversight of
biotech
Although advances in biotech may pave the way for medical
breakthroughs and carbon-free fuels, the industry needs government
oversight, biology pioneers George Church and Craig Venter said at
a meeting of a presidential bioethics panel. "If you have a
speed limit but no one enforcing it, you'll have people
speeding. You need to proactively set up a radar system and surveil
it," Church said.
Expert: Stem cell "pharmacies" could be
ready in 20 years
In two decades, stem cell banks could function as
"pharmacies" and offer tissue therapies tailored to
particular diseases and patients, said David Warburton, a professor
and one of the world's top stem cell experts. "Genomic
research is going to apply stem cell research not only to a
specific disease but to a specific person with a disease,"
Warburton said.
Food & Dietary
Health risks are higher for food, farm workers,
study shows
People who work in farming and food industries have higher rates of
metabolic syndrome -- a collection of risk factors for heart
disease, diabetes and stroke, according to the National Health and
Nutrition Examination Survey. In most cases, the risks appeared to
be linked to related factors such as smoking, weight, exercise and
race.
State soft drink tax efforts fall flat
Efforts to approve taxes on soft drinks have failed in New Mexico,
New York, Mississippi and elsewhere. Beverage lobbyists campaigned
against the increases, arguing that soft drinks aren't solely
responsible for obesity.
Michelle Obama talks food in live Web
chat
First lady Michelle Obama spoke about the availability of healthy
food, and childhood nutrition in general, during a live online chat
with AOL Health. She also discussed "food deserts," and
said Philadelphia's The Fresh Grocer is an example of a grocery
that is providing fresh food in an urban area.
Poll shows support for food safety laws
In a Consumers Union poll, 80% of Americans said they want a new
food safety law to be approved by Congress right away. The FDA Food
Safety Modernization Act, currently stalled in the Senate, includes
FDA authorization that would recall food and call for more safety
inspections.
Dip at your own risk
According to a study, one in 25 cases of food poisoning traced to
restaurants from 1998 to 2008 can be blamed on salsa or guacamole.
Risks are increased because the dips are made in large batches, and
are not cooked to kill harmful bacteria.
FDA sets new egg safety standards
The FDA says egg producers with laying hens totaling 50,000 or more
have to purchase their hens and chicks from sources that monitor
for salmonella, and must regularly test for the potentially harmful
bacteria. The new rules also require that eggs are refrigerated at
45 degrees during transportation and storage.
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.
