CONTENTS:
- Medical Devices
- Drugs & Biologics
- Food & Dietary
- Tobacco
MEDICAL DEVICES
Massachusetts device exports rose 11% a year over
past decade
A Deloitte & Touche report found that Massachusetts medical
device exports have increased 11% annually from 1998 to 2008 and
accounted for 10% of all U.S. device exports. The study, which will
be unveiled at the Massachusetts Medical Device Councils
conference, also noted that the device sector employed more than
24,000 employees in Massachusetts as of 2008, and that the states
venture-funded startups pulled in $286 million in 2010.
Medtronic chief exec delays plan to leave
post
Medtronic Chairman and Chief Executive Bill Hawkins said he will
put off his planned retirement because the companys board of
directors hasnt found his successor and is most likely to finalize
the search in early fiscal 2012. Hawkins was expected to leave his
post in April.
InVivo signs research deal with U. of
Miami
InVivo Therapeutics Holdings has partnered with the University of
Miami to conduct research and develop therapies for spinal cord
injuries. Under the five-year deal, InVivo will integrate its
biopolymer technology with the universitys Schwann cells and
cellular treatments.
Retina Implant reports positive results for
microchip-based implant
A clinical trial found that Retina Implants microchip-based eye
prosthesis helped restore a practical level of vision and improve
quality of life for seven patients with retinitis pigmentosa.
Results of the companys second study were released at the
Association of Research in Vision and Ophthalmologys annual
meeting.
FDA OKs Strides units Indian plant for cancer
medicines
The FDA cleared Agila Specialities facility in Bangalore, India, to
produce oral and injectable drugs for cancer. Agila, a unit of
Strides Arcolab, said the plant will be used in a licensing deal
with Pfizer to launch 40 generic treatments in the U.S.
Study looks at MBI, combined mammography and
ultrasound
Mayo Clinic researchers using a molecular breast imaging system
found that the method was able to identify additional disease in
patients with biopsy-proven breast cancer that were missed by
combined mammography and ultrasound. The finding led to a
modification in surgical treatment for 12% of the 98 patients
involved in the study, researchers reported in the Journal of
Nuclear Medicine.
Expert: RBMs are effective in curbing imaging
use
Dr. David C. Levin from Thomas Jefferson University in Philadelphia
presented 2008 data at the annual meeting of the American Roentgen
Ray Society showing that a payer experienced a 3.3% decrease in
imaging use through radiology benefits management companies. The
data also showed that through RBMs, 0.5% of studies adapted the use
of a more appropriate test. Levin said that use of computerized
physician order entry systems also can limit imaging misuse, but it
is not yet clear whether national trends and physician incentive
programs also are influencing the use of CPOE.
FCC debates rules for wireless tools as FDA
betters approval process
The FDA and the Federal Communications Commission are collaborating
as well as separately pursuing efforts to advance the development
of wireless and innovative medical devices. The FCC is close to
completing regulations that will make it easier to test wireless
technologies, said Kerry McDermott, the agencys director of health
care. Meanwhile, the FDA is reviewing a pilot application for a
neuroprosthetic arm as part of its innovation pathway program that
aims to accelerate device approvals.
CEO: Boston Scientific is optimistic on
drug-coated stent market
Boston Scientific is confident in its drug-eluting stent business
as it works to launch the Ion stent and a new version of its Promus
Element stent by 2012, CEO Ray Elliot said. Company officials said
they expect a slowdown in the cardiac rhythm management market in
the next six months as a result of a study, which found cases of
defibrillators implanted in patients who, according to guidelines,
werent fit to receive the devices.
FDA clears Spring Set Healths infusion
sets
The FDA has granted Spring Set Health Solutions, a unit of D
Medical Industries, the green light to sell its Spring Universal
Infusion Sets for insulin pumps. The company expects to introduce
the product in the U.S. this quarter, said Efri Argaman, D Medicals
chief executive.
Court will soon rule on head start for Ranbaxys
generic Lipitor
A federal court is expected to decide this week whether the FDA
should reject Ranbaxy Laboratories marketing application for a
generic version of Pfizers cholesterol-lowering medicine Lipitor.
Mylan said Ranbaxy, the first company to challenge Lipitors patent,
should be denied a 180-day exclusivity because it used false
manufacturing data in its application.
FDA allows wider use of Spectrums cancer drug
Fusilev
The FDA approved Spectrum Pharmaceuticals injectable drug Fusilev
for use with 5-fluorouracil to treat metastatic colorectal cancer.
Fusilev was first approved in 2008 for reducing toxicity of
methotrexate, a chemotherapy drug, in patients with a rare form of
bone cancer, osteosarcoma.
J&J pulls FDA application for drug combo
against ovarian cancer
Zeltia said partner Johnson & Johnson stopped seeking FDA
approval for the combination of Yondelis and Doxil to treat women
in remission from ovarian cancer. The decision comes after the
agency requested further testing. The combinations potential risks
reportedly outweigh its effectiveness.
Lilly aims to resolve SEC allegation of
bribery
Eli Lilly and Co. is negotiating with the Securities and Exchange
Commission to end an investigation into possible violations of
bribery law. Last month, Johnson & Johnson settled with the
commission for more than $70 million.
FDA approves Androgel formulation for testosterone
deficiency
Abbott Laboratories secured FDA approval for Androgel 1.62%, a
testosterone-replacement gel for men with hypogonadism. The
prescription drug is not interchangeable with an older formulation,
Androgel
1%.
GE Healthcare expands product offerings with new
acquisition
GE Healthcare has acquired Applied Precision, a provider of
imaging, scanning and restoration microscopy services. GE said the
deal will enable it to expand its offering of products and services
for pharmaceutical and life science research.
Studies back use of routine mammography at age
40
Two studies presented at the American Society of Breast Surgeons
annual meeting could challenge the U.S. Preventive Services Task
Forces recommendation that women should begin routine mammograms at
the age of 50. In one of the studies, researchers studied more than
300 women aged 40 to 49 and found that those who had mammograms had
an overall survival rate of 97% at five years compared with 78% for
those in the non-mammogram group. In the second study, researchers
found that minority women in their 40s who had mammography were
more likely to have early breast cancers than those in the older
population.
FDG-PET/CT performs well in detecting head, neck
tumors
FDG-PET/CT showed better identification of head and neck cancer
tumors compared with CT alone and allowed for treatment changes in
10% of patients and treatment modification in 33% of patients,
according to a study presented late last month at a conference on
cancer imaging. The researchers said facilities that handle head
and neck cancer should have modalities for multi-imaging
procedures.
Report: N.C. life sciences firms secured $1.1
billion in investments
A report from the North Carolina Biosciences Organization found
that life sciences firms in the state attracted equity investments
and grants worth more than $1.1 billion during the 12-month period
ended April 25, up 25% from the same period last year. The report
also found that companies spent more than $437.8 million on
expansions and renovation projects.
Securities sale brings in $300,00 for
BioBehavioral Diagnostics
BioBehavioral Diagnostics disclosed in a regulatory filing that it
has secured $300,000 from a sale of securities worth $500,000. The
Pennsylvania-based company plans to begin commercializing a new
version of its Quotient ADHD system, a test that can help diagnose
attention-deficit/hyperactivity disorder, in July, according to
Byron Hewett, BioBehaviorals executive chairman.
FDA issues draft guidelines for reprocessing
endoscopes
The FDA has issued a draft guidance detailing proper cleaning and
labeling procedures for reprocessed endoscopes, and it plans to
hold a two-day public workshop starting June 8 to discuss the
guidance with health providers. The agency received more than 28
reports of infections caused by reprocessed devices between January
2007 and May 2010.
Researchers develop imaging software with
live-chat feature
Malaysian researchers have developed an Android-based imaging
software that allows doctors to download medical images, including
PET scan results, while discussing them with other doctors in real
time. The Endeavour mobile software system lets doctors view images
on Android-based smartphones, tablet devices and
computers.
OncoMed gets FDA OK to begin early-stage study of
cancer drug
OncoMed Pharmaceuticals gained FDA clearance to initiate a Phase I
safety trial of OMP-18R5, a monoclonal antibody for advanced solid
malignancies. The compound works by inhibiting the Wnt signaling
pathway. OncoMed will receive a milestone fee of $20 million from
Bayer HealthCare Pharmaceuticals.
Attorney says federal rules on devices are
minefield for execs
Vague federal regulations on medical devices make it hard for
companies and executives to defend themselves against felony
charges, attorney Harvey Silverglate told an MIT Enterprise Forum.
Device firm executives face debarment from doing business with the
government if convicted of criminal charges, a penalty so severe it
can force a company to settle, he said. He advised companies facing
federal investigations not to alter records and to document every
detail of the investigation process.
Toshiba Medical acquires medical software
developer for about $273M
Toshiba Medical Systems has agreed to pay about $273 million, or
$18.75 per share, to acquire Vital Images, a Minnesota-based
developer of medical visualization and analysis software. Vital
Images Chief Executive Michael Carrel said the deal means we can
now accelerate our global presence with the strength and backing of
Toshiba Medical Systems.
Repetitive colonoscopy may affect doctors ability
to spot polyps
A study published in the American Journal of Gastroenterology found
that the number of polyps detected by doctors in patients who
underwent colonoscopies decreases as the day wears on. Smaller
lesions are being overlooked because of the repetitiveness of the
procedure thats making (doctors) less attentive toward the second
half of the day, the lead researcher Dr. Prakash Gyawali
speculated. The research suggests that doctors may benefit from
working in shifts rather than a full-day schedule.
Advanced life support boosts chances of survival
for some patients
Greek researchers found that advanced life support techniques, such
as the use of electronic monitoring and breathing devices, enhanced
survival after hospitalization by 50% compared with basic life
support for patients whose heart had stopped beating. The study in
the journal Resuscitation also found that the odds for survival
increased twofold when physicians are present in the ambulance. But
researchers found that advanced resuscitation can slightly reduce
the chances of survival for injured patients, possibly due to
prolonged time spent at the scene of the injury.
Brazil agency issues pricing data for cardiology,
orthopedic devices
Anvisa, Brazils regulatory agency for health care products, has
added to its national database pricing information for 365
cardiology products and 154 orthopedic devices both in Brazil and
in international markets. The information is aimed at helping
health care service managers compare prices and guide their
purchasing decisions, in order to help improve health resource
management, said Jose Agenor Alvares da Silva, director of
Anvisa.
Medicare considers covering scans for those with
MRI-safe pacemakers
Medicare released a memo saying it has proposed covering MRI scans
for patients with pacemakers used according to the FDA-approved
labeling for use in an MRI environment. The agency set a May 25
deadline for public comment. If the policy goes into effect,
Medtronic is likely to see an increase in adoption of its Revo MRI
SureScan pacemaker, the first approved by the FDA as MRI-safe.
Maquet gets 510(k) clearance for heart-lung
support system
Maquet Cardiovascular has received clearance from the FDA to market
its Cardiohelp heart-lung support system. The company expects to
begin commercializing the portable device, which it says is the
first of its kind to be approved for use in both air and ground
transport, this year.
FDA clears K2Ms pedicle screw system
K2M has received FDA clearance for its pedicle screw system,
Everest, designed to improve efficiency of dense bone fixation and
osteoporotic procedures. The polyaxial device can be used with two
different sizes of titanium ort cobalt chrome rods.
Advocacy group calls on FDA to ban latex
gloves
Public Citizen, an advocacy group, has renewed its call for the FDA
to ban latex and cornstarch-powdered gloves because they can expose
health care workers and patients to serious allergic reactions. The
FDA has proposed adding a warning to the packaging of such
products, but such action is grossly inadequate for dealing with
this problem and likely would have little to no impact, says a
letter from Public Citizen to the agency.
Biomet gets 510(k) clearance for hip replacement
device
The FDA has given Biomet the go-ahead to market its Active
Articulation E1 hip replacement system. The dual mobility device
provides an excellent combination of wear resistance and implant
stability, said Jon Serbousek, president of Biomets U.S. orthopedic
unit.
J&J expands into surgical-device market with
Synthes purchase
Johnson & Johnson agreed to buy Synthes for $21.3 billion. The
deal, which has been backed by the companies boards of directors,
will give J&J access to Synthes surgical devices used to treat
fractured bones and allow it to integrate Synthes with its DePuy
unit. J&J may have to shed some units to pass antitrust
reviews, according to one analyst.
Report: Theres a need to focus more on molecular
radiotherapy
There is a need to undertake more studies and allot more funding
for molecular radiotherapy in order for it to advance as a cancer
treatment, according to a report from the British Institute of
Radiology. The development of new pharmaceuticals, as well as
improvements in quantitative imaging and radiation dosimetry, can
lead to more applications for this method, according to the
report.
More studies needed to pinpoint use of FDG-PET in
thyroid patients
Dutch researchers who reviewed six studies involving 225 patients
with thyroid nodules said the use of FDG-PET to determine the need
for surgery yielded low positive predictive value. The finding
suggests that the incorporation of FDG-PET into the initial workup
of such patients before surgery deserves further investigation,
lead author Dr. Dennis Vriens and colleagues wrote in the journal
Cancer. The researchers plan to conduct further studies to
determine the role of FDG-PET in the care of such
patients.
Telehealth programs boost global sharing of
digital images
Telemedicine efforts are making headway globally, driven in part by
the technologys ability to allow remote sharing of medical images
and real-time access to specialists. A scanning solution helps
pathologists at a hospital in China collaborate with their peers at
Ronald Reagan UCLA Medical Center in Los Angeles, while a digital
imaging system gives specialists at a Canadian hospital access to
radiological images from community health facilities in that
country.
U.K. agency recommends protein marker test for
ovarian cancer
The U.K. National Institute for Health and Clinical Excellence
suggested that women experiencing bloating, lower abdominal pain
and other symptoms of ovarian cancer should undergo a blood test
that measures the level of the protein marker CA125. Women whose
protein levels are higher than the normal are advised to undergo
ultrasound scans.
BioControl starts safety trial of stimulation tool
for heart failure
BioControl Medical has begun a multicenter, randomized clinical
trial to test the efficacy and safety of CardioFit, its implantable
device that is meant to improve cardiac function in patients with
congestive heart failure through electrical stimulation. The
company will use the results from the investigational device
exemption study to seek premarket approval for the device in the
U.S.
FDA clears Acousticons hearing aid
system
The FDA has cleared Acousticons ACAM-5 system, which can help
audiologists assess the severity of hearing loss and tailor a
hearing aids fit. Harald Bonsel, an audiologist and CEO of
Acousticons parent company in Germany, first developed the device
in 1987.
U.K.s NICE recommends Nplate for patients with
blood disorder
The U.K. National Institute for Health and Clinical Excellence said
it is recommending Amgens Nplate, or romiplostim, to the National
Health Service as a treatment for adults with chronic idiopathic
immune thrombocytopenic purpura, a bleeding disorder. The condition
is characterized by a low level of platelets.
VeraLight gets approval for diabetes testing
device in Canada
Health Canada has given VeraLight the go-ahead to commercialize
Scout, a noninvasive device that uses light to quickly detect
diabetes. The company is awaiting marketing approval in the
European Union and hopes to secure about $15 million to seek FDA
approval for the device.
Medtronic and Lilly will develop drug-delivery
tool for Parkinsons
Medtronic will partner with Eli Lilly and Co. to develop an
implantable system that can directly deliver drugs to the brains of
patients with Parkinsons disease. The companies hope the system,
which consists of a drug pump and a catheter, will be able to cross
the blood-brain barrier, which blocks entry of certain substances,
including most drugs, to the brain.
Ubl suggests independent board to monitor
ACOs
Accountable care organizations should be implemented in a manner
that doesnt lessen the health care services provided to Medicare
patients, writes Stephen Ubl, AdvaMeds president and CEO. The ACO
draft regulations include provisions for monitoring by CMS, but an
independent monitor could ferret out problems that CMS might not
identify and would contribute to public confidence in the new
entities, Ubl writes.
Mobile health apps may improve chronic disease
management
The use of mobile health applications that feature medication
reminders or chronic disease management information could reduce
the risk of mortality and hospitalization in high-risk patients,
experts say. However, research indicates that awareness of mobile
health apps is low among patients and providers, and insurers lack
confidence that the technology can lower health costs.
Boston Scientifics drug-coated stent Ion gains FDA
approval
The FDA approved Boston Scientifics drug-coated stent Ion. The
company plans to launch the paclitaxel-coated device by mid-2012,
when a supply deal with Abbott Laboratories for an older stent
expires.
Doctors claims for thermography device lead to FDA
warning
As part of a broader crackdown, the FDA issued a warning letter to
Joseph Mercola saying the Chicago-area osteopathic physician is
promoting Meditherms Med2000, a thermographic camera, for
unapproved diagnostic purposes. We will fight the FDA on this issue
if they decide to take this further, Mercola said. Meditherm has
also received a warning letter saying it is promoting its device
for off-label uses.
Drug-eluting stents may have cost Medicare $1.57B
since 2003
A study published in the journal Archives of Internal Medicine
found that drug-coated stents might have contributed up to $1.57
billion to annual Medicare spending since the device reached the
market in 2003. It is time to clearly define what the value of this
extraordinary investment has been in terms of patient benefits and
study the harms and determine if we are getting good value for this
outlay, wrote Dr. Rita Redberg, the journals editor. An increase in
drug costs, for which the study didnt account, may be partially
responsible for the overall spending amount.
Researchers aim to improve diagnosis of traumatic
brain injury
Researchers at the University of Virginia Health System working
with federal laboratories are studying the potential of ultrasound
and PET in improving traumatic brain injury diagnosis. The PET
project aims to develop agents that can help identify signs of TBI,
including hypoxia, inflammation and apoptosis, among other
conditions. The initiatives are supported by $6 million in grants
from the Department of Defense.
Texas technology fund invests $2.5 million in
Speer Medical
The Texas Emerging Technology Fund has invested $2.5 million in
Speer Medical Devices, which is working on a portable device that
can monitor vital signs in patients who have suffered traumatic
injuries. Speer Medical will use the money to develop prototypes
and advance the device to clinical trials, said Jim Poage,
president and CEO of Startech, a technology advocacy group that
helped Speer secure funding.
Cianna Medical raises $12 million for breast
cancer treatment tool
Cianna Medical has pulled in $12 million in a funding round led by
Novo Ventures. The California-based company will use the funding to
support global sales and marketing efforts for SAVI, a
multicatheter system that delivers radiation therapy to patients
with early-stage breast cancer, and back the development of other
surgical and oncology tools.
SEC filing: Interrad Medical hopes to secure $10
million
Interrad Medical disclosed in its regulatory filing that it hopes
to secure $10 million. The Minnesota-based firm developed the
SecurAcath Universal Subcutaneous Catheter Securement System, which
was cleared by the FDA in July.
NxStage appoints new president for international
operations
Michael Miller Jr., formerly senior vice president of Philips
Healthcares cardiac care unit, has been appointed as NxStage
Medicals president for international operations. Miller will be
tasked with bolstering the companys growth in the European Union,
the Middle East and Asia-Pacific regions.
Philips to develop cancer imaging system with
Japanese firm
Philips and Japan-based NEC have agreed to develop and
commercialize a digital imaging system that can help clinicians
assess patients with breast and prostate cancers and devise
treatment plans by providing quantitative and qualitative data.
Under the deal, Philips will integrate its high-throughput
pathology slide scanner with NECs e-Pathologist Cancer Diagnosis
Assistance System.
Avantis appoints former Innovative Devices exec as
CEO
Avantis Medical Systems has appointed Rick Randall, former CEO of
Innovasive Devices and Target Therapeutics, as chairman and chief
executive. Avantis specializes in making catheter-mounted digital
imaging systems used in gastroenterology procedures.
University of Texas tech incubator to house
NanoLite Systems
NanoLite Systems will get infrastructure support, operational
guidance and other forms of assistance after joining the University
of Texas Austin Technology Incubator. NanoLite is working on a
microimaging technology that can diagnose diseases in real
time.
Minnesota firm hopes to raise $2.5M for heart
disease detection tool
Marie Johnson, AUM Cardiovasculars founder, seeks to raise $2.5
million to support the companys 510(k) application for a hand-held
device, CADence, that can be used for early detection of coronary
heart disease. Johnson said the Minnesota-based company will have
to secure $15 million to commercialize the minimally invasive
tool.
Jury awards $2.3 billion in St. Jude trade secrets
case
St. Jude Medicals Pacesetter unit was awarded $2.3 billion after a
California jury found Yongning Zou, a former St. Jude Medical
employee, and his current employer, Nervicon, liable for stealing
the divisions trade secrets. We did not expect such a high damages
result and we were pleased with the outcome, said Rita Bojalian,
St. Jude Medicals senior counsel.
Life Magnetics names chief executive,
president
Former Genomic Solutions CEO Jeff Williams has been named as chief
executive of Life Magnetics, a spinoff of the University of
Michigan. Life Magnetics, which is developing a diagnostic that can
rapidly assess how bacterial infections respond to antibiotics,
also appointed Sundu Brahmasandra, HandyLabs co-founder, as
president.
Swimmers ALS fundraising effort gets support from
Medtronic
Doug McConnell, a 53-year-old investment banker fitted with a
cervical disc replacement device from Medtronic, plans to swim
across the English Channel in August to raise funds for Lou Gehrigs
disease research. Medtronic will provide up to $50,000 for
McConnells effort, for which he already has secured about $20,000
in outside contributions.
CryoLife to roll out surgical adhesive in Japan by
May
CryoLife will launch in May its BioGlue Surgical Adhesive, designed
to treat aortic dissections, in Japan through its distribution
partner Century Medical. The Japanese Ministry of Health, Labor and
Welfare approved the product last year.
Doctors marketing claims for thermography device
lead to FDA warning
The FDA issued a warning letter to Dr. Joseph Mercola saying the
osteopathic physician is promoting Meditherms Med2000, a
thermographic camera, for diagnostic purposes not approved by the
agency. We will fight the FDA on this issue if they decide to take
this further, Mercola said. Earlier this month, Meditherm also
received a warning letter saying it is promoting its device for
off-label uses.
EnteroMedics announces plan for anti-obesity
device
EnteroMedics said it plans to begin implanting its Maestro system,
a device that treats obesity by blocking the vagus nerves, by the
second quarter and complete device implantations by the end of
2011. The company disclosed the plan as part of its first-quarter
results report.
Medtech leaders support repeal of device
tax
The 2.3% excise tax imposed on medical device makers as part of the
comprehensive health care law will reduce revenue and limit
investments in new technologies and innovations, write Boston
Scientific President and CEO Ray Elliott, C.R. Bard Chairman and
CEO Timothy M. Ring, and 3M Health Care Business Executive Vice
President Brad T. Sauer in this opinion piece. A repeal would allow
continued investment in the life-saving and life-enhancing
technologies of tomorrow and help protect the two million Americans
whose jobs are supported by the medical technology
sector.
DRUGS & BIOLOGICS
Lilly and Boehringers diabetes pill Tradjenta
gains FDA approval
The FDA approved Tradjenta, Boehringer Ingelheim and Eli Lilly and
Co.s drug for improving glucose control among adults with type 2
diabetes. The drug can be used as monotherapy or combined with
metformin or another older diabetes medicine.
FDA expedites review of Seattle Genetics-Takeda
lymphoma drug
The FDA granted priority-review designation to brentuximab vedotin,
a lymphoma drug from Seattle Genetics and Takeda Pharmaceutical.
The drugmakers are seeking to market the drug for Hodgkins lymphoma
or anaplastic large cell lymphoma in patients who no longer respond
to other therapies.
Judge dismisses Mylans suit to block Ranbaxys
generic Lipitor
A federal judge threw out a lawsuit by Mylan to force the FDA to
reject Ranbaxy Laboratories application for a generic version of
Pfizers cholesterol-lowering drug Lipitor. Mylan lacks standing to
sue the agency, the judge said. Ranbaxy could gain a six-month
exclusivity for being the first company to seek approval of a
generic Lipitor.
FDA approves another form of AstraZenecas antacid
Nexium
AstraZeneca received FDA approval for an IV formulation of
heartburn treatment Nexium, or esomeprazole. Nexium is indicated
for gastroesophageal reflux disease in patients as young as 1
month.
Teva is sued for planning to launch a generic
AndroGel
Abbott Products filed a patent-infringement lawsuit against Teva
Pharmaceuticals USA, which wants to launch a generic version of
hypogonadism treatment AndroGel. Abbott asked a federal court to
prevent Teva from selling its product before patent expiration in
2021.
Cephalon agrees to be acquired by Teva for $6.8
billion
Teva Pharmaceutical Industries agreed to pay $6.8 billion for
Cephalon, a deal that is expected to close during the third
quarter. The price is almost 12% more than Valeant Pharmaceuticals
Internationals $73-per-share unsolicited offer. Taking over
Cephalon will help Teva offset losses from generic competition for
multiple sclerosis drug Copaxone.
Many young children receive overdosed drugs, study
says
A review of more than 50,000 prescribed medications found about
four in 10 children younger than 2 months had received an overdose
of a drug, compared with 3% of those above age 1. Nearly one in 10
children ages 0 to 2 got more than double of the required dosage,
according to the study. It is critical to strive for accurate
narcotic prescribing by providers and dispensing by pharmacies,
considering that parents find it difficult to accurately measure
liquid medication, said Dr. William T. Basco Jr., in an American
Academy of Pediatrics news release.
Defibtech recalls defibrillators over software
glitch
Defibtech has voluntarily pulled from the market 65,885 units of
its DDU-100 series semi-automatic external defibrillators because
the affected devices may inappropriately cancel lifesaving shocks.
The action was classified by the FDA as a Class I recall. The
company has advised users to continue using their AEDs while it
issues instructions for a software fix.
Allergan is ordered to pay $212M over Botox brain
damage
A Virginia jury said Allergan must pay $200 million in punitive
damages as well as $12 million in compensatory damages to a man who
said Botox caused him permanent brain damage. Allergan denied the
plaintiffs failure-to-warn claim. Every known and knowable risk
associated with Botox treatment based on the scientific properties
of the drug was in fact warned about, a company spokeswoman
said.
Experts unanimously endorse Vertexs hepatitis C
drug telaprevir
An FDA advisory panel unanimously supported approval of telaprevir,
Vertex Pharmaceuticals drug candidate for hepatitis C. On
Wednesday, advisers endorsed a similar drug, boceprevir, from Merck
& Co. The protease inhibitors are proposed for use in
combination with the standard therapy of pegylated interferon and
ribavirin.
J&J unit gets FDA approval for prostate cancer
drug Zytiga
Centocor Ortho Biotech, a Johnson & Johnson subsidiary,
obtained FDA approval for Zytiga as an oral treatment for
castration-resistant prostate cancer in men who had prior
chemotherapy. Zytiga, which targets cytochrome P450 17A1, is
intended for use with prednisone.
EU investigates Cephalon-Teva patent deal for
Provigil
The European Commission began a formal investigation to determine
whether a 2005 patent settlement between Cephalon and Teva
Pharmaceutical Industries may have had the object or effect of
hindering the sale of a generic version of sleep-disorder drug
Provigil, in Europe.
Novartis hypertension combo Rasilamlo gains EU
approval
European regulators approved Novartis Rasilamlo, a hypertension
drug containing amlodipine and aliskiren. Research has shown that
patients receiving two blood pressure medications in a single-pill
combination are more likely to adhere to treatment, said Gordon
McInnes, a clinical pharmacology instructor at the University of
Glasgow.
Lilly says Cymbalta patents are safe
A federal judges ruling protects Eli Lilly and Co.s patent for
depression and fibromyalgia drug Cymbalta from generic competition
through June 2013, the company said. Defendants in the case were
ordered to inform the FDA that they are not seeking approval for
generic versions until Lillys patents expire.
FDA seeks comments on existing rules on devices,
drugs
With the intent of complying with an executive order signed in
January by President Barack Obama, the FDA is reviewing its
regulations on medical devices, drugs, food and other products and
is asking for public comment to determine if the rules need to be
revised or expanded for the agency to better address public health
needs. The agency has set a June 27 deadline for stakeholders
comments.
Par resolves overcharging claims for $153
million
Par Pharmaceutical agreed to pay $153 million to resolve lawsuits
alleging that the company inflated prices of medicines covered by
government programs. The lawsuits were filed by Ven-A-Care of the
Florida Keys as well as attorney generals of Kentucky, South
Carolina and Alaska.
FDA will study online drug ads influence on
consumers
The FDA proposed three studies to examine how websites of
prescription medicines influence a consumers understanding of a
products benefits. There are a number of questions surrounding how
to achieve fair balance in direct-to-consumer online advertising,
said the FDA. Such research is relevant to current policy questions
and debate and will complement qualitative research we plan to
conduct on issues surrounding social media, the agency
said.
Mercks hepatitis C drug boceprevir gains FDA
panels support
An FDA panel of outside experts unanimously endorsed the approval
of Merck & Co.s boceprevir, saying the drug candidate marks an
advance in the treatment of hepatitis C. The panel affirmed
clinical data showing the efficacy of boceprevir in combination
with standard medicines ribavirin and pegylated interferon. Merck
proposed to commercialize it as Victrelis.
Increasing number of drug shortages puts patients
at risk
Industry consolidation and quality issues left 211 medications in
short supply last year, and another 89 were added to the list by
the end of March. In response, health care providers are postponing
treatment, rationing drugs and prescribing less effective or less
safe substitutes. The FDA is permitting foreign importation of
certain drugs, and lawmakers have introduced a bill in Congress
that would require firms to quickly inform the FDA about problems
that might result in drug shortage.
FDA: Hepatitis C drug boceprevir works but has
safety issues
FDA staff agreed with Merck & Co.s assessment that adding
hepatitis C drug candidate boceprevir to the standard antiviral
therapy of pegylated interferon and ribavirin is significantly more
effective. However, reviewers expressed concern about an increased
frequency and severity of anemia. They also noted suicidal and
homicidal ideation in fewer than 1 percent of patients given
boceprevir during clinical trials but added that it is difficult to
make any meaningful clinical conclusions from this observation.
FDA plans to test single-page drug
instructions
Errors in taking or administering medications resulted in nearly 2
million hospital emergency-department visits in 2008, data show. To
simplify confusing labels, the FDA plans to test one-page consumer
information, and the U.S. Pharmacopeial Convention is developing a
national standard for drug labels.
Lawyers: HHS effort to ban Forest CEO could change
drug industry
HHS is working to exclude Forest Laboratories CEO Howard Solomon
from doing business with the federal government over his firms
improper marketing of antidepressants. The move is part of the
agencys effort to hold executives liable for company wrongdoing,
and lawyers say it could hurt innovation and tie companies in legal
knots. The use of sanctions such as exclusion and debarment to
punish individuals where the government is unable to prove a direct
legal or regulatory violation could have wide-ranging impact, said
Richard Westling, a defense attorney who has represented
executives.
GSKs epilepsy drug Lamictal XR gets wider FDA
approval
The FDA approved GlaxoSmithKlines Lamictal XR as a solo therapy for
partial seizures in patients age 13 and older. Lamictal XR had
already been approved as an add-on medicine for such
patients.
FDA staff affirms speed of Vertexs hepatitis C
drug telaprevir
FDA reviewers backed pivotal trial data indicating that adding
Vertex Pharmaceuticals telaprevir to standard combination therapy
cuts the time needed to treat and cure hepatitis C. An advisory
panel will decide Thursday whether to recommend the drugs
approval.
Takeda and a unit seek wider use of cancer
medicine Velcade
Takeda Pharmaceutical and subsidiary Millennium: The Takeda
Oncology Co. filed two supplemental FDA applications for Velcade,
which is approved for IV treatment of patients with mantle cell
lymphoma or multiple myeloma. The companies are seeking approval
for subcutaneous administration and Velcades use in combination
with rituximab for relapsed follicular non-Hodgkins
lymphoma.
Massachusetts House supports repealing a ban on
industry gifts
Massachusetts House members voted to overturn a 2008 ban on
pharmaceutical and medical-device firms gifts to physicians. The
proposed repeal is included in the Houses 2012 budget legislation.
Supporters said the restriction guards patients, preserves
prescription integrity and averts conflicts of interest in the
health care sector.
Supreme Court justices question Vt. limits on
selling Rx data
Vermont Assistant Attorney General Bridget Asay told the Supreme
Court that Vermonts law restricting pharmacies from selling
prescription information to marketers allows drugmakers to sell
their products as they choose while protecting prescribers privacy.
Justice Ruth Bader Ginsburg asked whether the law was meant to
encourage the use of generic drugs by restricting brand-name
manufacturers speech.
OIG: Drugmakers should disclose wholesale prices
to CMS
Medicare could save $4.4 million each year by reducing
reimbursement for drugs covered under Part B that have an average
sale price at least 5% more than the wholesale price, according to
an HHS Inspector Generals report. The CMS responded by saying doing
so would violate a court order against disclosing wholesale prices
to the public.
Horizons ulcer medicine Duexis gains FDA
approval
Horizon Pharma received FDA approval for Duexis, a two-drug
combination for reducing the risk of stomach ulcer. Duexis contains
800 milligrams of painkiller ibuprofen and 26.6 milligrams of
antacid famotidine. The drugmaker expects to commercialize Duexis
during the second half of the year.
FDA rejects Aricept skin patch for Alzheimers
disease
The FDA declined to approve Eisai and Teikoku Pharmas weekly
transdermal-patch version of Aricept, a treatment for Alzheimers
disease. The companies will review the agencys complete-response
letter to determine their next step, Eisai said.
FDA panel will review womens risk of
Trilipix-statin combo
An FDA advisory panel is scheduled May 19 to review clinical data
from the ACCORD Lipid trial showing that Abbott Laboratories
triglyceride-lowering drug Trilipix plus a statin caused more
cardiovascular events in women compared with only a statin.
Overall, the study found no statistically significant difference in
adverse events between patients given the combination and those
treated with a statin plus placebo, according to the FDA
website.
Dr. Reddys faces a patent lawsuit regarding
painkiller Vimovo
Pozen and AstraZeneca filed a lawsuit against Dr. Reddys
Laboratories for allegedly infringing their key patent on
painkiller Vimovo, a fixed-dose combination of naproxen and
esomeprazole. Dr. Reddys filed for FDA approval of a generic
version last month. At issue is a patent that lasts until 2023,
according to Pozen.
FDA OKs Aurobindos generic of neurological drug
Depakote
The FDA is allowing Aurobindo Pharma to produce and market a
generic version of Abbott Laboratories Depakote, a delayed-release
treatment for disorders of the central nervous system. The generic
will be available soon in 125-, 250- and 500-milligram strengths,
Aurobindo said.
FOOD & DIETARY
NYC may bar food-stamp purchases of sweetened
drinks
An anti-obesity plan in New York City to ban the use of food stamps
to buy beverages sweetened with sugar or high-fructose corn syrup
has sparked criticism from the food and beverage industries. Once
you start going into grocery carts, deciding what people can or
cannot buy, where do you stop? asked Kevin Keane, senior vice
president of the American Beverage Association, which has worked
with anti-hunger groups and the food industry to fight this
initiative.
How to prevent food recalls
The food industry, throughout the supply chain, must focus on
measures to keep food safe and prevent recalls. The adoption of
RFID tags will improve food tracking, and organizations benefit
from clear organizational structures that define who is accountable
for what.
List names top pathogen-food combos that make
people sick
A University of Florida report about risky combinations of foods
and pathogens put poultry contaminated with Campylobacter bacteria
at the top of the list because it sickens more than 600,000 people
each year. Salmonella was the top disease-causing microorganism,
and a variety of Salmonella-contaminated foods made the list of top
10 food-pathogen combinations, which also included Listeria in
meats and cheeses, Toxoplasma in pork and beef and E. coli in beef
and produce.
USDA promotes collaboration between schools,
farms
The Department of Agriculture on Wednesday introduced a buy local
rule to promote partnerships between schools and farms to get more
fruits, vegetables and unprocessed foods to students. However, some
experts said more work is needed to get youths to understand and
eat the nutritious foods.
Feds to ask food companies to limit advertising to
children
Several federal agencies are expected to reveal a proposal today
that would ask food companies, including restaurants, to
voluntarily limit advertising and marketing efforts aimed at
children to products that are low in salt, fat and sugar. The
guidelines would set strict parameters for what constitutes a
healthy product.
CDC finds low availability of healthy foods in
most states
The CDC reported that 32 states and the District of Columbia failed
to exceed the national average on an index that measures the number
of retailers that typically sell healthy foods. This report
underscores the need to make healthier choices easier for kids and
more accessible and affordable for parents, said CDC Director Dr.
Thomas Frieden.
USDA foresees steeper price increases for beef,
pork, vegetables
The USDA has maintained its overall food-inflation forecast for the
year at 3% to 4% but has increased its price predictions for beef,
pork and fresh vegetables. Beef prices are expected to increase 7%
to 8% in 2011, pork prices could go up 6.5% to 7.5% and vegetable
prices could increase 4.5% to 5.5%, according to the USDA.
Weak economy, food deserts are linked,
nutritionists tell legislators
Nutritionists and health experts who support a Nebraska bill to
create tax credits for grocery stores said the economy is creating
an increasing number of food deserts. Surging gas prices, business
closures and tight budgets have forced some families to opt for
cheaper and less-healthy foods, says nutrition expert Wanda
Koszewski.
Food-safety exemptions will vary for small
businesses
Although many rules in the Food Safety Modernization Act do not
apply to small food-makers and farmers, it will be up to the FDA to
determine which businesses must comply. Farms that are considered
food processors wont be exempt, and all farms will be subject to
rules on produce production.
TOBACCO
E-cigarettes will be regulated as tobacco, FDA
says
The FDA said it is pursuing a path that would allow it to oversee
electronic cigarettes as tobacco products. The agencys announcement
follows the December ruling of a three-judge federal appeals court
panel that e-cigarettes cannot be regulated as drugs or medical
devices.
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