CONTENTS:
MEDICAL DEVICES
Harbor aims for summer FDA clearance of
wound therapy device
Irvine, Calif.-based Harbor Medtech is seeking about $1 million in
additional funding as the company finalizes its 510(k) application
for NeuvoCell, a device that uses porcine tissue to treat diabetic
foot ulcers, burns and bedsores. The startup hopes to have the
device approved for sale to U.S. hospitals and wound care
facilities in the summer.
Edwards' Intuity aortic valve wins
approval in Europe
European regulators have granted Edwards Lifesciences CE Mark
approval for its Intuity aortic valve. The device, which is made of
bovine pericardial tissue, offers a way for patients to receive
aortic valve replacement less invasively.
Device industry stakeholders testify on
MDUFMA
During a hearing before a House panel, industry experts, consumer
groups, government officials and other stakeholders testified on
the negotiations with the FDA on user fees under the Medical Device
User Fee & Modernization Act. Industry officials and some
members of the subcommittee were critical of the FDA's
performance in providing consistent, timely review and approval of
medical devices.
Officials expand FDA email monitoring
investigation
The Office of Special Counsel expanded an investigation into the
FDA's personal email surveillance after it received claims of
retaliatory acts against employees for communicating with Congress
their device-approval concerns. "We are reviewing these
additional allegations and information from Congress and will take
appropriate action," the OSC said.
FDA OKs prostate cancer assay from
Gen-Probe
Gen-Probe has secured FDA approval for PROGENSA PCA3, which is
billed as the first molecular assay designed to help evaluate
whether men who previously had negative prostate biopsies need to
undergo a repeat biopsy.
Mass. diagnostics device firm secures $15M
credit facility
Waltham, Mass.-based BG Medicine has obtained a credit facility
worth $15 million from GE Capital, Comerica Bank and Healthcare
Financial Services. The funds will be used to help commercialize
the company's CardioSCORE stroke and heart attack assay, which
is awaiting FDA clearance, and an automated version of its BGM
Galectin-3 test.
Brazil issues revised rules on infusion,
transfusion devices
Anvisa, a regulatory agency in Brazil, has issued a resolution
amending the quality-assurance and marketing standards governing
single-use infusion and transfusion devices. The enforcement date
of the revised guidelines also has been pushed back to June of next
year.
Analysts see single-digit growth for
orthopedic devices in 2012
The market for knee and hip implants is stable but growth rates
fall in the low single-digit range, analysts said at the recent
American Academy of Orthopedic Surgeons conference in San
Francisco. The analysts noted that some surgeons reported increases
of up to two weeks in their surgery backlogs, while others reported
decreases. "The takeaway from AAOS was one of stability with
respect to hip/knee procedure volumes," analysts from Leerink
Swann reported in an investor's note.
Wireless DR system from Konica gets FDA
nod
Konica Minolta has received FDA clearance for its Aero DR wireless
system. The flat panel detector weighs less than eight pounds and
works with 17 x 17- and 14 x 17-inch cassette sizes.
FDA OKs features in Siemens' Biograph
mCT PET/CT scanner
The FDA has approved features incorporated in the Biograph mCT
PET/CT scanner from Siemens Healthcare. They include the OptisoHD
detector system, features that correct images and adjust for user
variation, and applications that capture quantifiable measurements
in cardiology, oncology and neurology imaging.
Imaging groups oppose Obama's 2013
budget proposal
Several imaging groups have expressed opposition to President
Barack Obama's proposed budget for 2013, which includes imaging
cuts. The administration's plan would raise the assumed use
rate for advanced imaging devices and implement a
prior-authorization program in Medicare for advanced diagnostic
imaging. The cuts could limit services to patients and increase
health care costs while affecting jobs, the groups said.
FDA panel to review HeartWare's
cardiac pump in April
An FDA advisory panel is set to meet April 25 to evaluate
HeartWare's premarket approval application for its HVAD system,
a left ventricular assist device tailored to end-stage heart
disease patients awaiting transplants. The company's shares
rose 2.4% on the news.
Becton beefs up microbiology diagnostics
business with Kiestra buy
Kiestra Lab Automation, a Dutch firm specializing in total lab and
work cell automation technology, has been acquired by Becton
Dickinson for an undisclosed sum. The deal will allow Kiestra to
operate under Becton's diagnostics unit, which markets
microbiology testing products to clinics, hospitals, blood banks
and reference labs.
Ohio startup secures new investor for
chronic pain device
Neuros Medical CEO Jon Snyder announced RiverVest Venture Partners,
a new backer, will take part in the company's series A1 funding
round targeted at $3.5 million. The Cleveland-based startup is
working on a nerve stimulation device that can help treat chronic
pain in amputees without the need for drugs. Snyder said the device
could arrive in the market in 2014.
Atossa plans $6 million
IPO
Atossa Genetics intends to raise $6 million by issuing 1 million
shares of stock in its IPO, according to SEC filings. The
Seattle-based biotech makes breast cancer diagnostic tests and
treatments.
Smith & Nephew's Exogen device
added to NICE appraisals list
The U.K. National Institute for Health and Clinical Excellence has
added Smith & Nephew?s Exogen system to its list of medtech
appraisals. The device is touted as having the potential to speed
up healing of broken bones through a single daily treatment session
that takes only 20 minutes.
Dynamic Medical looks to set up Chinese
subsidiary
Dynamic Medical Technologies plans to spend about $1 million to
indirectly establish a subsidiary in Beijing, China, which will
focus on medical device sales and maintenance services.
Siemens' MRI system tapped for brain,
heart research
The Magnetom 7T whole-body MRI scanner from Siemens Healthcare has
been deployed at the University of Oxford. The device will be used
for scanning the brain's structure and function as well as for
heart imaging and spectroscopy to advance clinical neuroscience and
cardiology research.
BSGI diagnoses breast cancer better than
mammography, ultrasound
Breast-specific gamma imaging showed higher overall sensitivity
than mammography and ultrasound in diagnosing breast cancer,
according to a study published in the American Journal of Roentgenology that
involved 1,042 patients. BSGI also showed greater diagnostic
accuracy compared with ultrasound for patients who had adjunctive
imaging tests with conflicting results.
Ariz. orthopedic device firm raises $10M
in funding round
A funding round brought in $10 million for Cayenne Medical, which
the company plans to use to boost its sales and develop new
products. The Scottsdale, Ariz.-based company, which markets soft
tissue repair products, is preparing to release this month its
Quattro Shoulder System for labral and rotator cuff
reconstruction.
Memphis accelerator program targets
medical device startups
An entrepreneurial accelerator program focused on medical device
startups in Memphis, Tenn., is taking applications for its first
batch of grant recipients. The program, called ZeroTo510, initially
will invest seed funds worth $50,000 each to six startups.
NICE endorses 4 CT scanners for heart
disease imaging
The U.K. National Institute for Health and Clinical Excellence has
approved the use of Siemens? Somatom Definition Flash CT scanner,
GE?s Discovery CT750, Toshiba?s Aquilion ONE and Philips?
Brilliance iCT for use with difficult-to-image cases of coronary
artery disease. The devices are endorsed for first-line imaging and
first-line assessment of disease progression.
Private equity company to purchase
SeraCare for $80.8M
An affiliate of Linden Capital Partners agreed to pay $80.8 million
to acquire SeraCare Life Sciences, which provides contract research
services and makes diagnostic control products and plasma-derived
reagents. The acquisition is expected to be finalized in the second
quarter.
Enforcement transparency proposals are
adopted by FDA
The FDA has put in place the eight recommendations crafted by its
transparency task force last year to improve access to compliance
and enforcement data, including finding ways to use social media to
boost communication with the public. The proposals were released for stakeholder
comments in October of last year.
FDA panel schedules review for
Stryker's Wingspan brain stent
An FDA panel is scheduled next month to evaluate premarket and
postmarket data on Stryker's Wingspan brain stent, which has
been approved for use under the humanitarian device exemption
program.
Funding round brings in $2.5 million for
Dymedix Diagnostics
Dymedix Diagnostics, which develops sensors used in sleep disorder
clinical trials, has gained $2.5 million in a funding round
targeted at $4 million. The Minnesota-based firm will use the
proceeds in part to create partnerships with the manufacturers of
equipment widely used in sleep labs in the U.S., as well as enhance
the sensors to make them work with a wider set of commercially
available polysomnographs.
Medical diagnostics firm eyes $100K
funding for new facility
Oxford Immunotec, which has headquarters in England and
Massachusetts, hopes to obtain $100,000 to help it fund a new
facility in Memphis. The $1.8 million expansion plan could generate
25 new local jobs by 2014.
Former Salient exec to join Oxford
Immunotec's C-suite team
Richard Altieri has been appointed chief financial officer of
Oxford Immunotec, maker of the T-Spot diagnostic tool for gauging
patients' immune responses to tuberculosis and related
conditions. Altieri most recently served as CFO of Salient Surgical
Technologies.
Researchers develop blood test for the
early diagnosis of cancer
Israeli researchers have developed a blood test that uses infrared
light to detect small changes in the blood of a person with cancer.
The researchers said the test can detect the cancer before it
spreads. Researchers hope to put the test, which detected cancer in
about 90% of patients in a study, into clinical trials within two
years.
MITA shuffles top tier
The Medical Imaging and Technology Alliance has named Gail
Rodriguez its new executive director, replacing David Fisher. MITA
also tapped Charles Konigsberg to serve as head of strategy and
policy, and promoted Lindsay Morris from director of government
relations and acting executive director to senior director.
FDA's proposed $4.5B budget heavily
depends on industry fees
The FDA asked for a $4.5 billion budget for fiscal 2013, up 17%
from this year. That number includes $387 million for medical
device program expenses, up $11 million from this year, and was
based on the assumption that the medical device user fee will be
reauthorized. Industry user fees, including seven new fees, would
account for 45% of the budget and would fund 98% of the
increase.
N.J. dental manufacturer agrees to FDA
consent decree
Dental products company Accurate Set entered a consent decree with
the FDA to discontinue operations until its devices meet agency
standards. A recent FDA inspection found issues concerning quality
control at the firm's Newark, N.J., plant.
Lawmakers introduce pediatric medtech
legislation
A bill introduced by Reps. Ed Markey, D-Mass., and Mike Rogers,
R-Mich., would mandate that manufacturers include pediatric data in
their FDA submissions for certain medical devices. A similar rule
was earlier pulled back by the FDA amid significant opposition.
Cellular-enabled insulin pump arrives in
U.K.
Cellnovo has announced the commercial release of its
cellular-enabled insulin pump and diabetes management system in the
U.K., and has also kicked off a usability trial of the device with
100 type 1 diabetes patients. The technology, also called Cellnovo,
already has CE mark approval, but has not yet obtained FDA
clearance.
FDA approves Medicrea's PASS MIS
surgical device
Medicrea said its PASS MIS system has received approval from the
FDA. A surgeon at Doylestown Hospital in Pennsylvania was the first
to perform surgery using the PASS MIS device, which employs a
percutaneous approach to allow for short- and multi-level complex
constructs.
PSS World Medical looks to sell $250M in
senior notes
PSS World Medical said it will offer senior notes worth about $250
million that will be due in 2022. The company plans to apply the
money from the offering in part for general corporate uses,
including possible acquisitions and stock buybacks.
Phraxis obtains $200K for kidney failure
therapy device
A financing round targeted at $1 million has brought in $200,000
for Phraxis. The startup, which hopes to ultimately obtain $5
million, is developing an implantable device that could offer a way
for kidney failure patients to receive hemodialysis treatment with
fewer infections.
Global Imaging Systems names new
CEO
Global Imaging Systems, a unit of Xerox serving North America, has
promoted Tom Salierno from executive vice president of corporate
operations to chief executive officer. Salierno replaces Michael
Shea, who will serve as the company's executive chairman.
Revised EU rule aims to delineate medical
device, IVD directives
The European Commission has issued revised guidelines on
determining whether a product is covered by the in vitro
diagnostics directive as well as identifying the risk
classification levels of IVD products. The new rules are intended
to differentiate products governed by the IVD directive from those
regulated by the medical devices directive or other
legislation.
Elekta wins FDA nod for radiotherapy
control system
The FDA has granted Elekta 510(k) clearance for Integrity R1.1, the
latest digital control system for the company's linear
accelerators. The technology, which was tested at eight pilot
clinical sites, has been shown to lower the delivery times of
radiation therapy by as much as 30%, according to the Swedish
company.
Cardionet buys ECG Scanning & Medical
Services for $5.8M
ECG Scanning & Medical Services has been acquired by Cardionet
for $5.8 million in cash, plus as much as $0.6 million once certain
performance goals are met.
Lawmakers press OMB on unique device
identifier rule
Three senators sent a letter asking the Office of Management and
Budget to issue a proposed rule that would require the creation of
a unique device identifier system for medical devices. The move
comes after the OMB failed to meet its October deadline for
releasing the rule, which was submitted by the FDA in July to
improve the agency's postmarket device surveillance.
Microfluidic device can detect
malaria-infected blood cells
Canadian researchers have developed a microfluidic device that can
help distinguish changes in red blood cells infected with the
malaria parasite Plasmodium falciparum. The device has the
potential to be modified for use in drug testing not only for
malaria but diseases such as sickle cell anemia, according to a
U.S. expert.
Ohio startup wins first big client for
intravenous device
Linebacker, maker of a device of the same name that the company
says can secure catheter and intravenous lines better than medical
tape, has signed a supply deal with OhioHealth, its first major
client. The deal should allow Linebacker to establish credibility
for its device and help it extend its reach to other hospital
systems, the company said in a statement.
Quanterix, Forsyth and Beth Israel unite
to develop TB test
Quanterix, the Forsyth Institute and the Beth Israel Deaconess
Medical Center are collaborating to develop a diagnostic test for
active tuberculosis using Quanterix's Single Molecule Array
technology. The SiMoA technology will be used to validate
low-abundance protein biomarkers that could help identify patients
with active tuberculosis.
FDA defends targeted surveillance of
private email
The FDA accessed the personal email accounts of certain employees
in the agency's device-evaluation office to determine whether
they inappropriately leaked confidential information to the public,
according to spokeswoman Erica Jefferson. "Our targeted
monitoring of email content of these individuals was not
initiated" until after a company informed the FDA of a public
disclosure in April 2010, Jefferson said.
DRUGS & BIOLOGICS
FDA gives orphan-drug status to CSL
hemophilia treatment
CSL Behring's treatment candidate for hemophilia A and B,
rVIIa-FP, was given orphan-drug status by the FDA. The drug
"is expected to exhibit a good tolerability profile and
improved pharmacokinetics that may enable prophylaxis," said
Russell Basser, CSL's senior vice president of global clinical
research and development.
Pfizer, Mylan end injection-patent rift
with Sanofi, Intelliject
Pfizer and Mylan settled a lawsuit alleging that Sanofi and
Intelliject's e-cue injection violates patents for EpiPen,
which treats severe allergic reaction. Intelliject and Sanofi
agreed not to launch their product before Nov. 15. The deal is
subject to review by the Justice Department and the Federal Trade
Commission.
Bedford recalls chemotherapy agent
cytarabine
Sterility concern prompted Boehringer Ingelheim unit Bedford
Laboratories to recall three batches of cytarabine, a generic
chemotherapy drug. Bedford said there have been no reports of
adverse effects related to the recall.
GSK pulls EU marketing request for
Tyverb-chemo regimen
The European Medicines Agency said GlaxoSmithKline withdrew an
application to promote breast cancer drug Tyverb with chemotherapy
agent paclitaxel. GSK's decision comes after the agency said a
lack of an active-controlled study on the combo therapy makes
regulatory assessment difficult.
U.K. agency seeks more information on
Tarceva's wider use
The U.K. National Institute for Health and Clinical Excellence does
not have enough information to determine whether to recommend
National Health Service coverage of Roche Holding's Tarceva as
first-line therapy for nonsmall-cell lung cancer, NICE CEO Andrew
Dillon said. NICE requested a cost-effective comparison between
Tarceva and AstraZeneca's Iressa.
Wyeth seeks $960 million in damages in
patent dispute with Sun
Wyeth Pharmaceuticals filed a $960 million patent-infringement
lawsuit against Sun Pharmaceutical Industries regarding ulcer drug
Protonix. Sun said it will explore legal remedies. In July 2010, a
U.S. court rejected Sun and Teva Pharmaceutical Industries'
motion to invalidate Protonix's patent.
Bill introduced that would accelerate
approval of targeted treatments
Sen. Kay Hagan, D-N.C., is introducing a bill that would accelerate
the approval process for some treatments. Known as the TREAT Act,
the legislation would cover therapies for conditions that do not
currently have treatments, targeted therapies for serious illnesses
and drugs that could provide significant improvement over standard
care.
Slow approval process thwarts innovation,
benefits behemoths
A long, complex, expensive approval process has prompted some
biotechnology companies to avoid developing treatments for common
diseases, such as diabetes and heart disease, and focus more on
rare diseases, so they can take advantage of the FDA's
accelerated approval process, writes Avik Roy. The agency allows
drugmakers to use surrogate endpoints for a narrow range of
life-threatening diseases, "neglecting serious but more
chronic ailments such as diabetes, where the cost of clinical
trials is prohibitive," Roy writes. Only drugmakers with the
deepest pockets can work on drugs for chronic diseases, he
writes.
Merck KGaA gets FDA warning about
unit's Swiss, Italian plants
An FDA warning letter to Merck KGaA details quality-system
deficiency at three plants -- one in Italy and two in Switzerland
-- operated by subsidiary Merck Serono. The agency said it expects
Merck KGaA to conduct a comprehensive global assessment of its
manufacturing operations to ensure adequate resolution of the
issue.
PhRMA chief: 2013 budget plan goes against
industry's best interests
President Barack Obama's fiscal 2013 budget proposal goes
against his goals of advancing biomedical innovation, creating jobs
and curbing medical costs for seniors, said John Castellani,
president and CEO of the Pharmaceutical Research and Manufacturers
of America. Castellani criticized proposed mandatory Medicare Part
D rebates, patent-settlement restrictions and shorter data
exclusivity for biologic drugs.
Biosimilar guidance prompts reviews of
patent protection
The FDA's recently released guidance for the approval of
biosimilar drugs is prompting biotech and pharmaceutical firms to
evaluate their patent positions and consider greater use of methods
such as keeping trade secrets to protect their intellectual
property, according to patent lawyer Konstantin Linnik. Companies
also will attempt to extend the protection of blockbuster drugs by
developing "biobetter" products, or improved versions of
existing drugs, Linnik said.
FDA agrees to expedite review of
Pfizer's tafamidis meglumine
The FDA accepted Pfizer's tafamidis meglumine for priority
evaluation and could hand down a decision as early as June. The
drug treats a rare neurodegenerative disorder called transthyretin
familial amyloid polyneuropathy. It was launched in Europe as
Vyndaqel in November.
Genzyme recalls batch of cancer drug
Fludara
Sanofi unit Genzyme recalled one batch of leukemia drug Fludara in
the U.S. because of a "lack of assurance of sterility,"
the FDA reported. The precautionary recall of 9,380 vials comes
after the FDA and the European Medicines Agency cited the
manufacturer, Boehringer Ingelheim's Ben Venue Laboratories,
for "serious deficiencies" last year.
Fears of counterfeit drugs in U.S.
grow
Authorities worry that counterfeit drugs continue to make their way
into the U.S. market after discovering that vials of fake Avastin
were distributed to at least 19 oncology practices. The clinics
said they are checking their inventories and will monitor patients
for safety issues.
FDA approves BioSante's hypogonadism
therapy Bio-T-Gel
BioSante Pharmaceuticals' Bio-T-Gel, a treatment for men with
low testosterone, received FDA approval. The transdermal drug will
be marketed by Teva Pharmaceutical Industries.
Roche and Genentech warn of counterfeit
Avastin
Roche Holding and its unit Genentech reported that a fake version
of their injectable cancer drug Avastin was found in the U.S. The
FDA is investigating and has alerted medical practices about the
counterfeit product.
Hospira's N.C. plant for injectables
resumes production
Hospira resumed operations at a Rocky Mount, N.C., plant for
injectable drugs. The firm is working with the FDA to resolve the
facility's quality control issues, CEO Michael Ball said.
"We are doing the best at getting better," Ball said.
Senator wants to attach drug-shortage
measure to highway bill
Sen. Amy Klobuchar, D-Minn., plans to advance legislation to
alleviate critical drug shortages by attaching it to a
transportation bill the Senate is considering. "We acknowledge
drug shortages may not have a lot to do with highways,"
Klobuchar said. "Maybe we have to try every bill, but we
can't wait a year to get this done."
3 lawmakers worry about delayed reporting
of trial data
Three House Democrats sent letters to FDA Commissioner Margaret
Hamburg and NIH Director Francis Collins expressing concern about a
BMJ report that drugmakers often do not publish findings of
clinical drug trials in a timely manner. Delayed publication might
"allow ineffective or dangerous drugs to remain on the market,
resulting in significant harm to patients and waste in the health
care system," they wrote.
Modernizing the FDA will help the U.S.
remain competitive
Policymakers have the opportunity to return the FDA to its former
position as the world's leader in medical product evaluation as
Congress considers the Prescription Drug User Fee Act
reauthorization bill, writes Andrew von Eschenbach, chairman of the
Manhattan Institute's Project FDA. "Congress should not
only set the fees and add resources for the agency but also
modernize it from the bottom up," including reviewing the
agency's processes and creating pilot programs to bring
promising therapies to patients more quickly, he writes.
FDA approves Merck's eye drug
Zioptan
Merck & Co. received FDA approval of Zioptan, a
preservative-free tafluprost solution to reduce intraocular
pressure in patients with open-angle glaucoma. The treatment, which
costs $97 for a 30-day supply, is expected to be available next
month.
Alliance for a Stronger FDA speaks out
against reliance on user fees
President Barack Obama's 2013 budget proposal includes higher
funding for the FDA, but the amount provided by the federal
government would remain flat while the proportion provided by user
fees would rise to 44%. The agency does not have the same
flexibility with user fees as it does with federal funds, and that
has some advocates worried. "The user fees pay for very
specific services, and they are really additive to what the FDA is
responsible for and what the FDA is responsible for
accomplishing," said Steven Grossman, deputy executive
director of Alliance for a Stronger FDA.
EU regulator sets pharmacogenetic
guideline for drugs
The European Medicines Agency issued a guideline for drugmakers on
how to take patients' genetic variability into consideration
when assessing how the body reacts to drugs. The guideline on
pharmacogenetic methodology in pharmacokinetic evaluation of
treatments should be followed by all companies applying for
marketing approval beginning Aug. 1, the agency said.
FDA asks Novartis to submit more data on
Menveo's wider use
Novartis said the FDA wants additional information on meningococcal
vaccine Menveo before deciding whether to allow it to be
administered in babies as young as 2 months. The company filed its
supplemental application in April.
Gilead's Truvada gets speedy FDA
review as HIV-prevention drug
The FDA announced that its evaluation for the use of Gilead
Sciences' combination drug Truvada in protecting against HIV
will get priority review. Advisers are scheduled to discuss the
proposed indication in May, and the FDA could decide by June
15.
FDA questions Chelsea's development
program for Northera
Chelsea Therapeutics CEO Simon Pedder disclosed that the FDA
questioned the short duration and limited population of clinical
research on Northera, a drug candidate for neurogenic orthostatic
hypotension in Parkinson's disease patients. The agency put
emphasis on post-market surveillance in Japan and long-term safety
data, Pedder said. Northera was licensed from Sumitomo Pharma and
has orphan-drug designation in the U.S.
Panel doesn't support wider FDA
approval of NeurogesX's Qutenza
NeurogesX's Qutenza should not be approved for HIV-associated
neuropathic pain because the indication is not supported by
substantial clinical evidence, an FDA advisory panel concluded.
Watson submits generic of Bayer
contraceptive for FDA approval
Watson Pharmaceuticals submitted an FDA application for a generic
version of Beyaz, Bayer HealthCare Pharmaceuticals' birth
control pill. Bayer HealthCare, its parent company and a Merck KGaA
unit sued to block Watson's product before patent expiry.
Guidance from FDA advises heparin makers
on safety
The FDA issued guidance to drugmakers on how to better control
heparin to prevent contamination. The posting comes four years
after a contamination case resulted in deaths.
Sunovion wins $18 million award in
patent-infringement case
A federal jury ruled that Mylan and its unit Dey Pharma
intentionally violated Sunovion Pharmaceuticals'
inhaler-technology patents. The jury awarded $18 million to
Sunovion. Mylan CEO Heather Bresch said the firm intends to
appeal.
Children's leukemia drug in short
supply
Since Ben Venue Laboratories, one of the largest U.S. suppliers of
injectible methotrexate, suspended its operations in Bedford, Ohio,
last November, supplies of the childhood leukemia drug have
gradually declined. "Supplies are just not meeting
demand," FDA official Valerie Jensen said. She added that the
other methotrexate producers in the country are attempting to
increase production.
U.S. charges former Takeda director with
insider trading
Brent Bankosky, a former Takeda Pharmaceutical director, partly
settled an insider trading lawsuit with the Securities and Exchange
Commission. Bankosky made $63,000 from call options ahead of
Takeda's partnership with Cell Genesys and acquisition of
Millennium Pharmaceuticals, the SEC said.
Cumberland gets notice of patent allowance
for Acetadote
The U.S. Patent and Trademark Office issued a notice of allowance
for Cumberland Pharmaceuticals' newly approved formulation of
injectable liver drug Acetadote. The patent, if officially granted,
will last until August 2025.
FOOD & DIETARY SUPPLEMENTS
The importance of import
vigilance
Contamination prevention is an ongoing struggle for companies that
import food. Despite the FDA's Food Safety Modernization Act,
companies such as Edible Arrangements and Taco Bell struggle to
scrutinize the handing of imported food.
FDA won't change fungicide limit for
juice imports
The FDA declined a request to lower the level of carbendazim
allowed in orange juice imports. The agency said making an
exception would be unfair to food manufacturers that spent money to
achieve federal standards. Brazil, where the fungicide is approved,
requested a delay until June 2013 to eliminate carbendazim from its
juice.
Penn. farmer is barred from selling raw
milk interstate
A federal judge barred Daniel Allgyer, owner of the Rainbow Acres
Farm in Pennsylvania, from marketing unpasteurized milk over state
lines, the Justice Department reported. The FDA said Allyger had
been warned but the dairy farmer tried to evade federal laws by
entering into cow-sharing agreements through a membership
organization.
Index: Food recalls increased 50% in
Q4
Fifty percent more food recalls were conducted in the fourth
quarter compared with the third quarter, according to the
ExpertRECALL Index. Undeclared allergens accounted for most of the
product withdrawals, followed by contamination with listeria and
other food-borne pathogens.
Obama proposes a lean budget for
USDA
President Barack Obama's proposed budget for the Department of
Agriculture in fiscal 2013 would decrease support for pathogen
testing. Agriculture Secretary Tom Vilsack said the budget proposal
also seeks increased funding for the Women, Infants and Children
program. The price of fruit and vegetable vouchers for children is
set to increase to $10.
Regeneca recalls herbal supplement with
undeclared ingredient
Regeneca withdrew one lot of its female sex-enhancing herbal
supplement containing a drug ingredient, tadalafil, not listed on
the product label, according to the company and the FDA. The
compound, approved for erectile dysfunction, could interact with
nitrates and dangerously lower blood pressure.
Vt. legislation would set rules for GMO
labeling
Vermont lawmakers are considering a bill that would forbid
food-makers that use genetically modified ingredients to use words
indicating a product is "natural" or "all
natural." The Vermont Right to Know Genetically Engineered
Food Act would consider food "misbranded if it is entirely or
partially produced with genetic engineering and it is not labeled
as genetically engineered."
House bill requires limits on arsenic,
lead in juices
Reps. Frank Pallone, D-N.J., and Rosa DeLauro, D-Conn., have
announced a bill that would require the FDA to set safety standards
on the levels of arsenic and lead in fruit juices within two years.
They noted that both chemicals can affect children's brain
development. "We must ensure that the juices our children
drink are safe," DeLauro said.
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