CONTENTS:
- Medical Devices
- Drugs & Biologics
- Food & Dietary Supplements
- Tobacco
Medical Devices
Boston Scientific aims to launch 24
products this year
Boston Scientific seeks to boost its profitability by rolling out
24 products this year, said company CEO Hank Kucheman at the J.P.
Morgan Healthcare conference on Wednesday. Plans include new U.S.
launches, for products such as the Incepta and Ingenio devices, and
global rollouts for current products, such as the PtCr Element
stent platform. The medical device giant also plans to expand its
drug-eluting stent portfolio in India and China, which Kucheman
said could be a key growth impetus for the company.
Toshiba promotes general manager and
senior VP to president
Toshiba America Medical Systems has selected Donald Fowler, its
general manager and senior vice president, to serve as company
president. Fowler served as vice president of Siemens Medical
Solutions' magnetic resonance business prior to joining
Toshiba.
Arguments begin in Stryker Biotech
marketing trial
A Boston jury heard opening arguments Thursday in the federal court
trial of Stryker Biotech and three former sales executives who are
accused of promoting to surgeons a combination of bone-healing
products for unapproved use. The products, which had humanitarian
device exemptions from the FDA, were never clinically tested in
combination, Assistant U.S. Attorney Susan Winkler said.
Torax wins unanimous FDA panel vote for
chronic heartburn device
A panel of FDA advisers unanimously agreed to recommend Torax
Medical's LINX device as safe and effective in the treatment of
chronic gastroesophageal reflux disease that doesn't respond to
drugs. The device has been commercially available in Italy, Germany
and the U.K. for about a couple of years, company President and CEO
Todd Berg said.
Siemens gets FDA OK for updated version of
ultrasound device
The FDA has granted Siemens Healthcare 510(k) clearance for version
2.0 of its Acuson SC2000 ultrasound device. The new version links
with the company's Acuson AcuNav ultrasound catheters to
support volumetric imaging and generates real-time heart scans in a
single cycle to reduce the need for electrocardiogram stitching or
gating, among other functions.
House subcommittee schedules February
hearing on user fees
A House Energy and Commerce health subcommittee will discuss the
Medical Device User Fee Act on Feb. 15. Jeffrey Shuren, director of
the FDA's Center for Devices and Radiological Health will
testify at the hearing to review the act, which expires on Sept.
30.
J&J unit receives FDA warning over
insulin pumps
The FDA warned Animas, a Johnson & Johnson unit, saying it did
not have an adequate procedure for the timely reporting of injury
complaints related to its insulin pumps. "We are dedicated to
quickly resolving the FDA's outstanding concerns," said
J&J spokeswoman Caroline Pavis.
Report outlines priority issues on medical
device reprocessing
A report gleaned from a two-day summit conducted by the Association
for the Advancement of Medical Instrumentation and the FDA maps
seven goals toward improving the way organizations reprocess
medical devices. The report also outlines 10 measures to boost
medical device reprocessing such as setting up a panel to evaluate
and address priority concerns.
Deep brain stimulation shows positive
results in Parkinson's trial
Patients who received deep brain stimulation therapy using St. Jude
Medical's Libra and LibraXP devices had longer hours of not
experiencing Parkinson?s disease symptoms such as dyskinesia
compared with those who did not undergo the treatment, according to
a study in the Lancet Neurology Journal. The study involved 136
patients from 15 U.S. clinical sites.
Riverain wins FDA clearance for lung
cancer detection tool
The FDA has given Riverain Technologies the green light to market
its Temporal Comparison X-ray system. The technology works by
comparing past and present chest X-ray scans electronically to help
radiologists identify early signs of lung cancer in patients.
NeuroLogica pulls in $12 million in
funding round
Medical imaging device maker NeuroLogica said in a regulatory
filing that it has secured $12 million in a financing round. The
Danvers, Mass.-based company will apply the proceeds for capital
and inventory purposes as it works to meet an increased demand for
the BodyTom device, its FDA-cleared portable CT scanner.
Launch Medical to spend $4.8 million on
Tenn. facility expansion
Medical device company Launch Medical has announced plans to expand
its facility in Bartlett, Tenn., into a 21,000-square-foot space.
The $4.8 million expansion could result in the creation of 40 jobs
in the area during the next five years.
Apollo wins FDA nod for SuMO endoscopy
device
The FDA has granted Apollo Endosurgery clearance for its SuMO
system for endoscopic tissue access and resection. The device is
designed to help doctors perform scarless surgery to extract large
and flat precancerous polyps and lesions during endoscopic
operations.
Dehaier Medical scores European approval
for 2 devices
Dehaier Medical Systems has earned CE mark approval for its DHR-998
sleep diagnostic tool, which is used to measure pulse, respiration,
oximetry and other body functions. The company also won European
approval to market its air compressors for use with medical
ventilators.
GE Healthcare gets FDA clearance for gamma
camera
GE Healthcare has received FDA clearance for its Brivo NM615, a
gamma camera that has SPECT functionality. The company said the
device can support patient weight of up to 500 pounds, and on-site
upgrades can convert the system to the Discovery NM630 or Discovery
NM/CT 670 SPECT/CT hybrid systems. The Brivo NM615 is also
compatible with GE's Xeleris system.
8 medtech firms sign supply deals with
Premier, Novation
Hospital group purchasing organization Premier has awarded supply
contracts to Steris, Nuvo, Stryker, Oasys, Skytron and Olympus
America for operating room integration tools, and to CJPS
Healthcare Supplies & Equipment for vital signs monitors and
telemonitoring devices. Novation, another hospital GPO, also signed
a deal with Teleflex to supply it with dialysis systems.
Visiogen CEO joins InterWest's medical
devices unit
InterWest Partners, a venture capital firm focused on the life
sciences and technology sectors, has named Reza Zadno to its
medical devices group. Zadno is the founder, CEO and president of
Visiogen, maker of an intraocular lens used to treat presbyopia and
cataracts.
Report: Medtech market in China to reach
$5 billion this year
A Citigroup report projects that the market for medical devices in
China will rise 17% to $5 billion this year, driven in part by a
growing demand from Chinese hospitals as they boost their
purchasing capital and plan for infrastructure upgrades. The report, based on a survey of 383 Chinese
hospitals, also noted that Medtronic, Stryker and Johnson &
Johson were the leaders in the medical consumables market, while GE
was ahead in the medical equipment segment.
RTI taps into medtech market with Remmele
acquisition
RTI International Metals plans to make inroads in the medical
device market with its acquisition of Remmele Engineering for
$164.5 million. RTI is looking to benefit from the demand of a
growing U.S. medical device contract manufacturing market, which is
predicted to hit $20.3 billion by 2016.
Global venture capital group to invest
$200M in biotech firms
Canaan Partners said it will allot a third of its new investment
fund worth $600 million to medical device, diagnostics and
biopharmaceutical firms. The global investment group is eyeing
medtech ventures focused on novel devices for treating major
conditions, minimally invasive therapy systems and other areas.
Partnership aims to develop test for
latent TB progression
Qiagen has partnered with the Max Planck Institute for Infection
Biology to create an assay that can determine whether a patient
with latent tuberculosis infection is at risk for developing active
disease. The test, which is targeted for completion as early as
2013, will be marketed by Quiagen.
CEO survey: Burdensome FDA process hinders
industry growth
Eight in 10 biomedical CEOs responding to a survey by the
California Healthcare Institute, BayBio and PwC view the taxing FDA
approval process as a key barrier to the growth of their
enterprises and the U.S. medtech industry. About 75% of the CEO
respondents also fear that the FDA process would put the
nation's leadership position in the global biomedical industry
in peril.
NanoLogix ramps up FDA submissions for
rapid bacteria assays
NanoLogix said it is working with an undisclosed company to submit
to the FDA applications for its rapid bacteria detection
technology. The applications will cover results of trials that
tested the technology's ability to spot Group B Streptococcus
and tuberculosis, the Hubbard, Ohio-based company said in a
statement.
China halts unapproved stem cell
therapies, trials
China's Ministry of Health, together with the State Food and
Drug Administration, has issued an order preventing hospitals and
clinics from offering unapproved stem cell treatments, which
attract both local and foreign patients. Applications for stem cell
projects will also be rejected by the ministry until July as part
of the government's one-year campaign to improve industry
regulations.
Varian Medical gets FDA nod for
radiotherapy planning tool
The FDA has granted Varian Medical Systems 510(k) clearance for its
new tool for radiotherapy treatment planning. The technology is
designed for use with the company's Eclipse system to speed up
planning for advanced therapies.
Handheld hemoglobin spot-checking device
arrives in U.S. market
Masimo said its Masimo Pronto-7 device has received 510(k)
clearance from the FDA and is now available commercially. The
handheld device is designed to allow clinicians to more quickly and
noninvasively spot-check total hemoglobin as well as pulse rate,
perfusion index and SpO2.
Baxter picks Medtronic exec to lead global
business unit
Baxter has appointed Jean-Luc Batel to serve as president of its
global operations effective Feb. 20. Batel currently serves as
executive vice president and international group president at
Medtronic.
U.K. regulators approve mobile health app
for burn injury
D4 has earned CE Mark approval in the U.K. for the Mersey Burns
mobile health application, which it co-developed with the Mersey
Plastic Surgery Unit. The technology, which runs on all iOS
devices, is designed to make it easier for doctors to calculate a
burn patient's affected body surface area and administer the
right amount of fluid within 24 hours after the injury.
Singapore firm unveils pulse-taking
peripheral for the iPhone
Zensorium has introduced the Tinke, an electronic device that
gathers medical data such as heart rate, respiration and blood
oxygen and is used as an iPhone attachment. The Singapore-based
company said the product, being exhibited this week at the
International Consumer Electronics Show, will go on sale to
consumers in the second half of this year for about $100.
Cook Medical to make $20 million R&D
investment in Ireland
Cook Medical said it will pump $20 million over four years into its
facility in Limerick, Ireland. The money will be used to set up an
advanced research and development hub that will promote
collaboration between clinicians and scientists as well as create a
more realistic setting for device trials. The company also eyes the
Limerick facility as its main site for developing its Zilver device
portfolio.
Medtronic aims for broader presence in
Israel in years ahead
Medtronic is looking to expand its research and development efforts
in Israel as part of its overall global strategy, company spokesman
Steve Cragle said. The company views Israel as a conducive place to
innovate, particularly in the areas of "imaging, software,
guidance and electronics," he said.
NICE questions Xarelto's
cost-effectiveness for stroke prevention
Bayer was asked by the U.K. National Institute for Health and
Clinical Excellence to submit more clinical data on
stroke-prevention drug Xarelto, or rivaroxaban. "The
population included in the single trial presented by the
manufacturer as evidence of rivaroxaban's cost-effectiveness
was not reflective of all the people with atrial fibrillation in
the U.K. who would be eligible for treatment with the drug,"
NICE said.
Social media is key to patient-centered
products
Social networking sites, blogs and YouTube have been used
successfully to gather ideas about patient-friendly product
innovations, and medical device manufacturers would be wise to
follow suit, writes communications expert Amy Munice in this
article. "There?s no question that companies creating products
and services for people with diabetes can get a good idea what it
is like to live with diabetes by looking in the social media
space," says Diabetes Stories volunteer blogger Riva
Greenberg, calling social media "free market
research."
Syndax, Ventana to devise companion
diagnostic test for cancer drug
Syndax Pharmaceuticals partnered with Ventana Medical Systems in
the development of a companion diagnostic test to identify
nonsmall-cell lung cancer patients suited for treatment with a
combination of erlotinib and Syndax's entinostat. A Phase II
study showed that patients with high levels of e-cadherin in their
tumors survived four months longer with erlotinib and entinostat
compared with an erlotinib and placebo combo.
Tengion relocates headquarters to N.C.
from Pennsylvania
Tengion has transferred its headquarters from Pennsylania to its
research and development facility in North Carolina. The move is
part of a restructuring effort to meet savings goals as the company
seeks a partner to support continued development of its tissue
regeneration tool.
FDA OKs use of Abbott's glucose test
strip with insulin pump
Abbott's Freestyle glucose test strip has received 510(k)
clearance from the FDA for use in combination with the OmniPod
insulin pump from Insulet. Insulet said the companies would
communicate with customers as soon as next week, after making
updates to product labels.
GAO finds inconsistent FDA reporting on
pediatric devices
The FDA lacks consistent data on devices that have been cleared for
use in pediatric patients under the premarket approval and
humanitarian device exemption programs, the Government
Accountability Office found. The FDA said it is updating its
reporting system, data quality controls and training program rules
for pediatric devices seeking premarket approval.
Smith & Nephew wins FDA nod for PICO
wound therapy device
Smith & Nephew has received FDA clearance for its PICO device,
a pocket-size system that uses negative pressure to treat wounds.
The clearance allows the use of the wound therapy device in
hospital and in-home settings as well as among a wider variety of
patients, the company said in a statement.
Medtech startup raises $1.6 million in
funding round
Medical device startup EpiEP said in a regulatory filing that it
has secured $1.6 million in its latest financing round targeted at
$2.25 million. The company's first product is the EpiAccess
device, which allows for minimally invasive management of heart
arrhythmia and other diseases.
Industry saw higher valuations, despite
slow M&A activity in 2011
A Dow Jones VentureSource report found that about 460 medtech firms
were purchased in 2011, a 13% decline from the previous year.
However, last year's transactions, valued at $46.4 billion,
were 30% higher than those in 2010, which totaled $35.6 billion.
Medtronic's $800 million acquisition of Ardian and Shire's
buyout of Advanced BioHealing for $750 million were cited as among
the biggest transactions in 2011.
Global point-of-care diagnostics market to
hit $16.5B by 2016
A BCC Research report predicts that the global point-of-care
testing market will grow from $13.8 billion last year to $16.5
billion in five years, driven in part by long-term cost benefits,
workforce shortages and aging populations. The research company
predicts that cardiac markers will achieve the fastest growth,
moving from $1 billion in 2011 to a projected $2 billion in
2016.
Wearable monitor measures calories without
relying on estimates
MetaLogics is developing an arm band, called MetaLogics Personal
Calorie Monitor, that the company says is the only such device that
can manage obesity with no guesswork involved. The Class II exempt
device employs a patented metabolics research tool to track body
heat and sends the data wirelessly to a readout that wearers can
use to set calorie goals and track progress. The Minnesota startup
plans to conduct beta trials of the device in the first quarter and
hopes to launch the product during the second half of 2012.
FDA clears vessel sealer for
Intuitive's surgical robot
The FDA has granted Intuitive Surgical clearance for its EndoWrist
vessel sealing device for use in combination with the company's
da Vinci surgical robot. The Sunnyvale, Calif.-based firm said it
plans a limited release of the EndoWrist device in the first
quarter of this year, while concurrently filing for CE Mark
approval.
Proposed guidelines for using 3D
echocardiography issued
The American Society of Echocardiography and the European
Association for Echocardiography have released their recommended
guidelines for maximizing the use of 3D echocardiography. The joint
guidelines, published in the Journal of the
American Society of Echocardiography, offer best practices for
using 3D echo imaging to assess and view heart structures.
CircuLite gets $950K boost to develop
cardiac device
The Cardiovascular Medical Research and Education Fund has awarded
CircuLite $950,000 to create a heart-assist device for use in
patients with pulmonary arterial hypertension. The Saddle Brook,
N.J.-based company is also investigating using its Synergy system
for other diseases the affect cardiac function and is working on a
version that could help children waiting for heart transplants.
Team seeks to create glucose monitoring
contact lens
Experts at Microsoft Research and the University of Washington have
teamed up to develop a contact lens that can detect blood glucose
levels and transmit the information digitally to the wearer's
eye. A prototype lens has been created that features an imbedded
LED display, a wireless data communications link and a power
harvesting unit.
Wright Medical releases 2 surgical tools
for ankle repair
Two ankle repair devices from Wright Medical are now available
commercially in the U.S. and select markets abroad. The Ortholoc
3Di device matches implants with a patient's anatomy and type
of fractured ankle, while the Quickdraw Knotless Soft Tissue
Fixation System is designed to make it easier for surgeons to
suture and restore detached tendons to the ankle and foot.
Iridex sells aesthetics unit to
concentrate on medtech business
Iridex, which has its headquarters in Mountain View, Calif., has
divested its France-based aesthetics division to Cutera in a $5.1
million deal slated to wrap up early this year. The move will allow
Iridex to focus on its medical device portfolio, specifically its
ophthalmology business.
Mich. clinical-stage device company gets
$34 million boost
Ann Arbor, Mich.-based CytoPherx has secured $34 million in a
financing round, which is said to be the biggest amount of venture
capital funding for an in-state firm since April 2009. The company,
which develops patent-protected and customized designs of existing
hollow fiber dialysis filters for inflammation treatment, will use
the money to advance clinical studies.
Pocared gets CE Mark for automated urine
test
European regulators have given Pocared Diagnostics the go-ahead to
market its automated tool that uses light refraction to spot
bacteria in urine samples in real time. The company plans to wait
for FDA approval before launching sales of the assay that it says
can generate results in a few minutes compared with existing
methods, which take one to two days.
Drugs & Biologics
Group wants another FDA panel review of
drospirenone
The Project on Government Oversight asked FDA Commissioner Margaret
Hamburg to assemble a different advisory panel to review the
benefit-risk profile of oral contraceptives based on drospirenone.
The request follows public disclosure of ties between pill
manufacturer Bayer and several advisers who previously voted that
drospirenone's benefits outweigh a risk of blood clots.
"The American public must be able to trust that the FDA and
its advisory committees are making decisions based on science, not
industry influence," said Danielle Brian, the group's
executive director.
Survey: Drugmakers aren't preparing
for generic competition
This year's patent losses are projected to cost drugmakers
almost $29 billion in U.S. revenue, but only 17% of pharmaceutical
and health care executives polled by The Economist Intelligence
Unit think the sector is prepared for this challenge. Drug sales in
Europe will decrease marginally for the fourth consecutive year,
The Economist predicted.
Teva also is working on powerful
hydrocodone painkiller
At a recent investor meeting, Teva Pharmaceutical Industries
unveiled a product, TD Hydrocodone, that is in late-stage
development. Documents filed with the NIH say that Teva is testing
an extended-release painkiller that contains as much as 45
milligrams of hydrocodone.
Oramed seeks patent for diabetes drug
combo
Oramed Pharmaceuticals submitted a provisional application seeking
a U.S. patent for an oral drug containing two diabetes compounds.
Preclinical tests found that the combination was better in
improving glucose regulation than administering the formulations
separately.
NICE: Jevtana's benefit for prostate
cancer doesn't justify cost
In a preliminary decision, the U.K. National Institute for Health
and Clinical Excellence said Sanofi's Jevtana is effective for
lengthening survival of men with advanced hormone-refractory
prostate cancer, but the drug also has adverse effects. Jevtana
would not be cost-effective for National Health Service use, NICE
CEO Andrew Dillon said.
Documents reveal ties between FDA advisers
and Bayer
Three members of an FDA advisory panel that affirmed the safety of
Bayer's oral contraceptives had a financial relationship with
the pharmaceutical company, according to documents filed in
litigation against Bayer. FDA official Jill Hartzler Warner said
the agency is not allowed to disclose financial information
provided by advisers.
Hemispherx gets more time to prepare
resubmission of Ampligen
The FDA granted Hemispherx Biopharma's request for an extension
to complete a modified application for Ampligen, a drug candidate
for chronic fatigue syndrome. The agency rejected Ampligen in 2009
and requested additional study. Hemispherx said researchers are
developing a companion diagnostic that could be relevant to
resubmission.
Questcor reacts ahead of blog post on
business strategy
Questcor Pharmaceutical learned that investigative blog Street
Sweeper will post a negative report about the drugmaker's
leadership and promotion of H.P. Acthar Gel, which treats multiple
sclerosis and other conditions. In response, Questcor said its
"marketing and business practices are consistent with
regulatory requirements and industry standard practices." The
drugmaker intends to meet with the blogger.
Wockhardt gets FDA OK for generic of nasal
spray Flonase
The FDA approved Wockhardt's generic version of 50-microgram
nasal spray Flonase, GlaxoSmithKline's treatment for allergic
rhinitis. Wockhardt is required to conduct studies, Chairman Habil
Khorakiwala said.
Arena's resubmission of lorcaserin is
accepted by FDA
The FDA accepted a resubmission of Arena Pharmaceuticals and
Eisai's obesity drug candidate lorcaserin. Arena recently
submitted to the agency an explanation for an observed association
between lorcaserin and breast cancer in rats as well as the
drug's effect on certain serotonin receptor subtypes.
Baxter seeks expanded FDA approval of
Gammagard Liquid
Baxter International filed a supplemental biologics-license
application requesting FDA approval to promote Gammagard Liquid 10%
as a treatment for multifocal motor neuropathy. The drug is
approved to treat people age 2 and older with primary humoral
immunodeficiency.
FDA confirms generic applications for 2
HIV drugs, one contraceptive
The FDA said it received applications from companies seeking to
produce generic versions of HIV medicines Isentress and Epivir as
well as oral contraceptive Beyaz. The brands are marketed by Merck
& Co., GlaxoSmithKline and Bayer, respectively.
$1B Risperdal trial begins in Texas for
J&J
Texas is seeking $1 billion in damages from Johnson & Johnson
over the off-label marketing of anti-psychotic Risperdal in a trial
that began Monday. Two weeks earlier, J&J agreed to a $1
billion settlement with the federal government.
FDA launches blog to shed light on agency
actions
The FDA Voice blog will "give FDA employees
the opportunity to go beneath the surface to tell you about what
they are working on," Commissioner Margaret Hamburg said in an
introductory post. Posts since the blog's Dec. 23 launch
covered guidance on medical devices, dosages for
acetaminophen-containing cold medicines and the agency's 2012
work program.
Lawmaker: FDA should view superpainkiller
with caution
The FDA should exercise caution when reviewing a pure form of
highly addictive painkiller hydrocodone as cases of
prescription-drug abuse and related crime increase, Sen. Charles
Schumer, D-N.Y., wrote in a letter to FDA Commissioner Margaret
Hamburg. Schumer advised the agency to "undertake robust
postmarket surveillance" if it approves such a medicine.
FDA drops proposed contraindication for
Vivus' obesity pill Qnexa
The FDA asked Vivus, which is seeking approval of Qnexa, to remove
from the obesity drug's proposed label a contraindication for
women in childbearing years. Based on the change, Vivus is
adjusting a strategy for risk evaluation and mitigation.
Mylan faces patent lawsuit regarding
generic Actoplus Met XR
Mylan was sued by Watson Pharmaceuticals, Andrx Labs and Takeda
Pharmaceutical after it filed an FDA marketing application for
generic Actoplus Met XR, a treatment for type 2 diabetes. The drug
contains extended-release metformin hydrochloride and pioglitazone
hydrochloride.
FDA alerts public about drugs from
Novartis plant
The FDA issued a public health advisory on potential mix-up between
Novartis' over-the-counter medicines and Endo
Pharmaceuticals' prescription opioids that were manufactured
and packaged at a recently closed plant in Nebraska. Novartis
initiated a recall after complaints of broken and mislabeled
products. The FDA said affected painkillers will not be pulled
because they are medically needed and have a small chance of
containing stray tablets.
GSK and Theravance plan regulatory filing
for lung drug Relovair
Theravance and GlaxoSmithKline will apply for U.S. and EU approval
of respiratory medicine Relovair by midyear. The companies said
Relovair did not outperform GSK's best-seller Advair during a
late-stage trial, but overall data improved prospects for the drug
candidate.
Novartis initiates precautionary recall of
4 OTC brands
Novartis said it withdrew certain batches of over-the-counter
medicines Excedrin, Bufferin, NoDoz and Gas-X Prevention because
they might "contain stray tablets, capsules or caplets from
other Novartis products, or contain broken or chipped pills."
The precautionary recall comes after the drugmaker suspended
operations at a Lincoln, Neb., plant to make improvements.
FDA gives AiCuris' letermovir
orphan-drug designation
AiCuris secured orphan-drug status from the FDA for letermovir, an
investigational compound against human cytomegalovirus. The
drugmaker expects to release shortly findings of a Phase IIb study
that evaluated letermovir as a prophylactic agent in patients who
underwent bone marrow transplant.
FDA warns about use of unapproved stem
cell treatments
The FDA is warning consumers to stay away from unapproved stem cell
treatments. "FDA will continue to aggressively pursue
perpetrators who expose the American public to the dangers of
unapproved stem cells and ensure that they are punished to the full
extent of the law," said Patrick Holland, special agent of
FDA's office of criminal investigations.
White House adviser is urged to help
readdress Plan B decision
Supporters of wider Plan B access asked John Holdren, chief science
and technology adviser to President Barack Obama, to find out the
administration's basis for continuing to require girls younger
than 17 to acquire the emergency contraceptive by prescription.
"We are asking you to work with us ... to readdress this
decision, find out how it was made and why," said Association
of Reproductive Health Professionals President Wayne Shields.
FDA allows study of NeuVax-Herceptin combo
for breast cancer
Galena Biopharma obtained FDA permission to launch a Phase II trial
of experimental drug candidate NeuVax in combination with
Herceptin, an approved medicine by Roche Holding unit Genentech.
NeuVax is targeted at breast cancer patients who are not eligible
for standard anti-HER2 therapy.
EU guidance on biosimilars will come this
year, official says
The European Medicines Agency plans to release in March or April a
final set of requirements for market approval of biosimilar
monoclonal antibodies, said Executive Director Guido Rasi. Draft
guidance on generic versions of other biotech drugs is expected to
follow.
FDA: J&J's Doribax was found
unsafe and ineffective for pneumonia
A clinical study testing Johnson & Johnson's antibiotic
Doribax for ventilator-associated pneumonia was halted because of a
lower cure rate and higher mortality among patients who took the
drug compared with a control group, according to the FDA. The
agency said Doribax remains safe and effective when used for
approved indications: abdominal and urinary infection.
Merck CEO says promising drugs are on the
horizon
After a difficult 2011, Merck & Co. sees better opportunities
for its pipeline in 2012, said CEO Kenneth Frazier. The company
plans to seek FDA approval of insomnia medicine suvorexant and a
stronger vaccine for human papillomavirus. Merck also aims for a
resubmission of postoperative drug Bridion.
Food & Dietary Supplements
Bill would make downer meat ban
permanent
Rep. Gary Ackerman, D-N.Y., reintroduced a bipartisan measure that
would require unhealthy livestock to be euthanized and prevented
from entering the food supply. The legislation would close a
loophole that could allow the USDA to permit the slaughter of
downed cattle, Ackerman said.
FDA imposes "test and hold" on
juice imports
The FDA temporarily blocked orange juice imports from all countries
while the agency is testing for residues of fungicide carbendazim.
Coca-Cola informed the FDA that some Brazilian growers used the
chemical, which is not approved for use in oranges by the U.S.
House panel highlights shortcomings in
third-party inspection
The House Energy and Commerce Committee found that FDA safety
guidelines were largely ignored by an independent auditor that gave
a "superior" rating to Colorado's Jensen Farms just
before deadly listeria outbreak that was traced to cantaloupe from
the farm. Democratic members wrote to FDA Commissioner Margaret
Hamburg saying the agency should reform its audit system and
develop a standard model for third-party inspection.
Cost-cutting plan won't threaten food
safety, USDA chief says
The USDA's decision to shutter 259 offices nationwide to save
$150 million is not expected to cause major disruption to services,
said Agriculture Secretary Tom Vilsack. Closure of offices
overseeing food-safety programs might take place after Oct. 1,
Vilsack said.
Food safety service losing 5 offices in
USDA cuts
The Food Safety and Inspection Service is among USDA departments
that will close offices under plans for $150 million in cuts
announced by Agriculture Secretary Tom Vilsack. The FSIS will lose
five district offices, in Beltsville, Md.; Minneapolis; Lawrence,
Kan.; Madison, Wis.; and Albany, N.Y.
FDA touts progress in food-safety
regulation over past year
The FDA reported that it has made significant strides in
implementing the Food Safety Modernization Act during the past
year. Among the agency's accomplishments: seizing potentially
tainted foods using its newly acquired authority; issuing safety
guidance on seafood and dietary supplements; and achieving a
mandate for overseas facility inspections.
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