CONTENTS:
- Medical Devices
- Drugs & Biologics
- Food & Dietary Supplements
- Tobacco
MEDICAL DEVICES
Exec: Device tax counters principles of economic growth,
job creation
The 2.3% medical device excise tax could lead to job cuts in the
medtech industry by lowering the demand for devices and driving
U.S. firms to move their operations overseas, writes BioOhio
President and CEO Tony Dennis, citing an
AdvaMed study. The tax, set to begin in 2013, "is counter
to principles of economic growth and job creation" and
"may stifle the kind of innovation that is essential to
patients and the overall health care system," Dennis
notes.
Proposal to boost FDA budget could ease talks on device
user fees
A bill that would give the FDA a $50 million increase to its 2012
budget, if approved, could reduce the pressure on talks between the
agency and the industry over medical device user fees. "It
gives the FDA a little bit more breathing room to negotiate with
industry. And it takes some of the pressure off industry to agree
to user fee levels that are greater than it would care to have to
pay," said Mark McCarty, Washington editor at Medical Device
Daily.
ITech Medical names new board chairman
ITech Medical's CEO, Warren Baker, has been named chairman of
the device company's board of directors.
Canadian regulator clears surgical video
technology
Health Canada has granted NDS Surgical Imaging approval for its
ZeroWire surgical video system. The wireless device employs an
ultra-wideband frequency spectrum to bring high-definition video to
the operating room.
Sphere Medical raises nearly $19 million on London Stock
Exchange
Sphere Medical has secured almost $19 million on its first day of
trading on London's AIM market. The U.K.-based firm
manufactures diagnostics and monitoring devices, including the
Proxima blood analyzer and a tool used to track a patient's
blood continuously during cardiopulmonary bypass procedures.
Study: CardioDx's Corus assay superior to MPI in CAD
diagnosis
A study presented at the 2011 American Heart Association meeting in
Florida found that CardioDx's Corus test, a blood-based
gene-expression assay, showed greater sensitivity and accuracy than
myocardial perfusion imaging in identifying a patient's risk of
obstructive coronary artery disease. The trial involved 537 stable
patients with CAD symptoms.
OrthoCor's knee brace system earns good
critique
The Active Knee System, developed by OrthoCor Medical, was one of
two devices featured last week on "The Dr. Oz Show."
Magnetic field therapy expert Dr. William Pawluk hailed the
FDA-cleared device as effective for knee pain therapy because of
its use of a combination of heat and electromagnetic waves to fight
pain and swelling in the joint.
Medtronic wins FDA approval for chronic pain
device
Medtronic has received FDA approval for its AdaptiveStim
RestoreSensor system, an implantable device used to treat patients
with chronic back and leg pain. The device, which uses
motion-sensing technology, works by adjusting stimulation levels
automatically according to a patient's body position.
Texas congressman wants to prevent regulation of genetic
tests
Rep. Michael Burgess, R-Texas, a physician by practice, has put
forth a bill in an attempt to block the FDA from regulating genetic
tests. Such regulations could slow U.S. innovation and leadership
in the field of genetic research, Burgess said.
Medtech industry veterans join SonoSite's executive
team
SonoSite has named Brian Noyes, a former executive at Ethicon
Endo-Surgery, as vice president of marketing for its North America
and South America operations. The Bothell, Wash.-based ultrasound
manufacturer also appointed Richard Salazar, a former executive at
Ventana Consulting and Renaudia Medical, as its new VP and general
manager for Europe and Africa.
Bain Capital to buy Medtronic unit for $487
million
Bain Capital has agreed to buy Physio-Control, Medtronic's
external defibrillator division, for $487 million in cash. The deal
is targeted for completion in the first quarter of next year, and
Physio-Control President Brian Webster will take over as CEO of the
business.
Synaptic Capital to invest in medtech firms, other health
sectors
Synaptic Capital is hoping to raise $250,000 or more for its
Synaptic Medical Fund, which aims to invest in medical device
companies, drugmakers and hospital systems.
St. Jude will move R&D facility to new location in
Sunnyvale, Calif.
St. Jude Medical will transfer its research-and-development
operations to a newly purchased facility in Sunnyvale, Calif. The
device company has allotted $5.7 million to renovate the new
R&D office.
JPL Medical to distribute Misonix's BoneScalpel in
Thailand
Bangkok-based JPL Medical has agreed to exclusively distribute
Misonix's BoneScalpel ultrasonic bone cutter in Thailand for
three years. The device, which offers a substitute to rotary bone
cutters, allows precision cutting through bones and hard tissue
while keeping soft tissue intact.
Swiss diagnostics firm raises $100 million in funding
round
Biocartis has secured $100 million in a round of series C financing
from Johnson & Johnson and other investors. The Swiss company
will use the money to support the development of its flagship
Apollo device, targeted for release in 2013, which can be used to
perform complex molecular assays on various samples and analyze
disease parameters in a single test.
AtriCure ends patient enrollment for hybrid ablation
trial
AtriCure has concluded patient enrollment in a feasibility study
intended to assess whether combining the company's minimally
invasive devices with catheter systems is effective and safe for
treating patients with atrial fibrillation. While this procedure,
known as hybrid ablation, is normally done in a single session, the
company decided that a staged approach, in which each part of the
combined procedure was scheduled separately, may be more
appropriate to a larger number of reviewers as it prepares for a
pivotal study.
Tandem gets FDA nod for touch-screen insulin
pump
Tandem Diabetes Care has received clearance from the FDA for its
t:slim Insulin Delivery System, the smallest such device to have
reached the U.S. market. The touch-screen device features an
environmentally friendly rechargeable battery and USB connectivity
to online disease management software.
Three questions for Michael Mussallem, CEO of Edwards
Lifesciences
MassDevice talks with Edwards Lifesciences CEO Michael Mussallem
about why the medical device industry works for him and what he
thinks was his biggest mistake in his career.
FDA sets date to discuss enhanced regulation of brain
stimulators
The FDA's Neurological Devices Panel of the Medical Devices
Advisory Committee is scheduled Feb. 10 to discuss whether cranial
electrotherapy stimulators should be subjected to pre-market
approval evaluation. The brain-stimulation devices, which are used
to treat anxiety, pain, depression and insomnia, are currently
subjected to the 510(k) clearance process.
C.R. Bard, Endologix end patent dispute over stent
graft
C.R. Bard has resolved a patent dispute with Endologix over a form
of plastic used to manufacture stent grafts. Both companies agreed
that Endologix be dismissed as a defendant in the case and were
ordered by the court to pay their own legal expenses.
Senators endorse bill that would expedite device approval
process
Sen. John Kerry, D-Mass., has joined Sens. Al Franken, D-Minn., Kay
Hagan, D-N.C., and Lamar Alexander, R-Tenn., in sponsoring a bill
that would speed up the device approval process by making it easier
for the FDA to seek advice from experts. "This legislation
strengthens the approval process while cutting the red tape that
keeps these critical devices from the hospitals, doctors and nurses
who can use them to save lives," Kerry said.
FDA clears X-Spine's spinal device
Miamisburg, Ohio-based X-Spine Systems has secured clearance from
the FDA for its Calix PC spinal implant device. The device, which
employs plasma coating technology, offered better resistance to
expulsion than noncoated implants during laboratory tests.
PositiveID's wireless glucose-tracking tool wins 510(k)
clearance
The FDA has granted PositiveID clearance for its
"iglucose" system for managing diabetes. The technology
can send glucometer readings to an online portal, where individuals
with diabetes can monitor their glucose levels and provide access
to clinicians and family members.
STAAR Surgical gets CE Mark for astigmatism
device
European regulators have given STAAR Surgical the go-ahead to
market its nanoFLEX Toric Collamer Single Piece IOL for treating
astigmatism in cataract patients.
Samsung expands footprint in medtech market with Nexus
buy
Nexus, a U.S. firm owned by ITC Nexus Holding whose concentration
is on point-of-care in vitro diagnostics for cardiovascular
diseases, has been acquired by Korean electronics firm Samsung for
undisclosed terms. The deal is Samsung's second investment in
the medtech sector and plays up its interest in the areas of in
vitro and in vivo diagnostics.
Report: Medicare spending on imaging is on a downward
trend
A review of Medicare data conducted by the Medical Imaging and
Technology Alliance found that imaging spending in Medicare has
decreased 13.2% since 2006, when imaging reimbursement fee cuts
started to be implemented as part of the Deficit Reduction Act.
Imaging use for each beneficiary decreased by an average of 3% in
2010, according to the study. "This analysis confirms the
downward trend in both imaging spending and utilization in Medicare
that has occurred in recent years," said David Fisher,
executive director of MITA. "The assumption that life-saving
diagnostic imaging and radiation therapy are increasing health care
costs is simply not true."
LifeVest defibrillator helps fuel revenue growth for Zoll
Medical
Zoll Medical generated $151.9 million in revenue during its fourth
quarter, up 26% from the same period last year. The growth was
driven in part by increased sales of the LifeVest defibrillator, a
wearable device used in helping restore a patient's normal
heart rhythm after a sudden cardiac arrest.
Accuray to reduce workforce as part of cost-cutting
measures
Accuray, which manufactures devices for cancer therapy, has
eliminated 29 jobs and will cut 22 more during fiscal 2012. The
move is part of the company's cost-reduction efforts in light
of its roughly $277 million takeover of TomoTherapy this year.
German dialysis firm picks new leaders for North American
unit
Fresenius Medical Care has appointed Simon Castellanos as executive
vice president, Franklin Maddux as chief medical officer and
Jeffrey Hymes as senior vice president and associate chief medical
officer for its North American headquarters. Castellanos was also
named president of Frensenius Medical Services, the company's
dialysis services subsidiary. The Germany-based firm provides
dialysis products and services.
CMS to roll out 3 demo programs next
year
The CMS is set to launch next year the Recovery Audit Contractor
program, which is meant to assess whether providers complied with
Medicare rules before they receive compensation. Two other
demonstration programs, also slated to begin in 2012, will require
providers in seven states to obtain prior authorization for power
mobility tools and related medical devices and allow Medicare Part
A and Part B rebilling among 380 volunteer hospitals.
Shuren tackles challenges tied to medical device
regulation
Increased employee turnover and flawed applications have triggered
a delay in the approval process for medical devices, said Dr.
Jeffrey Shuren, director of the FDA's device center. Concerns
have been raised that the FDA's taxing approval process is
forcing device companies to move their products and operations
overseas, but the U.S. regulatory framework is still stronger than
its European counterpart, Shuren said before a Senate committee
hearing on fostering innovation and ensuring patient
safety.
Becker names former FDA official as
director
Becker & Associates Consulting has appointed Tim Ulatowski as
director of medical devices for the company's expert advisory
panel. Ulatowski most recently served as director of the FDA's
Office of Compliance for medical devices.
Virtual colonoscopy drives up compliance with colon cancer
tests
Patients participating in a study published in The Lancet were 55%
more likely to agree to undergo colorectal cancer screening using
virtual colonoscopy or CT colonography compared with those asked to
undergo conventional colonoscopies. The study's authors noted
that traditional colonoscopy "identified significantly more
advanced neoplasia per 100 participants than did CT
colonography." However, increased participation in the virtual
screening made the two methods virtually even in overall
effectiveness.
Positive analyst outlook boosts shares of Smith &
Nephew
A positive outlook from analysts helped spur an increase in shares
for Smith & Nephew. The analysts at BNP Paribas were bullish
about the device company's growth goals over the long term,
which are supported by its $150 million savings program and a
projected revenue increase from sales of its orthopedic products in
emerging markets.
ThermalTherapeutic secures $800K for hyperthermic perfusion
device
Pittsburgh-based ThermalTherapeutic Systems has obtained $800,000
in a Series B financing round targeted at $2 million. The company
will use the funding to commercialize VeraTherm, a portable device
already cleared by the FDA for use in pumping fluid into a
patient's chest cavity or abdomen.
Boston Scientific strikes deal to market catheter device in
Europe
Boston Scientific has signed an exclusive agreement with Catheter
Robotics to supply the latter's CRI Amigo remote catheter
device in Austria and eight other European countries. The device,
which lets doctors control catheter-based systems remotely during
arrhythmia therapies, works well with several of Boston's
catheters, according to a news release.
Volcano reports positive trial results for coronary lesion
detector
A 131-patient study presented at the Transcatheter Cardiovascular
Therapeutics symposium in San Diego found that Volcano's
instant wave-Free Ratio detector showed an overall accuracy rate of
88% in diagnosing coronary lesions. The device is subject to
investigational device exemption in the U.S. as a drug-free
alternative to existing methods for evaluating constricted blood
vessels.
SpectraShield scores 2011 Product of the Year award in
N.H.
Foss Manufacturing Company has received the 2011 Product of the
Year award in New Hampshire for its SpectraShield surgical
respirator mask, which uses the FossShield antimicrobial technology
to trap pathogens that cause hospital-acquired infections. The
device can be used safely for about 14 days compared with the three
to four days permitted for existing masks.
Toshiba's vascular X-ray devices deployed at Wash.
hospital
Bremerton, Wash.-based Harrison Medical Center is using three of
Toshiba America Medical Systems' Infinix-i vascular X-ray
devices to enable radial access for virtually all patients. One of
the devices is called Infinix DP-i dual plane system, which allows
surgeons to perform both vascular and cardiac operations in one
room.
Industry voices concerns about India's drug-pricing
rule
An Indian draft policy to regulate prices for 60% of drug
formulations could result in a product shortage and harm the
interests of manufacturers and consumers, said Dilip Shanghvi, Sun
Pharmaceutical Industries' chairman and managing director.
Major industry bodies argued that the rule is shortsighted and does
not address long-term availability of medicines.
Amgen obtains EU approval for Vectibix-chemo
regimen
EU regulators approved the use of Amgen's Vectibix plus
chemotherapy to treat colorectal cancer in patients with a
nonmutated, or wild-type, KRAS gene. Vectibix was originally
approved as a stand-alone agent for patients with metastatic cancer
who failed to benefit from chemotherapy.
Maquet wins regulatory approvals for Cardiosave heart
pump
U.S. and European regulators have given Maquet Cardiovascular the
go-ahead to market its Cardiosave intra-aortic balloon pump for
treating patients with left ventricular failure and other heart
conditions. The device is targeted for commercial release in the
U.S. in January.
Senator seeks expedited review of devices for rare
diseases
During a visit to Medtronic's headquarters, Sen. Al Franken,
D-Minn., said he will propose a bill that could accelerate the
approval of medical devices used to treat rare conditions. Speaking
to some 800 Medtronic employees, Franken said his bill would allow
external experts to serve more easily on FDA panels assigned to
make recommendations on rare disease devices.
FDA asks for public input on device reclassification
system
The FDA will accept comments through Jan. 13 on whether its system
for reclassifying medical devices is effective and necessary as
well as on how the process can be improved. The agency also is
seeking ideas on how automated data gathering techniques can be
used to streamline the process for submitting requests for device
reclassification.
Canada OKs Allergan's Botox to prevent chronic
migraine
Allergan secured Canadian approval to promote anti-wrinkle
injection Botox as preventive therapy for adults who experience
chronic migraine at least 15 days per month. An updated Botox label
warns that neurotoxin used in the product might spread to other
body parts.
N.C. Medicaid office allows payment reimbursement for
Zoll's LifeVest
Zoll Medical obtained clearance from the North Carolina Division of
Medical Assistance that allows Medicaid patients who cannot use
implantable devices but are at risk of sudden cardiac death to
reimburse payments for the company's LifeVest wearable cardiac
defibrillator. The news drove Zoll's shares up by 8% on Nov.
11.
Baxter wraps up Baxa acquisition
Baxter has finalized its takeover of Baxa, a developer of pharmacy
tools and technology used to boost the preparation and delivery of
intravenous drugs. The $380 million buyout will allow Baxter to
expand its nutrition IV device offering.
3 medtech firms land supply deals with hospital
GPOs
Bard Electrophysiology Products, a C.R. Bard division, and Boston
Scientific have entered agreements to supply hospital group
purchasing organization Premier with electrophysiology devices.
Misonix also signed a contract to provide its BoneScalpel bone
cutter and SonaStar surgical aspirator to Cure Surgicals, a
hospital GPO based in India.
Mass. biotech center offers up to $750K in fall
loans
The Massachusetts Life Sciences Center has opened applications for
the fall round of its Accelerator Loan Program, and early-stage
biotech companies are invited to apply via the center's
website through Dec. 30. Loan awards of as much as $750,000
each will be announced in April.
Monitoring device flags cryogen leaks in MRI
machines
Genesis Magnet Services has introduced a compact monitor that
connects to an MRI and sends automatic alerts when it detects
cryogen leaks and other unusual readings from the machine. The
device, called ColdTRAC 2.0, is meant to identify and address
problems before cryogen is completely lost, according to the
Huntley, Ill.-based firm.
Landauer acquires IZI Medical for about $93
million
IZI Medical Products, a portfolio company of Riverside Partners,
has been acquired by Landauer for about $93 million in cash. IZI
Medical specializes in consumable accessories designed for use in
image-guided surgical procedures, radiology and radiation
therapy.
Glooko launches app, cable for diabetes
patients
Glooko has introduced its logbook app to enable diabetes patients
to monitor their blood glucose levels daily, and the MeterSync
cable to allow patients to download information from blood glucose
meters to their iPhones and have the results transmitted to their
health care providers.
GE files first module of 3D breast scanner's PMA
application
GE Healthcare has submitted to the FDA the first module supporting
its premarket approval application for a new add-on that will allow
the company's Senographe Essential technology to offer breast
tomosynthesis. The add-on device is designed to generate 3D images
for breast cancer scanning and diagnosis.
PSI Medical secures funds for HAI-targeting catheter
system
Ben Franklin Technology Partners of Pennsylvania has made
investments in two companies, including PSI Medical Catheter Care,
through its Erie Innovation Fund. PSI Medical is developing a
catheter device that can protect the bloodstream against bacteria
contamination to prevent hospital-acquired infections.
St. Jude's Portico heart valve shows positive trial
results
Patients who received St. Jude Medical's Portico device, a
transcatheter heart valve made of bovine pericardial tissue for the
treatment of severe aortic stenosis, reported no adverse events or
death, according to a 10-patient study conducted in Northern
Ireland. The results were presented at the Transcatheter
Cardiovascular Therapeutics conference in San Francisco.
Patient tracking, diagnostic tools win app
challenge
A mobile application that helps doctors look up a patient's
clinical data automatically during their rounds and a system that
evaluates a medical student's diagnostic ability have been
named the winners of the first app challenge sponsored by the
American Medical Association.
Draft rules on investigational device exemption trials
unveiled
The FDA has unveiled two draft
guidance documents for products seeking investigational device
exemption. The first details new feasibility research approaches to
guide a product's final design better and enable studies to
start sooner, while the second describes the process for approving
clinical trials. The agency also launched an amended standard
operating procedure for obtaining new data from devices undergoing
premarket evaluation.
FDA announces recall of surgical device over patient fall
risk
Reports of patient falls prompted the FDA to issue a
Class I Recall notice for Mizuho OSI's Modular Table
Systems, which situates patients during spinal surgery, orthopedic
trauma and thoracic procedures.
Device allows for incompatible organ
transplants
Swedish firm Glycorex has developed a device called Glycosorb ABO,
which employs a kidney dialysis-like process to make blood ready
for a transplant of an organ from a donor with a different blood
type from the patient. The device can be used for liver, kidney,
lungs, stem cells, skin and heart transplants. An Indian doctor
said initial transplants using the device were successful and that
about 10 patients are now awaiting a similar procedure.
ABIOMED's Impella device boosts survival rate in shock
patient trial
A study presented at the 2011 Transcatheter Cardiovascular
Therapeutics conference found that shock patients who received
ABIOMED's Impella 2.5 before percutaneous coronary intervention
reported a higher rate of survival compared with those who received
the device after PCI. The trial involved 119 patients from 32
clinical sites in the U.S.
Zimmer Holdings acquires ExtraOrtho
ExtraOrtho, an orthopedic device startup based in Memphis, Tenn.,
has been acquired by Zimmer Holdings for undisclosed terms. The
deal includes ExtraOrtho's XtraFix external fixation
device.
BioNano elects Integrated Diagnostics CEO to
board
Dr. Albert Luderer, former president and CEO at BioTrove, has
joined the board of directors at BioNano Genomics, maker of the
nano Analyzer technology platform. Luderer currently serves as
director and CEO at Integrated Diagnostics.
Israeli imaging device firm appoints new
CEO
Maiki Yoeli, former president and CEO of Cimatron, has been named
CEO of Real Imaging. The Lod, Israel-based company is the maker of
Ruth, a 3D imaging system used for early breast cancer
detection.
DRUGS & BIOLOGICS
Hamburg rescinds FDA approval of Avastin for breast
cancer
FDA Commissioner Margaret Hamburg revoked Avastin's approval
for metastatic breast cancer, saying clinical trials showed the
treatment does not significantly benefit patients but exposes them
to serious risks. "Sometimes, despite the hopes of
investigators, patients, industry and even the FDA itself, the
results of rigorous testing can be disappointing," Hamburg
said. Despite the revocation, maker Genentech will pursue a
late-stage trial of Avastin plus chemotherapy agent paclitaxel and
test a biomarker to identify patients most likely to benefit from
Avastin, a spokeswoman said.
FDA authorizes Regeneron's Eylea to treat wet
AMD
Regeneron Pharmaceuticals' Eylea was approved by the FDA for
wet age-related macular degeneration. The injectable treatment,
also called VEGF Trap-Eye or afilbercept, costs about $16,000
annually, Regeneron said. Studies found comparable efficacy between
Eylea and standard therapy Lucentis, made by Genentech.
EUSA's leukemia treatment Erwinaze is approved by
FDA
The FDA approved EUSA Pharma's Erwinaze to treat acute
lymphoblastic leukemia in patients who are allergic to pegaspargase
and asparaginase, chemotherapy agents derived from E. coli.
Erwinaze is given as a thrice-weekly injection into the muscle.
FDA plans to decide on 2 Takeda diabetes drugs by April
25
The FDA rescheduled a deadline for an approval decision on Takeda
Pharmaceutical's alogliptin, a drug candidate for type 2
diabetes, as well as a fixed-dose combination of Actos and
alogliptin. The agency, which was supposed to decide by Jan. 25,
needs three more months to review Takeda's resubmissions.
AstraZeneca gains EU panel recommendation for
vandetanib
A European Medicines Agency committee issued a positive opinion on
AstraZeneca's vandetanib as a treatment for advanced medullary
thyroid cancer. Vandetanib is also undergoing regulatory review in
Switzerland and Canada. The FDA approved the drug as Caprelsa.
Doctors are warned about Boehringer's stroke-prevention
pill
After 256 cases of fatal bleeding, the European Medicines Agency
urged doctors to exercise caution when using Boehringer
Ingelheim's stroke-prevention drug Pradaxa. The agency said the
pill demonstrates unchanged efficacy but needs to be administered
in lower doses in patients older than 75 to adequately manage
bleeding risk.
EU vows to accelerate development, approval of
anti-superbug drugs
The European Commission announced a comprehensive plan to combat
multidrug-resistant bacteria. Officials will take advantage of the
private-public Innovative Medicines Initiative to promote
"unprecedented open sharing of knowledge" among
drugmakers during the pre-competitive stage of research and
development. The commission also promised more flexible legislation
for faster approval of novel antibiotics and to collaborate with
governments for "adequate market and pricing
conditions."
Adcock appeals market withdrawal of painkiller
dextropropoxyphene
Adcock Ingram is challenging a decision by South Africa's
Medicines Control Council to halt sales of dextropropoxyphene, a
painkiller withdrawn in the U.S. and EU. Adcock said its
dextropropoxyphene-based products differ from those made by Western
drugmakers. The FDA sought market withdrawal of dextropropoxyphene
last year, concluding that it "can cause serious toxicity to
the heart."
Pfizer gains EU OK of neurodegenerative-disease drug
Vyndaqel
EU regulators approved Vyndaqel, Pfizer's drug for a rare
neurodegenerative disorder called transthyretin familial amyloid
polyneuropathy. The drugmaker said it will launch the treatment
early next year. In April, the FDA deemed Pfizer's Vyndaqel
application incomplete.
China escalates crackdown on fake
medicines
In a second major crackdown this month, Chinese authorities
confiscated $315 million in counterfeit drugs, arrested 1,770
people and raided more than 1,400 dens. Most of the products
reportedly were sold on the Internet or to illegal clinics and
pharmacies.
FDA advisers support broader use of Pfizer's vaccine
Prevnar 13
Prevnar 13, a vaccine by Pfizer, safely and effectively protects
people age 50 and older against pneumococcal disease, said an FDA
advisory committee. Agency staff previously issued positive
feedback on the expanded use. The FDA is scheduled Jan. 2 to hand
down an approval decision.
France will stop paying for Sanofi's heart drug
Multaq
The French health system will no longer cover Multaq, Sanofi's
treatment for nonpermanent atrial fibrillation, beginning Dec. 1.
In September, EU officials recommended limited prescription of
Multaq. The FDA is monitoring the drug for cardiovascular and liver
risks.
Senate plan would expedite FDA approval for some
drugs
A Senate proposal would allow drug manufacturers to bypass some
clinical-trial requirements and get faster FDA approval of
medications for conditions that do not have approved treatments.
The plan, by Sen. Kay Hagan, D-N.C., and the Biotechnology Industry
Organization, is based on the FDA's accelerated-approval
program and would let the agency approve drugs based on Phase II
trial results.
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