CONTENTS:
MEDICAL DEVICES
Policy analysis group joins push for
device tax repeal
The National Center for Policy Analysis has joined medtech
companies and industry advocates in calling for a repeal of the
2.3% excise tax set to take effect next year. "The tax will
boost the nation's medical bills while causing the loss of
high-paying manufacturing jobs, and the potential tax revenue is
relatively small compared to the costs," the group said in a
release.
Survey: Most small medtech firms plan
price hikes to offset tax
An Emergo Group survey of 180 industry executives, most from firms
with fewer than 50 employees, finds more than 50% intend to raise
product prices to offset the 2.3% medical device tax, while less
than 17% plan to cut jobs. Reducing production costs and limiting
research and development investments also were cited as ways to
deal with the tax.
MacMillan steps down as CEO of
Stryker
Stephen MacMillan has resigned his position as president, CEO and
chairman of Stryker for family reasons. The orthopedic device
company has appointed Chief Financial Officer Curt Hartman as
interim CEO and William Parfet as nonexecutive chairman.
MassDevice Podcast: Soteira CEO Larry
Jasinski
Soteira CEO Larry Jasinski talks to MassDevice about overcoming the
odds with spinal fusion devices and managing a 510(k) win even
after the FDA switched things up mid-stream. Listen to the podcast.
Smith & Nephew's hip implant shows
promising trial results
A U.K. study showed that Smith & Nephew's BIRMINGHAM HIP
Resurfacing System had a 99% satisfaction rate among the 400
patients who were treated with the device after 10 years. The study
also found that the implant demonstrated a 95.9% survival rate, far
surpassing the 10-year survival threshold of 90% established by
NICE.
SencorpWhite releases RFID-enabled medical
storage system
SencorpWhite has equipped its MicroVert storage device used to
secure pharmaceuticals, medical devices and other high-value
supplies with radio frequency identification technology. The
RFID-enabled device, which is being tested by several health care
firms, allows users to better manage inventories and monitor which
items are removed or returned automatically.
Hypothermia device maker raises $10.2
million in funding round
A round of Series B financing has brought in $10.2 million for
Velomedix. The Menlo Park, Calif.-based company will use the money
to help market its hypothermia therapy device in Europe and secure
FDA approval to conduct a U.S. clinical trial.
Wound Management Technologies sells Secure
eHealth unit
Wound Management Technologies has divested its Secure eHealth
division to two undisclosed buyers. The move will allow Wound
Management Technologies to concentrate on its flagship product
CellerateRx, which already has been cleared by the FDA for treating
all types of wounds, except third-degree burns.
Skin cancer imaging device from MedX
arrives in Canada
MedX Health said it has received the go-ahead from Health Canada to
market its MoleMate imaging system in that country. The device,
which is already commercially available in the U.S., U.K., Europe
and Australia, is used for noninvasive skin cancer detection.
Mass. device firm seeks to raise $10.5
million in funding round
NeuroMetrix hopes to obtain $10.5 million through a public offering
of warrants and company stock. The Waltham, Mass.-based company
will use the money to market its NC-stat DPNCheck nerve conduction
assay as well as develop its Sensus pain therapy device for
managing diabetic neuropathy.
Checkpoint Surgical gets $1.7M boost to
expand U.S. sales team
Checkpoint Surgical will use the $1.7 million it obtained from a
series B financing round to expand its sales force in the U.S. The
Cleveland-based firm, which already has FDA clearance for its
Checkpoint Stimulator/Locator used to stimulate motor nerves during
surgery, expects to obtain CE mark approval for the product in the
next few months.
Illumina turns down Roche's $5.7B
bid
Illumina's board rejected Roche's $5.7 billion takeover bid
and advised shareholders not to tender their shares to Roche.
Illumina said the bid undervalued the gene-sequencing firm. Roche
called the offer "full and fair" and said it was ready to
enter discussions with Illumina.
Navidea to open office in
Massachusetts
Ohio-based Navidea Biopharmaceuticals plans to set up an office in
Andover, Mass., to house the company's business-development and
marketing staff. The new office initially will focus on marketing
Lymphoseek, an imaging agent used to diagnose lymph node cancer
that the company intends to release later this year.
New ultrasound devices from Analogic
feature Quantum technology
Analogic has introduced a trio of BK Medical ultrasound systems
that integrate Quantum technology to enhance image quality. The
Flex Focus 500 device is intended for urology and general imaging
applications. The UltraView 800 and Flex Focus 800 systems can be
used for surgery, in addition to general and urology imaging.
Mich. hospital adopts Toshiba's
ultrasound device
The Aplio 500 ultrasound device from Toshiba America Medical
Systems has been deployed at Spectrum Health in Grand Rapids, Mich.
Among the device's features are advanced visualization
functions, Fly Thru technology to detect masses and lesions as well
as aid in interventional planning, and Smart Fusion to help
pinpoint lesions and assist in ultrasound-guided biopsies.
2 medical device makers receive FDA
warning letters
The FDA has issued a warning letter to PhotoMedex citing quality
violations and misbranding tied to some of the company's wound
dressing products. Merit Medical also received a warning letter for
failing to notify the FDA about a change in the manufacturing of
its diagnostic and catheter guidewires. The FDA asked the companies
to respond within 15 business days.
Ocular wins FDA approval for eye sealant
trial
The FDA has granted Ocular Therapeutix investigational device
exemption to conduct a clinical study of its ReSure Sealant, a
synthetic hydrogel used to seal corneal incisions during eye
surgeries. The trial, which will enroll as many as 24 clinical
sites, will test whether the device is safe and effective in
blocking fluid egress after cataract and intraocular lens placement
procedures.
India biotech needs regulation, seed money
to grow, Biocon leader says
Biocon chairman Kiran Mazumdar Shaw called on the Indian government
to move quickly to facilitate the growth of the biotech industry. A
regulatory framework and access to seed money, perhaps through a
stock exchange, are needed for startups to flourish, Shaw said. The
government task force that will create a regulatory framework has
been constituted, an official said.
Repealing device tax is a down payment on
tax reform, AdvaMed says
The 2.3% medical device levy is more of a tax issue than a health
reform issue, and repealing it "is the first down payment on
much-needed tax reform," AdvaMed President and CEO Stephen Ubl
said in a conference call Tuesday. On the same day, the group
issued a set of tax reform principles that include creating a level
playing field for global medtech companies and offering incentives
to encourage manufacturers to retain productions and jobs in the
U.S.
Mass. biotech firm hopes to raise $86.2
million in IPO
Radius Health has filed for an initial public offering in an effort
to secure as much as $86.2 million. The Cambridge, Mass.-based
company is developing new therapies for women's health
conditions, including its lead product candidate, BA058, for
treating osteoporosis.
OrthoCor nears target of $3 million in
angel investment round
OrthoCor Medical expects to close in May its round of angel
financing targeted at $3 million, said John Dinusson, the
company's CEO. The orthopedics device startup, which has
developed the Active Knee System, will use the money to employ two
or more salespeople.
Former EKR Therapeutics exec joins
Prometheus' C-suite team
Specialty drug and diagnostics firm Prometheus Laboratories has
selected Anthony Yost, a former chief commercial officer at EKR
Therapeutics, to serve as senior vice president and CCO.
Technology could shorten medical device
development, testing
A pair of University of Minnesota professors have created a 3D
visualization system that they say can reduce research and
development time and costs by allowing researchers to develop and
test devices without making a prototype. The technology works by
forming images that show how a device functions based on data, such
as blood flow or tissue information, imported into the system.
Wright's ankle device borrows from
knee replacement system
Wright Medical has adapted a knee replacement system to create a
device that can help doctors size and position ankle implants
during surgery. Called Prophecy Inbone Pre-Operative Navigation
Alignment Guide, the device is used in conjunction with the
company's Inbone Total Ankle Replacement System to treat severe
pain in ankle arthritis patients.
Case Medical gets FDA nod for
sterilization devices
The FDA has granted Case Medical 510(k) clearance for its MediTray
products and SteriTite container system. The devices can now be
used in the flexible, lumen and nonlumen cycles of the AMSCO V-PRO
1 Plus and V-PRO maX sterilizers.
Diagnostic Imaging Northwest adopts
GE's MRI system
The GE Optima 1.5 Tesla MRI scanner has been deployed at Diagnostic
Imaging Northwest. The device is designed for use in patients
requiring MRI scans of the hand, wrist, elbow and other
extremities.
Calif. private equity firm to acquire DMS
Health Technologies
Platinum Equity, a private equity firm based in Los Angeles, has
unveiled plans to acquire DMS Health Technologies, a unit of Otter
Tail that sells and services medical imaging devices. Terms of the
deal were not made public.
Budget office delays uniform medical device
coding system
A proposal for a standardized coding system to track medical
devices has stalled in the Office of Management and Budget, where
it was submitted last July by the FDA. Congress voted in 2007 to
direct the FDA to create the medical device coding system using
simple scanning technology, and the FDA has been coordinating with
device regulators in other countries to develop a harmonized
system. Until the OMB releases the proposed rule, the FDA cannot
move forward.
MindChild files 510(k) application for
Meridian device
MindChild Medical has submitted to the FDA an application seeking
510(k) clearance for Meridian, a noninvasive heart monitor used to
ensure safe deliveries by tracking the health of unborn babies. The
North Andover, Mass.-based startup anticipates receiving FDA
feedback in the second quarter and aims to start selling the device
after obtaining approval.
Boston Scientific to allot $1 billion for
buybacks, acquisitions
Boston Scientific expects to generate free cash flow of more than
$1 billion this year, which will be used to make strategic
acquisitions and repurchase company shares, Chief Financial Officer
Jeff Capello said in a conference call with industry analysts.
FDA clears Eden
Spine's vertebral body replacement device
The FDA has granted Eden Spine 510(k) clearance for GIZA, a device
used to replace and fuse a vertebral body that is unstable, damaged
or collapsed due to fracture or tumor.
75 lawmakers call for a vote on device
tax repeal
A group of 75 legislators on Monday sent a letter to the House GOP
leadership calling for a floor vote on the Protect Medical
Innovation Act of 2011 aimed at repealing the 2.3% medical device
excise tax. "We must act now to repeal this onerous and
irresponsible tax. With so many jobs hanging in the balance, this
should not be a political issue," the legislators wrote.
FDA approves cardiac ablation catheters,
generator from St. Jude
The FDA has granted St. Jude Medical premarket approval for its
Safire Blu Duo and Therapy Cool Path Duo catheters used to treat
patients suffering from typical trial flutter, a form of heart
arrhythmia. The device company also gained FDA approval for an
advanced version of its cardiac ablation generator.
CMS issues reimbursement guidelines for
heart implant procedures
The CMS has proposed reimbursement guidelines for using transcatheter aortic
valve implantation to treat symptomatic aortic stenosis, which are
up for comments through March 3 and include five coverage
requirements. Edwards Lifesciences lauded the proposal, which is a
boon for its Sapien heart valve.
Digital push will drive growth for
China's X-ray market, report says
An InMedica report predicts that the market for X-ray devices in
China will reach $1.3 billion by 2016. Growth will be driven by
Chinese hospitals and rural clinics upgrading their existing
analogue devices to digital X-ray systems as a result of a
government push for health care reform in that country.
Apollo Endosurgery closes $47.6 million
financing round
Austin-based Apollo Endosurgery has raised $47.6 million in its
latest round of financing. Company officials said the proceeds will
be used to support the commercial release of Apollo's flexible
surgical devices, including the second-generation OverStitch
Endoscopic Suturing System.
Funding round brings in $11.8M for tendon
injury treatment firm
Tenex Health, which has developed the Focused Aspiration of Soft
Tissue procedure to repair injured tendons and soft tissue, has
secured $11.8 million in a funding round. The company also has FDA
clearance for a portable device used in combination with the FAST
treatment to support the removal of soft tissue in the shoulder,
elbow, knee, ankle and foot.
Mako Surgical appoints new VP of
regulatory affairs
Lawrence Gibbons has been named vice president of regulatory
affairs at Mako Surgical, replacing James Keller, who stepped down
on Friday. Gibbons most recently worked with Fisher & Paykel
Healthcare and has held positions at various device firms,
including Baxter and St. Jude Medical.
Researchers develop biological dressing
for wounds
Researchers at the Massachusetts Institute of Technology have
developed a wound dressing that can stop bleeding quickly. The
sponges are coated with the blood-clotting protein thrombin and
tannic acid, a black tea component with antibacterial capacity. The
sponge could be useful in operating rooms and battlefields,
researchers said. The findings were published in the journal
Advanced Materials.
Prostate device from Medi-tate obtains EU
approval
Medi-tate has earned CE mark approval to market its mechanical
benign prostate hyperplasia device in Europe. The device is used to
reshape the urethra less invasively.
Pittsburgh life sciences fund gets more
than $8 million boost
The Pittsburgh Life Sciences Greenhouse's Accelerator Fund
focused on the life sciences sector has obtained $8.1 million in a
financing round. The fund is targeted at medical device,
therapeutic and diagnostic firms in the Pittsburgh area that have
previously completed programs and gained seed grants through
Greenhouse, the fund's managing director said.
Atlas Venture partner tapped to join
PerkinElmer's board
PerkinElmer has unveiled plans to name Peter Barrett to the
company's board, replacing a unnamed current member who is
nearing retirement age. Barrett is a partner at investment group
Atlas Venture and has held positions in various life sciences
companies, including Celera Genomics.
EU regulators OK Boston Scientific's
Infinion 16 lead
Boston Scientific has earned CE mark approval for its Infinion 16
percutaneous lead, which is used in conjunction with the
company's Precision Plus spinal cord stimulator device for
managing chronic pain. A patient at a hospital in Sweden was the
first in Europe to be implanted with the SCS device using the
Infinion 16 lead.
Doctors use fluorescent imaging to detect,
remove kidney tumors
Urologic surgeons in Chapel Hill, N.C., are using a fluorescent
imaging method to precisely pinpoint cancerous tumors in the kidney
to remove them. Doctors said the method has been used successfully
on three patients.
Feds issue proposed rules on device tax
definitions, exemptions
The Internal Revenue Service has issued guidelines on who must pay a 2.3% tax set to
take effect in January 2013, creating certain exemptions for
early-stage device firms and addressing double-tax concerns among
importers and manufacturers. The news didn't sit well with
industry supporters, and Rep. Erik Paulsen, R-Minn., called for an
urgent repeal of the "job-crushing tax."
Barco aims to gain foothold in
point-of-care market with JAOtech buy
Belgian medical visualization firm Barco has acquired JAOtech, a
U.K.-based maker of clinical monitors and other devices. The deal
was valued at less than a year's worth of sales for JAOtech,
which generated about $25 million in 2011, and is expected to help
Barco make inroads in the growing point-of-care space.
Testing is under way for enlarged prostate
therapy device
St. Paul, Minn.-based NxThera is conducting a clinical study of a
device that is intended as an alternative treatment for benign
prostatic hyperplasia when surgery or drug therapy has failed. The
technology, called Rezum, uses vapor or steam to provide targeted
treatment to the enlarged tissue of the prostate gland, while
sparing surrounding healthy tissue.
FDA user fee agreement gets mixed reaction
from device-makers
The tentative deal requiring medtech firms to pay $595 million over
five years in exchange for timely FDA reviews has gained support
from companies such as Boston Scientific and Medtronic, but Cook
Medical President Kem Hawkins isn't keen on the fee increase.
"There is a long history of higher fees without a commensurate
improvement in the time it takes to receive an FDA approval for a
device that has been proven to save lives or reduce
suffering," he said.
Consolidation effort drives up Q4 profit
margin for Smith & Nephew
Smith & Nephew posted a 25.2% operating profit margin in the
fourth quarter of 2011, beating the 24% forecast it made in
November and up substantially from the Q3 trading margin of 19.8%.
CEO Olivier Bohuon attributes the higher Q4 margins in large part
to the firm's cost management efforts, including consolidating
its endoscopy and orthopedics units.
Boston Scientific launches Promus Element
Plus stent in Europe
A patient in Milan, Italy, was the first in Europe to receive
Boston Scientific's Promus Element Plus device, a drug-eluting
coronary stent that the company says features a dual-layer balloon
design, better catheter delivery system and improved visibility.
The device earned approval in Europe and the U.S. last year.
Experimental blood test finds circulating
tumor cells
Researchers at the Scripps Research Institute in La Jolla, Calif.,
have developed a blood test that can detect circulating tumor cells
-- cells that separate from solid tumors and can cause metastasis.
The imaging test uses a chemical to illuminate CTCs in blood
samples.
DRUGS & BIOLOGICS
FDA releases draft guidance for
biosimilars
The FDA issued draft guidance for the approval of biosimilar
drugs. The proposal would require companies to submit data from
laboratory and clinical studies showing that biosimilars are
"highly similar" to the original drugs. Dr. Rachel
Sherman, the FDA's associate director for medical policy,
called the process "an abbreviated pathway that will depend on
existing data."
User-fee bill seeks to address backlog of
generic applications
A bipartisan group of House lawmakers proposed legislation that
would provide the FDA with $1.5 billion during the next five years
to eliminate a backlog of generic-drug applications. The bill is
based on a user-fee program negotiated between drugmakers and the
agency.
FDA panel doesn't support expanded use
of blood drug Dacogen
Eisai and Astex Pharmaceuticals failed to gain an FDA panel's
support for Dacogen to be approved to treat acute myeloid leukemia
in older patients. The FDA is set to decide on the indication March
6.
Mylan agrees to delay launch of generic
Doryx
The FDA approved Mylan's delayed-release doxycycline hyalite,
the generic equivalent of Warner Chilcott's anti-microbial drug
Doryx. Mylan agreed not to market its product until a federal court
decides on a patent-infringement case.
AstraZeneca loses bid to protect 2 Crestor
patents
A U.S. appeals court upheld the dismissal of AstraZeneca's
lawsuits against companies that sought regulatory approval of
generic versions of cholesterol drug Crestor. The decision covers
method-of-use patents expiring in 2018 and 2021.
Cubist aims to block Hospira's generic
of antibiotic Cubicin
Cubist Pharmaceuticals intends to sue Hospira for allegedly
infringing Cubist's patents for antibiotic Cubicin, or
daptomycin. Cubist said it was notified of Hospira's
application seeking FDA approval to sell a generic version.
FDA and Merck warn against using Victrelis
with some HIV drugs
The FDA warned that combining Merck & Co.'s hepatitis C
medicine Victrelis with ritonavir-boosted HIV drugs can potentially
reduce the effectiveness of both regimens. Merck said Victrelis
lowered blood concentration of antivirals Prezista, Kaletra and
Reyataz by 43% to 59% during a study. Drug-interaction data will be
added to Victrelis' label, according to the FDA and Merck.
Group challenges government's Plan B
restriction
The Center for Reproductive Rights requested that a federal judge
reopen a lawsuit challenging the age restriction on emergency
contraceptive Plan B. "We are asking the court to recognize
that the FDA has failed to meet its obligation to the public and
make decisions based on science, rather than politics," said
Suzanne Novak, the group's senior staff attorney. The group
also seeks to add HHS Secretary Kathleen Sebelius -- who overruled
the FDA on the matter -- as a defendant.
FDA is advised to reject wider use of
Amgen's Xgeva
An expert panel urged the FDA not to approve Amgen's Xgeva for
delaying the spread of prostate cancer to the bone, saying the
drug's benefits do not outweigh the risk of developing
osteonecrosis of the jaw. The FDA will issue a final ruling by
April 26.
J&J and Watson units end patent rift
over Ortho Tri-Cyclen Lo
Watson Laboratories and Janssen Pharmaceuticals, divisions of
Watson Pharmaceuticals and Johnson & Johnson, respectively,
settled a patent lawsuit involving contraceptive Ortho Tri-Cyclen
Lo. The settlement allows Watson to market and distribute an
authorized generic version at the end of 2015.
PPIs might raise C. difficile risk, FDA
warns
The FDA warned that proton pump inhibitors might increase the risk
of Clostridium difficile infection. Many cases of the complication
occur in patients with comorbidities or who are taking antibiotics,
but PPIs cannot be excluded as a possible contributor. Physicians
are advised to prescribe the lowest dose for the shortest duration
possible.
Smart regulation is the path to
innovation, FDA says
Lack of innovation and slow economic growth are often blamed on
regulation, but regulation done right is a pathway to achieving
innovation, writes FDA Commissioner Margaret Hamburg. "Smart,
science-based regulation instills consumer confidence in products
and treatments," she writes, adding that regulation can also
aid businesses, lessen litigation threats, curb recalls and foster
industry excellence. A strong, robust FDA will advance regulatory
science, review products quickly and remain flexible, she
writes.
Salix's HIV-related drug gets
priority-review status from FDA
Salix Pharmaceuticals obtained FDA priority-review designation for
crofelemer, a drug aimed at treating HIV-related diarrhea. An FDA
decision is expected by June 5.
5 drugmakers settle overpricing claims in
Louisiana
Boehringer Ingelheim, GlaxoSmithKline, Actavis, Schering-Plough and
Dey will pay Louisiana $25.2 million to end allegations that they
overcharged the state's Medicaid program, according to Attorney
General James Caldwell.
Judge sides with FDA on approving generic
of Sanofi's Lovenox
A federal judge ruled that the FDA acted within its authority when
it approved Sandoz's generic version of Sanofi's
anti-clotting drug Lovenox. In August 2010, another judge refused
to grant Sanofi a preliminary injunction to block the Sandoz
product.
Shire's Vyvanse capsule approved for
adult ADHD
The FDA authorized a capsule form of Shire's Vyvanse as
maintenance therapy for adults with attention-deficit/hyperactivity
disorder. The approval was supported by a clinical finding that
more Vyvanse-treated patients maintained symptom control compared
with the placebo group.
FDA accelerates review of Genentech breast
cancer drug
The FDA granted priority-review status for Genentech's
pertuzumab for treatment of breast cancer. The agency expects to
finish evaluating the drug by June 8.
Court order halts DEA action against 2 CVS
pharmacies
CVS Caremark won a temporary restraining order that allows
continued dispensing of controlled drugs at two pharmacies in
Sanford, Fla. The Drug Enforcement Agency raided the CVS pharmacies
Saturday and on Friday attempted to halt the sale of controlled
drugs through Cardinal Health's Lakeland distribution
facility.
Wash. bill for medication disposal faces
industry opposition
Washington legislators are seeking to require drug manufacturers to
create and finance a statewide program on safe disposal of unused
medicines. The Pharmaceutical Research and Manufacturers of America
opposes the measure, saying the drive would be difficult to justify
when there's an easier way to get rid of excess
pharmaceuticals.
FDA voices doubt about Qutenza's
efficacy for HIV-related pain
FDA staff voiced concern about mixed trial results for
NeurogesX's drug patch Qutenza as a treatment for neuropathic
pain associated with HIV. The agency plans to ask advisers Thursday
whether clinical data on Qutenza provide substantial evidence of
therapeutic benefit.
NIH to boost Alzheimer's research
funding; Obama to request more
The NIH will budget an additional $50 million for dementia
research, and President Barack Obama will ask Congress to allocate
$80 million more for Alzheimer's research in 2013. The
additional funding is part of the administration's National
Alzheimer's Plan, one goal of which is to develop effective
treatments for the disease by 2025. "This is a positive step
forward. It's going to take additional steps on the journey
that's going to get us to the end of this,"
Alzheimer's Association President Harry Johns said.
FDA denies ViroPharma's plan to
increase production of Cinryze
ViroPharma received a complete-response letter from the FDA about
an expansion plan for making hereditary angioedema drug Cinryze.
The agency made three comments regarding the validation of cleaning
procedures for industrial-scale production. ViroPharma plans to
immediately address the FDA's concerns.
DEA raids pharmacies, takes action against
Cardinal Health
The Drug Enforcement Administration is cracking down on Cardinal
Health and has raided two CVS pharmacies in Florida over what it
says are unusually high shipments of painkillers and other
controlled drugs. The agency tried to block shipments of pain pills
such as oxycodone and hydrocodone from a Lakeland, Fla.,
distribution center, but the judge halted the suspension.
FDA solicits feedback on distracting
elements of drug ads
The FDA reopened the comment period on its proposed rule for
direct-to-consumer marketing of prescription drugs. The decision
follows release of an agency-sponsored study that assessed the
impact of distracting images or statements in ads on consumers'
understanding of information about drug risks and benefits.
Xgeva's clinical benefit for wider use
seems unclear, FDA says
A preliminary FDA review questions whether Amgen's Xgeva should
be approved for expanded use to prevent or delay the spread of
prostate cancer to the bone. The FDA said that although Xgeva
proved effective in extending metastasis-free survival, it is
unclear whether this clinical finding is "meaningful"
given that Xgeva did not demonstrate significant difference versus
placebo in terms of overall survival.
FDA OKs safety-trial protocol for
Orexigen's obesity drug Contrave
The FDA and Orexigen Therapeutics agreed on a special protocol
assessment for an additional study of obesity drug candidate
Contrave. Orexigen designed the study to prove that Contrave's
cardiovascular risk profile is acceptable.
Merck will submit insomnia drug suvorexant
to FDA this year
Merck & Co. plans to seek FDA approval of suvorexant this year
after completing two late-stage tests that compared the insomnia
drug with a placebo. The firm also expects regulatory filings for
four other drug candidates by 2013.
FDA accepts Ziopharm's request to test
oral palifosfamide
An investigational new-drug application for Ziopharm Oncology's
oral version of cancer drug palifosfamide, or Zymafos, was accepted
by the FDA. Ziopharm is testing the drug for IV administration in
patients with advanced soft-tissue sarcoma and small-cell lung
cancer.
Cadence pulls one batch of IV
acetaminophen
Cadence Pharmaceuticals voluntarily recalled one lot of pain
medicine Ofirmev as a precautionary measure after an unidentified
particulate matter was found in a vial during routine
drug-stability testing. The product is an IV formulation of
acetaminophen. No adverse reactions have been reported, Cadence
said.
54 COPD drugs are in the pipeline,
organization reports
U.S. drugmakers are working on 54 drugs to treat chronic
obstructive pulmonary disease, according to the Pharmaceutical
Research and Manufacturers of America. Drugs under development
include one based on adult stem cells aimed at a COPD-related blood
protein and medicines that target inflammation associated with the
condition. COPD costs the U.S. $29.5 billion annually in direct
health care costs, the group says.
Talon's leukemia drug Marqibo will
face advisory panel review
A committee of FDA advisers will meet on March 21 to assess
Marqibo, Talon Therapeutics' drug candidate for Philadelphia
chromosome-negative acute lymphoblastic leukemia. Marqibo is a
capsule form of approved cancer treatment vincristine.
Health Canada allows study of
RedHill's chemo nausea drug
RedHill Biopharma secured approval from Health Canada to start a
late-stage clinical trial assessing the pharmacological equivalence
of controlled-release drug RHB-102 to GlaxoSmithKline's Zofran
for prevention of nausea and vomiting in cancer patients receiving
chemotherapy. The trial will start this quarter.
FDA expands access to Bayer's
investigational prostate cancer drug
The FDA approved an expanded-access program for Bayer
HealthCare's radium-223 chloride, which is being tested for
bone metastasis in men with castration-resistant prostate cancer.
The program makes radium-223 chloride available to patients who are
not eligible to participate in a clinical trial.
DelMar cancer compound obtains FDA's
orphan-drug status
DelMar Pharma secured orphan-drug designation from the FDA for
cancer drug candidate VAL-083. Data from clinical and preclinical
tests suggest that VAL-083 works against glioblastoma multiforme
and other kinds of tumor.
FDA lifts clinical hold on Idenix drug for
hepatitis C
The FDA removed a partial clinical hold on Idenix
Pharmaceuticals' nucleotide polymerase inhibitor IDX184. The
oral treatment, which is undergoing a midstage trial, has
demonstrated activity against genotype 1 hepatitis C without
causing serious adverse effects, the company reported.
Janssen Biotech fails to gain U.K.
agency's support for Zytiga
The U.K. National Institute for Health and Clinical Excellence
declined to endorse Janssen Biotech's prostate cancer medicine
Zytiga for National Health Service use. Zytiga's benefit does
not justify its high cost despite the drugmaker's proposed
discount, the agency said in draft guidance.
FOOD & DIETARY SUPPLEMENTS
USDA delays ban on additional E. coli
strains for 90 days
The USDA's Food Safety and Inspection Service postponed
implementation of a policy banning six more E. coli strains in beef
from March 5 to June 4. The extension will give processors more
time to validate their sampling methods for detecting the
additional pathogens, the agency said.
Consumer group urges standard for
shellfish industry
The Center for Science in the Public Interest renewed its call for
the FDA to establish a standard aimed at preventing illnesses from
raw or undercooked oysters and other shellfish contaminated with
Vibrio vulnificus. "In the nine years since FDA denied our
original petition, 262 people have suffered serious illnesses
including 121 people who died -- all of which could have been
averted," the group said.
Survey: Food safety is key concern for 41%
of manufacturers
A survey from Underwriters Laboratories examined consumer and
manufacturer attitudes toward food safety in China, India, Germany
and the U.S. Among the findings: 41% of manufacturers said safety
was a key concern, and 69% of customers said the country of origin
was more important than ingredients. "Food manufacturers
understand that product safety is imperative to the success of
their business, but a significant opportunity remains to better
demonstrate and communicate their commitment to boost consumer
confidence," said Hank Lambert, UL's general manager of
global food and water.
Biotech fish should undergo rigorous FDA
review, groups say
The Center for Food Safety, the Consumers Union and the Food &
Water Watch submitted a petition asking the FDA to designate
AquaBounty's genetically modified salmon a food additive, which
would require a more rigorous evaluation. Biotech foods are
currently evaluated under the same process as new veterinary drugs.
The FDA "must make a closer inquiry into the safety of its
consumption, including, but not limited to, subjecting it to
extensive premarket testing," the groups said.
Budget cuts could have long-term
consequence
Across-the-board spending reduction might generate short-term
savings but it could impair national food safety protection in the
long run, according to Dr. Steve Suppan, a policy analyst with the
Institute for Agriculture and Trade Policy. "It should not
take a spike in death or illness from foodborne disease to shock us
into recognition that food safety is not cheap, nor can food safety
be self-regulated among competing companies," Suppan
writes.
Congress to consider bill that would ban
negative ads on food, drink
Ad campaigns that criticize legal food and drinks as unhealthy
would not be allowed to use federal stimulus funds under a bill
proposed by Rep. Scott DesJarlais, R-Tenn. "I don't think
it's the federal government's (role) to try and regulate
people's habits on products that were deemed safe by the
FDA," he said. "The government is reaching too far into
our lives in trying to regulate personal habits."
Listeria threat spurs recall of 1M cooked
eggs
Michael Foods recalled about 15,000 buckets of hard-cooked eggs in
34 states over concern that they might be contaminated with
listeria. A company spokeswoman said the eggs were sold under six
brands for institutional use. No illnesses have been reported, the
FDA said.
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End date: 10/01/2011
