DRUGS & BIOLOGICS
Global group toughens code to stop
corruption in pharma sector
The International Federation of Pharmaceutical Manufacturers and
Associations adopted a more stringent code of practice as bribery
and corruption increase, particularly in less-regulated markets.
The code covers drugmakers' dealings with medical institutions,
health care professionals and patient groups. It also clarifies the
distinction between promotional aids and gifts.
FDA OKs Aptalis' pancreatic enzyme
drugs Ultresa and Viokase
The FDA approved Viokase and Ultresa, pancrelipase-based enzyme
therapies by Aptalis Pharma. Ultresa is indicated for cystic
fibrosis, while Viokase is combined with a proton pump inhibitor to
aid digestion in adults with pancreatitis or who underwent surgery
to remove the pancreas.
EU ends antitrust scrutiny of
Nycomed-AstraZeneca deal for Nexium
The European Commission ended investigation of a patent settlement
between AstraZeneca and Takeda Pharmaceutical unit Nycomed
concerning ulcer medicine Nexium. "Our investigation did not
enable us to conclude that AstraZeneca and Nycomed had infringed EU
antitrust rules," commission spokesman Antoine Colombani
said.
FDA postpones decision on anti-clotting
drug Eliquis until June 28
The FDA extended by three months its review of Pfizer and
Bristol-Myers Squibb's Eliquis for atrial fibrillation, a
condition that puts patients at risk of blood clots. The agency
needs to review additional data submitted by the drugmakers.
Columbia reduces workforce after
regulatory setback
Columbia Laboratories expects to save about $1.5 million annually
after cutting 10 jobs, or 42% of its workforce. The firm, which is
exploring strategic options, failed to secure FDA approval of
Prochieve, a hormone gel developed with Watson Pharmaceuticals to
prevent preterm delivery.
Judge: DEA can halt Cardinal's
distribution of controlled drugs
U.S. District Judge Reggie Walton backed the Drug Enforcement
Administration's decision to suspend the license of Cardinal
Health's Lakeland, Fla., distribution center to ship
potentially addictive medicines. "I think DEA is correct that
companies have an obligation to police themselves ... and to be
proactive in assessing whether diversion [of controlled substances]
is taking place," Walton said. Cardinal plans to appeal.
FDA cites violations at APP's N.Y.
plant
The FDA said in a warning letter that APP Pharmaceuticals did not
adequately address infestation and off-specification results for
heparin ingredients at a manufacturing facility in Grand Island,
N.Y. Other problems cited include APP's manufacturing of
unapproved drugs and failure to manage complaints.
MedImmune's vaccine FluMist
Quadrivalent receives FDA approval
The FDA approved FluMist Quadrivalent, a vaccine from MedImmune
that protects against two strains of influenza A and two of
influenza B. The nasal spray is intended for people ages 2 to
49.
Pfizer withdraws application for wider use
of Pristiq
Pfizer withdrew an FDA application to promote antidepressant
Pristiq for menopausal vasomotor symptoms, according to a
Securities and Exchange Commission filing. In September, the agency
issued a complete-response letter rejecting the expanded use.
Hi-Tech gets FDA OK to sell generic
Keppra
The FDA authorized Hi-Tech Pharmacal's oral solution of
levetiracetam, a generic version of UCB Pharma's epilepsy drug
Keppra. Hi-Tech will market its product in the dose of 100
milligrams per milliliter.
FDA approves Sun's generic of
antipsychotic Zyprexa Zydis
Sun Pharmaceutical Industries obtained FDA approval to produce and
market an orally disintegrating tablet of olanzapine in multiple
strengths. The antipsychotic is a generic version of Eli Lilly and
Co.'s Zyprexa Zydis.
FDA considers broadening eligibility for
Rx-to-OTC switch
The FDA will convene a public meeting March 22 and 23 to explore
allowing over-the-counter sales of certain prescription drugs.
Conditions of eligibility could include innovative technology and
pharmacist intervention to guarantee safe use, the FDA said.
FDA strengthens warning labels of
cholesterol-lowering statins
The FDA updated prescribing information on labels of
cholesterol-lowering statins, alerting about risks of muscle pain,
diabetes and memory loss. The change was based on medical
literature and adverse-event reports. "The value of statins in
preventing heart disease has been clearly established," said
FDA official Amy Egan. "Their benefit is indisputable, but
they need to be taken with care and knowledge of their side
effects."
Merck gets warning about postmarket
requirement for Januvia
The FDA sent Merck & Co. a warning letter for failing to
conduct a three-month study in rodents to further assess acute
pancreatitis risk associated with Januvia, an approved diabetes
treatment. Merck was supposed to meet the postmarket requirement by
June 15. The drugmaker responded by saying it will submit a final
protocol for the safety study within 30 days and begin testing in
six months.
Biogen's injectable pen for Avonex
receives FDA approval
The FDA approved Biogen Idec's user-friendly injectable pen for
delivering Avonex, a multiple sclerosis drug. Biogen also obtained
approval for a dosing schedule intended to relieve flu-like
symptoms normally associated with Avonex.
FDA: Children with rare diseases benefit
from Orphan Drug Act
More than three dozen orphan drugs for rare diseases affecting
children and teens were approved between 2000 and 2009, FDA
officials reported in the journal Pediatrics. The 10-year study
found that disorders involving the hormonal and metabolic systems
had the largest share of approvals, at 39%. The findings suggest
the Orphan Drug Act is working, officials said.
FDA gives orphan-drug status to
Ultragenyx's Sly syndrome drug
The FDA granted Ultragenyx Pharmaceutical orphan-drug status for
UX003, a therapeutic compound for Sly syndrome. The agency
previously gave the designation to UX001, Ultragenyx's lead
candidate for hereditary inclusion body myopathy.
FDA rejects vaginal gel Prochieve for
premature-birth prevention
The FDA declined to approve Columbia Laboratories and Watson
Pharmaceuticals' Prochieve, a vaginal gel candidate for
preventing preterm labor, and asked the drugmakers to conduct
additional research. A preliminary FDA review questioned
Prochieve's efficacy for women in the U.S., saying the
treatment's overall benefit might have largely been influenced
by strong clinical performance among foreign women.
FDA hastens review of Xarelto's use in
acute coronary syndrome
Bayer and Johnson & Johnson's Xarelto secured
priority-review designation from the FDA as acute coronary syndrome
therapy. The anticoagulant is used in patients undergoing hip or
knee replacement and those with atrial fibrillation. The FDA could
decide by late June whether to allow the third indication.
Vivus chief is confident the FDA will
approve Qnexa
Vivus expects the FDA to follow an advisory committee's
recommendation and approve weight-loss pill Qnexa, CEO Leland
Wilson said. "Our position is that we have adequate money to
take us through the approval process," Wilson said. Vivus
would launch the product domestically without a partner.
European Commission allows longer use of
Novartis' Glivec
The European Commission cleared an updated label for Novartis'
cancer drug Glivec, allowing as long as 36 months of adjuvant
treatment among adults with KIT (CD117)-positive gastrointestinal
stromal tumors whose estimated recurrence risk exceeds 50%.
Richter unit's myoma drug Esmya
obtains approval in EU
EU regulators approved Esmya, a drug developed by Gedeon Richter
unit PregLem for the preoperative treatment of uterine
fibroids.
Glenmark recalls contraceptive over
packaging error
Glenmark Generics recalled seven lots of an oral contraceptive made
of norgestimate and ethinyl estradiol that were shipped between
Sept. 21 and Dec. 20. The drugmaker found that some pills were
packaged out of sequence.
Canadian provinces stop funding
painkillers OxyContin, OxyNEO
Ontario and several other Canadian provinces will no longer
subsidize Purdue Pharma's painkiller OxyContin and its
abuse-resistant formulation, OxyNEO. Politicians and health care
professionals lauded the delisting as a significant victory in the
fight against opioid abuse, but experts argued that the move
doesn't go far enough in solving the country's addiction
problem.
Health groups push for antibiotics
research incentives
A group of health organizations, including the Infectious Diseases
Society of America, are calling on members of Congress to include
economic incentives for research and development of new antibiotics
in the Prescription Drug User Fee Act reauthorization. "Rich
or poor, all of us are dependent on the development of effective
new antibiotics," said Jeff Levi, executive director of the
Trust for America's Health.
FDA warns Fresenius over its unit's
generics plant in N.Y.
The FDA issued a warning letter about generic drugs from a Grand
Island, N.Y., plant operated by Fresenius subsidiary APP
Pharmaceuticals. Production is expected to continue, and APP will
respond within 15 business days, Fresenius said.
Packaging concern leads GSK to recall
anti-hypertensive DynaCirc
GlaxoSmithKline voluntarily withdrew about 394,200 bottles of
hypertension drug DynaCirc because of inconsistent packaging at
Novartis' plant in Lincoln, Neb., where the product was made.
GSK has not received any reports of mix-up or contamination,
spokesman Kevin Colgan said. He also said alternative medicines are
available to patients.
FDA tentatively OKs Mylan's generic of
HIV drug Epzicom
Mylan Laboratories obtained tentative FDA approval for a generic
equivalent of Epzicom, an HIV/AIDS treatment by ViiV Healthcare.
The product was authorized through the President's Emergency
Plan for AIDS Relief.
FOOD & DIETARY SUPPLEMENTS
Lawmakers question Hamburg over FDA's
proposed fees
At a House hearing, FDA Commissioner Margaret Hamburg was grilled
by lawmakers on the agency's plan to raise $220 million through
facility registration fees to support the Food Safety Modernization
Act. "Is this food safety fee really needed? I would argue,
emphatically, yes," Hamburg said. "We know that although
we have one of the safest food supplies in the world but we still
have some real vulnerabilities."
Rule for meat label goes into
effect
A policy that went into effect Thursday requires raw meat sold at
grocers to carry a nutrition label with information including
calories, calories from fat and the level of protein, cholesterol,
saturated fat, sodium and iron. "It's the kind of
information that consumers are asking for, and we just think
it's about helping people make their own best choices by having
the information that they need," said Dr. Elisabeth Hagen, the
USDA's undersecretary for food safety.
USDA website highlights local food
efforts
USDA officials unveiled a website highlighting local food projects,
with an interactive map and information about projects receiving
department support. The Know Your Farmer, Know Your Food Compass
shows where agency resources have been coordinated to help local
and regional growers, ranchers and farmers.
Sprout Safety Alliance to foster best
practices
The FDA and the Illinois Institute of Technology formed a one-year,
$100,000 initiative to develop training and outreach focused on
safely growing sprouts. The Sprout Safety Alliance will facilitate
educational activities to prepare growers for upcoming safety
requirements.
Groups seek detailed labeling information
on added sugars
The FDA is being urged to require that manufacturers list added
sugars in the ingredients section of food labels. In a letter to
FDA Commissioner Margaret Hamburg, a coalition of 14 health-focused
groups said specific information on added sugars will help
consumers make better-informed decisions.
Food-safety expert: "You cannot rely
on third parties"
Larry Goodridge, associate professor at the Center for Meat Safety
and Quality at Colorado State University, told farmers they are the
first line of defense in preventing food contamination.
"Everybody who produces food has to be responsible for the
safety of the food they produce," he said. "You cannot
rely on third parties. You just can't."
Industry: Proposed food safety-related
fees would hurt consumers
A coalition of 33 industry groups sent top lawmakers a letter
arguing against a government proposal to boost food safety by
collecting $220 million in registration fees from processing
establishments. "As food companies and consumers continue to
cope with a period of prolonged economic turbulence, the creation
of a new food tax would mean higher costs for food makers and
higher food prices for our consumers," the groups wrote.
FDA voices support for Facts Up Front
labels
In a letter to the Food Marketing Institute and the Grocery
Manufacturers Association, FDA Deputy Commissioner Michael Taylor
said their Facts Up Front label program might contribute to the
agency's public health goals. The letter stops short of
endorsing the program and says the agency would help the FMI and
GMA "determine whether consumers notice, understand and use
this front-of-pack labeling system."
Researchers explore method to protect
almonds from salmonella
Food-safety scientists said sequential infrared and hot air can
protect almonds from salmonella. The method "doesn't
require use of any chemicals and offers a simple, safe,
energy-efficient and environmentally friendly way to kill
salmonella while almonds are still at the packinghouse," said
researcher Zhongli Pan.
TOBACCO
Report to slam budget cuts for
anti-smoking campaigns
The U.S. Surgeon General is set to release March 8 a report that
criticizes states that have slashed funding for anti-tobacco
programs, according to Terry Pechacek, director for science at the
CDC's Office on Smoking and Health. "It is a hard-hitting
report and it's going to say, 'Why haven't we ended
this epidemic? Why are we still feeding all these replacement
smokers into a deadly industry?'" Pechacek said.
Judge says graphic labeling requirement
breaches free speech rights
A federal rule mandating illustrated warnings on tobacco packaging
is a violation of manufacturers' free speech rights, U.S. Judge
Richard Leon said. "Unfortunately, because Congress did not
consider the First Amendment implications of this legislation, it
did not concern itself with how the regulations could be narrowly
tailored to avoid unintentionally compelling commercial
speech," Leon wrotte in his 19-page decision.
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