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discount, the agency said in draft guidance.
Bill would accelerate development and
approval of essential drugs
Sen. Barbara Mikulski, D-Md., co-sponsored a bipartisan bill to
encourage development of innovative therapies for chronic illnesses
and prioritize their availability. The measure, which seeks
public-private cooperation, would allocate $50 million for speedier
FDA evaluation.
Merck's extended-release Janumet is
approved by FDA
The FDA authorized an extended-release formulation of Merck &
Co.'s type 2 diabetes treatment Janumet, a combination of the
firm's Januvia and older drug metformin. Tests found that
Janumet XR is comparable to its two main ingredients used
separately.
FDA tentatively approves Mylan's
generic Lipitor
Mylan obtained tentative FDA approval for a generic equivalent of
Lipitor, Pfizer's blockbuster cholesterol drug. Ranbaxy
Laboratories has the exclusive right to sell generic Lipitor for
180 days, competing with the branded product and Watson
Pharmaceuticals' authorized generic.
Pharma cut TV ad spending nearly a quarter
from 2007 to 2011
A Nielsen report shows that spending on TV ads for branded
prescription medicines dropped 23%, to $2.4 billion, from 2007 to
2011. Analysts expect the trend to continue because of generic
competition and increased scrutiny of drug ads' influence on
consumer behavior.
FDA OKs StemCells study of treatment for
dry AMD
The FDA is permitting StemCells to conduct a safety and efficacy
trial of therapeutic candidate HuCNS-SC among patients with dry
age-related macular degeneration. Last year, testing of the stem
cell treatment for a rare childhood brain disorder was halted
because of a lack of qualified participants.
Canada's high court won't hear
Pfizer appeal on Xalatan patent
The Canadian Supreme Court declined to consider Pfizer's
request to reverse an appeals-court decision that allows Apotex to
market latanoprost, a generic version of Pfizer's ophthalmic
drug Xalatan.
Drugmakers' protest leads senator to
change biotech bill
Sen. Kay Hagan, D-N.C., will introduce a revised bill to allow
accelerated approval of biotech drugs for certain diseases, after
some big drugmakers said her original proposal would water down
safety measures.
Vertex's CF drug Kalydeco gets FDA
approval
The FDA approved Vertex Pharmaceuticals' Kalydeco to treat
cystic fibrosis in patients age 6 and older with gene mutation
G551D. The drug costs $294,000 annually.
Pfizer contraceptives are recalled because
of packaging error
Pfizer recalled 14 batches of oral contraceptive Lo/Ovral and
another 14 of a generic version that were sold in 28-day blister
packs. The drugmaker said some packets might have an inexact tablet
count. Women exposed to the affected products should use
nonhormonal contraception immediately, Pfizer said.
Obesity drug lorcaserin will undergo FDA
panel review again
An FDA advisory panel scheduled a meeting next quarter to discuss a
resubmitted new-drug application for Eisai and Arena
Pharmaceutical's weight-loss drug lorcaserin. Arena said it
provided additional data that address concern about tumors seen in
rats.
FDA tentatively OKs Cipla's generic of
HIV drug Epzicom
Cipla's generic formulation of GlaxoSmithKline's HIV
medicine Epzicom was tentatively approved by the FDA under the
President's Emergency Plan for AIDS Relief. The FDA previously
gave tentative approval for a pediatric dose from Mylan
Pharmaceuticals.
Lawmakers might address drug shortages in
FDA user-fee bill
House lawmakers might add language to the Prescription Drug User
Fee Act to require the FDA to accelerate review of applications
from companies that want to change production to address a drug
shortage. Lawmakers also want drugmakers to notify the FDA of
potential shortages.
FDA allows wider use of Novartis'
stomach cancer drug Gleevec
The FDA authorized Gleevec, a cancer agent by Novartis, for adults
who underwent surgery to remove a gastrointestinal stromal tumor.
The agency also affirmed a clinical finding that Gleevec lengthens
survival when taken for 36 months instead of 12 months.
FDA approves trial of Mesoblast's stem
cell treatment for diabetes
Mesoblast secured FDA approval to start a Phase II clinical trial
assessing the safety and efficacy of its off-the-shelf stem cell
therapy in type 2 diabetes patients. The three-month study will
track patients' blood glucose levels, as well as hormones and
other markers, after an injection of mesenchymal precursor
cells.
Micromet shareholder's lawsuit calls
Amgen offer inadequate
A Micromet shareholder said in a lawsuit that Amgen's takeover
offer of $1 billion, or $11 a share, undervalues Micromet.
"Given the company's growth prospects and potential for
significant income," Micromet should be worth at least $12 a
share, according to the lawsuit.
FDA OKs Hi-Tech's generic of anxiety
treatment Intensol
Hi-Tech Pharmacal obtained FDA approval of lorazepam oral
concentrate, a generic equivalent of Roxane Laboratories'
anxiety medicine Intensol. Hi-Tech's product will be available
at 2 milligrams per milliliter.
Pfizer to submit menopause drug Aprela for
FDA approval
Pfizer expects to apply this year for FDA approval of Aprela, a
single-pill formulation of conjugated estrogen and selective
estrogen receptor modulator bazedoxifene. Aprela can potentially
ease menopausal symptoms and prevent osteoporosis, and it has a
better tolerability and safety profile compared with older
hormone-replacement therapies, Pfizer executive Olivier Brandicourt
said.
Leadership duties shift within
CDER
Bob Temple is giving up his post as acting director of the Office
of Drug Evaluation I at the FDA's Center for Drug Evaluation
and Research and will be replaced by Ellis Unger, the office's
deputy director. The change will allow Temple to devote more time
to his duties as deputy director for clinical science, according to
CDER Director Janet Woodcock.
Roche gains FDA approval of skin cancer
drug Erivedge
The FDA approved Roche Holding and Curis' Erivedge as treatment
for advanced basal cell carcinoma in adults whose disease cannot be
cured with surgery or radiation or whose skin cancer has already
spread to other body parts or recurred after surgery. Roche is also
seeking approval to sell Erivedge in Europe.
FDA OKs diabetes drug combo Jentadueto by
Boehringer and Lilly
Eli Lilly and Co. and Boehringer Ingelheim received FDA approval of
Jentadueto, a type 2 diabetes medicine intended for use with
exercise and diet. The oral treatment, which combines linagliptin
and metformin hydrochloride, can be taken alone or with commonly
prescribed sulfonylurea.
Pediatric experts recommend label change
for ADHD drug Focalin
An FDA advisory panel said Novartis' Focalin should carry a
warning about a risk of suicidal thoughts in children receiving the
attention-deficit/hyperactivity disorder treatment. The agency
identified eight cases of the adverse effect in the past six years.
FDA staff and advisers also recommended that Focalin's label
warn about angioedema and anaphylaxis risk.
Lannett's generic of anti-hypertensive
Microzide gets FDA OK
Lannett's marketing application for 12.5-milligram
hydrochlorothiazide was approved by the FDA. It is a generic
equivalent of Watson Pharmaceuticals' anti-hypertensive capsule
Microzide.
Cell Therapeutics cancels second FDA
application for pixantrone
Cell Therapeutics pulled a resubmitted FDA application to
commercialize lymphoma drug Pixuvri, or pixantrone. The biotech
firm had requested extra time to prepare for a panel review, but
the FDA refused to reschedule the Feb. 9 meeting.
Policy can reduce sugar consumption,
professor says
Robert Lustig, professor of pediatrics at the University of
California, said consumption of sugar and other sweeteners can be
reduced by policies including charging a tax and limiting sales of
sweetened food and drinks during school hours. In the journal
Nature, Lustig said sugar "meets all the criteria for societal
intervention that alcohol and tobacco meet."
New standards announced for school
milk
U.S. schools can no longer serve low-fat flavored milk under
regulations announced recently as part of the Healthy, Hunger-Free
Kids Act. The rule, which goes into effect in the coming school
year, still allows fat-free flavored milk, and also requires that
schools offer 8-ounce containers of milk with every breakfast and
lunch served.
10-state salmonella outbreak is linked to
Taco Bell
Investigators found that some cases of salmonella enteritidis
infection reported in 10 states in late 2011 were linked to Taco
Bell restaurants. "They believe that the problem likely
occurred at the supplier level before it was delivered to any
restaurant or food outlet," according to a Taco Bell
statement.
FDA takes action against cheese
manufacturer
New York's Mexicali Cheese failed to correct unsanitary
conditions and product contamination despite repeated warnings from
state and federal authorities, the FDA said. The Justice
Department, acting on behalf of the FDA, is requesting a permanent
injunction against the cheese maker.
Industry seeks adequate food safety
funding
The federal government should ensure that food safety programs are
adequately funded instead of proposing taxes or user fees on
manufacturers and consumers, according to a coalition of trade
organizations. "The creation of new food taxes or regulatory
fees would mean higher costs for food makers and lead to higher
food prices for consumers," the groups wrote in a letter to
White House Budget Director Jeffrey Zients and HHS Secretary
Kathleen Sebelius.
Proposed FSIS changes have significant
advantages, official says
A proposal by the USDA's Food Safety Inspection Service to
shift focus from monitoring quality assurance to evaluating safety
procedures in poultry production would have significant benefits,
Deputy Administrator Philip Derfler said during an FDLI conference.
"We're going to emphasize food safety, totally, as the
emphasis for what we're doing ... We really do believe that
product is going to be a lot safer as a result," Derfler
said.
USDA wants to revamp packaging
standards
The USDA's Agriculture Marketing Service is accepting comments
on a proposal to change packaging standards. AMS creates and
revises inspection standards for food packaging and said recently
developed packaging doesn't match standards. The department
wants the revision to bring inspection up to date, but if the
proposal sticks, more than 22,000 food manufacturers might be
affected.
Tobacco
Douglas Pharmaceuticals' isotretinoin
obtains FDA approval
The FDA authorized generic acne medicine isotretinoin, produced by
Douglas Pharmaceuticals. The company faced regulatory challenges in
the past 10 years, including creating a brand name for isotretinoin
and proving its bioequivalency to Roche Holding's Accutane,
Director Jeff Douglas said. Douglas Pharmaceuticals' product
will be marketed as Myorisan by U.S. partner VersaPharm.
Rule aims for more transparency in
Medicaid drug reimbursement
The CMS proposed a rule to bolster transparency in Medicaid drug
reimbursement and better align medication costs with what
pharmacies pay. The move could help federal and state governments
save about $17.7 billion over five years. Public input will be
accepted until April 2.
FTC lawsuit aims to stop Omnicare's
takeover of PharMerica
The Federal Trade Commission filed a lawsuit to block
Omnicare's proposed $440.8 million acquisition of PharMerica. A
merger of the drug suppliers would "diminish competition and
raise health care costs, leaving taxpayers and patients to foot the
bill," said Richard Feinstein, head of the FTC's Bureau of
Competition.
EU grants orphan-drug designation to
Celator's leukemia agent
Celator Pharmaceuticals secured orphan-drug status in the EU for
CPX-351, a combination of cytarabine and daunorubicin to treat
acute myeloid leukemia. The liposome injection has the same
designation in the U.S.
Pfizer gets FDA approval of kidney cancer
drug Inlyta
The FDA approved Pfizer's Inlyta, saying the drug works in
patients with metastatic kidney cancer whose initial therapy did
not work. Inlyta, or axitinib, delayed tumor progression by two
months during a head-to-head trial with Nexavar, a targeted agent
by Bayer and Onyx Pharmaceuticals.
FDA approves weekly diabetes therapy
Bydureon
Amylin Pharmaceuticals and Alkermes' Bydureon, or exenatide,
was approved by the FDA as a once-weekly treatment for type 2
diabetes. The glucagonlike peptide-1 receptor agonist costs about
$4,200 a year. Amylin is conducting an FDA-requested trial to
determine whether Bydureon heightens the risk of heart attacks,
thyroid cancer and pancreatitis.
Cephalon pulls one batch of lymphoma
medicine Treanda
Cephalon withdrew a single lot of injectable blood cancer drug
Treanda after discovering particulate contamination in a glass vial
of 25 milligrams per 8 milliliters. Treanda is used with
chemotherapy in some patients with indolent B-cell non-Hodgkin
lymphoma. The drugmaker said it has not received reports of adverse
effects.
FDA agrees to review Pfizer's leukemia
drug bosutinib
Pfizer's bosutinib, an oral drug candidate for chronic myeloid
leukemia, was accepted for FDA evaluation. The drug is targeted at
adults previously treated with Bristol-Myers Squibb's Sprycel
and Novartis' Tasigna.
EU drops complaint about Servier's
argument in antitrust inquiry
The European Commission closed a case alleging that Les
Laboratoires Servier gave misleading information during an
investigation into a practice that delays generic-drug launches.
The commission said it will focus on pending antitrust cases
against several drugmakers, including Servier.
Pharma ads put symptom checklists in
patients' hands
Pharmaceutical companies' marketing of symptom checklists
encourages patients to "diagnose their own ailments, to take
some control over their own health," writes Dr. Pauline Chen.
Chen expects the use of this marketing strategy to continue and
says the U.S. is one of four countries to allow direct-to-consumer
pharmaceutical advertising.
Food & Dietary Supplements
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.
Ind. lawmakers advance legislation on
sales of raw milk
The Indiana Senate approved a bill that would allow farmers with
fewer than 20 cows to sell raw milk directly to the public. LuAnn
Troxel, president of Indiana Professional Dairy Producers, said the
bill is not ready for approval. "If we're going to truly
discuss legalizing the sale of unpasteurized milk, there should be
a discussion among the stakeholders involved, the public health
officials and scientists," Troxel said.
U.S. Chamber supports tobacco firms in
case against FDA
The U.S. Chamber of Commerce backed a lawsuit by tobacco
manufacturers challenging the FDA's graphic labeling
requirement. The policy is a "radical departure from
traditional government efforts to regulate speech insofar as they
force commercial enterprises to disparage the very products that
they are lawfully marketing," the group says in its
friend-of-the-court brief.
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