Eli Lilly gets FDA nod for once-a-day Cialis
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1

  • What’s this

By Tom Murphy, The Associated Press

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- Drug maker Eli Lilly and Co. has received FDA approval to offer its erectile dysfunction drug, Cialis, in a new daily dose.

The daily version will take pressure off users who would otherwise have a “shot clock” or window of cialis generic search
to worry about, Lilly officials say. Cialis also is offered at a higher dose that provides a 36-hour window.

With the daily dose, men will not need to take Cialis in anticipation of sex because it is already in their system, said Shawn Heffern, Lilly’s U.S. marketing director for the drug.

“They’ve got a lot of pressure to perform, and the worst thing we can do is then put a shot clock on them or some limited amount of time … where they need to have sex or otherwise it’s out of their system and doesn’t work,” he said.

Lilly said in a statement the daily dose is geared for men who anticipate having sex twice a week or more frequently.

Cialis rang up US$798 million in sales during the first nine months last year. In 2006, it registered $971 million for the full year, a 30 per cent increase over 2005.

Heffern said the drug is on track to top $1 billion in sales for 2007. He declined to say how the daily dose will affect revenue.

Cialis trails market leader Viagra in sales. The Pfizer Inc. erectile dysfunction drug collected $1.26 billion in sales during the first nine months of 2007.

The daily dose could increase Cialis sales depending on how it’s priced, said George Farra, co-founder and principal of Woodley Farra Manion Portfolio Management. His firm manages nearly 285,000 Lilly shares.

“The cost will probably be an issue. It becomes more of a monthly fixed cost,” Farra said. “For those who favour spontaneity, this is about as good as it gets.”

Viagra and another erectile dysfunction drug, Levitra, also can be taken daily. But Cialis is the only drug approved for a daily treatment regimen.

Shares of Boards link message optional url zyban
Eli Lilly rose $1.51, or 2.8 per cent, to $56.06 Tuesday. Farra said he thinks the FDA approval helped spur the increase.

“It’s positive news without a doubt,” he said.

Doping up Canadians is priority 1 for Harper and the Drug companies.

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Draftfcb Healthcare Takes Pulse of Social Media with Radian6
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FDA approves daily Cialis doses
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NEW YORK (Reuters) -
Eli Lilly and Co on Tuesday said U.S.
regulators approved sale tadalafil
use of two low-dose forms of its
Cialis anti-impotence drug, offering greater convenience for
men expecting frequent sexual activity.

The Indianapolis drugmaker said the once-daily
formulations, in dosages of 2.5 milligrams and 5 milligrams,
will allow men to attempt sexual activity any time between
doses.

“In clinical trials, when taken without restrictions on the
timing of sexual activity, Cialis for once daily use improved
erectile function over the course of therapy,” Lilly said in a
release.

The low-dose daily formulations, already approved in parts
of Europe, “may be most cialis tadalafil
for men with erectile
dysfunction who anticipate more frequent sexual activity (e.g.
twice weekly),” Lilly said.

The company said the low-dose formulations provide “a new
option for men who may be looking for a dosing option that can
be taken without regard to timing of sexual activity.”

The treatment, which has global annual sales of $1.2
billion, has been available in the United States since 2003 in
dosages of 5 milligrams, 10 milligrams and 20 milligrams, and
taken as needed. Those dosages provide effectiveness for up to
36 hours.

Company generic cialis tadalafil price comparison
Keri McGrath said no dosage forms of
the medicine, including the newly approved lower ones, are
appropriate for heart patients who take nitrates, including
tadalafil 20mg
.

Members of the class of drugs to which Cialis belongs –
including Pfizer Inc's rival Viagra and GlaxoSmithKline Plc's
Levitra — can dangerously lower blood pressure when used
alongside nitrates.

The drugs, used by millions of men worldwide, also carry
new warnings about potential risk of sudden hearing loss.

Shares of Lilly were up $1.05, or 1.9 percent, to $55.60 in
morning trading on the New York Stock Exchange, in line with a
2 percent advance for the drug sector.

(Reporting by Ransdell Pierson, editing by Gerald E.
McCormick)

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France seizes 224,000 fake anti-impotence pills
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PARIS (Reuters) -
French customs officials have tadalafil guenstig

a shipment of 224,000 fake Viagra and Cialis alternative tadalafil

pills worth 2.4 million euros ($3.5 million), the Budget
Ministry said on Monday.

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The copies of the best-selling drugs were found on December
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Roissy, in a freight cargo on its way to Brazil from India.

“Branded Powergra and Compare viagra to cialis
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“The tadalafil tablet
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France seizes 224,000 fake anti-impotence pills
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PARIS (Reuters) -
French customs officials have intercepted
a shipment of 224,000 fake Viagra and Cialis anti-impotence
pills worth 2.4 million euros ($3.5 million), the Budget
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The copies of the best-selling drugs were found on December
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Men give up too fast if impotence pill fails: study
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LONDON (Reuters) -
A third of men with erectile dysfunction
could not perform after taking their first tablet of an
impotence drug and gave up sex entirely, according to a study
presented at the European Society of Sexual Medicine on
Tuesday.

The findings show the tadalafil cialis
of the tadalafil loc mx pill for
erectile dysfunction patients who could potentially see better
results by switching tablets or increasing the dose, Dr. David
Edwards, a general practitioner in Ed pills
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Erectile dysfunction drugs like Pfizer Inc.'s Viagra, Eli
Lilly and Co's Cialis and Bayer AG's Levitra work by increasing
blood flow to the genitals.

The study presented at a conference in Lisbon and funded by
Bayer looked at 631 men with an average age of 55 who had
erectile dysfunction. All had at some point taken a pill for
their condition, and 70 percent were still on some medication.

When the pills did not work the first time, 68 percent of
men reported a loss of self-esteem, 32 percent felt depressed
and 24 percent said they believed their condition could never
be treated.

One third simply did not return to their doctor to try an
alternative treatment after a failed attempt, something the
researchers said tadalafil 20mg
the fact many men delay or ignore
treating their problem.

“These data confirm that men are still reluctant to seek
help for their erectile dysfunction and highlight the
importance of first-time success on improving aspects of
well-being,” the researchers wrote in an abstract.

(Reporting by Michael Kahn; Editing by Maggie Fox)

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Lilly COO promoted to CEO ahead of coming struggle
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NEW YORK (Reuters) -
Eli Lilly and Co (LLY.N) said on
Tuesday chief executive Sidney Taurel will retire on March 31,
turning the reins over to Chief Operating Officer John
Lechleiter as the drugmaker prepares for tough times ahead.

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The appointment of Lechleiter, 54, comes ahead of looming
patent expirations on three of Lilly's top drugs. The
CEO-designate earlier this month said the company will face
“its biggest challenge” ever as the drugs contend with cheaper
generics, but he said new Lilly products would help offset lost
revenue.

“My experience equips me to meet the company's biggest
challenge, which is to bring new molecules forward,” Lechleiter
said in an interview on Tuesday. He said he intends to give
Lilly scientists the breathing space needed for invention.

The 58-year-old Taurel's retirement and the selection of
Lechleiter to succeed him had been widely expected since
Lechleiter was promoted to COO in October 2005 and assumed ever
greater responsibility and a higher profile with the
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Lechleiter came to Lilly in 1979 as an organic chemist and
over the next 15 years took a number of senior executive roles
in research and development, including stints in England and
Europe. In 2004, the year before he became Taurel's top deputy,
he was named head of Lilly's pharmaceutical operations.

Lechleiter said Lilly's future success could hinge in part
on its ability to create medicines tailored for the genetic
makeup of patients, a discipline Lilly calls “tailored
cream for erectile dysfunction
.”

“We want to make sure the right patients get the right dose
of the right medicine at the right time,” Lechleiter said.

Lehman Brothers analyst Tony Butler predicted Lechleiter
will continue Lilly's pattern of forging partnerships with
other drugmakers — the kinds of deals that have brought it the
widely used impotence treatment Cialis, and Byetta for diabetes
– while coaxing important new drugs from Lilly's laboratories.

HIS FORTE

“Understanding how to make a drug and how to deal with
regulators have been his forte and will serve him well as CEO,”
said Butler, who noted Lechleiter headed regulatory affairs for
Lilly in the mid-1990s before taking charge of pharmaceutical
operations.

“Over the last decade, Lilly has been one of the most
innovative companies, producing novel drugs and not losing
sight about the importance of research, and that's what John
brings to the table,” Butler said.

Taurel joined Lilly as a marketing associate in 1971 and
took the helm of the company in July 1998. He has been chairman
since early 1999. He will continue as board chairman until the
end of 2008, Lilly said.

Under Taurel, Lilly has been recognized for its research,
developing medicines that have become blockbuster products,
including schizophrenia treatment Zyprexa, anti-depressant
Cymbalta and chemotherapy agent Gemzar.

But Lechleiter cialis generic india
in an earlier Reuters interview
this month that it will be difficult for Lilly to make up the
revenue shortfall when those three drugs face patent
expirations between 2010 and 2012.

“There's no question we will face the biggest challenge of
our history at the beginning of the next decade, but we're
confident we can meet that challenge based on new products
being launched before and during that period,” he said.

Toward that end, Lechleiter said Lilly aims to launch two
new drugs per year, on average, beginning in 2011, increasing
to three per year by 2014. It aims to move at least 10
additional drugs into late-stage studies by 2011.

The company also has financial strength to license or buy
more drugs, said Lechleiter.

At a Lilly meeting with investors and analysts in New York
on December 6, Taurel remained largely out of the spotlight,
allowing Lechleiter to take the lead in describing company
strategy.

Lilly shares traded up almost 1 percent to $53.67 in
late-afternoon trading Tuesday on the New York Stock Exchange,
in line with gains for the drug sector.

(Reporting by Ransdell Pierson; Editing by Brian Moss and
John Wallace)

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Calgary’s Stephen Ames picks up first PGA Tour victory of year at Disney
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By The Canadian Press

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LAKE BUENA VISTA, Fla. - Stephen Ames waited until the final tadalafil rezeptfrei
PGA Tour event of the season to pick up his first victory of the year.

The Calgary buy cheap generic cialis
held on for a one-shot victory over Tim Clark at the Children’s Miracle Network Classic.

Ames closed with a 68 on Disney’s Magnolia Golf Course for a 17-under-par 271.

Ames last won at the Players Championship in 2006.

His only other PGA Tour victory came in 2004 when he won the Cialis Western Open.

Ames entered the tournament ranked No. 49 in the world.

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Hearing loss warning on impotence drugs
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It’s not clear that the drugs truly trigger hearing loss, but the Food and Drug Administration decided Thursday to add a warning about the possible risk after counting 29 reports of the problem since 1996 among users of this family of medicines.

The impotence drugs Viagra, Cialis and Levitra will bear the warnings. So will Revatio, a drug for pulmonary hypertension, which contains the same ingredient as Viagra.

Viagra’s label already mentioned hearing loss as a possibility, because a few cases were reported during initial testing of that drug. But given that hearing loss is a risk of advancing age and certain cialis tadalafil generic rezeptfrei
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But in poring over FDA’s database of possible drug tadalafil prezzo
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FDA urged patients who experience any hearing problems — loss or ringing in the ears — to promptly call their doctors and stop taking the impotence drugs.

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Health Highlights: Oct. 19, 2007
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Here are some of the latest health and medical news developments,
compiled by editors of HealthDay:

Impotence Drugs to Carry Hearing Loss
Warnings

New warnings about the potential risk of sudden hearing loss will be
added to the labels of Viagra and other drugs to treat erectile
dysfunction, the U.S. Food and Drug Administration says.

While it's not clear whether the drugs actually do cause hearing loss,
the FDA said that since 1996 there have been 29 reports of hearing
problems among users of these kinds of drugs, the Associated Press
reported.

The new warnings will be carried by the impotence drugs Viagra, Cialis
and Levitra, as well as the pulmonary hypertension drug Revatio, which
contains the same ingredient as Viagra.

In the 29 reports noted by the FDA, hearing loss occurred within hours
to two days after patients took one of the drugs, said FDA ear-and-nose
specialist Dr. Robert Boucher.

“We don't know enough to say that it's ironclad caused by the drugs,
but we see enough to say we can't ignore it either,” he told the
AP.

People who take the drugs and experience hearing loss or ringing in the
ears should stop the medications and contact their doctor, the FDA
said.

—–

San Francisco May Consider Dosage tadalafil

Site

In what may turn out to be the first step toward opening a
safe-injection site, San Francisco officials co-sponsored a symposium
Thursday on a facility in Vancouver, British Columbia, the only such
program in North America, the Associated Press reported.

At the Vancouver site, about 700 intravenous drug users shoot up
heroin, cocaine and other narcotics under the supervision of nurses. San
Francisco health officials may consider a safe-injection site as a way to
reduce the city's high rate of fatal drug overdoses.

“Having the conversation today will help us figure out whether this is
a way to reduce the harms and improve the health of our community,” said
Grant Colfax, director of HIV prevention for the San Francisco Department
of Health, the AP reported.

However, a federal official said the city's consideration of a
safe-injection site was “disconcerting” and “poor public policy.”

“The underlying philosophy is, 'We accept drug addiction, we accept the
state of affairs as acceptable. This is a form of giving up,” Bertha
Madras, deputy director of demand reduction for the White House Office of
National Drug Control Policy, told the AP.

There are 65 safe-injection sites in 27 cities in eight countries. So
far, San Francisco is the only U.S. city to consider creating a legal
safe-injection site, said Hilary McQuie, Western director for the
nonprofit Harm Reduction Coalition, which promotes alternative drug
treatment methods.

—–

CDC Redesigns Spanish Web Site

The U.S. Centers for Disease Control and Prevention says it's
redesigned its Spanish Web site, CDC en Espanol, with a new look and features meant to
make it more usable and functional.

The redesigned site has a more useful and powerful search engine, quick
access to the 20 trattamento cronico tadalafil
topics of information, a user-friendly A-Z
index, and other features that will make it easier for people to find the
health and science information they seek, the CDC said.

The site, which provides information in Spanish on health issues of
special interest to Hispanic communities, has more than six million
visitors a year and its weekly distribution list includes almost 6,000
members in more than 40 countries.

—–

Sunlight May Decrease Risk of Advanced Breast
Cancer

Exposure to sunlight — which boosts levels of vitamin D in the body –
may reduce the risk of advanced breast cancer, according to a U.S. study
published online this week in the American Journal of
Epidemiology
.

The study of 1,788 breast cancer patients and 2,129 women who didn't
have the disease found that women with high sun exposure had half the risk
of developing advanced breast cancer than women with low sun exposure.
However, this effect was noted only in women with naturally light skin
color.

“We believe that sunlight helps to reduce women's risk of breast cancer
because the body manufactures the active form of vitamin D from exposure
to sunlight,” lead researcher Esther John, of the Northern California
Cancer Center, said in a statement. “It is possible that these effects
were observed only among bulk citrate powder tadalafil
women because sun exposure produces
less vitamin D among women with naturally darker pigmentation.”

John and her colleagues emphasized that women should not sunbathe in an
attempt to reduce their breast cancer risk.

“If future studies continue to show reductions in breast cancer risk
associated with sun exposure, increasing vitamin D intake from diet and
supplements may be the safest solution to achieve adequate levels of
vitamin D,” co-researcher Gary Schwartz, of the Comprehensive Cancer
Center at Wake Forest University School of Medicine, said in a
statement.

—–

Bad Habits Increase Osteoporosis
Risk

Smoking, excess alcohol consumption, being underweight, lack of
exercise, and poor nutrition are factors that could increase the risk of
osteoporosis later in life, says an Erectile dysfunction advices
Osteoporosis Foundation
(IOF) report released to mark World Osteoporosis Day on Oct. 20.

Osteoporosis risk factors fall into two main categories, modifiable and
fixed. People can't control fixed risk factors — such as age, gender, and
family history — but they can do things that may lessen their
effects.

Following a bone-healthy lifestyle — including eating a nutritious
diet, getting regular exercise, and avoiding smoking and excess alcohol
consumption — can help build strong bones and prevent fractures, the IOF
said.

By 2050, it's estimated that the incidence of hip fracture (a major
consequence of osteoporosis) will increase by 310 percent in men and 240
percent in women, according to IOF Chief Executive Officer Daniel
Navid.

Report author and IOF board member Professor Cyrus Cooper said if
“people recognize osteoporosis risk factors when they are young and take
appropriate action, it can have enormous positive impact on their bone
health in later years.”

—–

Millions of American Teens Smoke, Drink, Use
Drugs Each Day: Report

On an average day in 2006, 1.2 million American teens smoked
cigarettes, 631,000 drank, 586,000 used marijuana, almost 50,000 used
inhalants, 27,000 used hallucinogens, 13,000 used cocaine, and 3,800 used
heroin, according to a government report released Thursday.

It also found that on an average day, almost 8,000 adolescents ages 12
to 17 drank alcohol for the first time, about 4,300 used an illicit drug
for the first time, about 4,000 smoked cigarettes for the first time,
almost 3,600 used marijuana for the first time, and about 2,500 abused
pain reliever for the first time.

The report, by the U.S. Substance Abuse and Mental Health Services
Administration (SAMHSA), is based on national surveys conducted and
analyzed by the agency's Office of Applied Studies.

“While other studies have shown that significant progress has been made
in lowering the levels of substance abuse among young people in the last
few years, this report shows many young people are still engaging in risky
behavior,” SAMHSA Administrator Terry Cline said in a prepared
statement.

“By breaking the data down and analyzing on a day-to-day basis, we gain
fresh perspective on how deeply substance abuse pervades the lives of many
young people and their families,” Cline said.

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