InfoAnda - Glaxo's cancer vaccine inches toward approval

Pakistanis angry over detentions in Times Sq. case
Monday, May 24, 2010
ISLAMABAD – Relatives of three men detained by Pakistan for alleged links to the suspect in the attempted Times Square bombing say the men are innocent.
They

Taiwan denies boycotting Australian film festival
Thursday, August 6, 2009

AFP - Thursday, August 6TAIPEI (AFP) - - Taiwan's Beijing-friendly government on Wednesday denied boycotting an Australian film festival amid a row over the e

Merkel's support dips, regional ally resigns International
Thursday, September 3, 2009

By Sarah Marsh and Noah Barkin

BERLIN (Reuters) - Chancellor Angela Merkel suffered a double blow on Thursday as a senior party ally in east German

Minister seeks closure of anti-Berlusconi websites
Wednesday, December 16, 2009
ROME (AFP) - – The Italian government moved Tuesday to close down Internet sites encouraging further violence against Prime Minister Silvio Berlusconi, who

Asian markets mixed after Wall Street rally
Wednesday, March 18, 2009

By ELAINE KURTENBACH,AP Business Writer AP - Wednesday, March 18SHANGHAI - Asia's stock market rally seemed to be running out of steam Wednesday, despite an

Nicolas Cage arrested in New Orleans | | 19 April 2011
Elpida says Taiwan Memory seeks 10 pct stake | 30 June 2009
NATO: 3 service members killed in Afghanistan | 2 December 2010

Viacom video lawsuit vs Google's YouTube revived | | 5 April 2012

Forum Views () Forum Replies ()

Read more with google mobile : Glaxo's cancer vaccine inches toward approval

Yahoo! My Yahoo! Mail Yahoo! Search Search: Sign InNew User? Sign Up News Home - Help Navigation Primary Navigation Home Singapore Asia Pacific World Business Entertainment Sports Technology Top Stories Most Popular Secondary Navigation Africa Europe Latin America Middle East North America Search Search: Glaxo's cancer vaccine inches toward approval By MATTHEW PERRONE,AP Business Writer AP - 2 hours 51 minutes ago WASHINGTON - Federal regulators said Friday that a GlaxoSmithKline vaccine prevents the leading cause of cervical cancer in women, bringing the company one step closer to competing with Merck's blockbuster Gardasil, which has controlled the U.S. market for three years. ADVERTISEMENT In documents posted online, the Food and Drug Administration said Cervarix _ Glaxo's vaccine against human papilloma virus or HPV _ successfully blocked the two leading strains of the virus nearly 93 percent of the time. But even as the British drugmaker moves closer to competing in the U.S., Merck is poised to begin marketing Gardasil to boys and men. In a separate review, the FDA said that vaccine prevented genital warts in males 90 percent of the time. The agency will ask a panel of vaccine experts next week to weigh in on both vaccines. The FDA is not required to follow the group's advice, though it usually does. While Merck has suggested the approval for boys could double the potential market for Gardasil, Leerink Swann analyst Seamus Fernandez said the benefit likely will be minimal. Genital warts caused by HPV usually clear up by themselves, and the cancers caused by the virus are extremely rare in men. "If it's not preventing something serious like cervical cancer and there are questions about safety, I think parents' acceptance of the vaccine in young boys might be less urgent than for their girls," said Fernandez. Glaxo has won a number of government contracts for Cervarix in Europe, but its U.S. launch was delayed in 2007 when the FDA said it needed more data about the vaccine. Earlier studies of Cervarix showed a higher number of muscular and neurological problems among patients who used the vaccine compared with an alternate treatment. The FDA said Friday that outside experts have now determined Cervarix did not cause those problems. "The conclusion in the case of each of these efforts was that the data are not sufficient to establish a link," the agency said in its review. Glaxo wants its vaccine approved for girls and women ages 10 to 25. The FDA is expected to make a decision on the vaccine later this year, but analysts say Glaxo may still have trouble making inroads into the U.S. market. Gardasil and Cervarix both defend against HPV strains 16 and 18, which cause about 70 percent of cervical cancer cases. But Merck's vaccine also defends against two other HPV types that cause 90 percent of genital warts, something Cervarix does not target. Gardasil became an early success story for Merck after its 2006 launch, achieving sales that are rare for a vaccine. The company has sold about 50 million doses worldwide, with more than $1.4 billion in revenue last year. But sales have been slowing amid questions about the longevity of the vaccine's effect and its price tag of nearly $400. In the most recent quarter, Gardasil sales fell to $268 million, down 18 percent from the prior year period. A government-funded study last year found that the HPV vaccine is cost-effective for young teens, but not for women in their 20s. And labeling for the vaccine notes that the "duration of protection of Gardasil has not been established." Company trials have only tracked immunity out to five years after receiving the three-injection regimen. Whitehouse, N.J.-based Merck will make the case on Sept. 9 for approving the vaccine for boys and men ages 9 to 26. But the company is expected to face push-back next week from public health activists who already question the vaccine's benefit for its main target market: women. Some argue that $375 is too much to pay to protect against genital warts and diseases like penile cancer, which affect less than 1 percent of American men. "It's a lot of money for a little bit of extra protection from a disease that is not a big problem in this country," said Dr. Diana Zuckerman of the Research Center for Women and Families in Washington. Zuckerman, who is scheduled to speak at next week's meeting, says the additional use will do more to boost Merck's sales than control HPV-related diseases. "This is great for the company. The more people use this vaccine, the more money the company makes," Zuckerman said. Cancer of the penis and anus are extremely rare, with less than 2,000 cases reported annually. But Merck argues the cost of treating those cases is often underestimated. "When I talk to people I often say the burden of these diseases in men is understated and unrecognized," said Dr. Richard Haupt, Merck's head researcher for Gardasil. "Gardasil is highly efficacious and we should see an impact on men's health because of that." Each year about 6 million people in the U.S. contract HPV, which usually causes no symptoms and goes away within two years. While 40 strains of the virus are spread through sexual contact, only about 15 cause cancer in men and women. Last year nearly 4,000 women died of cervical cancer in the U.S., less than 1 percent of all cancer related deaths. "Protection against cervical cancer is a very important health need for girls and young women, and we believe Cervarix has an important role to play in addressing this," said Glaxo spokeswoman Lisa Behrens. Email Story IM Story Printable View Blog This Sign in to recommend this article » 0 users recommend Related Articles: World Web-monitoring software gathers data on kid chatsAP - 1 hour 58 minutes ago White House comments limited on Obama adviserAP - 1 hour 59 minutes ago Congress' return energizes health care lobbyistsAP - 2 hours 5 minutes ago WTO rules European subsidies to Airbus illegal: reportAFP - 2 hours 10 minutes ago Madonna lights Sabbath candles with Israel PMAP - 2 hours 13 minutes ago Most Popular – World Viewed Poignant final farewell as Jackson laid to rest World heading for climate 'abyss': UN chief Chappaquiddick 'haunts me,' Kennedy said First baby born from new egg-screening technique BP unveils 'giant' oil discovery in Gulf of Mexico View Complete List » Search: Home Singapore Asia Pacific World Business Entertainment Sports Technology Top Stories Most Popular Copyright © 2009 Yahoo! Southeast Asia Pte Ltd. (Co. Reg. No. 199700735D). All Rights Reserved. Privacy Policy - Terms of Service - Community - Intellectual Property Rights Policy - Help

Other News on Saturday, 5 September 2009
U.S., Israel on collision course over settlements
Merkel juggernaut rumbling toward victory: polls
Got a dream but no cash? The Internet can help
US unemployment hits 9.7%, job losses narrow further
Israeli plan for settlement building angers US
Iraq sends thousands more police to Syrian border
W.House denounces Israeli settlement plans
Azerbaijan puts opposition bloggers on trial
Turkey says Georgia to free tanker captain
Iraq sends anti-militant police to Syrian border
Canadian firm predicts victory in Microsoft patent case
Iran cleric says "time to export the revolution"
French soldier killed in Afghanistan: Sarkozy
Samsung: LED TV sales to grow at least five fold in '10
Britain, US defend Afghanistan strategy
Samsung: LED TV sales to grow at least five fold in '10
Ala. man dies when hit by train for second time
Court to give same-day audio in Clinton movie case
Charter boats in Gulf accused of breaking laws
Montana mom pleads guilty, drove son to break-ins
Got a dream but no cash? The Internet can help | Technology |
Cops: Calif. corrections worker held wife captive
Motorola to sink or swim on Android phones | Technology |
Philly DA hopeful dons monitoring bracelet
Mobile technology may help city dwellers hitch ride | Technology |
Tahoe kidnap case prompts look at other cold cases
Five dead in latest unrest in far-west China
Big chunk of space junk misses space station
Police: Texas grandma made bomb threat to school
Pacquiao aiming to conquer political ring
Press watchdog condemns 'mounting crackdown' in Vietnam
Glaxo's cancer vaccine inches toward approval
Five dead in protests in restive Chinese city
Security guards a source of insecurity in China
Five dead in protests in China's Urumqi: official
Army: 5 militants killed in northwest Pakistan
Vietnam arrests blogger in crackdown on critics
Air India aborts takeoff after fire, but none hurt
Indonesian quake toll at 64, dozens still missing
G20 seek to bridge splits over bankers' bonuses
China to raise foreign fund limits to one bln dlrs
PSA Peugeot Citroen eyes Mitsubishi tie up: press report
Toyota says hybrid sales reach two-million mark
Coca-Cola to invest $200 million in Vietnam
Trade ministers agree in India to restart talks
No redemption for this 'Bad Lieutenant'
Dexter author offers latest tale of murder | Entertainment |
British author Keith Waterhouse dies at 80
Statues draw attention to plight of Kenya's lions
Germany's birth rate stagnates
French director heads film festival jury
Fox adds on-air tweets to `Fringe' reruns
Robbie Williams charts route back to the top
Afghans mourn dead under outcry of NATO bombing
WTO ruling says Airbus gained from subsidies: sources
Calm returns to China city, but ethnic ire simmers | International |
Google's investors look for next big thing
Tackling wider air pollution would speed climate action: UN
Madonna lights Sabbath candles with Israel PM
Arrest made in Salvador murder of French filmmaker
Mobile technology may help city dwellers hitch ride
IMF chief welcomes EU boost ahead of G20 meeting
U.S., Israel on collision course over settlements
Motorola to sink or swim on Android phones
Irish warning as EU treaty support slips
Israel OK for new settler homes outrages Palestinians
Iran dismisses bomb studies intelligence as forged | International |
Graphic British car crash warning prove YouTube hit
US unemployment hits 9.7%, job losses narrow further
Colombians protest in streets over Chavez actions | International |
Yemen blames northern rebels for breaking truce | International |
Fujii tipped as Japan finance minister: report | International |
Motorola to sink or swim on Android phones
Google's investors look for next big thing | Technology |
Rampaging elephants kill farmer in Indonesia
US, SKorea envoys discuss NKorean nuclear claim
Deputies breaking for cup of joe spot suspects
US, SKorea in top-level talks on NKorea
Chinese city quiet after protests left 5 dead
Firefighters remembered as murder case picks up
Top Islamic militant arrested in Philippines: police
Sisters of 9/11 activist widow walk similar path
NY researchers breeding rare native ladybugs
Asia Celsius
Bush official can be sued by 'terror' witness: court
Weather forecast for the Asia-Pacific region
SEC report shows repeated bungling of Madoff probe
Experts see no construction at NKorea nuclear site
Australia rise from Ashes with opening ODI win
Officials: CIA chief Panetta staying put
Cal governor announces $100,000 reward in wildfire
Gibbs: Squabble over Obama's speech 'silly season'
Film festival opens in Deauville
Cage, Mendes bring Hollywood to Venice
Pakistan central bank buys 37.5 bln rupees of govt paper
Coke says to double Vietnam investment
No prosecution for guard in Conn. model scuffle
Trade chiefs say tough work ahead to clinch Doha deal
Basra alcohol ban triggers fear among Christians
Beatles playing for keeps with Rock Band game | Entertainment |
Motown vignettes: Clinton, Judd, others talk music
Motown turns 50, but the party's far from over
Beatles playing for keeps with "Rock Band" game
Audigier won't make Jackson's home a public space
Guests for the Sunday TV news shows
Amnesty urges Sudan to withdraw charges in 'trouser trial'
Thousands around world rally against Hugo Chavez
Complications increase in Spector imprisonment
Iran dismisses bomb studies intelligence as forged
Russia kills man 'planning Moscow suicide attack'
G20 close to striking deal on bankers' bonuses: source
NATO seeks to calm Afghans after deadly air strike | International |
Ex-U.S. soldier gets life in prison for Iraqi assault
Mastermind of Ingush leader attack killed: reports
G20 close to agreement on bankers' bonuses: source
Afghanistan postpones latest vote result release
Pakistani troops kill 43 militants in Khyber strikes | International |
Palestinian teen killed in Gaza shooting | International |
Nigeria rebels want clear plans for those who disarm | International |
Implats strike still on, union to meet workers Monday | International |
Chavez to visit gas-rich Turkmenistan | International |
Madagascar opposition reject Rajoelina's unity govt | International |
Bangladesh ex-finance minister dies in road crash
Pakistan: 37 suspected militants killed in Khyber
US, SKorea envoys discuss NKorean nuclear claim
Pakistan: 30 suspected militants killed in Khyber
Pakistani court resumes trial of Mumbai suspects
WHO seeks funds for displaced in Philippines
Mobile technology may help city dwellers hitch ride | Technology |
Time to act on health care, Dem negotiator says
Power broker choice has postelection Japan nervous
Fla. boaters urged to look out for missing robot
Myanmar: Explosives plant found near China border
NATO investigates airstrike on hijacked tankers
Airplane trade ruling may reflect old truths
Dems signal resistance to Afghan troop increase
Man who called 911 charged with mobile home deaths
After first year, Smithsonian chief has big ideas
Police in U.S. arrest man over trailer killings
Pakistan sells 14.4 bln rupees of Islamic bond
Hopes fade for missing after Indonesia quake
Australia 'secretly supported' ETimor independence
Filmmaker Herzog is up against himself in Venice | Entertainment |
Airlines rachet up prevention to target swine flu
Greece at new risk of being pushed off euro
Bodies of missing Tenn. mom, Jo Ann Bain, and daughter found
Female Breasts Are Bigger Than Ever
AMD Trinity Accelerated Processing Units Now in Volume Production
The Avengers (2012 film), made the second biggest opening- and single-day gross of all-time
AMD to Start Production of piledriver
Ivy Bridge Quad-Core, Four-Thread Desktop CPUs
Islamists Protest Lady Gaga's Concert in Indonesia
Japan Successfully Broadcasts an 8K Signal Over the Air
ECB boosts loans to 1 trillion Euro to stop credit crunch
Egypt : Mohammed Morsi won with 52 percent
What do you call 100,000 Frenchmen with their hands up
AMD Launches AMD Embedded R-Series APU Platform
Fed Should not Ignore Emerging Market Crisis
Fed casts shadow over India, emerging markets
Why are Chinese tourists so rude? A few insights

USD EUR - 1 year graph	VPN on MacOSX	BlogMeter 1.01