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US Delay on GSK Cancer Vaccine
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Andrew Jack / FT.com | July 1, 2008
GlaxoSmithKline, the UK-based pharmaceutical company, is unlikely to receive US approval for its key cervical cancer vaccine until 2010 at the earliest, under a new timetable it released yesterday.
After requests for fresh information on Cervarix from the Food & Drug Administration in December, GSK said it had decided to await completion of a pivotal clinical trial to be filed with the US regulator during the first half of next year.
Cervarix is a probable blockbuster treatment that is central to the company’s future growth. The cervical cancer vaccine market is expected to be worth more than $1bn a year in sales.
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GSK’s timetable change confirms long-standing analysts’ fears of delays for Cervarix, which is competing with a rival vaccine, Gardasil, produced by Merck of the US and already on sale in north America.
GSK filed originally for US approval from the FDA in March 2007, and it has refused to reveal the regulator’s precise concerns other than to say they relate to “safety and efficacy”.
Observers believe the queries focus on the nature of Cervarix’s proprietary adjuvant, a chemical that boosts the immune response to the vaccine. The FDA has not approved a new adjuvant since the 1930s.
Cervarix has been approved for sale in 67 countries, including across Europe, which has sparked an intensifying competition for contracts between Merck and GSK in recent months.
GSK said it was confident in the data that would be generated later this year from its long-term efficacy trial, HPV-008, which has monitored progress in those vaccinated over the past four years.
| WATCH ALEX JONES’ ENDGAME ONLINE NOW in its entirety. View more High quality trailers at www.endgamethemovie.com |
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July 1st, 2008 at 8:54 pm
They already have a cure for canser, but they make to much money on surgury and treatment to give us the cure.
July 2nd, 2008 at 11:22 am
vagina cancer is a myth!
July 2nd, 2008 at 11:58 am
These vaccines should not be trusted….EVER. Change your diet, take good supplements and try to reduce stress. Staying healthy is the only was to rise above. Build up your immune system.
Parents who offer up their children to be poisoned by vaccines, are criminals.
July 2nd, 2008 at 1:48 pm
The circumcision is the best protection !
All medical statistcs clearly show that there is no cervical cancer in the countries (Israel, Moslems regions..) where the circumcision on men is practiced – but, these statistics are not givien to the people. In my books of pathology it is written … but this knowledge is not profitable for the pharmaceutical industry.
The profit is always the most important element in our reality – no health, no justice, no peace….
Because of that, we should build a society where the UNIVERSAL GRATUITY based on the voluntary work and fair share and PERSONAL SOVEREIGNTY+ INDIVIDUAL DIVINITY will reign!
No profit= honesty
July 2nd, 2008 at 7:58 pm
Go to Idaho Observer.com. I think AJ got his information from those people there. EXCELLENT web site. I’ve been following them for years, met them both in person and went to a couple of meetings. Cool people.
July 2nd, 2008 at 8:05 pm
At this point…if you take vaccines, you deserve what you get. If you think our system supports preventative measures over disease control than you’ve been living under a rock for the last 60 years or more. It doesn’t take a microbiologist and virologist to figure out that this type of medicine is archaic and unlogical.
Too bad we didn’t know this prior to injecting majority of the population with potentially life altering diseases that our scientistist knew nothing about, especially in terms of long term effects.
What a bunch of idiots we are for trusting.
July 4th, 2008 at 2:02 am
Very sad to realize that criminals rule the world. I donate $o for cancer and other foundations and only because I have stopped believing that it is for a good cause. I do not want to ‘donate’ those who care less about people. What a corrupted world we live in, and how sad to know.
All the best everyone
December 4th, 2008 at 8:58 am
The cure for cancer is apricot seeds.
March 5th, 2009 at 1:39 pm
Cancer is a government-made illness. They made it for population control…and they put carcinogenic (cancer causing) chemicals in our food and vaccines… there is no such thing as a “cancer vaccine” that will work. here’s a number of organic cures for cancer:
hemp oil, apricot seeds (as tony mentioned), cherries, apple cider vinager, oil of oregano… the list goes on… and watch your pH balance… if you keep it in check… you’ll never have cancer. also eat a healthy balanced diet as close to organic as you possibly can. Avoid eating at restaurants, beacuse I have worked as a chef at a few higher class restaurants, and they still use the cheapest food known to mankind. Cheap food is almost guaranteed GMO and carcinogenic. If they do that at higher quality restaurants… think what ingredients they use at a McDonald’s… where millions of poor families feed their kids at least five times a week.