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Old nuclear reactor avoids replacement
Published: May 16, 2008 at 4:16 PM
OTTAWA, May 16 (UPI) -- The world's oldest nuclear reactor won't be replaced due to budgetary and scheduling concerns, Atomic Energy of Canada Ltd. says. -
U.S. markets closed mixed
Published: May 16, 2008 at 4:16 PM
NEW YORK, May 16 (UPI) -- U.S. market indexes closed mixed Friday as a wavering afternoon rally could not bring the Dow Jones index out of the doldrums. -
Family and school stress linger for teens
Published: May 16, 2008 at 4:12 PM
LOS ANGELES, May 16 (UPI) -- Some teens may not do well in school because stress at home affects their academic performance and vice versa, U.S. researchers said.
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Old nuclear reactor avoids replacement
Published: May 16, 2008 at 4:16 PM
OTTAWA, May 16 (UPI) -- The world's oldest nuclear reactor won't be replaced due to budgetary and scheduling concerns, Atomic Energy of Canada Ltd. says. -
U.S. markets closed mixed
Published: May 16, 2008 at 4:16 PM
NEW YORK, May 16 (UPI) -- U.S. market indexes closed mixed Friday as a wavering afternoon rally could not bring the Dow Jones index out of the doldrums. -
Family and school stress linger for teens
Published: May 16, 2008 at 4:12 PM
LOS ANGELES, May 16 (UPI) -- Some teens may not do well in school because stress at home affects their academic performance and vice versa, U.S. researchers said. -
Canadian youth to face lighter sentencing
Published: May 16, 2008 at 4:11 PM
OTTAWA, May 16 (UPI) -- Young people in Canada convicted of violent crimes won't routinely face adult sentences in the future, the Supreme Court of Canada has ruled. -
Cows stampede on California highway
Published: May 16, 2008 at 4:07 PM
CONCORD , Calif., May 16 (UPI) -- The California Highway Patrol said 10 cows wandered into traffic after they escaped from a trailer on Highway 4, near the interchange with Interstate 680. -
Crime rate among Canadian young rising
Published: May 16, 2008 at 4:07 PM
TORONTO, May 16 (UPI) -- The crime rate among Canadian residents ages 12 to 17 increased by 3 percent from 2005 to 2006, a study has found.
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Analysis: FDA delays GSK cancer vaccine
Published: May 31, 2007 at 8:32 PM
By STEVE MITCHELL
UPI Senior Medical Correspondent
WASHINGTON, May 31 (UPI) -- GlaxoSmithKline, still reeling from a study suggesting its diabetes drug Avandia causes heart problems, took another hit Thursday as the Food and Drug Administration declined a priority review for its cervical cancer vaccine, Cervarix.
The FDA's move means Cervarix likely won't get approval until 2008, delaying its entry onto the market even further behind Merck's vaccine Gardasil, which was approved last year.
Dresdner Kleinwort analyst Ben Yeoh said while the FDA's rejection of the priority review request was not surprising, it still may have a negative impact on GSK shares.
The priority review "was not likely given that Gardasil, a very similar product from Merck, is already approved and priority reviews are generally only given to drugs that are considered an advance on current therapy," Yeoh stated in a research report. "That said, there was a small chance that it would have been granted and this is a slight negative for sentiment."
Yeoh said he expects the FDA's decision on Cervarix to come by January, while Europe may approve the vaccine later this year.
Meanwhile, GSK continued its efforts this week to ward off the negative impact of a study published in the New England Journal of Medicine last week that indicated Avandia increased the risk of heart attacks and heart death.
The Lancet published a letter Wednesday from GSK Chief Medical Officer Ronald Krall that essentially rehashed the company's talking points since the controversy began: The NEJM study's findings are suspect because it was a meta-review, and GSK's own studies have not found an increased risk of heart attack associated with Avandia.
However, GSK submitted its own meta-review to the FDA last year that agreed with the NEJM study that Avandia was associated with an increased risk of heart attack.
The company's pushback doesn't appear to be having much impact on investors. GSK's stock price closed down 1.02 percent Thursday at $52.18.
Yeoh called the Lancet letter as well as an editorial the journal ran last week urging patients and physicians to await the results of the company's RECORD trial reassuring, but said Avandia prescriptions will probably lag until the FDA clarifies its view of the drug.
"We expect U.S. scripts to be very soft until the FDA takes a stance on possible label revisions," Yeoh stated. "We think that the dampening impact of Avandia safety concerns on European scripts is likely to be less pronounced, given the EMEA's statement that Avandia looked safe in its approved indications."
The FDA, which plans to have an advisory committee review Avandia and other drugs in the class, previously revealed its own analysis agreed with the NEJM study that Avandia raises the risk of heart attack but said there were other conflicting studies and that its evaluation was ongoing.
J.P. Morgan analyst Craig Maxwell presented a more dire future for Avandia, saying there's a 50 percent probability the drug could be pulled from the global market and even in a best-case scenario that the drug is not withdrawn, sales will decline by as much as 30 percent next year.
If Avandia is withdrawn from the market, GSK could also face "substantial class action litigation" resulting in approximately $5 billion in settlements, Maxwell stated in a research report.
Goldman Sachs analyst John Murphy, on the other hand, sees a more moderate future for Avandia. Murphy thinks a labeling change about the heart risks is the most likely outcome after the FDA's advisory panel discusses the issue.
"Our expected outcome of an advisory committee is a stronger labeling regarding cardiovascular event profile, similar to that in Europe," Murphy stated in a research report.
However, uncertainty will continue to surround Avandia in the coming months, with a congressional hearing planned next week and the FDA's advisory panel looming on the horizon.
UPI Senior Medical Correspondent
WASHINGTON, May 31 (UPI) -- GlaxoSmithKline, still reeling from a study suggesting its diabetes drug Avandia causes heart problems, took another hit Thursday as the Food and Drug Administration declined a priority review for its cervical cancer vaccine, Cervarix.
The FDA's move means Cervarix likely won't get approval until 2008, delaying its entry onto the market even further behind Merck's vaccine Gardasil, which was approved last year.
Dresdner Kleinwort analyst Ben Yeoh said while the FDA's rejection of the priority review request was not surprising, it still may have a negative impact on GSK shares.
The priority review "was not likely given that Gardasil, a very similar product from Merck, is already approved and priority reviews are generally only given to drugs that are considered an advance on current therapy," Yeoh stated in a research report. "That said, there was a small chance that it would have been granted and this is a slight negative for sentiment."
Yeoh said he expects the FDA's decision on Cervarix to come by January, while Europe may approve the vaccine later this year.
Meanwhile, GSK continued its efforts this week to ward off the negative impact of a study published in the New England Journal of Medicine last week that indicated Avandia increased the risk of heart attacks and heart death.
The Lancet published a letter Wednesday from GSK Chief Medical Officer Ronald Krall that essentially rehashed the company's talking points since the controversy began: The NEJM study's findings are suspect because it was a meta-review, and GSK's own studies have not found an increased risk of heart attack associated with Avandia.
However, GSK submitted its own meta-review to the FDA last year that agreed with the NEJM study that Avandia was associated with an increased risk of heart attack.
The company's pushback doesn't appear to be having much impact on investors. GSK's stock price closed down 1.02 percent Thursday at $52.18.
Yeoh called the Lancet letter as well as an editorial the journal ran last week urging patients and physicians to await the results of the company's RECORD trial reassuring, but said Avandia prescriptions will probably lag until the FDA clarifies its view of the drug.
"We expect U.S. scripts to be very soft until the FDA takes a stance on possible label revisions," Yeoh stated. "We think that the dampening impact of Avandia safety concerns on European scripts is likely to be less pronounced, given the EMEA's statement that Avandia looked safe in its approved indications."
The FDA, which plans to have an advisory committee review Avandia and other drugs in the class, previously revealed its own analysis agreed with the NEJM study that Avandia raises the risk of heart attack but said there were other conflicting studies and that its evaluation was ongoing.
J.P. Morgan analyst Craig Maxwell presented a more dire future for Avandia, saying there's a 50 percent probability the drug could be pulled from the global market and even in a best-case scenario that the drug is not withdrawn, sales will decline by as much as 30 percent next year.
If Avandia is withdrawn from the market, GSK could also face "substantial class action litigation" resulting in approximately $5 billion in settlements, Maxwell stated in a research report.
Goldman Sachs analyst John Murphy, on the other hand, sees a more moderate future for Avandia. Murphy thinks a labeling change about the heart risks is the most likely outcome after the FDA's advisory panel discusses the issue.
"Our expected outcome of an advisory committee is a stronger labeling regarding cardiovascular event profile, similar to that in Europe," Murphy stated in a research report.
However, uncertainty will continue to surround Avandia in the coming months, with a congressional hearing planned next week and the FDA's advisory panel looming on the horizon.
© 2007 United Press International. All Rights Reserved.
This material may not be reproduced, redistributed, or manipulated in any form.
This material may not be reproduced, redistributed, or manipulated in any form.
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