drug safety news from FiercePharma
NewsDid GSK ignore early abacavir warning?
Back in 2005, Swedish pharma monitors raised a red flag on the HIV fighter abacavir and its possible link to heart attacks, The Independent is reporting. Thirty-four patients taking abacavir had Read more...
How the FDA will spend your fees
Curious how the FDA might spend its PDUFA fees? A new five-year plan shows that FDA will plow the money into post-marketing safety to meet its commitments under the new law passed last fall. The Read more...
FDA backpedals on inspection funding
Now you see it, now you don't. Congress thought--or pretended to think, you never know on Capitol Hill--that the FDA had ball-parked the funding it needs to beef up foreign inspections. That would Read more...
Enbrel gets black-box infection warning
Enbrel's new black box is now official. Wyeth and Amgen have put the final touches on a Read more...
FDA aims to hire 1,300 by October
In answer to its critics, FDA is mounting a major hiring push to expand its drug safety operations. By October, it hopes to add 1,300 to its payroll--600 new positions and 700 vacancies that have Read more...
Merck warned on vaccine plant problems
Last week, we heard the warning would be coming. And here it is. The FDA has Read more...
Safety questions on Fosamax, Actos, et al.
It must be tough for pharma execs to open a newspaper these days. If reporters aren't going on about Read more...
FDA: Drugmakers responsible for safety
Congress may be all fired up about funding more foreign inspections by the FDA, but the agency itself? Not so much. In Read more...
Regulators find problems at Merck plant
FDA inspectors found 49 problems at Merck's West Point, PA, vaccine plant--problems independent experts called "serious concerns." Among the issues cited were fibers on the stoppers of vaccine vials, Read more...
U.S., China trade blame on heparin
Call it the blame game. The U.S. FDA says it's traced contaminated heparin back to 12 companies in China. Chinese officials, however, claim the problem started in the U.S.--and they plan to visit a Read more...
| Press ReleasesPRESS RELEASE: FDA's Safety Reviews of Prilosec and Nexium Find No Evidence of Increased Rates of Cardiac Events FDA's Safety Reviews of Prilosec and Nexium Find No Evidence of Increased Rates of Cardiac Events Background: On May 29, 2007 AstraZeneca, the maker of Prilosec (omeprazole) and Nexium Read more... PRESS RELEASE: Merck Agreement to Resolve U.S. VIOXX Product Liability Lawsuits Merck Agreement to Resolve U.S. VIOXX® Product Liability Lawsuits Agreement Provides for $4.85 Billion Payment WHITEHOUSE STATION, N.J., Nov. 9, 2007 - Merck & Co., Inc. today announced Read more... SPEECH: President Bush Discusses Import Safety President Bush Discusses Import Safety THE PRESIDENT: Thank you all. Good afternoon. I just had an important briefing from Secretary Leavitt and other members of the inter-agency working group on Read more... PRESS RELEASE: Fact Sheet: Import Safety Action Plan: Increasing Protection of American Consumers Fact Sheet: Import Safety Action Plan: Increasing Protection of American Consumers Interagency Working Group On Import Safety Presents Action Plan To President Bush Today, the Interagency Working Read more... PRESS RELEASE: GlaxoSmithKline responds to JAMA articles GlaxoSmithKline responds to JAMA articles PHILADELPHIA, PA–September 11, 2007 - GlaxoSmithKline believes that conclusions drawn from the most recent meta-analyses published by Drs. Nissen et. al. Read more... |
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