FDA news from FiercePharma
NewsHow 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...
AZ stock falls on Symbicort patent loss
What a difference one patent ruling can make. AstraZeneca lost almost $1.3 billion in market value today after announcing that the European Patent Office yanked a patent covering its blockbuster Read more...
Quick Cimzia launch overjoys UCB
UCB Pharma was delirious with glee when it managed to launch its new TNF inhibitor Cimzia for 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...
J&J laying off 400 in marketing overhaul
With Procrit under siege, Johnson & Johnson wants to divert its promotional efforts elsewhere--a strategy that will lead to some 400 job cuts in its sales-and-marketing ranks. The company told Read more...
Wyeth to slash another 1,200 jobs
And the ax is falling again. Wyeth notified employees last Friday than another 1,200 jobs will be slashed from the payroll. That's on top of the Read more...
SPOTLIGHT: AstraZeneca wants FDA ad review
AstraZeneca is lobbying Congress for FDA review of television ads. Last fall lawmakers created a program that would require up-front scrutiny of DTC ads, but didn't give the FDA authority to collect Read more...
Pharma drags feet on promised studies
We once saw a sign in a newsroom that said, "Deadlines, schmedlines, as long as I get paid." Maybe Big Pharma has similar signage posted at its various HQs. According to newly released FDA Read more...
SPOTLIGHT: Shire gets Vyvanse nod for adult use
Shire got its longed-for blessing from the FDA to sell Vyvanse, an ADHD treatment, for use in adults. Some one-third of Vyvanse scrips already go to grownups, off-label, but the FDA OK will let Read more...
FDA Commish chided over import safety
FDA Commissioner Andy von Eschenbach found himself in the hot seat again at a Congressional Read more...
| Press ReleasesPRESS RELEASE: FDA Announces Steps to Improve Advisory Committee Processes FDA Announces Steps to Improve Advisory Committee Processes The Food and Drug Administration is announcing several steps to strengthen its advisory committee processes in ways consistent with Read more... PRESS RELEASE: FDA Sends Sanofi Warning Letter for Ketek Study FDA Sends Sanofi Warning Letter for Ketek Study ROCKVILLE, Md., Oct. 24, 2007--The FDA posted on its web site a letter to Sanofi-aventis regarding a study with the antibiotic Ketek. DEPARTMENT OF Read more... PRESS RELEASE: OIG Releases Report of FDA’s Oversight of Clinical Trials OIG Releases Report of FDA’s Oversight of Clinical Trials, Concludes Improvement of Information Systems and Processes is Needed WASHINGTON, Sept. 28, 2007—Weaknesses in the Food and Drug Read more... PRESS RELEASE: FDA Clears Genetic Lab Test for Warfarin Sensitivity FDA Clears Genetic Lab Test for Warfarin Sensitivity The U.S. Food and Drug Administration today cleared for marketing a new genetic test that will help physicians assess whether a patient may be Read more... PRESS RELEASE: Cephalon Warns Doctors Over Pain Drug Deaths Says FDA Cephalon Warns Doctors Over Pain Drug Deaths Says FDA FRAZER, Pa., Sept. 13 -- Cephalon, Inc. today communicated with healthcare professionals to clarify the appropriate patient selection, dosing Read more... |
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