FDA

Sanofi's Lovenox patents 'unenforceable'

admin — Thu, 15 May 2008 06:59:56 -0400

Will the way soon be clear for a generic form of Lovenox? Sanofi-Aventis just lost a bid to save its Read more...

The FDA's surprising plea for cash

admin — Wed, 14 May 2008 06:59:55 -0400

Finally, FDA chief Andrew von Eschenbach is crying uncle. After weeks of pressure from Congress to request more money for the agency--and weeks of Read more...

How the FDA will spend your fees

admin — Thu, 08 May 2008 06:59:55 -0400

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

admin — Wed, 07 May 2008 06:59:56 -0400

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

admin — Tue, 06 May 2008 06:59:54 -0400

UCB Pharma was delirious with glee when it managed to launch its new TNF inhibitor Cimzia for Read more...

FDA backpedals on inspection funding

admin — Fri, 02 May 2008 06:59:58 -0400

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

admin — Wed, 30 Apr 2008 06:59:56 -0400

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

admin — Tue, 29 Apr 2008 06:59:58 -0400

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

admin — Mon, 28 Apr 2008 06:59:52 -0400

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

admin — Thu, 24 Apr 2008 06:59:55 -0400

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...