Latest Headlines

Latest Headlines

Yaz plaintiffs ask judge to weigh alleged FDA conflicts

Plaintiffs in the Yaz and Yasmin litigation are asking U.S. District Judge David Herndon to check out evidence of possible conflicts-of-interest on an FDA advisory panel that considered the pills'

FDA didn't disclose safety panel's ties to Bayer, WSJ says

When an FDA advisory panel voted to support Bayer 's birth control pills after new data emerged on their potential to cause blood clots, the agency didn't disclose that three of the committee members

NICE wants more data on Bayer's Xarelto

U.K. cost-effectiveness watchdogs aren't quite convinced about Bayer 's anti-clotting drug Xarelto. The National Institute for Health and Clinical Excellence says it's asking Bayer for more data on

Judge calls off Yaz trial, orders suits into mediation

The first Yaz trial won't open as scheduled. A federal judge delayed the bellwether patient lawsuit, set for trial next week, and appointed a special master to mediate instead. And this special

Bayer predicts blockbuster success for four of its late-stage drugs

You can count Bayer among the Big Pharma companies unwilling to back down from their multibillion-dollar gambles on drug research. The company boldly predicted that four of its late-stage programs

EU brings Bayer's Xarelto into German market

Bayer has now gotten European regulators to sign off on selling its stroke prevention drug Xarelto in Germany, barely a month after the FDA approved the drug for sale in the U.S. The approval is a

Bayer bracing for profit-margin drop

Bayer 's profit margins are dropping as a result of the European debt crisis. The German drug giant is responding as any cautious drug company would--by stocking up on cash, Reuters is reporting.

FDA panel wants label change for Yaz, Yasmin

An FDA advisory committee backed Bayer's ($BAY) birth control pills Yaz and Yasmin in a 15-11 vote yesterday, saying their benefits outweigh their risks. But the panel also recommended changes to the

Ampio to seek foreign OKs for premature ejaculation drug

Ampio Pharmaceuticals ($AMPE) is gearing up to seek international regulatory approval for its drug to treat premature ejaculation. The company disclosed Dec. 5 that it is preparing for this, in part,

Ex-FDA chief: Bayer held back Yasmin safety info

FDA reviewers are calling for more research on the safety of newer birth-control pills. The agency's expert panelists are gearing up to weigh evidence at a meeting later this week. Canadian