Topic:
Regulatory
Latest Headlines
Latest Headlines
Bayer's radiotherapy Xofigo wins FDA nod in prostate cancer
The FDA has hit the green light for Xofigo--initially called Alpharadin or radium-223 chloride--for castration-resistant prostate cancer.
Prosecutors want jail time, fine for disgraced PIP CEO
The long and colorful Poly Implant Prothèse saga is slowly drawing to a close, as prosecutors are asking for a four-year jail sentence and $128,000 fine for the CEO who presided over the sale of faulty breast implants to thousands of women.
UPDATED: FDA OKs pinpoint prostate cancer radiation drug Xofigo from Bayer, Algeta
The approval comes just three months after the FDA granted priority review status for Alpharadin, a radiopharmaceutical from Bayer and Norway's Algeta that will now enter an increasingly competitive--and growing--market.
Roche wins new targeted OK for Tarceva in EGFR-positive lung cancer
Along with its partner, Astellas, Roche has won FDA approval for a new, first-line use for its lung cancer drug Tarceva in patients whose cancers test positive for specific mutations of the EGFR gene. Roche also got the nod for a diagnostic test to identify eligible patients.
Elixir snags CE mark for dissolvable stent
While Abbott Laboratories leads the way in the dissolvable stent market, California's Elixir Medical is right on its heels, winning CE mark approval for the DESolve device.
Suspicious lawmakers query FDA's Hamburg on sudden departure of deputy commish
A revolving door inside the FDA has captured the attention of a group of Republican lawmakers in Congress. Just a few months after Leona Brenner-Gati was named Acting Deputy Commissioner for Medical Products and Tobacco to replace the outgoing Steven Spielberg, who served only a brief stint at the post, Brenner-Gati is gone as well.
Bard forks over $48.3M to settle kickback lawsuit
C.R. Bard will fork over $48.3 million to settle allegations that it resorted to kickbacks to boost the use of its radioactive brachytherapy seeds to treat prostate cancer.
Boston Scientific accused of circumventing sale injunction in stent patent fight
OrbusNeich Medical accuses Boston Scientific of using a U.K. subsidiary to circumvent a preliminary court injunction in Germany that prevented the sale of some of its stents at the center of a patent dispute between the two companies.
Ranbaxy inks record-setting $500M manufacturing settlement with the feds
The India-based generics maker pleaded guilty to U.S. drug safety violations and agreed to pay $500 million in penalties, in the largest-ever federal settlement with a maker of copycat drugs.
Invacare takes steps to get out from under FDA
Invacare has been hamstrung by an FDA consent decree, halting production at an Ohio plant, but the company is moving back toward normalcy, completing the first of three audits.
