Topic:
Regulatory
Latest Headlines
Latest Headlines
Novo CEO scolds European officials for 'empty promises' on new drugs
If austerity-minded governments aren't willing to pay for new drugs, then his company may have to choose not to launch new products there, choosing on a country-by-country basis where to do so.
Colitis nod puts J&J's Simponi one step closer to blockbuster
Johnson & Johnson's new-generation rheumatoid arthritis drug now has a new approval in ulcerative colitis. Simponi, which J&J developed as a follow-up to its top-selling autoimmune therapy Remicade, could leap to blockbuster status with the help of this new indication, analysts say.
St. Jude snags CE mark for 3-D stent imaging
St Jude Medical has won European clearance for the Ilumien Optis PCI Optimization System, technology designed to help treat coronary artery disease by modeling vessels and guiding stent placement.
Recalls jump 32% in first quarter
The FDA cast a wider net this year as it sent inspectors into what it called 30 "high risk" compounding pharmacies, those that made sterile drugs that can easily be contaminated. The attack has had a pronounced effect on the number of recalls the agency has ordered.
Hospira hit with another FDA warning letter over pumps
Hospira is back in the FDA's spotlight as the agency issued another warning letter over problems in the company's infusion pump manufacturing, this time targeting the device Hospira hopes to carry it back to revenue growth.
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.
