Topic:
Regulatory
Latest Headlines
Latest Headlines
Vascular Solutions sues Boston Scientific for 'blatant' patent infringement
Vascular Solutions is suing Boston Scientific, claiming the company's Guidezilla extension catheter infringes on its patents and asking a Minnesota court to hault the device's sale.
Thoratec wins FDA nod for HeartMate controller
Thoratec scored the FDA's blessing to market a next-generation controller for the HeartMate II implant, giving the company a user-friendly face for its market-leading left ventricular assist device.
EMA says Bayer's Diane-35 has more benefit than risk
France drug regulator in January yanked Bayer's contraceptive Diane-35 off the market and insisted the European Medicines Agency investigate its off-label use as an acne treatment and its risks of blood clots. The EMA has done that and has come down in support of the drug, even for the off-label use.
Shorter Tryton side branch stent wins CE mark
Tryton Medical won a CE mark for a short version of its Side Branch Stent to treat bifurcated lesions, a crucial step toward reaching more patients and pursuing the company's U.S. approval pathway.
J&J will abandon metal hip replacement sales
Johnson & Johnson has had enough with metal-on-metal and ceramic-on-metal hips, disclosing that it will leave those business lines entirely behind by the end of 2014.
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.
