Topic:
Regulatory
Latest Headlines
Latest Headlines
Elixir bolsters recent CE mark with successful pivotal trial
Less than a week after securing a CE mark for its DESolve drug-eluting stent, Elixir Medical reported successful results in a pivotal trial of the same device, which should reach the market by the end of this year.
Abbott CE mark covers extra-long stent size
In the fiercely competitive global stent market, Abbott seems to view size as mattering most.
Vermont passes assisted-suicide law, with drug-dispensing safeguards
The law includes safeguards, including requirements that terminally ill patients ask for the requisite drugs three times before they're actually dispensed.
Impax calls on former Teva, Watson execs to confront FDA issues
Having failed so far to get its extended-release Parkinson's drug Rytary to market, Impax Laboratories ($IPXL) is turning to asking three big-name specialists what it should do.
Will U.K. watchdogs change their minds on Avastin in ovarian cancer?
The U.K.'s cost-effectiveness police have been arresting Roche's Avastin development efforts once again. As Cover magazine reports, the National Institute for Health and Clinical Excellence has nixed two proposed uses for the drug in ovarian cancer, one of the hardest-to-treat forms of the disease.
UPDATED: German cops seize Boston Scientific stents in cutthroat patent fight
OrbusNeich Medical called the cops on Boston Scientific in Germany in a nasty escalation of their ongoing stent patent dispute.
Impax brings in big guns to get on top of manufacturing problems
Impax Laboratories is bringing in the big guns to help it accomplish what it has been unable to do on its own.
Sequester cuts threaten FDA's access to industry user fees
According to AdvaMed, the user fees that industry players contribute to the FDA, money that currently helps the agency retain staff and support programs, may now take a hit to the tune of about $2.9 million.
Supreme Court takes up Medtronic, Boston Scientific patent spat
The lengthy patent dispute between Medtronic and Boston Scientific will end in the nation's highest courtroom, as the Supreme Court has agreed to hear Medtronic's plea to avoid paying cardiac device royalties.
Covidien O2 saturation measurement devices win FDA's 510(k)
Covidien nailed down a 510(k) clearance, this time for a group of next-generation Nellcor pulse oximetry monitoring devices--a regulatory win that will likely help fuel continued robust growth in the line.
