Topic:
Regulatory
Latest Headlines
Latest Headlines
Pradaxa leads FDA MedWatch list of fatalities
Boehringer Ingelheim's blockbuster anticoagulant Pradaxa resulted in more reports to the FDA of fatalities of than any other drug last year.
FDA slams Siemens for marketing test without PMA approval
The FDA has cited Siemens Healthcare's diagnostics arm for marketing a diagnostic test system used to assess everything from allergies to anemia and hepatitis without formal approval.
House would cut $16 million from FDA funding
A proposed House subcommittee budget would stick it to the FDA next year, proposing not only lower total dollars in FDA discretionary spending than suggested by the White House and Senate, but $16.3 million less than the current year.
U.K. pharma balks at value-based pricing ideas
Drugmakers are squaring off against the U.K.'s price-setting proposals.
Stryker offers $33M to settle DOJ knee implant inquiry
Stryker ($SYK) expects it will pay $33 million to settle a federal investigation into the sales and marketing of its OtisKnee implant.
FDA hits trap door button on Merck's weak ridaforolimus bid
In another self-inflicted wound for Merck, the FDA has handed back its new drug application for ridaforolimus, saying the pharma giant will need to run additional clinical trials to test its effectiveness on sarcomas before it can issue an approval.
FDA wants more info on pen delivery for Amylin's Bydureon
Amylin is looking to expand Bydureon, its Type 2 diabetes drug, with a new drug delivery method: pre-filled injection pens instead of syringes.
Zogenix looks to expand DosePro tech with drug app
Zogenix has filed an investigational new drug application with the FDA for Relday, a schizophrenia treatment that uses the company's DosePro drug delivery tech.
WuXi PharmaTech speaks out on compound theft by former employee
WuXi PharmaTech calls the 2011 incident the only known case of its kind in its 11-year history.
Device tax repeal would cost $30B over a decade, CBO says
As the U.S. House of Representatives gears up to vote on a bill that would repeal the 2.3% device industry tax this week, the Congressional Budget Office says the measure will place a hefty price tag on the federal budget.
