Skip to main content

Regulatory and Washington

  • Lilly receives complete response letter for liprotamase

    INDIANAPOLIS — The Food and Drug Administration declined to approve a drug made by Eli Lilly for treating a disease of the pancreas that often occurs in patients with cystic fibrosis, Lilly said.

  • Report: Kansas makes switch to NPLEx system to track pseudoephedrine sales

    TOPEKA, Kansas — Kansas on Monday officially made the move from a paper tracking system for pseudoephedrine sales to the electronic tracking capabilities afforded through the National Precursor Log Exchange, according to an Associated Press report published Monday. Kansas first announced its intent to switch over to NPLEx in March 2010.

  • CDC experts spotlighted in 'Killer Outbreaks'

    ATLANTA — The Centers for Disease Control and Prevention is participating in a new docudrama that debuts on Animal Planet beginning Friday at 9 p.m., the agency announced earlier this week.

    Animal Planet has ordered six episodes of the new series “Killer Outbreaks.” Each episode features potentially deadly viruses and includes commentary from CDC experts and victims of the outbreaks. "Killer Outbreaks" began production in March 2010, and in total, producers interviewed 43 subject matter experts from across the agency.

  • PhRMA honors scientists that helped discover Januvia

    JERSEY CITY, N.J. — The main trade group representing branded drug makers gave an award to two Merck scientists who helped discover an oral medication for Type 2 diabetes.

  • Takeda's Edarbi enters market

    DEERFIELD, Ill. — Takeda Pharmaceutical has launched a new treatment for high blood pressure, the company said Friday.

    Takeda announced the launch of Edarbi (azilsartan medoxomil), which the Food and Drug Administration approved on Feb. 25 as a once-daily pill for hypertension.

  • Abbott Diagnostics seeks FDA approval for vitamin D assay

    ABBOTT PARK, Ill. — Abbott Diagnostics on Friday announced its filing of a submission for clearance by the Food and Drug Administration for a fully automated vitamin D assay performed on its Architect testing system for use by healthcare professionals.

    "Increasing interest in vitamin D is fueling a surge in orders for tests as more healthcare professionals and consumers become aware of the rising prevalence of vitamin D deficiencies in otherwise healthy people and the potential health risks," stated Sudarshan Hebbar, senior medical director of Abbott Diagnostics.

  • FDA: Certain TNF blockers could be linked to rare cancer

    SILVER SPRING, Md. — The Food and Drug Administration has received reports of a rare and usually deadly cancer in patients using a class of biotech drugs to treat autoimmune and inflammatory diseases, the agency said Thursday.

  • First Dietary Supplement Caucus briefing hosted for the 112th Congress

    WASHINGTON — The congressional Dietary Supplement Caucus held its first briefing for the 112th Congress April 6 to a capacity crowd of 60 House and Senate staffers, the caucus announced Thursday.

    The DSC recently was relaunched for the 112th Congress. The caucus serves as a bipartisan, bicameral group of members to facilitate discussions among lawmakers about the benefits of dietary supplements, provide tips and insights for better health and wellness, and promote research into the healthcare savings provided by dietary supplements.

X
This ad will auto-close in 10 seconds