Johnson & Johnson/Bayer’s Xarelto (rivaroxaban) received FDA approval for stroke prevention in atrial fibrillation (SPAF), the second novel anticoagulant to gain US marketing approval for SPAF.
The Supreme Court struck a blow to FDA pre-emption of state laws with a 6-3 decision in Wyeth v. Levine finding the company liable for a failure-to-warn claim under Vermont state law.
Monthly Prescribing Reference (MPR) has relaunched its website with a number of enhancements to functionality and design, as well as a new, easier-to-remember URL, www.eMPR.com.
Waxman: FDA career staff objected to preemption policies
Career staffers at the FDA objected to new drug labeling regulations that favor pre-emption of state liability lawsuits, according to a report from Rep. Henry Waxman’s Committee on Oversight and Government Reform.
The FDA on Wednesday announced it is proposing revisions to physician labeling for Rx drugs to include more info about their use by pregnant and/or breast-feeding mothers.
King reduces workforce by 20%, cuts mostly sales jobs
King Pharmaceuticals will cut 20% of its 2,600 employee workforce after a federal appeals court judge ruled against a patent extension on the company’s blood pressure treatment Altace.
Amgen seeks to ease investor concerns as staff cuts loom
FDA rang in the era of personalized medicine with a labeling change on blood thinner warfarin cautioning that patients with either of two genetic variations might respond differently to the drug, which is sold by BMS under the Coumadin brand.