An appeals court reinstated a wrongful-death lawsuit against Teva Pharmaceuticals, saying the lower court improperly ignored witnesses’ expertise and sent it back to a California federal court for a new…

PhRMA, BIO and The Pew Charitable Trusts have banded together to ask Congress to include language in the fiscal 2018 appropriations bills to clarify the FDA’s power to regulate compounding…

The PTO invalidated two more AbbVie patents on dosing regimens for Humira after continuing challenges from Coherus, which plans to submit its biosimilar version of the blockbuster drug for FDA…

Following further reports of drug tampering, Australia’s Therapeutic Goods Administration expanded an ongoing recall to include Arrow Pharmaceuticals and Novartis’ Sandoz. Source: Drug Industry Daily

The FDA highlighted two fictional case studies it published on the role biomarker qualification plays in drug development — as part of a reorganization of the agency’s biomarker materials —…

The FDA published a set of revisions to an ICH supplement, answering industry questions on the evaluation of certain drugs’ potential to produce abnormal heart rhythms. Source: Drug Industry Daily