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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 trial. Read More
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 pharmacies. Read More
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 approval later this year. Read More
Following further reports of drug tampering, Australia’s Therapeutic Goods Administration expanded an ongoing recall to include Arrow Pharmaceuticals and Novartis’ Sandoz. Read More
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 — to help drugmakers understand the validation studies necessary to support qualification, the collaborative efforts involved and the potential benefits. Read More
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. Read More