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

The FDA warned A-S Medication Solutions over failures to comply with the Food, Drug & Cosmetic Act’s drug listing requirements, following a May 2016 review. Source: Drug Industry Daily

The FDA is seeking comment on a proposal to study how advertising disclosure statements and drug promotion affect consumers. Source: Drug Industry Daily

Patients are 266 percent more likely to not pick up brand-name medications after requesting them at a pharmacy, compared to generic prescriptions, according to the Association for Accessible Medicine’s annual…

In a case that may change how drug companies deal with patent infringement cases, the U.S. Supreme Court agreed to consider the constitutionality of the PTO’s inter partes review process,…

The FDA is planning a public workshop in July to evaluate the impact of abuse-deterrent formulations of opioid painkillers, and to find ways to better inform the agency’s regulatory approach,…