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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, which allows the validity of patents to be challenged based on whether their claims are considered obvious at the time they are awarded. Read More
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, following recently renewed calls to action. Read More
The Senate Health, Education, Labor and Pensions Committee sought to answer basic questions on what is driving drug prices sky high, in a Tuesday hearing ostensibly dedicated to the pharmaceutical industry — though it was frequently derailed by Democrats’ concerns over Republican efforts to repeal and replace the Affordable Care Act. Read More
The EMA says it will continue to invite patients to in-person discussions between reviewers and product sponsors — following a successful two-year pilot project involving five medicines. Read More
The European Commission has opened a formal antitrust investigation into South African manufacturer Aspen Pharma over concerns of excessive pricing of five cancer medicines. Read More