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Marketing authorization holders, wholesalers, distributors and manufacturers should have a shortage prevention plan specific to their role and strengthen the reliability and resilience of their supply chains to help prevent a drug shortage, according to a new guidance from the European Medicines Agency. Read More
The U.S. Supreme Court (SCOTUS) on Thursday struck down Amgen’s attempt to revive patents on its cholesterol medicine Repatha (evolocumab), effectively preventing the company from monopolizing an entire class of drug antibodies. Read More
The FTC and Congress were on the same drug pricing track this week as the trade commission extended an inquiry into pharmacy benefit managers’ (PBM) impact on the cost of prescription drugs and a House subcommittee unanimously voted in favor of a bill requiring hospitals to identify standard charges, including drugs. Read More
FDA Commissioner Robert Califf said Alzheimer’s disease drugs and glucagon-like peptide-1 (GLP-1) agonists for diabetes and obesity could be “major game changers in the ongoing battle with chronic diseases that cause the vast majority of death and disability in our country.” Read More
Two draft guidances released by the FDA on Wednesday aim to reduce lag time between approval of a drug for adult use and its subsequent pediatric approval by clarifying requirements and processes for pediatric drug development. Read More
The Securities and Exchange Commission (SEC) announced Monday that Quanta and two of its top executives have agreed to settle fraud charges brought against the company, stemming from statements the company made related to a proposed COVID-19 treatment in 2021. Read More
The FTC announced Tuesday that it is suing to block Amgen from its intended $27.8 billion acquisition of Horizon Therapeutics, claiming the buy would create a monopoly on drugs used to treat two serious illnesses. Read More
The FDA is seeking feedback on a discussion paper focused on using AI and machine learning (ML) in drug development as well as in the development of medical devices intended to be used with drugs. Read More
Four bills aimed at encouraging drug development and controlling costs survived markup by the Senate Health, Education, Labor and Pensions (HELP) Committee on Thursday, lining them up for consideration and vote by the full chamber. Read More
A U.S. District Court in Illinois has ordered Eli Lilly to pay triple damages — $183.7 million — for violating the False Claims Act by underpaying rebates to Medicaid. Read More