We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The Ironworkers District Council of New England Health and Welfare Fund has filed a class action complaint against Teva Pharmaceuticals accusing the company of a nearly decade-long anticompetitive scheme to delay generic competition for its QVAR (beclomethasone dipropionate HFA) asthma inhalers. Read More
An FDA advisory committee turned down Intercept Pharmaceuticals’ push for an Accelerated Approval for its fatty liver drug Ocaliva (obeticholic acid) by a 15-1 vote, but did leave the door open for full approval if data from an ongoing phase 3 trial show Ocaliva’s benefits outweigh its risks. Read More
Center for Biologics Evaluation and Research (CBER) Director Peter Marks and Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni laid out their centers’ current priorities and how they’re tackling ongoing challenges in separate sessions at the FDLI Annual Conference, May 17-18. Read More
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