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The House Energy and Commerce Committee marked up and advanced a bill last week that would improve cost transparency for pharmacy benefit managers (PBM) by requiring that hospitals provide patients with itemized lists for “shoppable services,” including the amount the hospital has negotiated with third-party payers for such services. Read More
The European Medicines Agency (EMA), along with the regulatory authorities of three member nations, is starting a one-year pilot to test the use of electronic product information (ePI) for human medicines in the EU. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
A potential cure for amyotrophic lateral sclerosis (ALS) remained elusive this week as two pharma companies shuttered trials that just barely missed the efficacy mark. Read More
The clinical research industry is falling behind the innovation curve, says Ken Getz, executive director of the Tufts Center for the Study of Drug Development (CSDD), taking years — and sometimes decades — to evaluate, adopt and fully implement new technologies and methods. Read More
Over the past week, the FDA issued a notice of Abbott’s withdrawal of Cylert NDA, draft guidance on generally accepted scientific knowledge and final guidance on covariates in randomized clinical trials. Read More
The FDA issued four guidance documents on Thursday covering a variety of topics, including efficacy endpoints for antidiabetic drugs, adjusting for covariates in randomized clinical trials, electronic submission of study data and tissue containment systems used during power morcellation procedures.Read More
This month, our review of recent clinical trial results features a drug for anemia due to chronic kidney disease that saw success after an FDA complete response letter, positive results for an ovarian cancer treatment and a hemophilia therapy as well as a lymphoma drug trial derailed by a serious adverse reaction.Read More
A New Jersey federal judge has ruled that Mylan cannot pursue a generic version of Janssen Pharmaceuticals’ injectable schizophrenia drug, Invega Trinza. Read More