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A revised report from the Institute for Clinical Evaluation and Research (ICER) has reiterated that two experimental gene therapies for sickle cell disease (SCD) would likely be cost-effective if priced at $2 million. Read More
The European Medicines Agency (EMA) is conducting a safety review of GLP-1 receptor agonists such as Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide) following 150 reports from the Icelandic Medicines Agency of suicidal thoughts and self-injury in people using one of the drugs for weight loss or type 2 diabetes. Read More
The CMS notice comes after U.S. Supreme Court decision that ruled the agency had underpaid for 340B medications from 2018 through most of 2022. Read More
EMA has issued revised guidance for its PRIority MEdicines (PRIME) scheme that provides early consultation and scientific advice between applicants and regulators for medicines under development and not currently authorized in the EU. Read More
Optimizing dietary management during drug trials is critical to accurately assessing drug efficacy in clinical trials for inborn errors of metabolism (IEM), the FDA says in a new draft guidance. Read More
CMS has issued a proposed rule that aims to spend $9 billion to reimburse nearly 1,650 hospitals participating in the 340B drug discount program for underpayment of fees over the past five years. Read More
Novo Nordisk has sought legal action against 10 medical spas, weight loss and wellness clinics, and compounding pharmacies in four states for illegally selling non-FDA-approved compounded and counterfeit semaglutide products. Read More
The European Medicines Agency (EMA), the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the “extraordinary regulatory flexibilities” that were put in place during the COVID-19 pandemic to ease potential medicine shortages. Read More
Use of real-world data (RWD) and real world evidence (RWE) continues to gain traction in countries around the world, as seen in a draft reflection paper endorsed by the International Council on Harmonisation and issued for comment by the European Medicines Authority (EMA). Read More