The U.S. government, through the Centers for Medicare and Medicaid Services (CMS), has unveiled fresh modifications to its drug price negotiation process under Medicare. These changes aim to enhance transparency and efficacy as the second round of talks with pharmaceutical manufacturers looms on
Over the next three months, the U.S. Food and Drug Administration (FDA) will be issuing several pivotal decisions that could significantly impact the biopharma market. In particular, FDA approvals are pending for five critical drugs from companies such as BridgeBio Pharma, AstraZeneca, Daiichi
Europe's rich heritage in pharmaceutical innovation has significantly shaped the global landscape. Yet, recent decades have seen this continent cede its leading position to the U.S. and witness emerging markets like China and India surge ahead. The question now is whether Europe can chart a
Sanofi is gearing up to address the rising demand for its respiratory syncytial virus (RSV) antibody drug, Beyfortus, by leveraging a recently approved manufacturing line. The company's proactive measures aim to ensure that there is no repeat of last year's shortages, which created
The recent decision by the Supreme Court to overturn the Chevron doctrine marks a significant shift in administrative law, with profound implications for the healthcare industry, particularly for federal regulators like the FDA (Food and Drug Administration) and the CMS (Centers for Medicare
In a significant milestone for the biopharmaceutical industry, AGC Biologics' Seattle site successfully underwent a multi-product inspection by the U.S. Food and Drug Administration (FDA) in March 2024. This comprehensive evaluation was aimed at supporting Biologics License Applications (BLA)
