Regulatory

Are Biopharma Companies Ready for Today's Regulatory Challenges? The biopharmaceutical sector is rapidly evolving, with companies constantly innovating to develop new treatments for a variety of diseases. However, navigating the regulatory landscape remains a significant challenge. Stricter

The U.S. Food and Drug Administration (FDA) recently paused clinical trials for Novavax's combination COVID-19 and influenza vaccine, as well as its standalone flu vaccine. This unexpected halt was prompted by a serious adverse event involving motor neuropathy in a participant from the Phase 2

The biopharmaceutical industry has been shaken by the European Union's recent ban on Triton X-100, a detergent essential for preventing viral contamination in biologics and plasma-derived products. Since its enactment in 2021, this regulatory change has catalyzed a worldwide search for

As the U.S. presidential election looms, the conversation around pharmaceutical policies intensifies, with Vice President Kamala Harris and former President Donald Trump proposing divergent paths. Harris and Trump represent fundamentally different approaches to drug pricing reforms, reflecting

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