Regulatory & Compliance

Why Did the FDA Halt Novavax's COVID-Flu Vaccine Trials?
Management & Regulatory Why Did the FDA Halt Novavax's COVID-Flu Vaccine Trials?

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

EU Ban on Triton X-100 Spurs Global Innovation in Biopharma Industry
Management & Regulatory EU Ban on Triton X-100 Spurs Global Innovation in Biopharma Industry

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

Will Trump or Harris Shape the Future of US Drug Pricing Reforms?
Management & Regulatory Will Trump or Harris Shape the Future of US Drug Pricing Reforms?

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

Medicare Refines Drug Price Negotiation Process, Enhances Transparency
Management & Regulatory Medicare Refines Drug Price Negotiation Process, Enhances Transparency

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

Which FDA Decisions Will Shape the Biopharma Market in Q4 2023?
Management & Regulatory Which FDA Decisions Will Shape the Biopharma Market in Q4 2023?

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

Can Europe Overcome Challenges to Lead Biopharma Innovation Again?
Management & Regulatory Can Europe Overcome Challenges to Lead Biopharma Innovation Again?

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 path

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