Regulatory

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

Sanofi Boosts Beyfortus Output for RSV Season with FDA Approval
Management & Regulatory Sanofi Boosts Beyfortus Output for RSV Season with FDA Approval

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

How Will Overturning Chevron Doctrine Affect Biopharma Industry?
Management & Regulatory How Will Overturning Chevron Doctrine Affect Biopharma Industry?

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

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