Quantum BioPharma Ltd., a biotech firm specializing in neurodegenerative and metabolic disorders, has recently taken legal action against CIBC World Markets and RBC Dominion Securities. The lawsuit, filed in the United States District Court for the Southern District of New York, claims that these
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
