BioSpace News Archive

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• 

  Amit Patel

  Amit Patel is the vice president of Strategic Initiatives and Operations, Enterprise Medical Solutions at Indegene.
• 

  Policy

  Post-Chevron Legal Battles: Three Key Cases to Watch

  The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, power has shifted from federal agencies to the courts, with potential implications for everything from the FDA shortage list to CMS drug price negotiations.

  June 2, 2025

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  7 min read

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  Ben Hargreaves
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  Regulatory

  FDA Action Alert: Merck, Moderna, Gilead, Regeneron/Sanofi and More

  Arguably the most notable of the FDA’s upcoming decisions is that regarding Gilead’s twice-yearly HIV prophylaxis lenacapavir.

  June 2, 2025

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  6 min read

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  Tristan Manalac
• 

  Vaccines

  Moderna Wins FDA Approval for Next-Gen COVID-19 Vaccine Despite ‘Investor Nervousness’

  Jefferies analysts said the approval was largely expected and an “incremental positive” for Moderna amid questions about the FDA’s attitude toward mRNA and COVID-19 vaccines that have investors worried.

  June 2, 2025

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  3 min read

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  Nick Paul Taylor
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  Cancer

  Arcus Kidney Cancer Drug Casdatifan Advances to Challenge Merck’s Welireg

  Updated Phase I/Ib data in hand, Arcus will launch a Phase III trial as it aims to compete with Merck, whose drug secured approval for a type of kidney cancer in 2023.
  

  June 2, 2025

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  2 min read

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  Nick Paul Taylor
• 

  Artificial intelligence

  AstraZeneca Racks Up AI Partners, Seeking To Stop Cancer at All Stages

  AstraZeneca has put hundreds of millions of dollars into AI deals, with an eye toward not just accelerating the development of drugs that treat cancer after it appears but also in creating diagnostics that can catch cancer earlier than current methods allow.

  June 2, 2025

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  4 min read

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  Dan Samorodnitsky
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  Opinion

  Opinion: New FDA Guidelines Raise the Bar on Nitrosamine Testing for Pharma Industry

  Here’s how companies can ensure they’re in compliance with new requirements that go into effect in August.

  June 2, 2025

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  6 min read

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  Shankar Sankaran
• 

  Cancer

  Bicara Responds to Rival Merus With Early Survival Data at ASCO25

  Following Merus’ splash last month with a “best-in-disease profile” for its head and neck cancer bispecific, Bicara touted positive results for its monocolonal antibody, but analysts say Merus still has the upper hand.

  June 2, 2025

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  2 min read

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  David Adam
• 

  Deals

  BMS Commits up to $11B+ To Work With BioNTech on Solid Tumor Bispecific

  Bristol Myers Squibb is dropping at least $3.5 billion to jointly develop the bispecific antibody, which will race with Summit Therapeutics, Merck and Pfizer in the crowded PD-1/PD-L1xVEGF space.

  June 2, 2025

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  2 min read

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  David Adam
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  Obesity

  Amid Rough Waters, Regeneron Puts Nearly $2B on the Line For Chinese Obesity Drug

  Regeneron’s shares have declined nearly 17% following the failure of the company’s Dupixent follow-up itepekimab.

  June 2, 2025

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  2 min read

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  Dan Samorodnitsky