BioSpace News Archive

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• 

  Manufacturing

  Companies Confront Challenge of Making Bespoke mRNA Therapies Fast

  To tailor cancer therapies to individual patients, Moderna, BioNTech and other companies are rethinking how they optimize manufacturing schedules and resources.

  October 21, 2025

   · 

  4 min read

   · 

  Nick Paul Taylor
• 

  Lung cancer

  Summit Eyes 2025 FDA Application for Ivonescimab Despite Overall Survival Miss

  In May, Summit released early data from the Phase III HARMONi study showing that while the PD-1/VEGF inhibitor resulted in significant progression-free survival improvements, it fell short of the overall survival bar.

  October 21, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Cancer

  Exelixis’ Kinase Blocker Sets ‘New Survival Bar’ in Third-Line Colorectal Cancer, Opening Road to FDA

  With data from the Phase III STELLAR-303 study in the books, Exelixis is plotting a 2025 regulatory application for zanzalintinib.

  October 21, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  FDA

  Krystal Biotech’s FDA Platform Designation Pushes Limits of the Award

  The company’s technology, a modified herpes simplex virus used to deliver gene therapies, was given the FDA’s new designation based on its approved topical skin cream. What this will mean for Krystal’s still-in-development eye drop is unclear.

  October 21, 2025

   · 

  2 min read

   · 

  Dan Samorodnitsky
• 

  IN PARTNERSHIP WITH ELEMENT

  Cost Control to Capability Building: Rethinking Supply and Strategy in Pharma

  In this episode presented by Element Materials Technology, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney will explore how healthcare and pharmaceutical players are rethinking their strategies amid global supply chain disruption.

  October 21, 2025

   · 

  1 min read

   · 

  BioSpace Insights
• 

  Cell therapy

  Galapagos Exits Cell Therapy, Cuts 365 Employees

  Galapagos at the start of the year had planned to split into two businesses, with one resulting entity focused on cell therapies. The biotech nixed these plans a few months later, instead choosing to put up for sale multiple cell therapy assets.

  October 21, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Neuropsychiatric disorders

  Neuphoria’s Social Anxiety Drug Flunks Late-Stage Trial

  The company is dropping its social anxiety disorder program but will still test the molecule in post-traumatic stress disorder.

  October 21, 2025

   · 

  2 min read

   · 

  Dan Samorodnitsky
• 

  C-suite

  Novo Foundation Replaces Pharma’s Board, Revealing Deep Divisions Over Leadership

  Seven Novo Nordisk board members have resigned. The new board headed by former Novo Nordisk CEO Lars Rebien Sørensen will align behind the new CEO’s massive restructuring plan.

  October 21, 2025

   · 

  4 min read

   · 

  Annalee Armstrong
• 

  Metabolic disorders

  Ascendis Skids as FDA Detects Death in Patient Formerly on Yorvipath

  The death occurred in a patient who had a complex medical background and who was being managed with several drugs, according to RBC Capital.

  October 21, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• Press Releases

  Immatics Highlights Compelling Anti-Tumor Activity of Anzu-cel PRAME Cell Therapy in Metastatic Uveal Melanoma at the ESMO 2025 Presidential Symposium

  October 21, 2025

   · 

  9 min read