BioSpace News Archive

Year

• 2005
• 2006
• 2007
• 2008
• 2009
• 2010
• 2011
• 2012
• 2013
• 2014
• 2015
• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025

Month

• January
• February
• March
• April
• May
• June
• July
• August
• September
• October
• November
• December

Day

• 2
• 3
• 4
• 5
• 6
• 7
• 10
• 11
• 12
• 13
• 14
• 17
• 18
• 19
• 20
• 21
• 24
• 25
• 26
• 27
• 28

• 

  Manufacturing

  As CGT Struggles To Scale, FDA’s New Designation Could Smooth Post-Approval Pivots

  Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.

  November 25, 2025

   · 

  4 min read

   · 

  Nick Paul Taylor
• 

  Government

  Former DARPA Official Jackson Named ARPA-H Head

  Alicia Jackson formerly served as deputy director of the Biological Technologies Office at the Defense Advanced Research Projects Agency.

  November 25, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Weight loss

  Lilly Redefines the Pharma Mega-Blockbuster

  Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.

  November 25, 2025

   · 

  2 min read

   · 

  Annalee Armstrong
• 

  Obesity

  Novo Bounces Back With ‘Competitive’ Mid-Stage Weight Loss Data for Amycretin

  Novo Nordisk’s amycretin showed no weight-loss plateau over 36 weeks in patients with type 2 diabetes, suggesting its efficacy could become even stronger with longer follow-up, according to analysts at BMO Capital Markets.

  November 25, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  FDA

  Pazdur Questions Safety, Legality of FDA’s Expedited Drug Approval Programs

  Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several FDA initiatives seeking to shorten the drug review process.

  November 25, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Cancer

  ASH25: Late-Stage Data For J&J’s Tecvayli/Darzalex Combo Could ‘Shift Paradigm’ in Myeloma

  Tecvayli plus Darzalex led to an 83% boost to progression-free survival versus the current standard therapy in relapsed or refractory multiple myeloma, results analysts at Guggenheim Securities called “remarkable.”

  November 25, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Approvals

  Novartis Expands Spinal Muscular Atrophy Gene Therapy Market With FDA’s Itvisma Greenlight

  The FDA approved an intrathecal form of Novartis’ spinal muscular atrophy gene therapy Zolgensma on Monday, broadening access to patients two years and older in what one Stanford Medicine professor called a “game changing advance” for the field.

  November 25, 2025

   · 

  3 min read

   · 

  Heather McKenzie
• 

  Mergers & acquisitions

  Avidity Played Hardball To Land Favorable Terms in $12B Novartis Deal

  At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise.

  November 25, 2025

   · 

  3 min read

   · 

  Annalee Armstrong
• Press Releases

  LivaNova’s VNS Therapy for Drug-Resistant Epilepsy Procedures Receives Increased Provider Reimbursement from U.S. Centers for Medicare & Medicaid Services

  November 25, 2025

   · 

  4 min read
• Press Releases

  HKeyBio Launches the HKEY-AIDMD 3.0--a Next-Generation Platform to Crack the Toughest Challenge in Autoimmune and Allergy Drug Development: Multi-target Combination Strategy Optimization

  November 25, 2025

   · 

  4 min read