GSK conducted pivotal Phase III trials in China and is seeking US FDA Breakthrough Therapy Designation.

The entities involved

• GSK →

  British multinational pharmaceutical and biotechnology company

  • Clement Fourny joins Biodextris as CEO, a company that originated as a GSK development center.Mon 15:26
  • GSK acquired Sierra Oncology.Mon 14:28
• China →

  cultural region, ancient civilization, and nation in East Asia; mostly refers to the People's Republic of China in political situation and rarely refers to the Republic of China

  • The European Central Bank is forced to raise interest rates due to energy price shocks from the Iran war and an influx of Chinese exports.Mon 17:49
  • The Middle Corridor, linking Central Asia and Europe, is gaining significance in regional trade and energy routes.Mon 17:06
• FDA →
  • Generic medicine services are seeking approval for launch from the FDA.Mon 17:49
  • A company is seeking FDA feedback on its NEO212 program, with a meeting scheduled at the FDA's White Oak campus.Mon 14:56

Related events

• CStone Pharmaceuticals is seeking consensus on a global Phase III protocol for Pralsetinib, while sales increased by 500% year-over-year.Aug 31
• TELIX Pharmaceuticals is conducting Phase 3 trials and seeking alignment on the New Drug Application pathway with the FDA.Sep 2
• The FDA granted Safe to Proceed for the Pivotal Phase 3 study of Vivace Therapeutics, Inc.Aug 26
• Altimmune successfully launched its global Phase 3 trial in MASH and received Breakthrough Therapy Designation from the FDA.Sep 8
• FDA is adjusting drug review strategies, showing openness to less data, while China surpasses the U.S. in drug research.Jun 8