BioSpace News Archive

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  Psychedelics

  Can Psychedelics Break Through in Depression? Recent Readouts Leave Investors Wanting More

  Market reaction to recent readouts from Compass Pathways and Beckley Psytech/atai in treatment-resistant depression speaks to the hurdles psychedelic therapies must clear to quell concerns about commercial viability.

  July 14, 2025

   · 

  8 min read

   · 

  Heather McKenzie
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  Obesity

  Obesity in Focus: ADA Reveals R&D Priorities for Blockbusters-in-Waiting

  New data and analyses presented at the American Diabetes Association’s annual meeting highlight the priorities for the next generation of weight loss medicines: muscle preservation, limited side effects and novel targets.

  July 14, 2025

   · 

  9 min read

   · 

  Tristan Manalac
• 

  Regulatory

  FDA Mulls Speedier Reviews to Companies Willing To Lower Drug Costs

  Through its recently unveiled Priority Voucher program, the FDA seeks to accelerate the review process for companies that promise to keep prices down.

  July 14, 2025

   · 

  1 min read

   · 

  Tristan Manalac
• 

  FDA

  FDA Action Alert: Roche, GSK, Regeneron, More

  The FDA has several big-ticket decisions lined up to close out July, including applications in lymphoma, rare diseases and a hormone deficiency, while GSK dares to DREAMM again in multiple myeloma.

  July 14, 2025

   · 

  7 min read

   · 

  Tristan Manalac
• 

  Rare diseases

  Ultragenyx Takes Second Hit as FDA Rejects Gene Therapy for Sanfilippo Syndrome

  The FDA cited manufacturing issues but did not flag problems with Ultragenyx’s data package for UX111, with the biotech noting that the regulator found its neurodevelopmental findings for the gene therapy to be “robust.”

  July 14, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Opinion

  Tomorrow’s Precision Therapeutics Depend on Precision Diagnostics

  Only with the adoption of digital imaging and AI-powered analysis will next-generation precision oncology therapies reach their full potential and ensure no eligible patient is overlooked.

  July 14, 2025

   · 

  3 min read

   · 

  Robert Monroe
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  Depression

  After Three Strikes, Relmada Abandons Depression Drug Esmethadone 

  The development saga for the depression molecule has been rocky for years, unable to ease symptoms in multiple late-stage trials.

  July 14, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Neuroscience

  Takeda Establishes Lead in Narcolepsy Race With Back-to-Back Phase III Wins

  Takeda’s oveporexton improved wakefulness, attention and other key narcolepsy endpoints “with a high degree of statistical significance,” according to Jefferies analysts.

  July 14, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Cardiovascular disease

  AstraZeneca’s Baxdrostat Pushes Blood Pressure Lower in Phase III Trial

  The drug came to AstraZeneca through its acquisition of CinCor Pharma in 2023, with the hopes of beefing up its cardiovascular and kidney disease pipelines.

  July 14, 2025

   · 

  1 min read

   · 

  Dan Samorodnitsky
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  Drug Development

  The Gap Between the Administration’s Pro-Innovation Words and Policy
  

  Despite the FDA commissioner’s promises of partnership and collaboration, personnel changes and continued federal cuts create uncertainty for an industry already struggling with nearly half a decade of investment scarcity.
  
  

  July 14, 2025

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  6 min read

   · 

  Lori Ellis