BioSpace News Archive

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• 

  Manufacturing

  Drug Manufacturers See Long-Term Opportunity in Climbing AI Use

  Companies are moving from using AI for distinct operations to applying the technology for control and optimization of the whole production process.

  September 30, 2025

   · 

  4 min read

   · 

  Nick Paul Taylor
• 

  Friedreich’s ataxia

  Larimar’s Friedreich’s Ataxia Drug Troubled by Anaphylaxis Concerns; Shares Fall

  Despite tolerability concerns, nomlabofusp’s overall efficacy represents a “large win” for Larimar, according to analysts at William Blair, who lauded the therapy’s functional benefits.

  September 30, 2025

   · 

  2 min read

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  Tristan Manalac
• 

  Series A

  Novo-Backed Crystalys Debuts With $205M to Tackle Gout

  Already approved in Japan, China and other Asian countries, Crystalys’ dotinurad works to lower serum uric acid levels.

  September 30, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Obesity

  Metsera’s Obesity Drug Shows ‘Very Encouraging’ Mid-Stage Efficacy, Supporting Pfizer’s $4.9B Bet

  MET-097i’s mid-stage performance “bodes well” for Pfizer’s proposed buyout of Metsera, according to BMO Capital Markets, a deal centered heavily on the investigational GLP-1 drug.

  September 30, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Regulatory

  FDA’s Tidmarsh Singles Out Aurinia’s Drug in LinkedIn Post About Surrogate Endpoints

  Without naming Aurinia Pharmaceuticals, the CDER director in a now-deleted LinkedIn post claimed that for lupus nephritis, companies have not conducted post-approval studies “to demonstrate a benefit on hard clinical endpoints.”

  September 30, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Opinion

  How To Bring Generic Drug Manufacturing Back to the US

  Reshoring generic pharmaceutical production is essential in today’s era of geopolitical instability and heightened awareness surrounding national health security. And it is possible—if done right.

  September 30, 2025

   · 

  5 min read

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  Vic Suarez
• 

  Layoffs

  Sutro Makes Deeper Cuts To Extend Runway Into 2027, Reach Key Data Readout

  After parting with 50% of its employees earlier this year, Sutro Biopharma will lay another third of its staff in a restructuring effort geared toward reaching key inflection points.

  September 30, 2025

   · 

  1 min read

   · 

  Dan Samorodnitsky
• 

  IN PARTNERSHIP WITH ELEMENT

  Webinar: Resilience Through Reinvention: How Pharma is Navigating Uncertainty During Turbulent Times

  In this discussion, our guests give their observations and recommendations on how companies can navigate within the United States market and beyond. Watch now.
  

  September 30, 2025

   · 

  1 min read

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  BioSpace Insights
• 

  Drug pricing

  Pfizer To Offer Drugs at a Discount in Agreement with US Government

  Pfizer CEO Albert Bourla directly credited the threat of tariffs with leading to the deal, in which the company will offer drugs on a soon-to-be-launched website called TrumpRx.

  September 30, 2025

   · 

  2 min read

   · 

  Dan Samorodnitsky
• Press Releases

  Kardigan Announces Presentation of Positive Phase 2a Data for Danicamtiv in Patients with Dilated Cardiomyopathy at HFSA Annual Scientific Meeting 2025

  September 30, 2025

   · 

  5 min read