BioSpace News Archive

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  Regulatory

  FDA Hands Out First Commissioner’s Priority Vouchers to Regeneron, Sanofi, Disc, Others

  The Commissioner’s National Priority Voucher awards companies that align with specific national priorities—such as boosting domestic manufacturing and lowering drug prices—with faster reviews and more frequent interactions with the FDA.

  October 17, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Drug pricing

  In Affordability Push, EMD Serono Joins TrumpRx While Roche Launches DTC Program

  EMD Serono will offer its fertility treatments on TrumpRx at a steep discount, and Roche’s direct-to-consumer offering will cover its flu pill Xofluza.

  October 17, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Collaboration

  Kite Makes $1.5B+ Cell Therapy Pact With Pregene as Others Pull Back

  With more than $1.5 billion on the line, Gilead looks to bolster its CAR T portfolio.

  October 17, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Antibody-drug conjugate (ADC)

  Roche Inks Another China ADC Pact With $1.5B Hansoh Bet

  Roche will gain worldwide rights outside of the Greater China region to Hansoh’s HS-20110, an antibody-drug conjugate in early-stage development for colorectal cancer.

  October 17, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Drug pricing

  Novo, Lilly Shares Drop as Trump Promises $150 Ozempic

  CMS Administrator Mehmet Oz clarified that a deal has not yet been sealed with the manufacturer of semaglutide, Novo Nordisk, or any other GLP-1 drugmaker.

  October 17, 2025

   · 

  3 min read

   · 

  Annalee Armstrong
• Press Releases

  Kezar Life Sciences Announces Regulatory Update on Zetomipzomib Program in Autoimmune Hepatitis and Plans to Explore Strategic Alternatives

  October 17, 2025

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  10 min read
• Press Releases

  EMD Serono Announces Unprecedented Agreement with U.S. Government to Expand Access to IVF Therapies

  October 17, 2025

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  6 min read
• Press Releases

  AVITA Medical Announces CEO Transition

  October 17, 2025

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  5 min read
• Press Releases

  Ferring Expands Growing Body of Real-World Evidence Reinforcing Use of ADSTILADRIN® (nadofaragene firadenovec-vncg) in Urology Practices

  October 17, 2025

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  8 min read
• Press Releases

  Disc Medicine Announces Receipt of FDA Commissioner’s National Priority Voucher (CNPV) for Bitopertin in Erythropoietic Protoporphyria (EPP)

  October 17, 2025

   · 

  6 min read