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BIO:ON Insight #17 · Sep 22, 2026

The edge in drugs is moving — from what you discover to how you make it

Novartis puts $1.2B into radiopharma manufacturing, Ultragenyx wins FDA approval for a Sanfilippo gene therapy once rejected over manufacturing, priced at $3.95M, and Roche bets up to $1B on screening 300,000 bispecifics. This week, the edge is in how drugs get made, moved and found.

Manufacturing & qualityCell & gene therapyNew modalitiesBD, licensing & M&A한국어판 보기

What I learned this week

If there's one line for this week, it's this: the edge in new drugs is moving from discovery to the process. The radiopharma story stayed with me most. Even a great drug can make a patient miss a treatment cycle if it arrives a few days late, and that changes what "making a drug" really means. See you next issue. 🙏

Yaehyun Lee · Quoted from the Editor's Insight I wrote for this issue.

Stories in this issue

  1. Market Trends

    Novartis signs a $1.2B manufacturing deal for Pluvicto supply

    NovartisPluvicto

  2. FDA Approvals

    Ultragenyx wins FDA approval for Fayuvi, a Sanfilippo syndrome gene therapy

    UltragenyxFayuviUS FDA

  3. Pipeline Analysis

    Roche × Dualitas: up to $1B for bispecific antibody screening

    RocheDualitas

AI summary

  1. 1Novartis committed $1.2B to a manufacturing deal for its radiopharmaceutical Pluvicto.
  2. 2Ultragenyx's Sanfilippo gene therapy Fayuvi, once rejected over manufacturing, won FDA approval at $3.95M.
  3. 3Roche signed a deal worth up to $1B with Dualitas to screen 300,000 bispecific combinations.

Relevant rolesCMC & QARegulatory affairsR&D

Summary and tags generated by AI from the issue text.

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