CATALENT

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News

• Sionna says good-bye to 46% of staffers, including exec
  Follow along as BioSpace tracks job cuts and restructuring initiatives.
  biospace · 2d ago
• Novo drops ‘Nordisk’ moniker, turns bull toward future in corporate rebrand
  Analysts tentatively welcomed Novo’s new corporate rebrand—so long as it comes with a larger change to the company’s overall business strategy.
  biospace · 4d ago
• Scholar Rock secures first FDA approval for muscle-targeting rare disease drug
  Scholar Rock’s spinal muscular atrophy drug, now to be called Isembyld, was originally rejected in September 2025, when the FDA cited compliance problems at a third-party manufacturer.
  biospace · 5d ago
• Multispecifics are transforming the CDMO development architecture
  Manufacturers are being pushed beyond mAb‑era platforms into a new design model built around molecular engineering, complex analytics and amplified upstream and downstream processing.
  biospace · 22d ago
• Scholar Rock rejigs approval filing after FDA flags violations at Novo plant
  Despite earlier claims of improvement at the fill-finish plant, the FDA has classified the facility as Official Action Indicated based on inspection findings.
  biospace · 1mo ago
• Scholar Rock ditches Novo’s legacy Catalent plant in FDA refiling of SMA drug
  Scholar Rock has dropped Novo Nordisk’s troubled Catalent facility as a contract manufacturer in its FDA refiling for apitegromab, a spinal muscular atrophy candidate, after a recent inspection of…
  fiercebiotech · 1mo ago
• Lisata lays off 72% of staffers, sues Kuva after planned merger falls apart
  Lisata is laying off 72% of its workforce, including its chief medical officer, as the solid tumor biotech tries to navigate a new future after a planned merger with cancer imaging company Kuva Lab…
  fiercebiotech · 1mo ago
• Kyverna taps ElevateBio to secure commercial supply of autoimmune CAR-T therapy
  ElevateBio will be the primary source of Kyverna’s autologous CAR-T cell therapy for anticipated U.S. and global launches in autoimmune indications.
  biospace · 1mo ago
• Catalent to divest UK site; Rottendorf, Evonik announce manufacturing builds
  Plus, news about RoslinCT, Novo Nordisk and more. 🇬🇧 Catalent to sell UK site to Codis: The CDMO is set to take Catalent’s oral solid dose factory in Nottingham, with ...
  endpoints · 2mo ago
• Mammalian hair, roof leaks: Novo Nordisk's site in Indiana under FDA scrutiny once again
  Novo Nordisk’s troubled factory in Indiana that it got from Catalent continues to face contamination issues, with a re-inspection in April finding mammalian hair in finished drugs and water leaks t…
  endpoints · 3mo ago