News|Articles|January 20, 2026

FDA October 2025 Draft Guidance Sparks Industry Biosimilars Buzz

By allowing developers to bypass comparative efficacy studies when advanced analytics are successful substitutes, the FDA draft guidance avoids one of the most expensive steps, potentially cutting years from timelines and expanding patient access. For developers though, the burden doesn’t disappear; it shifts directly from clinical trials to analytical testing.

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Beam Therapeutics’ base-edited cell therapy risto-cel meets its primary endpoint in the BEACON sickle cell disease trial, Amgen’s CD40L antagonist dazodalibep reduces systemic disease activity in the phase 3 OASIZ-301 Sjögren’s disease trial, and ImvivaBio’s allogeneic CD19/BCMA CAR-T CTA313 sustains lupus remission through 12 months.

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Q&A: Who Is Accountable When AI Gets Drug Development Wrong?

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ProBio Licenses Oncology Antibody to AbTis for Site-Specific ADC

ProBio grants AbTis exclusive global rights to a discovery-stage oncology antibody for development as a site-specific antibody-drug conjugate.

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ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months

ImvivaBio’s off-the-shelf CD19/BCMA CAR-T cell therapy CTA313 kept 88% of evaluable patients with refractory lupus in DORIS remission at Month 12, according to longer-term phase 1 data presented at ACR Convergence 2026.

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Beam's Risto-cel Meets Primary Endpoint in Sickle Cell Trial

Beam’s base-edited cell therapy met its primary endpoint in the BEACON trial, and a U.S. biologics license application is planned as early as year-end.

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Amgen’s Dazodalibep Reduces Systemic Disease Activity in Phase 3 Sjögren’s Trial

Full phase 3 OASIZ-301 results show both dosing regimens of Amgen’s CD40L antagonist fusion protein dazodalibep reduced systemic disease activity in Sjögren’s disease at Week 48. The every-four-weeks dose also improved patient-reported dryness.

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AstraZeneca Acquires Omniose, Adding Bioconjugate Vaccine Platform

AstraZeneca acquired preclinical biotech Omniose, adding a bioconjugation platform for conjugate vaccines against serious bacterial infections.

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The BioPharm Brief: FDA Designations for a Bispecific CAR-T, a BLA for Friedreich’s Ataxia, and Phase 2b MASH Data for Efinopegdutide

FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.

FDA October 2025 Draft Guidance Sparks Industry Biosimilars Buzz

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AstraZeneca Acquires Omniose, Adding Bioconjugate Vaccine Platform

Amgen’s Dazodalibep Reduces Systemic Disease Activity in Phase 3 Sjögren’s Trial

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The BioPharm Brief: FDA Designations for a Bispecific CAR-T, a BLA for Friedreich’s Ataxia, and Phase 2b MASH Data for Efinopegdutide

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