Manufacturing

Regulatory Science

Optimi Health ships psilocybin to UK for Phase 2 clinical trial

The Canadian GMP manufacturer completed its first UK psilocybin export, supplying 5mg capsules and biomass under Health Canada and UK Home Office authorisations.
The Canadian GMP manufacturer completed its first UK psilocybin export, supplying 5mg capsules and biomass under Health Canada and UK Home Office authorisations.
The Biotech Times Editorial Team  · 
Bioprocessing
Regulatory Science

Alvotech resubmits FDA BLAs for golimumab and aflibercept biosimilars

Alvotech has resubmitted US licence applications for AVT05 and AVT06 following FDA manufacturing queries at its Reykjavik facility, with a six-month review expected.
Alvotech has resubmitted US licence applications for AVT05 and AVT06 following FDA manufacturing queries at its Reykjavik facility, with a six-month review expected.
The Biotech Times Editorial Team  · 
Bioprocessing

Stipple Bio licenses Lonza ADC platform for precision oncology push

Stipple Bio has struck a multi-target licence with Lonza to pair its epitope-discovery platform with Lonza's GlycoConnect ADC technology, beginning with lead
Stipple Bio has struck a multi-target licence with Lonza to pair its epitope-discovery platform with Lonza's GlycoConnect ADC technology, beginning with lead
The Biotech Times Editorial Team  · 
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