Manufacturing

Biotech
Regulatory Science

Humacyte prices $50m public offering to fund Symvess rollout

Humacyte is raising $50 million via a public share sale to accelerate Symvess commercialisation and file a hemodialysis BLA supplement.
Humacyte is raising $50 million via a public share sale to accelerate Symvess commercialisation and file a hemodialysis BLA supplement.
The Biotech Times Editorial Team  · 
Bioprocessing

Neion Bio closes $23m Series A for egg-based biologics platform

The New York biotech raised an oversubscribed Series A led by Caffeinated Capital to scale its Raptor egg-based biomanufacturing platform.
The New York biotech raised an oversubscribed Series A led by Caffeinated Capital to scale its Raptor egg-based biomanufacturing platform.
The Biotech Times Editorial Team  · 
Bioprocessing
Diagnostics

RadioMedix wins FDA approval for generic Ga-68 PSMA-11 PET agent

RadioMedix's generic gallium-68 PSMA-11 PET diagnostic for prostate cancer has received FDA approval, with the Houston facility clearing inspection with no observations.
RadioMedix's generic gallium-68 PSMA-11 PET diagnostic for prostate cancer has received FDA approval, with the Houston facility clearing inspection with no observations.
The Biotech Times Editorial Team  · 
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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