Cell & Gene Therapy
Biologics
Bioprocessing

Avaí Bio and Austrianova confirm Klotho secretion in encapsulated cells

Joint venture Klothonova has shown GMP-banked Klotho-producing cells remain viable and secrete therapeutic protein inside Cell-in-a-Box capsules.
Joint venture Klothonova has shown GMP-banked Klotho-producing cells remain viable and secrete therapeutic protein inside Cell-in-a-Box capsules.
Cell & Gene Therapy
Biologics

Immix Biopharma prices $125m share offering to fund NXC-201

The Los Angeles CAR-T company raised $125m at $11.00 per share, with J.P. Morgan sole book-runner and backing from Wellington and
The Los Angeles CAR-T company raised $125m at $11.00 per share, with J.P. Morgan sole book-runner and backing from Wellington and
Biologics
Synthetic Biology
Bioprocessing

NorthStrive Biosciences engages Charles River for probiotic CRO work

NorthStrive Biosciences has signed a statement of work with Charles River Laboratories to characterise plasmid copy numbers in its EL-22 and EL-32 engineered
NorthStrive Biosciences has signed a statement of work with Charles River Laboratories to characterise plasmid copy numbers in its EL-22 and EL-32 engineered
Cell & Gene Therapy
Genomics

AAVantgarde sees early efficacy signals in dual-AAV eye therapy

AAVantgarde Bio presented Phase 1/2 data showing visual function gains in Usher syndrome and strong preclinical support for its Stargardt programme at EURetina 2026.
AAVantgarde Bio presented Phase 1/2 data showing visual function gains in Usher syndrome and strong preclinical support for its Stargardt programme at EURetina 2026.
Medical Devices
Biologics

Cuprina to acquire seven-clinic Singapore healthcare group for S$4m

Nasdaq-listed Cuprina is buying East Coast Podiatry and Orchard Clinic to integrate clinical delivery with its wound-care and collagen technologies.
Nasdaq-listed Cuprina is buying East Coast Podiatry and Orchard Clinic to integrate clinical delivery with its wound-care and collagen technologies.
Cell & Gene Therapy
Biologics

ProKidney to present eight rilparencel abstracts at ASN Kidney Week 2026

ProKidney will share Phase 2 pooled data and preclinical mechanistic evidence for rilparencel at ASN Kidney Week in Denver, 21-25 October.
ProKidney will share Phase 2 pooled data and preclinical mechanistic evidence for rilparencel at ASN Kidney Week in Denver, 21-25 October.
Pharmaceuticals
Regulatory Science

Psyence BioMed secures exclusive US ibogaine licence for Texas unit

Psyence BioMed's Texas subsidiary has signed a binding term sheet granting exclusive US rights to PsyLabs' pharmaceutical-grade ibogaine, ahead of a planned development
Psyence BioMed's Texas subsidiary has signed a binding term sheet granting exclusive US rights to PsyLabs' pharmaceutical-grade ibogaine, ahead of a planned development
Cell & Gene Therapy
Biologics

CAR-T safety events dent rheumatologist confidence, Spherix finds

A Spherix Global Insights survey shows physician confidence in autologous CAR-T fell sharply after trial pauses at Novartis and Bristol Myers Squibb.
A Spherix Global Insights survey shows physician confidence in autologous CAR-T fell sharply after trial pauses at Novartis and Bristol Myers Squibb.
Pharmaceuticals
Biologics

Daré Bioscience patents lopinavir-ritonavir insert for HPV clearance

A new US patent extends IP protection for DARE-HPV to at least 2039 as the Phase 2 trial progresses, backed by $12m in non
A new US patent extends IP protection for DARE-HPV to at least 2039 as the Phase 2 trial progresses, backed by $12m in non
Cell & Gene Therapy
Bioprocessing
Regulatory Science

Teknova and Pluristyx file FDA Drug Master File for PluriFreeze

The cryopreservation system's Type II DMF lets cell therapy developers cross-reference regulatory documentation in IND and BLA submissions.
The cryopreservation system's Type II DMF lets cell therapy developers cross-reference regulatory documentation in IND and BLA submissions.
Cell & Gene Therapy

Ernexa Therapeutics names Spiegel to board ahead of ERNA-101 IND

Ernexa Therapeutics has appointed oncology veteran Robert Spiegel to its board as it targets a Q4 2026 IND filing for its lead iMSC cell therapy.
Ernexa Therapeutics has appointed oncology veteran Robert Spiegel to its board as it targets a Q4 2026 IND filing for its lead iMSC cell therapy.
Medical Devices
Regulatory Science

Inspire Medical wins new CPT codes for its Inspire V device

New Category I CPT codes covering Inspire V's single-lead hypoglossal nerve stimulator are set to take effect on 1 January 2028.
New Category I CPT codes covering Inspire V's single-lead hypoglossal nerve stimulator are set to take effect on 1 January 2028.
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