Regulatory Science
Biologics

60 Degrees Pharma options FSU castanospermine IP for tick-borne diseases

The NASDAQ-listed vector-borne disease specialist has secured exclusive option rights to FSU's castanospermine IP covering four tick-borne indications.
The NASDAQ-listed vector-borne disease specialist has secured exclusive option rights to FSU's castanospermine IP covering four tick-borne indications.
The Biotech Times Editorial Team  · 
Biologics

Adlai Nortye doses first patient in weekly arm of AN9025 Phase 1

The NASDAQ-listed biotech has opened a weekly dosing cohort in its global Phase 1 trial of pan-RAS(ON) inhibitor AN9025, with both arms
The NASDAQ-listed biotech has opened a weekly dosing cohort in its global Phase 1 trial of pan-RAS(ON) inhibitor AN9025, with both arms
The Biotech Times Editorial Team  · 
Biologics

Cellution Biologics acquires SimpliDerm ADM business for up to $11m

Cellution Biologics is buying Elutia's SimpliDerm acellular dermal matrix unit to enter the US reconstructive surgery market.
Cellution Biologics is buying Elutia's SimpliDerm acellular dermal matrix unit to enter the US reconstructive surgery market.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

DBV Technologies targets Q3 BLA filing for VIASKIN Peanut Patch

DBV Technologies expects to submit its peanut-patch BLA in Q3 2026, backed by $174.9m in cash and active FDA engagement.
DBV Technologies expects to submit its peanut-patch BLA in Q3 2026, backed by $174.9m in cash and active FDA engagement.
The Biotech Times Editorial Team  · 
Biologics

Diagonal Therapeutics doses first patient in HHT antibody trial

The Watertown biotech has initiated its DIAMOND Phase 1/2 trial of DIAG723, a clustering agonist antibody targeting the ALK1 pathway in a rare vascular
The Watertown biotech has initiated its DIAMOND Phase 1/2 trial of DIAG723, a clustering agonist antibody targeting the ALK1 pathway in a rare vascular
The Biotech Times Editorial Team  · 
Biologics

Compass Therapeutics tovecimig data wins oral slot at ESMO 2026

Phase 2/3 COMPANION-002 biliary tract cancer results will be presented orally at ESMO in Madrid on 24 October 2026.
Phase 2/3 COMPANION-002 biliary tract cancer results will be presented orally at ESMO in Madrid on 24 October 2026.
The Biotech Times Editorial Team  · 
Biologics

InnoCare TYK2 inhibitor soficitinib meets Phase II endpoint in vitiligo

InnoCare's oral TYK2 inhibitor soficitinib cut facial vitiligo scores by up to 41% versus 2.2% for placebo at Week 24.
InnoCare's oral TYK2 inhibitor soficitinib cut facial vitiligo scores by up to 41% versus 2.2% for placebo at Week 24.
The Biotech Times Editorial Team  · 
Biologics

Grifols doses first patients in Phase 3 SIGMA and XPERT Ig trials

Grifols has initiated two Phase 3 trials seeking to broaden US label approvals for its GAMUNEX-C and XEMBIFY immunoglobulin therapies.
Grifols has initiated two Phase 3 trials seeking to broaden US label approvals for its GAMUNEX-C and XEMBIFY immunoglobulin therapies.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Arbutus files international LNP patent suits against Pfizer and BioNTech

Arbutus and Genevant have launched three international lawsuits over LNP patents while banking $178m from a Moderna settlement.
Arbutus and Genevant have launched three international lawsuits over LNP patents while banking $178m from a Moderna settlement.
The Biotech Times Editorial Team  · 
Biologics

Angelini Pharma completes $4.1bn Catalyst Pharmaceuticals buyout

The Italian pharma group has taken full ownership of Nasdaq-listed Catalyst, backed by €1bn each from Blackstone and CDP Equity.
The Italian pharma group has taken full ownership of Nasdaq-listed Catalyst, backed by €1bn each from Blackstone and CDP Equity.
The Biotech Times Editorial Team  · 
Regulatory Science

Adneuris licenses cebranopadol to Conba for Greater China pain market

Adneuris will receive $17.5m upfront and up to $100m in milestones as Conba gains rights to the dual-receptor pain candidate across Greater China.
Adneuris will receive $17.5m upfront and up to $100m in milestones as Conba gains rights to the dual-receptor pain candidate across Greater China.
The Biotech Times Editorial Team  · 

AMT Medical SAFE-CAB II trial data published in JTCVS

AMT Medical's sutureless, laser-assisted coronary bypass system met its safety endpoint in 71 patients, with 97.5% patency using the latest catheter.
AMT Medical's sutureless, laser-assisted coronary bypass system met its safety endpoint in 71 patients, with 97.5% patency using the latest catheter.
The Biotech Times Editorial Team  · 
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