Biologics

Manufactured-protein therapeutics: monoclonal antibodies (mAbs); bispecifics & fusion proteins; therapeutic proteins & enzymes; vaccines; and blood & plasma products. Distinct from Cell & Gene Therapy (living cells / genetic material) and from chemically-synthesised small molecules (which stay under Pharmaceuticals).

Biologics
Regulatory Science

Capricor DMD cell therapy data in The Lancet before FDA ruling

Deramiocel slowed upper limb decline by 54% versus placebo in a Phase 3 trial, with an FDA decision due 22 August 2026.
Deramiocel slowed upper limb decline by 54% versus placebo in a Phase 3 trial, with an FDA decision due 22 August 2026.
The Biotech Times Editorial Team  · 
Biologics

Crystalys raises $130m Series B for gout drug dotinurad

The oversubscribed round will fund two Phase 3 trials and commercialisation preparation for dotinurad, a once-daily URAT1 inhibitor for gout.
The oversubscribed round will fund two Phase 3 trials and commercialisation preparation for dotinurad, a once-daily URAT1 inhibitor for gout.
The Biotech Times Editorial Team  · 
Biologics

Humacyte wins FDA IND clearance for CTEV coronary bypass study

Humacyte's bioengineered coronary vessel cleared for a first-in-human Phase 2a trial in CABG patients, with study start targeted this quarter.
Humacyte's bioengineered coronary vessel cleared for a first-in-human Phase 2a trial in CABG patients, with study start targeted this quarter.
The Biotech Times Editorial Team  · 
Diagnostics
Regulatory Science
Biologics

OraSure wins FDA EUA for second-generation OraQuick Ebola 2.0 test

OraSure's updated rapid antigen test detects all four disease-causing Ebola viruses and was developed with BARDA funding amid a live DRC outbreak.
OraSure's updated rapid antigen test detects all four disease-causing Ebola viruses and was developed with BARDA funding amid a live DRC outbreak.
The Biotech Times Editorial Team  · 
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

BriaCell adds Sunnybrook to Phase 3 breast cancer trial

Sunnybrook's Odette Cancer Centre becomes BriaCell's first Canadian site for its pivotal Bria-IMT Phase 3 study in metastatic breast cancer.
Sunnybrook's Odette Cancer Centre becomes BriaCell's first Canadian site for its pivotal Bria-IMT Phase 3 study in metastatic breast cancer.
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

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
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

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  · 
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

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

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
Regulatory Science

Novartis Fabhalta wins FDA traditional approval in IgA nephropathy

Iptacopan slowed eGFR decline by 48% versus placebo over two years in the Phase III APPLAUSE-IgAN study, converting an accelerated approval granted in 2024.
Iptacopan slowed eGFR decline by 48% versus placebo over two years in the Phase III APPLAUSE-IgAN study, converting an accelerated approval granted in 2024.
The Biotech Times Editorial Team  · 
Biologics

Teva licenses Polpharma ocrelizumab biosimilar for global markets

Teva secures exclusive commercialisation rights to Polpharma Biologics' ocrelizumab biosimilar candidate across key markets including the US, EU and Brazil.
Teva secures exclusive commercialisation rights to Polpharma Biologics' ocrelizumab biosimilar candidate across key markets including the US, EU and Brazil.
The Biotech Times Editorial Team  · 
Biologics

Allogene ALLO-316 achieves 31% response rate in solid tumour Phase 1

Full TRAVERSE Phase 1 data, published in JCO, show durable remissions in CD70-high metastatic renal cell carcinoma with a single allogeneic CAR T infusion.
Full TRAVERSE Phase 1 data, published in JCO, show durable remissions in CD70-high metastatic renal cell carcinoma with a single allogeneic CAR T infusion.
The Biotech Times Editorial Team  · 
Biologics

Boehringer starts Phase II for triple receptor agonist BI 3034701

Boehringer Ingelheim has dosed first patients in a Phase II trial of BI 3034701, a GLP-1/GIP/NPY2 triple agonist targeting obesity.
Boehringer Ingelheim has dosed first patients in a Phase II trial of BI 3034701, a GLP-1/GIP/NPY2 triple agonist targeting obesity.
The Biotech Times Editorial Team  · 
Biologics

Cellectar publishes Phase 1 iopofosine I 131 data in multiple myeloma

Phase 1 results in 31 heavily pretreated patients showed a 30% response rate at higher doses and a manageable hematologic safety profile.
Phase 1 results in 31 heavily pretreated patients showed a 30% response rate at higher doses and a manageable hematologic safety profile.
The Biotech Times Editorial Team  · 
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