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

Rani Therapeutics RT-114 oral GLP-1/2 agonist tops subcutaneous exposure

Phase 1a data showed oral RT-114 achieved more than 150% bioavailability relative to a matched subcutaneous dose, with a mild adverse-event profile.
Phase 1a data showed oral RT-114 achieved more than 150% bioavailability relative to a matched subcutaneous dose, with a mild adverse-event profile.
The Biotech Times Editorial Team  · 
Biologics

InnoCare's orelabrutinib cuts CLL/SLL progression risk by 68% in Phase 3

Phase 3 data published in STTT show orelabrutinib delivered a hazard ratio of 0.32 versus chemoimmunotherapy in treatment-naive CLL/SLL patients.
Phase 3 data published in STTT show orelabrutinib delivered a hazard ratio of 0.32 versus chemoimmunotherapy in treatment-naive CLL/SLL patients.
The Biotech Times Editorial Team  · 
Biologics

Spero Therapeutics licenses anti-CD40L antibody SP001 from Innovent

Spero gains ex-China rights to a Phase 2-ready monoclonal antibody targeting autoimmune diseases, in a deal worth up to $1.1 billion.
Spero gains ex-China rights to a Phase 2-ready monoclonal antibody targeting autoimmune diseases, in a deal worth up to $1.1 billion.
The Biotech Times Editorial Team  · 
Biologics

Spero Therapeutics raises $105m royalty financing to fund SP001 Phase 2

The Cambridge biotech is monetising Utebzi royalties via a KKR-backed deal to fund its anti-CD40L immunology candidate SP001.
The Cambridge biotech is monetising Utebzi royalties via a KKR-backed deal to fund its anti-CD40L immunology candidate SP001.
The Biotech Times Editorial Team  · 
Biologics

Aligos receives $25m upfront as China HBV licence deal activates

Aligos Therapeutics has received the first cash payment from its Greater China licence of HBV candidate pevifoscorvir sodium, which also secured China's Breakthrough
Aligos Therapeutics has received the first cash payment from its Greater China licence of HBV candidate pevifoscorvir sodium, which also secured China's Breakthrough
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Bavarian Nordic files chikungunya vaccine for approval in Brazil

Partner Eurofarma has submitted CHIKV VLP to Anvisa, targeting a country that reported more than half of global chikungunya cases in 2025.
Partner Eurofarma has submitted CHIKV VLP to Anvisa, targeting a country that reported more than half of global chikungunya cases in 2025.
The Biotech Times Editorial Team  · 
Biologics

Cadrenal Phase 2 data show 25% thrombotic event cut in HIT

CAD-1005 cut new thrombotic events by more than 25% versus placebo in the first randomised, blinded trial in heparin-induced thrombocytopenia.
CAD-1005 cut new thrombotic events by more than 25% versus placebo in the first randomised, blinded trial in heparin-induced thrombocytopenia.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Elevar Therapeutics receives FDA CRL for rivoceranib-camrelizumab in HCC

The FDA cited manufacturing deficiencies at a listed site, not clinical data concerns, in declining to approve the first-line hepatocellular carcinoma combination.
The FDA cited manufacturing deficiencies at a listed site, not clinical data concerns, in declining to approve the first-line hepatocellular carcinoma combination.
The Biotech Times Editorial Team  · 
Biologics

FDA clears lecanemab subcutaneous autoinjector for Alzheimer's

Eisai and Biogen's LEQEMBI IQLIK autoinjector gains FDA approval as an initiation dose, offering patients a home-use alternative to intravenous infusion.
Eisai and Biogen's LEQEMBI IQLIK autoinjector gains FDA approval as an initiation dose, offering patients a home-use alternative to intravenous infusion.
The Biotech Times Editorial Team  · 
Biologics

Immutep efti shows 30.9-month mOS in 1L NSCLC despite trial setback

Mature INSIGHT-003 data show efti plus pembrolizumab and chemotherapy achieved 30.9-month mOS in low PD-L1 first-line NSCLC patients.
Mature INSIGHT-003 data show efti plus pembrolizumab and chemotherapy achieved 30.9-month mOS in low PD-L1 first-line NSCLC patients.
The Biotech Times Editorial Team  · 
Biologics

Mesoblast hits 300-patient target in Phase 3 back pain trial

Mesoblast said its pivotal rexlemestrocel-L trial is now fully enrolled, with top-line results expected in mid-2027 and a BLA filing to follow.
Mesoblast said its pivotal rexlemestrocel-L trial is now fully enrolled, with top-line results expected in mid-2027 and a BLA filing to follow.
The Biotech Times Editorial Team  · 
Biologics

Sana Biotech's HIP-modified islets show durable function at 14 months

NEJM follow-up data show HIP-modified islet cells surviving and producing insulin at 14 months in a type 1 diabetes patient without immunosuppression.
NEJM follow-up data show HIP-modified islet cells surviving and producing insulin at 14 months in a type 1 diabetes patient without immunosuppression.
The Biotech Times Editorial Team  · 
Biologics

Ipsen Dysport hits Phase III endpoints in episodic and chronic migraine

Ipsen's abobotulinumtoxinA met primary endpoints in both BEOND trials, becoming the first botulinum toxin with Phase III efficacy across episodic and chronic migraine.
Ipsen's abobotulinumtoxinA met primary endpoints in both BEOND trials, becoming the first botulinum toxin with Phase III efficacy across episodic and chronic migraine.
The Biotech Times Editorial Team  · 
Diagnostics
Biologics

Roche wins CE Mark for automated blood test for latent TB

The Elecsys IGRA TB test processes samples in 19 minutes, cutting standard IGRA turnaround in half and integrating with Roche's existing cobas immunoassay platforms.
The Elecsys IGRA TB test processes samples in 19 minutes, cutting standard IGRA turnaround in half and integrating with Roche's existing cobas immunoassay platforms.
The Biotech Times Editorial Team  · 
Biologics

Xeltis makes first commercial implant of aXess vascular access device

The Eindhoven medtech has begun its European commercial rollout of aXess, a bioabsorbable hemodialysis graft designed to regenerate into the patient's own living vessel.
The Eindhoven medtech has begun its European commercial rollout of aXess, a bioabsorbable hemodialysis graft designed to regenerate into the patient's own living vessel.
The Biotech Times Editorial Team  · 
Biologics

Anaveon promotes Laetitia Pouzol to Chief Scientific Officer

The Basel biotech has elevated its Head of Immunology to CSO, as ANV200 advances through IND-enabling studies toward clinical testing.
The Basel biotech has elevated its Head of Immunology to CSO, as ANV200 advances through IND-enabling studies toward clinical testing.
The Biotech Times Editorial Team  · 
Biologics

FibroBiologics wins patent allowance for 3D spheroid wound therapy

The Houston biotech secured USPTO allowance for fibroblast spheroid wound healing claims that directly cover its Phase 1/2 CYWC628 diabetic foot ulcer programme.
The Houston biotech secured USPTO allowance for fibroblast spheroid wound healing claims that directly cover its Phase 1/2 CYWC628 diabetic foot ulcer programme.
The Biotech Times Editorial Team  · 
Biologics

NewAmsterdam Pharma to present obicetrapib Alzheimer's data at AAIC 2026

NewAmsterdam Pharma will share four BROADWAY-derived analyses at AAIC 2026, including biomarker data suggesting obicetrapib may slow Alzheimer's pathology.
NewAmsterdam Pharma will share four BROADWAY-derived analyses at AAIC 2026, including biomarker data suggesting obicetrapib may slow Alzheimer's pathology.
The Biotech Times Editorial Team  · 
Biologics
Bioprocessing

Pluristyx secures Japan patent for synthetic mRNA iPSC reprogramming

The Seattle biotech's licensed mRNA technology cuts iPSC line generation to under 30 days, addressing a key bottleneck for commercial cell therapy manufacturing.
The Seattle biotech's licensed mRNA technology cuts iPSC line generation to under 30 days, addressing a key bottleneck for commercial cell therapy manufacturing.
The Biotech Times Editorial Team  · 
Biologics
Bioprocessing

VERAXA Biotech taps ATUM to develop cell lines for BiTAC-TCE programme

VERAXA has engaged ATUM's Leap-In Transposase technology to generate stable clonal cell lines for its lead conditional T-cell engager candidate ahead of
VERAXA has engaged ATUM's Leap-In Transposase technology to generate stable clonal cell lines for its lead conditional T-cell engager candidate ahead of
The Biotech Times Editorial Team  · 
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