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

Truveta study finds 16% of adalimumab biosimilar switchers revert

Real-world data from 67,594 US patients shows biosimilar adoption peaked after formulary changes, but switch-back rates highlight gaps in patient support.
Real-world data from 67,594 US patients shows biosimilar adoption peaked after formulary changes, but switch-back rates highlight gaps in patient support.
The Biotech Times Editorial Team  · 
Biologics

Nicox partner Kowa files NDA for NCX 470 glaucoma eye drop

Kowa's US NDA submission for the nitric oxide-donating bimatoprost drop triggers a €3m milestone and targets FDA approval by mid-2027.
Kowa's US NDA submission for the nitric oxide-donating bimatoprost drop triggers a €3m milestone and targets FDA approval by mid-2027.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Novartis wins EC approval for Itvisma in broader SMA population

The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

PolarityBio files BLA for SkinTE in diabetic foot ulcers

PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
The Biotech Times Editorial Team  · 
Biologics

4DMT completes 4FRONT-2 Phase 3 enrolment four months ahead of schedule

4D Molecular Therapeutics has finished global enrolment for its wet AMD gene therapy trial, with topline 52-week data expected in the second half of
4D Molecular Therapeutics has finished global enrolment for its wet AMD gene therapy trial, with topline 52-week data expected in the second half of
The Biotech Times Editorial Team  · 
Biologics

Abivax ABTECT Part 2 data back obefazimod NDA submission in UC

Phase 3 maintenance data show obefazimod rescued remission in refractory ulcerative colitis patients, with an NDA filing planned for Q4 2026.
Phase 3 maintenance data show obefazimod rescued remission in refractory ulcerative colitis patients, with an NDA filing planned for Q4 2026.
The Biotech Times Editorial Team  · 
Biologics

AC Immune ACI-24 shows dose-response in Phase 1b/2 Alzheimer's trial

Interim 12-month data from the ABATE trial show ACI-24 is well tolerated with antibody responses at all dose levels in prodromal Alzheimer's
Interim 12-month data from the ABATE trial show ACI-24 is well tolerated with antibody responses at all dose levels in prodromal Alzheimer's
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

AdJane reports first human proof-of-concept for intranasal OMV vaccine

The Dutch biotech's Phase I data show its nOMV platform induced mucosal and systemic immunity in healthy adults, published in peer-reviewed journal Vaccines.
The Dutch biotech's Phase I data show its nOMV platform induced mucosal and systemic immunity in healthy adults, published in peer-reviewed journal Vaccines.
The Biotech Times Editorial Team  · 
Biologics

Candel Therapeutics opens Phase 3 AURORA trial for CAN-2409 in NSCLC

Candel has activated the first site in its 150-site pivotal AURORA trial, testing viral immunotherapy aglatimagene against docetaxel in ICI-refractory lung cancer.
Candel has activated the first site in its 150-site pivotal AURORA trial, testing viral immunotherapy aglatimagene against docetaxel in ICI-refractory lung cancer.
The Biotech Times Editorial Team  · 
Biologics

Ascendis TransCon CNP sustains leg alignment gains at two years

Week 104 data from the ApproaCH trial show tibial-femoral angle continued improving in children with achondroplasia, with greater gains in those with preexisting leg
Week 104 data from the ApproaCH trial show tibial-femoral angle continued improving in children with achondroplasia, with greater gains in those with preexisting leg
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Roche's Enspryng wins FDA Priority Review for thyroid eye disease

The FDA has accepted Roche's sBLA for satralizumab in TED, with a decision expected by 15 October 2026 based on Phase 3 SatraGO data.
The FDA has accepted Roche's sBLA for satralizumab in TED, with a decision expected by 15 October 2026 based on Phase 3 SatraGO data.
The Biotech Times Editorial Team  · 
Biologics

Moleculin's Annamycin hits 3x control CR rate in R/R AML interim

Interim MIRACLE trial data showed Annamycin complete remission rates up to 43% versus 12% for control in relapsed or refractory AML patients.
Interim MIRACLE trial data showed Annamycin complete remission rates up to 43% versus 12% for control in relapsed or refractory AML patients.
The Biotech Times Editorial Team  · 
Biologics

Kyowa Kirin PROSPER data show mogamulizumab eases CTCL symptoms

Real-world study in 73 patients found clinically meaningful skin symptom improvements from week 4, sustained through 48 weeks of follow-up.
Real-world study in 73 patients found clinically meaningful skin symptom improvements from week 4, sustained through 48 weeks of follow-up.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Sanofi's Nexviazyme hits all endpoints in infantile Pompe phase 3

Baby-COMET data showed avalglucosidase alfa kept treated infants alive and ventilator-free at 52 weeks, supporting a US label extension filing in H2 2026.
Baby-COMET data showed avalglucosidase alfa kept treated infants alive and ventilator-free at 52 weeks, supporting a US label extension filing in H2 2026.
The Biotech Times Editorial Team  · 
Biologics

Lycia Therapeutics raises $75m Series D for LYTAC pipeline

The oversubscribed round, co-led by Janus Henderson and Balyasny, funds two autoimmune degrader candidates toward Phase 1 proof-of-concept.
The oversubscribed round, co-led by Janus Henderson and Balyasny, funds two autoimmune degrader candidates toward Phase 1 proof-of-concept.
The Biotech Times Editorial Team  · 
Biologics

Atea Pharmaceuticals completes enrolment in Phase 3 C-FORWARD HCV trial

Atea has fully enrolled its 880-patient global HCV trial, with topline data from the head-to-head DAA study expected around year-end 2026.
Atea has fully enrolled its 880-patient global HCV trial, with topline data from the head-to-head DAA study expected around year-end 2026.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Capricor's DMD cell therapy Deramiocel heads to FDA advisory panel

The FDA's CTGTAC will review Capricor's BLA for Deramiocel on 29 July, ahead of an August 2026 PDUFA action date.
The FDA's CTGTAC will review Capricor's BLA for Deramiocel on 29 July, ahead of an August 2026 PDUFA action date.
The Biotech Times Editorial Team  · 
Biologics

J&J's teclistamab plus daratumumab gets CHMP backing for myeloma

The EMA advisory committee has recommended expanding teclistamab's label to cover second-line relapsed/refractory myeloma, backed by Phase 3 overall survival data.
The EMA advisory committee has recommended expanding teclistamab's label to cover second-line relapsed/refractory myeloma, backed by Phase 3 overall survival data.
The Biotech Times Editorial Team  · 
Biologics

Absci reports clean Phase 1 safety data for anti-PRLR antibody ABS-201

Absci's AI-designed hair-loss antibody showed no serious adverse events across four SAD cohorts and a half-life of at least 65 days.
Absci's AI-designed hair-loss antibody showed no serious adverse events across four SAD cohorts and a half-life of at least 65 days.
The Biotech Times Editorial Team  · 
Biologics

AnaCardio Phase 1b/2a heart failure data published in The Lancet

AC01, an oral ghrelin mimetic, showed haemodynamic gains and no serious adverse events in 58 HFrEF patients, supporting a Phase 2b trial.
AC01, an oral ghrelin mimetic, showed haemodynamic gains and no serious adverse events in 58 HFrEF patients, supporting a Phase 2b trial.
The Biotech Times Editorial Team  · 
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