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).

Cell & Gene Therapy
Biologics
Pharmaceuticals

Legend Biotech to present five-year CARVYKTI data at IMS 2026

Legend Biotech will show long-term CARTITUDE-2 and real-world cilta-cel data at the International Myeloma Society meeting in Glasgow this month.
Legend Biotech will show long-term CARTITUDE-2 and real-world cilta-cel data at the International Myeloma Society meeting in Glasgow this month.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics
Medical Devices

MannKind and Rose Pharma partner on inhaled GLP-1 for weight loss

MannKind will supply its Technosphere platform and manufacturing support to develop ROSE-010, an inhaled rapid-acting GLP-1, through Phase 1b.
MannKind will supply its Technosphere platform and manufacturing support to develop ROSE-010, an inhaled rapid-acting GLP-1, through Phase 1b.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Giovanni Caforio joins CD&R as Operating Advisor for healthcare

The former Bristol Myers Squibb CEO brings 35 years of biopharma experience to CD&R's healthcare investment and portfolio strategy.
The former Bristol Myers Squibb CEO brings 35 years of biopharma experience to CD&R's healthcare investment and portfolio strategy.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Beeline Medicines' afimetoran meets Phase 2 primary endpoint in SLE

The Stamford biotech reported highly significant SRI-4 response rates versus placebo at Week 48, supporting pivotal development in systemic and cutaneous lupus.
The Stamford biotech reported highly significant SRI-4 response rates versus placebo at Week 48, supporting pivotal development in systemic and cutaneous lupus.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Disc Medicine RESTORE-PV data show DISC-3405 cut phlebotomy in PV

Phase 2 results show the anti-TMPRSS6 antibody reduced mean phlebotomy events from 4.0 to 0.6 over 26 weeks, with 61.5% of
Phase 2 results show the anti-TMPRSS6 antibody reduced mean phlebotomy events from 4.0 to 0.6 over 26 weeks, with 61.5% of
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Solstice Oncology launches with $225m Series A for CTLA-4 antibody

The Boston immuno-oncology startup closed a $225m Series A to advance porustobart, a next-generation CTLA-4 antibody, in neoadjuvant colon cancer.
The Boston immuno-oncology startup closed a $225m Series A to advance porustobart, a next-generation CTLA-4 antibody, in neoadjuvant colon cancer.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Ascendis Pharma reports 52-week infant data for TransCon CNP at ESPE

Week 52 sentinel cohort data show navepegritide stabilised foramen magnum stenosis and improved linear growth in infants with achondroplasia.
Week 52 sentinel cohort data show navepegritide stabilised foramen magnum stenosis and improved linear growth in infants with achondroplasia.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Sobi wins FDA Fast Track for pacritinib in VEXAS syndrome

The designation accelerates review of the dual IRAK1/JAK2 inhibitor in a rare autoinflammatory disease with no approved treatments; topline Phase 2 data expected in
The designation accelerates review of the dual IRAK1/JAK2 inhibitor in a rare autoinflammatory disease with no approved treatments; topline Phase 2 data expected in
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Caspian Therapeutics launches with $50m to target diabetes

Kura Oncology's newly spun-out subsidiary will use menin inhibition to try to restore pancreatic beta-cell function in Type 1 and Type 2
Kura Oncology's newly spun-out subsidiary will use menin inhibition to try to restore pancreatic beta-cell function in Type 1 and Type 2
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

SOTIO doses first patient in CDH17-targeting ADC trial for CRC

SOTIO Biotech has initiated its CADENCIA-01 Phase 1/2 trial of SOT109, the only CDH17-targeting ADC with FDA Fast Track Designation, in advanced
SOTIO Biotech has initiated its CADENCIA-01 Phase 1/2 trial of SOT109, the only CDH17-targeting ADC with FDA Fast Track Designation, in advanced
The Biotech Times Editorial Team  · 
Biologics
Medical Devices
Regulatory Science

Humacyte wins FDA nod to extend Symvess shelf life to 36 months

The FDA has authorised doubling Symvess's expiry dating, easing hospital inventory management for the bioengineered vascular conduit approved in 2024.
The FDA has authorised doubling Symvess's expiry dating, easing hospital inventory management for the bioengineered vascular conduit approved in 2024.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Roche wins FDA Priority Review for Enspryng in MOGAD

The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.
The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Roivant's mosliciguat hits Phase 2 primary endpoint in PH-ILD

Phase 2 PHocus trial showed a 56.3% placebo-adjusted PVR reduction; Roivant has now initiated the Phase 3 PHrontier study in the same indication.
Phase 2 PHocus trial showed a 56.3% placebo-adjusted PVR reduction; Roivant has now initiated the Phase 3 PHrontier study in the same indication.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science
Biologics

Pharvaris HAE prophylaxis trial hits 83% attack rate reduction

Pharvaris's CHAPTER-3 Phase 3 study of once-daily deucrictibant XR met all endpoints, with NDA submissions planned for the first half of 2027.
Pharvaris's CHAPTER-3 Phase 3 study of once-daily deucrictibant XR met all endpoints, with NDA submissions planned for the first half of 2027.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics
Regulatory Science

Monte Rosa pockets $50m milestone as Novartis starts MRT-6160 Phase 2

Novartis has dosed its first Sjögren's disease patient with MRT-6160, triggering a $50m payment to Monte Rosa under the pair's $2.1bn
Novartis has dosed its first Sjögren's disease patient with MRT-6160, triggering a $50m payment to Monte Rosa under the pair's $2.1bn
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Spyre Therapeutics completes IBD proof-of-concept with SPY003 data

SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Novartis HARBOR Phase III trial misses primary endpoint in DM1

Del-desiran failed to improve hand myotonia in a 150-patient Phase III study, though secondary endpoints showed signs of clinical activity.
Del-desiran failed to improve hand myotonia in a 150-patient Phase III study, though secondary endpoints showed signs of clinical activity.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

NorthStrive files patents for EL-22 and EL-32 in spaceflight muscle loss

NorthStrive Biosciences has filed two US patent applications extending its myostatin-targeting probiotic candidates into microgravity-induced muscle atrophy.
NorthStrive Biosciences has filed two US patent applications extending its myostatin-targeting probiotic candidates into microgravity-induced muscle atrophy.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Ascendis to present infant achondroplasia data at ESPE 2026

Ascendis Pharma will share sentinel cohort data from its reACHin pivotal trial of navepegritide in infants under two at ESPE 2026.
Ascendis Pharma will share sentinel cohort data from its reACHin pivotal trial of navepegritide in infants under two at ESPE 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Novo Nordisk: semaglutide clears obesity threshold in 40% of children

Phase 3 STEP Young data show 40.4% of children aged 6 to 11 treated with semaglutide dropped below the obesity BMI threshold after 68
Phase 3 STEP Young data show 40.4% of children aged 6 to 11 treated with semaglutide dropped below the obesity BMI threshold after 68
The Biotech Times Editorial Team  · 
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