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).

Medical Devices
Diagnostics
Pharmaceuticals
Cell & Gene Therapy
Biologics

Penn Medicine and IBA form Noventra Oncology Alliance JV

The joint venture will offer end-to-end advisory and operational support to health systems building or expanding proton therapy programmes worldwide.
The joint venture will offer end-to-end advisory and operational support to health systems building or expanding proton therapy programmes worldwide.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Absci plans Phase 2 STORYLINE trial of ABS-201 for endometriosis

Absci will launch a global, placebo-controlled Phase 2 study of its AI-designed anti-PRLR antibody ABS-201 in endometriosis patients from mid-2027.
Absci will launch a global, placebo-controlled Phase 2 study of its AI-designed anti-PRLR antibody ABS-201 in endometriosis patients from mid-2027.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics
Cell & Gene Therapy

C4 Therapeutics cemsidomide shows T-cell data at IMS 2026

Biomarker data from two trials support cemsidomide's T-cell activating mechanism, as the 75 µg dose combination with elranatamab clears safety review.
Biomarker data from two trials support cemsidomide's T-cell activating mechanism, as the 75 µg dose combination with elranatamab clears safety review.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

Celularity closes $10m first tranche of $28m recapitalisation

Celularity has completed an initial $10m raise from convertible notes, targeting positive monthly operating cash flow by end of Q1 2027.
Celularity has completed an initial $10m raise from convertible notes, targeting positive monthly operating cash flow by end of Q1 2027.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

CIRM awards $9m to Enloe Health for Northern California CGT centre

The California Institute for Regenerative Medicine is funding a new Community Care Centre of Excellence in Chico, extending CAR-T access to underserved Northern
The California Institute for Regenerative Medicine is funding a new Community Care Centre of Excellence in Chico, extending CAR-T access to underserved Northern
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Medicenna to present bizaxofusp rGBM survival data at SNO 2026

Medicenna's IL-4-targeted glioblastoma candidate will receive an oral slot at the Society for Neuro-Oncology meeting in November.
Medicenna's IL-4-targeted glioblastoma candidate will receive an oral slot at the Society for Neuro-Oncology meeting in November.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

PridCor Therapeutics advances Phase 2 SHIELD Long COVID study

The Alabama biotech has made its first payment to Mount Sinai under a clinical agreement, with enrollment in the 150-patient SHIELD trial expected shortly.
The Alabama biotech has made its first payment to Mount Sinai under a clinical agreement, with enrollment in the 150-patient SHIELD trial expected shortly.
The Biotech Times Editorial Team  · 
Diagnostics
Biologics
Cell & Gene Therapy

Adaptive Biotechnologies cites clonoSEQ in new myeloma cure definition

A new IMS consensus definition places sustained MRD negativity at the centre of determining cure in multiple myeloma, boosting the case for NGS-based testing.
A new IMS consensus definition places sustained MRD negativity at the centre of determining cure in multiple myeloma, boosting the case for NGS-based testing.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

ADARx Pharmaceuticals prices $446m IPO on Nasdaq

The San Diego siRNA biotech raised up to $535m including an AbbVie cornerstone placement, valuing one of 2026's larger biotech listings.
The San Diego siRNA biotech raised up to $535m including an AbbVie cornerstone placement, valuing one of 2026's larger biotech listings.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Addex regains global GABAB PAM rights after Indivior R&D pullback

Addex Therapeutics has reclaimed its full GABAB positive allosteric modulator portfolio from Indivior, citing the UK firm's R&D rationalisation ahead of a planned
Addex Therapeutics has reclaimed its full GABAB positive allosteric modulator portfolio from Indivior, citing the UK firm's R&D rationalisation ahead of a planned
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Avacta presents FOCUS-01 trial design and AVA6103 PDAC data at AACR

Avacta Therapeutics shared preclinical PDX data and Phase 1 trial design for its FAP-targeted peptide-drug conjugate AVA6103 at the AACR pancreatic cancer conference.
Avacta Therapeutics shared preclinical PDX data and Phase 1 trial design for its FAP-targeted peptide-drug conjugate AVA6103 at the AACR pancreatic cancer conference.
The Biotech Times Editorial Team  · 
Proteomics
Diagnostics
Biologics

Alamar Biosciences platform underpins Lancet Neurology lecanemab study

A Washington University cohort study used Alamar's 130-protein plasma panel to show amyloid clearance and cognitive response reflect distinct biological processes.
A Washington University cohort study used Alamar's 130-protein plasma panel to show amyloid clearance and cognitive response reflect distinct biological processes.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

CARVYKTI: half of earlier-line myeloma patients free at five years

Five-year CARTITUDE-2 data show 50% of RRMM patients remained alive and progression-free after a single cilta-cel infusion, with overall survival at
Five-year CARTITUDE-2 data show 50% of RRMM patients remained alive and progression-free after a single cilta-cel infusion, with overall survival at
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Pharming wins FDA Priority Review for Joenja in lighter children

Pharming's sNDA for lower leniolisib doses in children weighing 13-27 kg with APDS has a PDUFA date of 30 January 2027.
Pharming's sNDA for lower leniolisib doses in children weighing 13-27 kg with APDS has a PDUFA date of 30 January 2027.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Pharmaceuticals

CARVYKTI gives five-year remissions to 50% in early-line myeloma

Five-year CARTITUDE-2 data show half of early-line RRMM patients remained alive and progression-free after a single cilta-cel infusion, with no
Five-year CARTITUDE-2 data show half of early-line RRMM patients remained alive and progression-free after a single cilta-cel infusion, with no
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals
Regulatory Science

aTyr Pharma secures FDA alignment on efzofitimod Phase 3 design

aTyr Pharma has agreed a Phase 3 protocol with the FDA for efzofitimod in pulmonary sarcoidosis, with study activities due to begin in Q4 2026.
aTyr Pharma has agreed a Phase 3 protocol with the FDA for efzofitimod in pulmonary sarcoidosis, with study activities due to begin in Q4 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Elicio Therapeutics AMPLIFY-7P data selected for ESMO 2026 oral slot

Phase 2 KRAS-targeting immunotherapy data will be presented at ESMO Congress in Madrid on 23 October, informing a refined Phase 3 strategy.
Phase 2 KRAS-targeting immunotherapy data will be presented at ESMO Congress in Madrid on 23 October, informing a refined Phase 3 strategy.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

IMUNON reports 14.7-month OS gain from Phase 2 ovarian cancer trial

IMUNON's IMNN-001 showed a 14.7-month median overall survival advantage over standard care in a 112-patient Phase 2 study, as its
IMUNON's IMNN-001 showed a 14.7-month median overall survival advantage over standard care in a 112-patient Phase 2 study, as its
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Rezolute's ersodetug shows strong interim data in tumour HI trial

Seven of eight enrolled participants met the primary endpoint in the upLIFT Phase 3 study; topline results are expected before end of 2026.
Seven of eight enrolled participants met the primary endpoint in the upLIFT Phase 3 study; topline results are expected before end of 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Satellos wins FDA IND clearance for forazapadin in FSHD

Satellos Bioscience has cleared an IND for its AAK1 inhibitor in a second muscle disease, backed by US$5m from the FSHD Canada Foundation.
Satellos Bioscience has cleared an IND for its AAK1 inhibitor in a second muscle disease, backed by US$5m from the FSHD Canada Foundation.
The Biotech Times Editorial Team  · 
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