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).

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  · 
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  · 
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  · 
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  · 
Biologics
Regulatory Science

Vaxart secures European patent for oral norovirus vaccine platform

The EPO has granted Vaxart protection for its room-temperature, needle-free norovirus pill vaccine across 13 European markets until at least 2036.
The EPO has granted Vaxart protection for its room-temperature, needle-free norovirus pill vaccine across 13 European markets until at least 2036.
The Biotech Times Editorial Team  · 
Diagnostics
Medical Devices
Biologics

Cytek Biosciences to showcase spectral cytometry at ESCCA and ICCS

Cytek will present Full Spectrum Profiling technology at two clinical cytometry conferences in September and October, with a focus on MRD monitoring.
Cytek will present Full Spectrum Profiling technology at two clinical cytometry conferences in September and October, with a focus on MRD monitoring.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Pulmovant to present Phase 2 PHocus topline data at ERS 2026

Pulmovant will share Phase 2 results for inhaled sGC activator mosliciguat in PH-ILD at ERS Congress on 8 September 2026.
Pulmovant will share Phase 2 results for inhaled sGC activator mosliciguat in PH-ILD at ERS Congress on 8 September 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Roivant to unveil mosliciguat Phase 2 PH-ILD data at ERS 2026

Topline results from the PHocus study will be presented at the European Respiratory Society Congress on 8 September, followed by an investor call.
Topline results from the PHocus study will be presented at the European Respiratory Society Congress on 8 September, followed by an investor call.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Silexion Therapeutics prices $2.5m offering to fund SIL204 trial

The NASDAQ-listed RNAi oncology biotech will use net proceeds to advance its Phase 2/3 SIL204 trial in locally advanced pancreatic cancer.
The NASDAQ-listed RNAi oncology biotech will use net proceeds to advance its Phase 2/3 SIL204 trial in locally advanced pancreatic cancer.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

HCW Biologics wins patent allowance for HCW9302 in alopecia areata

The Florida biotech has secured a USPTO notice of allowance covering HCW9302 as an alopecia areata treatment, as Phase 1 data show early signs of
The Florida biotech has secured a USPTO notice of allowance covering HCW9302 as an alopecia areata treatment, as Phase 1 data show early signs of
The Biotech Times Editorial Team  · 
Medical Devices
Pharmaceuticals
Regulatory Science
Biologics

IBA joins PFAROS consortium to test electron beam PFAS destruction

IBA will co-lead end-of-life and waste-management work in a 91-partner EU initiative targeting PFAS removal from healthcare and pharmaceutical waste
IBA will co-lead end-of-life and waste-management work in a 91-partner EU initiative targeting PFAS removal from healthcare and pharmaceutical waste
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Nxera Pharma to receive $8.6m milestone from Lilly-owned Centessa

A late-stage development advance in Centessa's OX2R agonist pipeline triggers an $8.6 million payment to Nxera, which retains future milestone and royalty
A late-stage development advance in Centessa's OX2R agonist pipeline triggers an $8.6 million payment to Nxera, which retains future milestone and royalty
The Biotech Times Editorial Team  · 
Biologics
Bioprocessing

PMGC Holdings signs term sheet for spaceflight muscle-loss study

NorthStrive Biosciences will test probiotic candidates EL-22 and EL-32 in a live-mouse microgravity study under a non-binding deal with Australia's
NorthStrive Biosciences will test probiotic candidates EL-22 and EL-32 in a live-mouse microgravity study under a non-binding deal with Australia's
The Biotech Times Editorial Team  · 
Medical Devices
Pharmaceuticals
Biologics

Vivos publishes peer-reviewed data on PrecisionGel thermogel

Vivos Inc. has validated its PrecisionGel polymer platform in an Elsevier journal, supporting clinical programmes at Mayo Clinic and licensing talks with pharmaceutical
Vivos Inc. has validated its PrecisionGel polymer platform in an Elsevier journal, supporting clinical programmes at Mayo Clinic and licensing talks with pharmaceutical
The Biotech Times Editorial Team  · 
Medical Devices
Biologics

BioStem's VENDAJE products gain Vizient and Premier GPO coverage

BioStem Technologies has secured GPO contract coverage for VENDAJE and VENDAJE AC through Vizient and Premier, opening hospital access for the first time.
BioStem Technologies has secured GPO contract coverage for VENDAJE and VENDAJE AC through Vizient and Premier, opening hospital access for the first time.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics
Diagnostics

Cosmos Health posts record H1 revenue of $36.9m, retires debt early

The NASDAQ-listed healthcare group reported 29.7% revenue growth in H1 2026 and repaid an $8m convertible note twelve months ahead of schedule.
The NASDAQ-listed healthcare group reported 29.7% revenue growth in H1 2026 and repaid an $8m convertible note twelve months ahead of schedule.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Pharmaceuticals

Intellia Therapeutics secures $400m debt facility with OrbiMed

The CRISPR biotech drew an initial $75m at closing, with further tranches tied to milestones for its HAE gene-editing candidate lonvo-z.
The CRISPR biotech drew an initial $75m at closing, with further tranches tied to milestones for its HAE gene-editing candidate lonvo-z.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Novartis pelacarsen Phase III trial fails to cut CV events

The Lp(a)HORIZON outcomes trial in 8,323 patients met its Lp(a)-lowering goal but did not reduce the composite cardiovascular endpoint versus
The Lp(a)HORIZON outcomes trial in 8,323 patients met its Lp(a)-lowering goal but did not reduce the composite cardiovascular endpoint versus
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Persica Pharmaceuticals publishes PK/PD case for PP353 in back pain

New modelling data links antibiotic disc exposure to clinical benefit, strengthening the rationale for PP353 as a targeted, non-opioid therapy for vertebrogenic lumbar
New modelling data links antibiotic disc exposure to clinical benefit, strengthening the rationale for PP353 as a targeted, non-opioid therapy for vertebrogenic lumbar
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Novartis pelacarsen trial misses primary endpoint in Lp(a) study

The HORIZON Phase 3 trial of pelacarsen failed its primary cardiovascular endpoint, but royalty backer Royalty Pharma says it still expects a modest positive return.
The HORIZON Phase 3 trial of pelacarsen failed its primary cardiovascular endpoint, but royalty backer Royalty Pharma says it still expects a modest positive return.
The Biotech Times Editorial Team  · 
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