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

Tenax Therapeutics presents Phase 3 LEVEL data at ESC 2026

TNX-103 showed a 26.3-metre walk improvement and 47% NT-proBNP reduction in lower-function PH-HFpEF patients, shaping the LEVEL-2 trial
TNX-103 showed a 26.3-metre walk improvement and 47% NT-proBNP reduction in lower-function PH-HFpEF patients, shaping the LEVEL-2 trial
The Biotech Times Editorial Team  · 
Biologics

BioXcel Therapeutics files Chapter 11, eyes Teva asset sale

BioXcel Therapeutics has entered Chapter 11 bankruptcy, naming Teva as stalking-horse bidder for IGALMI and a pending agitation sNDA.
BioXcel Therapeutics has entered Chapter 11 bankruptcy, naming Teva as stalking-horse bidder for IGALMI and a pending agitation sNDA.
The Biotech Times Editorial Team  · 
Biologics

CRISPR Therapeutics' CTX310 shows durable lipid cuts at one year

Phase 1a data published in NEJM show a single CTX310 infusion sustained 79% mean ANGPTL3 reduction and 53% LDL reduction at one year.
Phase 1a data published in NEJM show a single CTX310 infusion sustained 79% mean ANGPTL3 reduction and 53% LDL reduction at one year.
The Biotech Times Editorial Team  · 
Biologics
Biotech

Eascra Biotech wins $7.96m NASA contract for space-made nanomedicine

The Worcester, MA startup will use microgravity manufacturing to advance its RNA-delivery nanoparticle platform toward FDA clinical trials by 2028.
The Worcester, MA startup will use microgravity manufacturing to advance its RNA-delivery nanoparticle platform toward FDA clinical trials by 2028.
The Biotech Times Editorial Team  · 
Diagnostics
Regulatory Science
Biologics

hVIVO acquires CRS Berlin to enter dermatology and women's health

hVIVO has bought the Berlin-based Phase I/II unit for a nominal upfront fee plus a revenue-linked earnout capped at roughly €6 million.
hVIVO has bought the Berlin-based Phase I/II unit for a nominal upfront fee plus a revenue-linked earnout capped at roughly €6 million.
The Biotech Times Editorial Team  · 
Biologics
Diagnostics

IBA swings to profit in H1 2026 as proton therapy orders surge

The Belgian particle accelerator group posted a €9.3m net profit in H1 2026, reversing a prior-year loss, with proton therapy order intake more
The Belgian particle accelerator group posted a €9.3m net profit in H1 2026, reversing a prior-year loss, with proton therapy order intake more
The Biotech Times Editorial Team  · 
Biologics

Amarin REDUCE-IT legacy analysis suggests durable CV benefit after IPE

A post hoc analysis of REDUCE-IT, presented at ESC 2026, suggests icosapent ethyl's cardiovascular benefit may persist years after treatment stops in adherent
A post hoc analysis of REDUCE-IT, presented at ESC 2026, suggests icosapent ethyl's cardiovascular benefit may persist years after treatment stops in adherent
The Biotech Times Editorial Team  · 
Biologics

Roche Vabysmo shows sustained two-year data in PCV subtype of nAMD

Two-year SALWEEN results show faricimab cleared polypoidal lesions in most patients and extended dosing intervals to 20 weeks in 61% by year two.
Two-year SALWEEN results show faricimab cleared polypoidal lesions in most patients and extended dosing intervals to 20 weeks in 61% by year two.
The Biotech Times Editorial Team  · 
Biologics

argenx acquires Forte Biosciences, adding anti-CD122 antibody

argenx has completed its takeover of Forte Biosciences, gaining FB102, an anti-CD122 antibody with clinical data in vitiligo and coeliac disease.
argenx has completed its takeover of Forte Biosciences, gaining FB102, an anti-CD122 antibody with clinical data in vitiligo and coeliac disease.
The Biotech Times Editorial Team  · 
Biologics

Corvus Pharmaceuticals publishes Phase 1 soquelitinib data in Blood

Final Phase 1/1b data for the ITK inhibitor in T cell lymphoma show durable responses and support an ongoing Phase 3 trial in relapsed
Final Phase 1/1b data for the ITK inhibitor in T cell lymphoma show durable responses and support an ongoing Phase 3 trial in relapsed
The Biotech Times Editorial Team  · 
Biologics

CytomX wins FDA Fast Track for EpCAM ADC in metastatic colorectal cancer

The FDA granted Fast Track Designation to Varseta-M, an EpCAM-directed ADC, ahead of a planned registrational study starting in early 2027.
The FDA granted Fast Track Designation to Varseta-M, an EpCAM-directed ADC, ahead of a planned registrational study starting in early 2027.
The Biotech Times Editorial Team  · 
Biologics

MBX Biosciences doses first patient in Phase 3 canvuparatide trial

The NASDAQ-listed biotech has initiated its pivotal oPTimize study of once-weekly canvuparatide in roughly 160 adults with chronic hypoparathyroidism.
The NASDAQ-listed biotech has initiated its pivotal oPTimize study of once-weekly canvuparatide in roughly 160 adults with chronic hypoparathyroidism.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Pfizer and BioNTech win FDA approval for XFG-adapted COMIRNATY

The companies' 2026-2027 mRNA COVID-19 vaccine, targeting the XFG variant, has been approved for high-risk adults and children aged five and over.
The companies' 2026-2027 mRNA COVID-19 vaccine, targeting the XFG variant, has been approved for high-risk adults and children aged five and over.
The Biotech Times Editorial Team  · 
Biologics

Priovant wins FDA approval for brepocitinib in dermatomyositis

LISRAYA becomes the first targeted oral therapy approved for dermatomyositis, backed by Phase 3 data showing significant steroid-sparing and disease-activity benefits.
LISRAYA becomes the first targeted oral therapy approved for dermatomyositis, backed by Phase 3 data showing significant steroid-sparing and disease-activity benefits.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Roivant's brepocitinib wins FDA approval for dermatomyositis

LISRAYA becomes the first targeted therapy approved for dermatomyositis, a rare autoimmune disease with few treatment advances in decades.
LISRAYA becomes the first targeted therapy approved for dermatomyositis, a rare autoimmune disease with few treatment advances in decades.
The Biotech Times Editorial Team  · 
Biologics

SOTIO's SOT106 ADC wins FDA Fast Track for soft tissue sarcoma

SOTIO Biotech's LRRC15-targeting antibody-drug conjugate gained Fast Track Designation, with a first-in-human study expected before year end.
SOTIO Biotech's LRRC15-targeting antibody-drug conjugate gained Fast Track Designation, with a first-in-human study expected before year end.
The Biotech Times Editorial Team  · 
Regulatory Science
Biologics

INmune Bio files EMA packages for Ebstrocel in rare skin disease

INmune Bio has submitted an orphan drug designation application and pre-MAA scientific advice package to the EMA for its cell therapy Ebstrocel in RDEB.
INmune Bio has submitted an orphan drug designation application and pre-MAA scientific advice package to the EMA for its cell therapy Ebstrocel in RDEB.
The Biotech Times Editorial Team  · 
Biologics

Priovant's brepocitinib hits skin remission targets in Phase 3 DM trial

JAMA Dermatology publishes secondary endpoint data showing rapid, durable skin improvements for brepocitinib versus placebo in dermatomyositis.
JAMA Dermatology publishes secondary endpoint data showing rapid, durable skin improvements for brepocitinib versus placebo in dermatomyositis.
The Biotech Times Editorial Team  · 
Digital Health
Biologics

Johns Hopkins wins NIH R01 to study GLP-1 long-term value

A five-year NIDDK-funded study will use Truveta's 140-million-patient dataset to assess GLP-1 cost-effectiveness and inform coverage decisions.
A five-year NIDDK-funded study will use Truveta's 140-million-patient dataset to assess GLP-1 cost-effectiveness and inform coverage decisions.
The Biotech Times Editorial Team  · 
Regulatory Science
Biologics

Mereo BioPharma licenses alvelestat to Sentynl in $475m-plus US deal

Mereo will receive up to $475m and tiered royalties if Sentynl exercises its US commercialisation option for the oral AATD-LD candidate.
Mereo will receive up to $475m and tiered royalties if Sentynl exercises its US commercialisation option for the oral AATD-LD candidate.
The Biotech Times Editorial Team  · 
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