Biologics
Regulatory Science

Novartis Fabhalta wins FDA traditional approval in IgA nephropathy

Iptacopan slowed eGFR decline by 48% versus placebo over two years in the Phase III APPLAUSE-IgAN study, converting an accelerated approval granted in 2024.
Iptacopan slowed eGFR decline by 48% versus placebo over two years in the Phase III APPLAUSE-IgAN study, converting an accelerated approval granted in 2024.

RapidPulse closes $48m Series B to advance TURBO stroke trial

The Miami medtech secured an oversubscribed round co-led by Medtronic to fund its IDE study of pulsed aspiration thrombectomy and pursue FDA clearance.
The Miami medtech secured an oversubscribed round co-led by Medtronic to fund its IDE study of pulsed aspiration thrombectomy and pursue FDA clearance.
Biologics

Teva licenses Polpharma ocrelizumab biosimilar for global markets

Teva secures exclusive commercialisation rights to Polpharma Biologics' ocrelizumab biosimilar candidate across key markets including the US, EU and Brazil.
Teva secures exclusive commercialisation rights to Polpharma Biologics' ocrelizumab biosimilar candidate across key markets including the US, EU and Brazil.
Biologics

Allogene ALLO-316 achieves 31% response rate in solid tumour Phase 1

Full TRAVERSE Phase 1 data, published in JCO, show durable remissions in CD70-high metastatic renal cell carcinoma with a single allogeneic CAR T infusion.
Full TRAVERSE Phase 1 data, published in JCO, show durable remissions in CD70-high metastatic renal cell carcinoma with a single allogeneic CAR T infusion.
Diagnostics

Alpha Tau treats first immunocompromised cSCC patient in ADMIRE trial

Alpha Tau's ADMIRE study has dosed its first patient, targeting a population for whom standard checkpoint immunotherapy carries significant organ-rejection risk.
Alpha Tau's ADMIRE study has dosed its first patient, targeting a population for whom standard checkpoint immunotherapy carries significant organ-rejection risk.
Biologics

Boehringer starts Phase II for triple receptor agonist BI 3034701

Boehringer Ingelheim has dosed first patients in a Phase II trial of BI 3034701, a GLP-1/GIP/NPY2 triple agonist targeting obesity.
Boehringer Ingelheim has dosed first patients in a Phase II trial of BI 3034701, a GLP-1/GIP/NPY2 triple agonist targeting obesity.
Biologics

Cellectar publishes Phase 1 iopofosine I 131 data in multiple myeloma

Phase 1 results in 31 heavily pretreated patients showed a 30% response rate at higher doses and a manageable hematologic safety profile.
Phase 1 results in 31 heavily pretreated patients showed a 30% response rate at higher doses and a manageable hematologic safety profile.
Biologics

InnoCare soficitinib meets Phase III endpoint in atopic dermatitis

InnoCare's oral TYK2 inhibitor soficitinib met its primary endpoint with statistical significance in a registrational Phase III atopic dermatitis trial.
InnoCare's oral TYK2 inhibitor soficitinib met its primary endpoint with statistical significance in a registrational Phase III atopic dermatitis trial.
Digital Health

Kestra Medical secures $200m non-dilutive loan facility with Pharmakon

The Nasdaq-listed wearable cardiovascular device maker replaces a $45m term loan and unlocks up to $357m in total liquidity.
The Nasdaq-listed wearable cardiovascular device maker replaces a $45m term loan and unlocks up to $357m in total liquidity.
Biologics

ENDURANCE trial: two-year lenalidomide matches lifelong therapy

A phase III NEJM study found two years of lenalidomide maintenance equals indefinite treatment for survival in standard-risk multiple myeloma patients.
A phase III NEJM study found two years of lenalidomide maintenance equals indefinite treatment for survival in standard-risk multiple myeloma patients.
Biologics

Neutrolis publishes NEJM case report on NET-degrading SLE therapy

A single-patient compassionate-use case in NEJM shows NTR-441 rapidly cleared SLE symptoms caused by congenital DNASE1L3 deficiency.
A single-patient compassionate-use case in NEJM shows NTR-441 rapidly cleared SLE symptoms caused by congenital DNASE1L3 deficiency.
Diagnostics
Biologics

IGeneX single-step immunoblot nearly doubles early Lyme detection rate

A peer-reviewed study found IGeneX's FDA-cleared IB tests detected early Lyme disease in 58.3% of cases versus 30.0% with standard
A peer-reviewed study found IGeneX's FDA-cleared IB tests detected early Lyme disease in 58.3% of cases versus 30.0% with standard
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