North America

The United States and Canada.
Biologics

Diagonal Therapeutics doses first patient in HHT antibody trial

The Watertown biotech has initiated its DIAMOND Phase 1/2 trial of DIAG723, a clustering agonist antibody targeting the ALK1 pathway in a rare vascular
The Watertown biotech has initiated its DIAMOND Phase 1/2 trial of DIAG723, a clustering agonist antibody targeting the ALK1 pathway in a rare vascular
Biologics

Cellution Biologics acquires SimpliDerm ADM business for up to $11m

Cellution Biologics is buying Elutia's SimpliDerm acellular dermal matrix unit to enter the US reconstructive surgery market.
Cellution Biologics is buying Elutia's SimpliDerm acellular dermal matrix unit to enter the US reconstructive surgery market.
Regulatory Science
Biologics

60 Degrees Pharma options FSU castanospermine IP for tick-borne diseases

The NASDAQ-listed vector-borne disease specialist has secured exclusive option rights to FSU's castanospermine IP covering four tick-borne indications.
The NASDAQ-listed vector-borne disease specialist has secured exclusive option rights to FSU's castanospermine IP covering four tick-borne indications.

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
Regulatory Science

Arbutus files international LNP patent suits against Pfizer and BioNTech

Arbutus and Genevant have launched three international lawsuits over LNP patents while banking $178m from a Moderna settlement.
Arbutus and Genevant have launched three international lawsuits over LNP patents while banking $178m from a Moderna settlement.
Biologics

Grifols doses first patients in Phase 3 SIGMA and XPERT Ig trials

Grifols has initiated two Phase 3 trials seeking to broaden US label approvals for its GAMUNEX-C and XEMBIFY immunoglobulin therapies.
Grifols has initiated two Phase 3 trials seeking to broaden US label approvals for its GAMUNEX-C and XEMBIFY immunoglobulin therapies.
Biologics

Angelini Pharma completes $4.1bn Catalyst Pharmaceuticals buyout

The Italian pharma group has taken full ownership of Nasdaq-listed Catalyst, backed by €1bn each from Blackstone and CDP Equity.
The Italian pharma group has taken full ownership of Nasdaq-listed Catalyst, backed by €1bn each from Blackstone and CDP Equity.

Intuitive Surgical Q2 revenue rises 19% as da Vinci placements surge

The robotic-surgery giant posted $2.89bn in Q2 revenue and placed 468 da Vinci systems, as global procedure volumes grew 16% year-on-year.
The robotic-surgery giant posted $2.89bn in Q2 revenue and placed 468 da Vinci systems, as global procedure volumes grew 16% year-on-year.

IPG Photonics bids €300m for Lumibird Medical to build laser platform

IPG Photonics has made a binding offer to acquire ophthalmic laser maker Lumibird Medical for up to €350m, combining ophthalmology and urology franchises.
IPG Photonics has made a binding offer to acquire ophthalmic laser maker Lumibird Medical for up to €350m, combining ophthalmology and urology franchises.

AMT Medical SAFE-CAB II trial data published in JTCVS

AMT Medical's sutureless, laser-assisted coronary bypass system met its safety endpoint in 71 patients, with 97.5% patency using the latest catheter.
AMT Medical's sutureless, laser-assisted coronary bypass system met its safety endpoint in 71 patients, with 97.5% patency using the latest catheter.
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.
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.
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
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

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.
Bioinformatics

Sinopia Biosciences publishes PKA-II modulator data in Science TM

Sinopia's SB-0110 reduced levodopa-induced dyskinesia while boosting motor benefit in primate models, with first-in-human studies targeted for 2027.
Sinopia's SB-0110 reduced levodopa-induced dyskinesia while boosting motor benefit in primate models, with first-in-human studies targeted for 2027.
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.
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

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.
Biologics

Rani Therapeutics RT-114 oral GLP-1/2 agonist tops subcutaneous exposure

Phase 1a data showed oral RT-114 achieved more than 150% bioavailability relative to a matched subcutaneous dose, with a mild adverse-event profile.
Phase 1a data showed oral RT-114 achieved more than 150% bioavailability relative to a matched subcutaneous dose, with a mild adverse-event profile.
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