North America

The United States and Canada.
Diagnostics
Regulatory Science
Biologics

OraSure wins FDA EUA for second-generation OraQuick Ebola 2.0 test

OraSure's updated rapid antigen test detects all four disease-causing Ebola viruses and was developed with BARDA funding amid a live DRC outbreak.
OraSure's updated rapid antigen test detects all four disease-causing Ebola viruses and was developed with BARDA funding amid a live DRC outbreak.
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.
Biologics

Adlai Nortye doses first patient in weekly arm of AN9025 Phase 1

The NASDAQ-listed biotech has opened a weekly dosing cohort in its global Phase 1 trial of pan-RAS(ON) inhibitor AN9025, with both arms
The NASDAQ-listed biotech has opened a weekly dosing cohort in its global Phase 1 trial of pan-RAS(ON) inhibitor AN9025, with both arms
Biologics

BriaCell adds Sunnybrook to Phase 3 breast cancer trial

Sunnybrook's Odette Cancer Centre becomes BriaCell's first Canadian site for its pivotal Bria-IMT Phase 3 study in metastatic breast cancer.
Sunnybrook's Odette Cancer Centre becomes BriaCell's first Canadian site for its pivotal Bria-IMT Phase 3 study in metastatic breast cancer.
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.
Biologics

Compass Therapeutics tovecimig data wins oral slot at ESMO 2026

Phase 2/3 COMPANION-002 biliary tract cancer results will be presented orally at ESMO in Madrid on 24 October 2026.
Phase 2/3 COMPANION-002 biliary tract cancer results will be presented orally at ESMO in Madrid on 24 October 2026.
Biologics
Regulatory Science

DBV Technologies targets Q3 BLA filing for VIASKIN Peanut Patch

DBV Technologies expects to submit its peanut-patch BLA in Q3 2026, backed by $174.9m in cash and active FDA engagement.
DBV Technologies expects to submit its peanut-patch BLA in Q3 2026, backed by $174.9m in cash and active FDA engagement.
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

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

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.
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.

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.
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

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

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.
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.
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