North America

The United States and Canada.
Cell & Gene Therapy
Genomics

Sangamo hires Raymond James to explore strategic alternatives

The genomic medicine company is weighing a sale or partnership as it advances a BLA-ready Fabry gene therapy and two CNS programmes.
The genomic medicine company is weighing a sale or partnership as it advances a BLA-ready Fabry gene therapy and two CNS programmes.
Diagnostics

Sequel Med Tech twiist AID System cuts HbA1c in type 2 pivotal trial

A 307-patient pivotal trial showed twiist reduced HbA1c by 0.7 points and raised time in range by 16 percentage points over 13 weeks.
A 307-patient pivotal trial showed twiist reduced HbA1c by 0.7 points and raised time in range by 16 percentage points over 13 weeks.
Diagnostics

Sparrow Pharma Phase 2a data back clofutriben in Type 2 diabetes

Sparrow Pharmaceuticals reported statistically significant HbA1c and cholesterol reductions from a placebo-controlled trial, with larger benefits in cortisol-enriched
Sparrow Pharmaceuticals reported statistically significant HbA1c and cholesterol reductions from a placebo-controlled trial, with larger benefits in cortisol-enriched

Standard BioTools and Treeline Biosciences agree all-stock merger

The combined company will operate as Treeline Biosciences, with over $900m in cash and three Phase 1 oncology programmes already under way.
The combined company will operate as Treeline Biosciences, with over $900m in cash and three Phase 1 oncology programmes already under way.
Regulatory Science

Agios licenses SYK inhibitor cevidoplenib from Oscotec in $1bn ITP deal

Agios will pay $25m upfront for global rights to cevidoplenib, a next-generation oral SYK inhibitor targeting immune thrombocytopenia, with Phase 3 planned for 2028.
Agios will pay $25m upfront for global rights to cevidoplenib, a next-generation oral SYK inhibitor targeting immune thrombocytopenia, with Phase 3 planned for 2028.
Bioprocessing
Regulatory Science

Alvotech resubmits FDA BLAs for golimumab and aflibercept biosimilars

Alvotech has resubmitted US licence applications for AVT05 and AVT06 following FDA manufacturing queries at its Reykjavik facility, with a six-month review expected.
Alvotech has resubmitted US licence applications for AVT05 and AVT06 following FDA manufacturing queries at its Reykjavik facility, with a six-month review expected.
Diagnostics

Diasome Phase 2b data shows HDV-insulin cuts hypoglycemia in T1D

OPTI-2 trial data show HDV-LIS matched glycaemic control while significantly reducing hypoglycaemic events versus standard insulin lispro in 226 adults.
OPTI-2 trial data show HDV-LIS matched glycaemic control while significantly reducing hypoglycaemic events versus standard insulin lispro in 226 adults.
Digital Health

Health Catalyst divests Vitalware to Med-Metrix for $147m

Health Catalyst will sell its mid-revenue cycle unit to fund AI investment and fully repay a $160m term loan.
Health Catalyst will sell its mid-revenue cycle unit to fund AI investment and fully repay a $160m term loan.
Regulatory Science

PharmAla Biotech licenses ALA-002 U.S. rights to Jupiter Neurosciences

PharmAla will receive up to $100m in milestones and royalties for exclusive U.S. rights to its non-racemic MDMA candidate ALA-002.
PharmAla will receive up to $100m in milestones and royalties for exclusive U.S. rights to its non-racemic MDMA candidate ALA-002.
Bioprocessing

Stipple Bio licenses Lonza ADC platform for precision oncology push

Stipple Bio has struck a multi-target licence with Lonza to pair its epitope-discovery platform with Lonza's GlycoConnect ADC technology, beginning with lead
Stipple Bio has struck a multi-target licence with Lonza to pair its epitope-discovery platform with Lonza's GlycoConnect ADC technology, beginning with lead
Pharmaceuticals

Survodutide Phase III data show 34% visceral and 63% liver fat cuts

Boehringer Ingelheim's glucagon/GLP-1 dual agonist met primary endpoints in two Phase III trials, with lean mass largely preserved, data published in NEJM
Boehringer Ingelheim's glucagon/GLP-1 dual agonist met primary endpoints in two Phase III trials, with lean mass largely preserved, data published in NEJM
Diagnostics

Biomea Fusion presents icovamenib diabetes data at ADA 2026

Phase II findings show durable HbA1c reductions and beta cell preservation in both type 1 and type 2 diabetes, with no immune activation signals.
Phase II findings show durable HbA1c reductions and beta cell preservation in both type 1 and type 2 diabetes, with no immune activation signals.

Cullinan Therapeutics' CLN-978 shows remissions in SLE and RA at EULAR

Phase 1 data from 29 patients show deep B cell depletion and clinical remissions in refractory lupus and rheumatoid arthritis after a single dose.
Phase 1 data from 29 patients show deep B cell depletion and clinical remissions in refractory lupus and rheumatoid arthritis after a single dose.
Diagnostics
Digital Health

Senseonics presents real-world Eversense 365 data at ADA 2026

New data from 12,360 sensors show the implantable one-year CGM maintained strong glycaemic control and adherence across both open and closed-loop systems.
New data from 12,360 sensors show the implantable one-year CGM maintained strong glycaemic control and adherence across both open and closed-loop systems.
Regulatory Science

Signati Medical wins FDA IDE approval for Separo vasectomy device trial

The Providence-based medtech has cleared FDA's IDE process, unlocking a 120-subject pivotal RCT comparing Separo to standard mucosal cautery vasectomy.
The Providence-based medtech has cleared FDA's IDE process, unlocking a 120-subject pivotal RCT comparing Separo to standard mucosal cautery vasectomy.
Diagnostics

Cloudbreak Pharma completes final visits for Phase 3 pterygium trial

Topline 12-month efficacy data for CBT-001, a potential first FDA-approved pterygium drug, are expected in Q3 2026.
Topline 12-month efficacy data for CBT-001, a potential first FDA-approved pterygium drug, are expected in Q3 2026.
Regulatory Science

BioCardia wins FDA backing for single-trial PMA path for CardiAMP

FDA confirmed that BioCardia's ongoing CardiAMP HF II trial may alone support a Premarket Approval application for its autologous cell therapy in ischaemic HFrEF.
FDA confirmed that BioCardia's ongoing CardiAMP HF II trial may alone support a Premarket Approval application for its autologous cell therapy in ischaemic HFrEF.

Fractyl Health: Revita holds 78% of GLP-1 weight loss at one year

One-year REVEAL-1 open-label data show a single endoscopic Revita procedure sustains most GLP-1-induced weight loss after drug discontinuation.
One-year REVEAL-1 open-label data show a single endoscopic Revita procedure sustains most GLP-1-induced weight loss after drug discontinuation.
Biotech

Hengrui and Kailera report ribupatide Phase 2 oral data at ADA 2026

Oral ribupatide delivered up to 12.1% mean weight loss at 26 weeks in a China Phase 2 trial, with no observed plateau and a
Oral ribupatide delivered up to 12.1% mean weight loss at 26 weeks in a China Phase 2 trial, with no observed plateau and a
Biotech

Zealand Pharma petrelintide hits 10.7% weight loss at 42 weeks

Phase 2 ZUPREME-1 data show the amylin analogue achieved double-digit weight reduction with near-placebo tolerability, ahead of planned Phase 3 initiation.
Phase 2 ZUPREME-1 data show the amylin analogue achieved double-digit weight reduction with near-placebo tolerability, ahead of planned Phase 3 initiation.
Subscribe to North America