North America

The United States and Canada.
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 

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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 

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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Biotech

SynCardia's Emperor TAH completes next-gen preclinical implant series

Picard Medical said three acute animal implant procedures demonstrated stable full circulatory support for its fully implantable artificial heart platform.
Picard Medical said three acute animal implant procedures demonstrated stable full circulatory support for its fully implantable artificial heart platform.
The Biotech Times Editorial Team  · 
Diagnostics
Biotech

ACTG launches Phase 2 trial of dasatinib to shrink HIV reservoir

The global trials network has opened study A5413, testing whether the repurposed cancer drug dasatinib can reduce latent HIV by blocking CD4 cell proliferation.
The global trials network has opened study A5413, testing whether the repurposed cancer drug dasatinib can reduce latent HIV by blocking CD4 cell proliferation.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

Alpha Tau and Tolmar partner to commercialise Alpha DaRT in U.S.

Alpha Tau secures a $35M upfront package from Tolmar, plus up to $161.5M in milestones, for exclusive U.S. prostate cancer rights to its
Alpha Tau secures a $35M upfront package from Tolmar, plus up to $161.5M in milestones, for exclusive U.S. prostate cancer rights to its
The Biotech Times Editorial Team  · 
Regulatory Science

Attralus wins FDA orphan drug status for AL amyloidosis candidate AT-02

Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.
Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.
The Biotech Times Editorial Team  · 
Genomics

Biogen's salanersen wins FDA Breakthrough Therapy tag for SMA

The designation is backed by Phase 1b data showing motor function gains in children who had a suboptimal response to prior gene therapy.
The designation is backed by Phase 1b data showing motor function gains in children who had a suboptimal response to prior gene therapy.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

GH Research publishes Phase 2a PPD data for inhaled GH001

All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
The Biotech Times Editorial Team  · 
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