Disease

Pharmaceuticals
Diagnostics

Galimedix to present eDREAM Phase 2 GA data at EURETINA 2026

Galimedix Therapeutics will present five abstracts from its Phase 2 eDREAM study of GAL-101 in geographic atrophy at the Vienna congress in October.
Galimedix Therapeutics will present five abstracts from its Phase 2 eDREAM study of GAL-101 in geographic atrophy at the Vienna congress in October.
Medical Devices
Diagnostics

Hexiris Ophthalmics to show OBi glaucoma data at five meetings

Hexiris Ophthalmics will present first-in-human OBi Core results across five European and North American ophthalmology meetings this autumn.
Hexiris Ophthalmics will present first-in-human OBi Core results across five European and North American ophthalmology meetings this autumn.
Pharmaceuticals
Diagnostics

Quantum BioPharma clears FDA IND for PAD2-targeting MS drug Lucid-MS

Quantum BioPharma has FDA clearance to begin a Phase 2 trial of Lucid-MS, a PAD2 inhibitor designed to target demyelination rather than suppress the
Quantum BioPharma has FDA clearance to begin a Phase 2 trial of Lucid-MS, a PAD2 inhibitor designed to target demyelination rather than suppress the
Medical Devices
Pharmaceuticals
Digital Health

HOPE Therapeutics first to deploy Zeta Surgical's robotic TMS system

NRx subsidiary HOPE Therapeutics is training clinical staff on Zeta Surgical's FDA-cleared robotic TMS platform ahead of Florida deployment and a DARPA-backed
NRx subsidiary HOPE Therapeutics is training clinical staff on Zeta Surgical's FDA-cleared robotic TMS platform ahead of Florida deployment and a DARPA-backed
Pharmaceuticals
Biologics

Rhythm Pharma setmelanotide shows BMI gains in paediatric HO data

Real-world French data and Phase 3 post-hoc analyses reinforce setmelanotide's cardiometabolic benefits in paediatric acquired hypothalamic obesity.
Real-world French data and Phase 3 post-hoc analyses reinforce setmelanotide's cardiometabolic benefits in paediatric acquired hypothalamic obesity.
Pharmaceuticals
Genomics
Regulatory Science

CAMP4 Therapeutics wins MHRA nod for CMP-002 SYNGAP1 Phase 1/2 trial

CAMP4 Therapeutics has secured MHRA authorisation to include UK sites in its global Phase 1/2 study of CMP-002, an ASO targeting SYNGAP1-related
CAMP4 Therapeutics has secured MHRA authorisation to include UK sites in its global Phase 1/2 study of CMP-002, an ASO targeting SYNGAP1-related
Biologics
Pharmaceuticals

Electra Therapeutics starts Phase 1 of SIRPγ antibody ELA822

Electra's second SIRP-targeted candidate enters the clinic targeting selective depletion of pathogenic T cells in chronic immune and inflammatory diseases.
Electra's second SIRP-targeted candidate enters the clinic targeting selective depletion of pathogenic T cells in chronic immune and inflammatory diseases.
Pharmaceuticals
Biologics

Pharming wins FDA approval for Joenja in children aged 4 to 11 with APDS

The Netherlands-based biotech secured a supplemental approval making leniolisib the first FDA-approved treatment for younger children with the rare immunodeficiency APDS.
The Netherlands-based biotech secured a supplemental approval making leniolisib the first FDA-approved treatment for younger children with the rare immunodeficiency APDS.
Pharmaceuticals
Regulatory Science

Nicox NCX 470 NDA accepted for review by China's NMPA

China's NMPA has accepted the NCX 470 glaucoma NDA filed by Nicox's licensee Ocumension, with a regulatory decision expected within 12 to 18
China's NMPA has accepted the NCX 470 glaucoma NDA filed by Nicox's licensee Ocumension, with a regulatory decision expected within 12 to 18
AgriTech
Diagnostics

Rad Source launches Sterile Insect Farms division for mosquito control

Rad Source Technologies is commercialising X-ray-sterilised male mosquitoes for public health districts seeking a non-chemical population control method.
Rad Source Technologies is commercialising X-ray-sterilised male mosquitoes for public health districts seeking a non-chemical population control method.
Medical Devices

Health Textiles Nigeria begins PermaNet Dual net production

Vestergaard's new Lagos facility is Nigeria's first to manufacture dual-active ingredient insecticide-treated nets, targeting 10 million units a year.
Vestergaard's new Lagos facility is Nigeria's first to manufacture dual-active ingredient insecticide-treated nets, targeting 10 million units a year.
Pharmaceuticals
Regulatory Science

Adneuris presents Phase 3 and abuse-potential data for cebranopadol

Pivotal ALLEVIATE studies met primary endpoints for acute pain, and new data suggest cebranopadol carries lower abuse potential than oxycodone.
Pivotal ALLEVIATE studies met primary endpoints for acute pain, and new data suggest cebranopadol carries lower abuse potential than oxycodone.
Biologics
Pharmaceuticals
Regulatory Science

Ethris secures €30M EIB loan to advance mRNA antiviral ETH47

The Munich biotech will use the HERA Invest-backed funds to progress its interferon-lambda mRNA candidate into Phase 2b trials in asthma and COPD.
The Munich biotech will use the HERA Invest-backed funds to progress its interferon-lambda mRNA candidate into Phase 2b trials in asthma and COPD.
Pharmaceuticals
Biologics
Medical Devices

MannKind and Rose Pharma partner on inhaled GLP-1 for weight loss

MannKind will supply its Technosphere platform and manufacturing support to develop ROSE-010, an inhaled rapid-acting GLP-1, through Phase 1b.
MannKind will supply its Technosphere platform and manufacturing support to develop ROSE-010, an inhaled rapid-acting GLP-1, through Phase 1b.
Pharmaceuticals
Diagnostics

Medicus Pharma selects 200 µg SkinJect dose after Phase 2 BCC readout

Medicus Pharma published its Phase 2 CSR for SkinJect, selecting the 200 µg patch dose and pivoting development toward rare Gorlin syndrome.
Medicus Pharma published its Phase 2 CSR for SkinJect, selecting the 200 µg patch dose and pivoting development toward rare Gorlin syndrome.
Pharmaceuticals
Bioprocessing

Optimi Health to launch Phase 2 psilocybin trial for depression

The Vancouver-based manufacturer will run a 200-participant, Health Canada-authorised study of naturally derived psilocybin in major depressive disorder.
The Vancouver-based manufacturer will run a 200-participant, Health Canada-authorised study of naturally derived psilocybin in major depressive disorder.
Pharmaceuticals
Biologics

Beeline Medicines' afimetoran meets Phase 2 primary endpoint in SLE

The Stamford biotech reported highly significant SRI-4 response rates versus placebo at Week 48, supporting pivotal development in systemic and cutaneous lupus.
The Stamford biotech reported highly significant SRI-4 response rates versus placebo at Week 48, supporting pivotal development in systemic and cutaneous lupus.
Biologics
Pharmaceuticals

Disc Medicine RESTORE-PV data show DISC-3405 cut phlebotomy in PV

Phase 2 results show the anti-TMPRSS6 antibody reduced mean phlebotomy events from 4.0 to 0.6 over 26 weeks, with 61.5% of
Phase 2 results show the anti-TMPRSS6 antibody reduced mean phlebotomy events from 4.0 to 0.6 over 26 weeks, with 61.5% of
Pharmaceuticals
Biologics

Ascendis Pharma reports 52-week infant data for TransCon CNP at ESPE

Week 52 sentinel cohort data show navepegritide stabilised foramen magnum stenosis and improved linear growth in infants with achondroplasia.
Week 52 sentinel cohort data show navepegritide stabilised foramen magnum stenosis and improved linear growth in infants with achondroplasia.
Pharmaceuticals
Diagnostics

ImPact Biotech completes ENLIGHTED Phase 3 for padeliporfin VTP

ImPact Biotech has treated all 91 patients in its Phase 3 LG-UTUC trial and expects to file an NDA with the FDA in 2027.
ImPact Biotech has treated all 91 patients in its Phase 3 LG-UTUC trial and expects to file an NDA with the FDA in 2027.
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