Regulation

Diagnostics
Genomics

Veracyte acquires Convergent Genomics for up to $180m

Veracyte is adding the UroAmp urinary tumour DNA platform to its bladder cancer portfolio, with commercialisation targeted for late 2028.
Veracyte is adding the UroAmp urinary tumour DNA platform to its bladder cancer portfolio, with commercialisation targeted for late 2028.
Biologics
Pharmaceuticals

Leads Biolabs opamtistomig hits 87% ORR in squamous NSCLC at WCLC

Phase II data for the PD-L1/4-1BB bispecific showed consistent responses regardless of PD-L1 expression, as an NDA advances under NMPA priority
Phase II data for the PD-L1/4-1BB bispecific showed consistent responses regardless of PD-L1 expression, as an NDA advances under NMPA priority
Medical Devices
Diagnostics
Digital Health

Nanox reports 37% revenue rise but takes $40.7m impairment charge

Nano-X Imaging grew Q2 revenues to $4.2m but recorded a $40.7m intangible asset impairment, widening its GAAP net loss to $55.5m.
Nano-X Imaging grew Q2 revenues to $4.2m but recorded a $40.7m intangible asset impairment, widening its GAAP net loss to $55.5m.
Medical Devices

SS Innovations reports 14,000+ procedures and telesurgery record

SS Innovations says its SSi Mantra system has surpassed 14,100 cumulative procedures and set a new longest-distance telesurgery record spanning 13,600 miles.
SS Innovations says its SSi Mantra system has surpassed 14,100 cumulative procedures and set a new longest-distance telesurgery record spanning 13,600 miles.
Digital Health
Regulatory Science

Sequoia Project, AHIMA and HCPro launch information blocking training

The three organisations have released a four-course online series to help healthcare workforces comply with US federal information blocking rules now under active
The three organisations have released a four-course online series to help healthcare workforces comply with US federal information blocking rules now under active
Pharmaceuticals

Verrica to present YCANTH and VP-315 data at two dermatology meetings

Post-hoc Phase 3 data show YCANTH cleared molluscum in over half of long-duration patients, while VP-315 showed abscopal-like activity in untreated
Post-hoc Phase 3 data show YCANTH cleared molluscum in over half of long-duration patients, while VP-315 showed abscopal-like activity in untreated
Biotech
Bioprocessing

Cannara Biotech expands credit facility to C$80m with BMO and TD

The Québec cannabis producer has upsized its syndicated debt facility by C$30m and extended its maturity to December 2029.
The Québec cannabis producer has upsized its syndicated debt facility by C$30m and extended its maturity to December 2029.
Diagnostics
Pharmaceuticals
Digital Health

Cerenome secures $20m royalty-based facility to scale CNSide platform

The Houston CNS oncology company said the senior secured facility extends its cash runway into 2028 and funds commercial scale-up of its CSF assay
The Houston CNS oncology company said the senior secured facility extends its cash runway into 2028 and funds commercial scale-up of its CSF assay
Medical Devices
Diagnostics

CooperCompanies retains CooperSurgical and lifts buyback to $3bn

CooperCompanies concluded its nine-month strategic review by keeping CooperSurgical and expanding its share repurchase programme by $1 billion.
CooperCompanies concluded its nine-month strategic review by keeping CooperSurgical and expanding its share repurchase programme by $1 billion.
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
Biologics
Pharmaceuticals

Immutep refocuses efti on HNSCC and sarcoma after trial failure

Immutep has identified a manufacturing scale difference as the likely cause of TACTI-004's failure and will restart efti trials in 2H 2027.
Immutep has identified a manufacturing scale difference as the likely cause of TACTI-004's failure and will restart efti trials in 2H 2027.
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
Biotech

RWB acquires controlling stake in European cannabis platform

Red White & Bloom has entered Germany and the UK via a deal giving it majority control of an integrated medical cannabis platform dispensing over 12
Red White & Bloom has entered Germany and the UK via a deal giving it majority control of an integrated medical cannabis platform dispensing over 12
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.
Biologics
Pharmaceuticals

Tam-Peli cuts SCLC death risk 54% in Phase III, Roche reports

MediLink's B7-H3 ADC beat topotecan on overall survival and response rate in 451-patient Chinese trial, with an NDA now accepted by China
MediLink's B7-H3 ADC beat topotecan on overall survival and response rate in 451-patient Chinese trial, with an NDA now accepted by China
Diagnostics
Genomics
Regulatory Science

Bionano Labs OGM test in line for Medicare coverage under proposed LCD

MolDX has issued a proposed LCD that could establish Medicare coverage for optical genome mapping in hematologic malignancy workups.
MolDX has issued a proposed LCD that could establish Medicare coverage for optical genome mapping in hematologic malignancy workups.
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
Medical Devices
Digital Health
Diagnostics

Circle CVI positions cvi42 for TAVR volume surge after CMS ruling

CMS has finalised expanded Medicare coverage for TAVR in asymptomatic aortic stenosis, and Circle CVI says its imaging platform is ready to absorb the expected
CMS has finalised expanded Medicare coverage for TAVR in asymptomatic aortic stenosis, and Circle CVI says its imaging platform is ready to absorb the expected
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.
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