Regulation

Medical Devices

Elixir Medical wins Japan approval for DynamX coronary bioadaptor

Japan's MHLW has approved Elixir Medical's DynamX bioadaptor for coronary artery disease, creating a new device category in the country.
Japan's MHLW has approved Elixir Medical's DynamX bioadaptor for coronary artery disease, creating a new device category in the country.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Pharmazz wins FDA Orphan Drug Designation for sovateltide in NHIE

Pharmazz's endothelin-B receptor agonist sovateltide gains Orphan Drug Designation for neonatal hypoxic-ischaemic encephalopathy, unlocking US development incentives.
Pharmazz's endothelin-B receptor agonist sovateltide gains Orphan Drug Designation for neonatal hypoxic-ischaemic encephalopathy, unlocking US development incentives.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Revelyx Bio Phase 2 data back recombinant liquid botulinum toxin YY003

YY003 hit its composite primary endpoint in 80.8% of participants at the 40-unit dose, with rapid onset by week one and no neutralising
YY003 hit its composite primary endpoint in 80.8% of participants at the 40-unit dose, with rapid onset by week one and no neutralising
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Genomics

Tenaya wins FDA RMAT designation for ARVC gene therapy TN-401

Tenaya Therapeutics has secured RMAT designation for TN-401, its AAV9-based gene therapy for PKP2-associated ARVC, backed by Phase 1b/2 interim data.
Tenaya Therapeutics has secured RMAT designation for TN-401, its AAV9-based gene therapy for PKP2-associated ARVC, backed by Phase 1b/2 interim data.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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