Pharmaceuticals
Regulatory Science

Liquidia loses patent ruling on YUTREPIA PH-ILD indication

A Delaware district court found two claims of United Therapeutics' '327 patent valid and infringed, putting YUTREPIA's PH-ILD label at risk.
A Delaware district court found two claims of United Therapeutics' '327 patent valid and infringed, putting YUTREPIA's PH-ILD label at risk.
The Biotech Times Editorial Team  · 
Medical Devices

Integra LifeSciences cuts 2026 guidance after Cincinnati flood

Flooding at Integra's Ohio manufacturing site will cost up to $27m in lost revenue across Q3 and Q4, prompting a downgrade to full-year
Flooding at Integra's Ohio manufacturing site will cost up to $27m in lost revenue across Q3 and Q4, prompting a downgrade to full-year
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Gain Therapeutics: rexaceract holds motor scores stable at 12 months

Phase 1b open-label extension data show no clinically meaningful motor progression in 12 Parkinson's patients after a full year of daily oral rexaceract.
Phase 1b open-label extension data show no clinically meaningful motor progression in 12 Parkinson's patients after a full year of daily oral rexaceract.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Pharmaceuticals

MiNK Therapeutics to show iNKT cell data at SITC 2026

MiNK will present two posters at SITC covering checkpoint-resistant colorectal cancer and senescent tumour-cell clearance using its iNKT platform.
MiNK will present two posters at SITC covering checkpoint-resistant colorectal cancer and senescent tumour-cell clearance using its iNKT platform.
The Biotech Times Editorial Team  · 
Medical Devices
Pharmaceuticals

Elutia receives $8m Boston Scientific escrow; funded into 2029

Elutia has cleared its final 2026 funding milestone, receiving the full $8m holdback from its BioEnvelope sale with no indemnity claims.
Elutia has cleared its final 2026 funding milestone, receiving the full $8m holdback from its BioEnvelope sale with no indemnity claims.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Genmab's Rina-S hits 46% response rate in PROC trial

Phase 2 data show Rina-S achieved a 45.9% objective response rate and 12.1-month median duration of response in heavily pretreated platinum
Phase 2 data show Rina-S achieved a 45.9% objective response rate and 12.1-month median duration of response in heavily pretreated platinum
The Biotech Times Editorial Team  · 
Medical Devices
Regulatory Science

Inspire Medical wins new CPT codes for its Inspire V device

New Category I CPT codes covering Inspire V's single-lead hypoglossal nerve stimulator are set to take effect on 1 January 2028.
New Category I CPT codes covering Inspire V's single-lead hypoglossal nerve stimulator are set to take effect on 1 January 2028.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics

Autonomix Medical secures FDA support for 510(k) sensing platform

Autonomix Medical says FDA pre-submission feedback supports a Class II substantial-equivalence route, targeting clearance of its neural sensing platform in roughly 15
Autonomix Medical says FDA pre-submission feedback supports a Class II substantial-equivalence route, targeting clearance of its neural sensing platform in roughly 15
The Biotech Times Editorial Team  · 
Medical Devices

Nexalin Technology signs 10-year South America distribution deal

Nexalin Technology has appointed Inovanexa as exclusive distributor for its ANVISA-approved Sync neurostimulation device across seven Latin American countries.
Nexalin Technology has appointed Inovanexa as exclusive distributor for its ANVISA-approved Sync neurostimulation device across seven Latin American countries.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Novo Nordisk's denecimig BLA delayed by manufacturing site remediation

The FDA has extended its review of denecimig for haemophilia A due to facility remediation issues, with no new decision timeline given.
The FDA has extended its review of denecimig for haemophilia A due to facility remediation issues, with no new decision timeline given.
The Biotech Times Editorial Team  · 
Medical Devices
Pharmaceuticals

SpyGlass Pharma buys AVS for $13m to lock in IOL supply

The Nasdaq-listed ophthalmic biotech has acquired its existing IOL manufacturer from Santen, securing Phase 3 supply and a route to premium lens options.
The Nasdaq-listed ophthalmic biotech has acquired its existing IOL manufacturer from Santen, securing Phase 3 supply and a route to premium lens options.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Bioprocessing

Samfara acquires Chr. Olesen Synthesis in controlled-substance API deal

London PE firm Samfara has completed its first acquisition, buying Danish cGMP manufacturer Chr. Olesen Synthesis, which specialises in buprenorphine and lisdexamfetamine
London PE firm Samfara has completed its first acquisition, buying Danish cGMP manufacturer Chr. Olesen Synthesis, which specialises in buprenorphine and lisdexamfetamine
The Biotech Times Editorial Team  · 
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