Regulatory Science

Trump health deals lack enforcement, raising durability concerns

Voluntary, vaguely documented US health industry agreements on drug prices and nutrition may fade without federal enforcement mechanisms, analysts warn.
Voluntary, vaguely documented US health industry agreements on drug prices and nutrition may fade without federal enforcement mechanisms, analysts warn.
The Biotech Times Editorial Team  · 
Biologics

Alvotech and Lotus sign $150m biosimilar deal for two biologics

Alvotech and Lotus Pharmaceutical will co-commercialise durvalumab and emicizumab biosimilars across the US and eight Asian markets.
Alvotech and Lotus Pharmaceutical will co-commercialise durvalumab and emicizumab biosimilars across the US and eight Asian markets.
The Biotech Times Editorial Team  · 
Biologics

Ascendis shares two-year YUVIWEL data at ISDS 2026

Ascendis Pharma will present Week 104 ApproaCH Trial data on navepegritide in achondroplasia, with FDA approval secured and an EMA decision due Q4 2026.
Ascendis Pharma will present Week 104 ApproaCH Trial data on navepegritide in achondroplasia, with FDA approval secured and an EMA decision due Q4 2026.
The Biotech Times Editorial Team  · 

Creative Medical completes ADAPT trial enrolment for Olastrocel

CELZ-201 / Olastrocel has treated all patients across the FDA-cleared ADAPT trial, including the opioid cohort, ahead of RMAT evaluation and Phase 3 planning.
CELZ-201 / Olastrocel has treated all patients across the FDA-cleared ADAPT trial, including the opioid cohort, ahead of RMAT evaluation and Phase 3 planning.
The Biotech Times Editorial Team  · 
Biologics

Monte Rosa doses first patient in Phase 2 MRT-2359 prostate cancer study

Monte Rosa Therapeutics has initiated MODeFIRe-1, a Phase 2 trial of its GSPT1 degrader MRT-2359 plus apalutamide in AR mutation-positive mCRPC patients.
Monte Rosa Therapeutics has initiated MODeFIRe-1, a Phase 2 trial of its GSPT1 degrader MRT-2359 plus apalutamide in AR mutation-positive mCRPC patients.
The Biotech Times Editorial Team  · 
Diagnostics

RenovoRx publishes PK/PD data showing 51% tumour-site drug extraction

Peer-reviewed sub-study data from the Phase III TIGeR-PaC trial supports the TAMP platform's targeted delivery mechanism in locally advanced pancreatic cancer.
Peer-reviewed sub-study data from the Phase III TIGeR-PaC trial supports the TAMP platform's targeted delivery mechanism in locally advanced pancreatic cancer.
The Biotech Times Editorial Team  · 
Diagnostics

Vivos Inc. ships first IsoPet batches from in-house US facility

Vivos has begun domestic IsoPet shipments from its Richland, WA site and secured Indian nuclear regulatory approval for a second international manufacturing centre.
Vivos has begun domestic IsoPet shipments from its Richland, WA site and secured Indian nuclear regulatory approval for a second international manufacturing centre.
The Biotech Times Editorial Team  · 
Diagnostics

SeaStar Medical grows QUELIMMUNE revenue 82% as adult AKI trial advances

SeaStar Medical added three top-rated children's hospitals to its QUELIMMUNE customer base and enrolled 223 of 339 patients in its adult AKI pivotal
SeaStar Medical added three top-rated children's hospitals to its QUELIMMUNE customer base and enrolled 223 of 339 patients in its adult AKI pivotal
The Biotech Times Editorial Team  · 
Biologics

Spyre Therapeutics' SPY072 misses RA monotherapy bar in SKYWAY Phase 2

SPY072 showed statistically significant benefits in rheumatoid arthritis but fell short of Spyre's internal threshold to advance it as a standalone therapy.
SPY072 showed statistically significant benefits in rheumatoid arthritis but fell short of Spyre's internal threshold to advance it as a standalone therapy.
The Biotech Times Editorial Team  · 
Biologics

Apollo Therapeutics: Phase 1 pan-rhinovirus vaccine data positive

APL-10456 induced broad cross-reactive T cell responses against all three rhinovirus species in a 144-participant Phase 1 trial, with no serious adverse
APL-10456 induced broad cross-reactive T cell responses against all three rhinovirus species in a 144-participant Phase 1 trial, with no serious adverse
The Biotech Times Editorial Team  · 

Nuwellis signs co-promotion deal with Atrility for AtriAmp device

Nuwellis will co-promote Atrility's FDA-cleared cardiac pacing monitor across 14 US states, with an option to become exclusive national distributor.
Nuwellis will co-promote Atrility's FDA-cleared cardiac pacing monitor across 14 US states, with an option to become exclusive national distributor.
The Biotech Times Editorial Team  · 
Biologics

Beyond Air sells NeuroNOS stake to UNIVO for equity and milestones

Beyond Air is offloading its 58% stake in Israeli neuro-oncology spinout NeuroNOS to TASE-listed UNIVO in exchange for a 19.99% shareholding and
Beyond Air is offloading its 58% stake in Israeli neuro-oncology spinout NeuroNOS to TASE-listed UNIVO in exchange for a 19.99% shareholding and
The Biotech Times Editorial Team  · 
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