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Radiopharma consolidation and manufacturing scale
Telix agreed to acquire ITM Isotope Technologies Munich in a deal that values ITM at up to $2.35 billion, including $1.65 billion upfront plus backloaded milestones tied to ITM-11. The transaction...
Clinical advances in genomics-led ocular gene therapy
Beacon reported that its X-linked retinitis pigmentosa gene therapy laruparetigene zovaparvovec (laru-zova) met the FDA-endorsed primary endpoint of improving low luminance visual acuity in its...
FDA accelerates oncology drug pathway decisions under new trial requirements
Compass Therapeutics reported that the FDA recommended it conduct another trial before submitting a regulatory package for tovecimig in previously treated biliary tract cancer. The feedback...
New funding for immune reprogramming and precision regulatory T-cell therapy
Regcell raised $66 million in new financing and Japanese government support to bring its epigenetic Treg reprogramming platform toward the clinic. The funding supports clinical development of its...
FDA approval expands treatment options for ultra-rare neurologic disease
The FDA approved Aqneursa (levacetylleucine) for ataxia-telangiectasia, positioning it as the first treatment for the disorder. The approval follows an earlier FDA nod for Aqneursa in Niemann-Pick...
Oncology microbiology platform expands toward IND-enabling studies
Beactica began IND-enabling studies for BEA-17, an oral degrader targeting LSD1 and CoREST being developed as a precision immunotherapy for glioblastoma. The company is working toward an EU...
Clinical development acceleration via FDA’s QRI-assisted IND pilot
The FDA launched a pilot program pairing sponsors with prequalified research institutions to expedite Phase I trial IND preparation and review. The program supports rolling acceptance of IND...
Cell therapy and gene therapy manufacturing software upgrades
Beckman Coulter Life Sciences introduced Vi-CELL BLU 2.0 software for viability analyzers, targeting data integrity and GMP readiness for cell analysis workflows. The update adds role-based access...
Regulatory and healthcare operations: trial conduct hinges on EHR compliance
The UK’s MHRA warned that inadequate electronic health record (eHR) systems are costing clinical trials by creating risks around site selection and data reconstructability. The regulator said...
Autoimmune therapy advancement in Sjögren’s disease
Amgen reported preliminary Phase 3 success for dazodalibep in Sjögren’s disease, setting up a potential first targeted therapy for a condition that currently has no approved treatments. The fusion...
FDA decision pressure on ALS drug pathway
Otsuka and Ionis Pharmaceuticals advanced their amyotrophic lateral sclerosis program after a Phase 3 study hit its primary endpoint. The result positions the partners to seek expedited regulatory...
Radiopharma consolidation accelerates with Telix–ITM merger
Telix agreed to acquire ITM Isotope Technologies Munich in a deal worth up to $2.35 billion, aiming to secure isotope supply and scale manufacturing capacity as radiopharmaceutical competition...
Emerging gene therapy approval track in X-linked retinitis pigmentosa
Beacon Therapeutics reported pivotal progress for laruparetigene zovaparvovec (laru-zova) in X-linked retinitis pigmentosa, describing a Phase 2/3 outcome that met the FDA-endorsed primary...
RNA splicing deal bets on precision oncology targets
Envisagenics and Boehringer Ingelheim inked a multi-target, option-style collaboration valued at up to $1 billion-plus, centered on Envisagenics’ alternative RNA splicing SpliceCore platform....
Regulatory pressure on chronic hives therapy safety
Celldex’s barzolvolimab landed two Phase 3 chronic spontaneous urticaria wins but triggered new safety scrutiny after reports of life-threatening anaphylaxis cases associated with treatment. The...
Chronic kidney disease label push hinges on urine response data at Vertex
Vertex reported positive Phase 2b measures tied to a urine-based endpoint for its kidney disease candidate inaxaplin, while looking ahead to pivotal readouts. The company said improvements were...
Regulatory and trial execution risks in early-stage research timelines
The UK’s medicines regulator, the MHRA, warned that inadequate electronic health record systems are costing hospitals clinical trial competitiveness. In guidance on eHR compliance with GCP...
FDA pilot program targets faster Phase I starts
The FDA launched a pilot program designed to expedite Phase I trials by pairing sponsors with prequalified research institutions. Under the initiative, qualified research institutions (QRIs)...
GLP-1/GIP obesity franchise expands with longer-interval maintenance data and wider pipeline bets
Viking Therapeutics said trial participants on its GLP-1/GIP obesity candidate VK-2735 maintained weight loss after stepping down from weekly dosing to every-other-week or monthly schedules,...
Obesity drug dosing durability at Viking
Viking Therapeutics said updated data from its Phase 2 obesity program suggest patients who moved from weekly dosing to less frequent regimens can maintain weight control over a 12-week window....