Roche Tecentriq FDA approval expands treatment for stage III dMMR colon cancer
FDA approval moves Tecentriq into adjuvant stage III dMMR colon cancer after ATOMIC showed a 50% reduction in recurrence or death risk.
Pharma & Biotech
Pharma & Biotech
Illumina launches SpliceAI2 genomic AI model for rare disease variant interpretation
Illumina says SpliceAI2 found 17% more disease-relevant splice variants, but clinical use will require more than stronger AI prediction.
Pharma & Biotech
Why Vaxcyte is seeking $1bn just days after VAX-31’s pivotal vaccine readout
Vaxcyte’s VAX-31 met pivotal Phase 3 immune-response endpoints as the company prices $1 billion to fund trials and manufacturing scale-up.
Pharma & Biotech
How Rhapsido’s symptomatic dermographism approval expands Novartis immunology strategy
Novartis’ Rhapsido won the first FDA label for symptomatic dermographism after a 29.3% complete response in Phase 3 RemIND.
Pharma & Biotech
SurVaxM showed a four-month survival gap in younger glioblastoma patients. Can MimiVax overcome the missed primary endpoint?
MimiVax and Roswell Park reported a 2.5-month median overall-survival difference for SurVaxM in the 233-patient SURVIVE trial, but the full-population primary endpoint did not reach statistical significance. A prespecified group aged 65 or younger showed a stronger and statistically significant survival result, leaving the FDA to assess whether the signal is sufficient to define the
Features & Analysis
Solengepras cut Parkinson’s OFF time by 37 minutes. Is a non-dopamine mechanism enough to matter?
Cerevance’s solengepras has met the primary endpoint in the Phase 3 ARISE trial, reducing daily Parkinson’s OFF time by 0.61 hours versus placebo while also improving ON time and daily motor function. The result validates a novel GPR6-based, non-dopaminergic approach, but the absolute effect was smaller than in Phase 2 and arrives just as AbbVie
Pharma & Biotech
argenx halts Phase 3 efgartigimod Sjögren’s trial after futility analysis
argenx stops the Phase 3 UNITY efgartigimod trial in Sjögren’s disease for futility despite earlier positive Phase 2 results.
Pharma & Biotech
Can Roche’s petrelintide challenge GLP-1 drugs after strong obesity and diabetes data?
Zealand Pharma and Roche have reported positive Phase 2 data for petrelintide in people with obesity and type 2 diabetes, combining up to 9.2% weight loss with improved glycemic control and a low gastrointestinal discontinuation rate as the amylin therapy enters a roughly 7,000-patient Phase 3 program.
Pharma & Biotech
Pfizer takes Tukysa into first-line HER2+ breast cancer maintenance after 8.6-month PFS gain
FDA approval moves Pfizer’s Tukysa into first-line maintenance for HER2-positive metastatic breast cancer after the regimen extended median progression-free survival from 16.3 to 24.9 months, although severe hepatotoxicity has emerged as an important treatment consideration.
Features & Analysis
Rhapsido doubles complete hive response rate as Novartis secures new FDA indication
FDA approves Novartis Rhapsido as the first treatment specifically for symptomatic dermographism after positive Phase III RemIND results.