Can IMAAVY’s sustained control data reshape earlier treatment of generalized myasthenia gravis?
Discover what Johnson & Johnson’s new IMAAVY data mean for earlier gMG treatment, sustained control, safety and FcRn competition.
Pharma & Biotech
Pharma & Biotech
Nippon Shinyaku backs EXG-7001 as full-length dystrophin mRNA strategy enters Duchenne race
Discover how Nippon Shinyaku’s EXG-7001 option could advance full-length dystrophin mRNA therapy for Duchenne muscular dystrophy.
Pharma & Biotech
Can Anixa’s breast cancer vaccine and lira-cel CAR-T therapy translate early immune signals into clinical benefit?
Anixa Biosciences has presented completed Phase 1 data for its alpha-lactalbumin breast cancer vaccine and updated survival observations for liraltagene autoleucel in recurrent ovarian cancer. The findings strengthen the biological rationale behind both programmes, but controlled efficacy evidence, biomarker clarity and successful dose optimisation remain essential before either platform can be considered clinically validated.
Pharma & Biotech
Lupin’s tentative FDA approval for enzalutamide sets up a high-value generic challenge to Xtandi
Lupin Limited has moved closer to the United States enzalutamide market with proposed 120 mg and 160 mg tablets that could reduce pill burden. Patent timing, final approval, market access and competition will determine whether that formulation advantage becomes commercially meaningful.
Pharma & Biotech
Why LEO Pharma is shifting the chronic hand eczema debate from skin clearance to life impact
New analyses from the DELTA FORCE and DELTA TEEN programmes extend the chronic hand eczema discussion beyond skin clearance. The findings could strengthen the clinical and economic case for delgocitinib, although real-world effectiveness, adolescent regulation and treatment access remain important tests.
Pharma & Biotech
Glaukos completes enrollment in GLK-321 trial as Demodex therapy competition grows
Discover how Glaukos’ GLK-321 Phase 2 trial could reshape Demodex blepharitis care through a dropless eyelid-applied treatment.
Pharma & Biotech
Merck and Gilead secure FDA approval for a new ADC-immunotherapy backbone in advanced TNBC
The new regimen replaces conventional chemotherapy with a Trop-2-directed antibody-drug conjugate while retaining PD-1 blockade, offering longer disease control but leaving overall survival, sequencing and cost questions unresolved.
Pharma & Biotech
Gilead expands Trodelvy into first-line metastatic TNBC, but survival questions remain unresolved
The decision gives clinicians a Trodelvy-based option for patients who cannot receive checkpoint inhibitors and a Trodelvy plus Keytruda regimen for PD-L1-positive disease. The immediate clinical impact is substantial, although immature overall-survival data, toxicity management and treatment cost will influence how rapidly the new pathways displace chemotherapy.
Pharma & Biotech
Ionis Pharmaceuticals moves beyond rare disease as Tryngolza enters the wider triglyceride market
Tryngolza is no longer confined to the rare familial chylomicronemia syndrome market. Its broader United States approval gives clinicians the first therapy specifically shown to reduce acute pancreatitis risk in adults with severe hypertriglyceridemia, although questions surrounding dose selection, hepatic monitoring, reimbursement and long-term use will influence how quickly the treatment changes practice.
Pharma & Biotech
Pfizer’s Ibrance wins broader FDA role as metastatic breast cancer treatment becomes more complex
The FDA approval brings CDK4/6 inhibition into HR-positive, HER2-positive metastatic breast cancer maintenance, although toxicity, immature survival data and a rapidly changing first-line market could shape adoption.