Merck and Moderna report 42% lower melanoma recurrence risk in Phase 3 mRNA trial
Merck and Moderna report 42% lower melanoma recurrence risk with intismeran plus Keytruda. Survival, safety and manufacturing remain key.
Pharma & Biotech
Pharma & Biotech
Zydus gains regulatory milestone in $31.7bn Keytruda biosimilar market
The FDA has accepted FYB206, a proposed biosimilar to Merck's Keytruda, for review, with a decision potentially due in the third quarter of 2027. Zydus and Formycon pursued a streamlined development programme without a comparative Phase 3 efficacy trial, but approval, patent clearance and commercial launch remain separate hurdles.
Pharma & Biotech
Can Merck’s remigromig compete with anti-VEGF treatments after BRUNELLO results?
Merck's remigromig met BRUNELLO's vision endpoint, but higher retinal complication rates complicate its potential in diabetic macular edema.
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
Merck’s $3bn EyeBio bet clears first pivotal test as remigromig matches Lucentis
Merck & Co.’s remigromig matched ranibizumab on vision improvement in a pivotal diabetic macular edema trial, validating a novel Wnt-targeting approach while higher rates of proliferative diabetic retinopathy and vitreous hemorrhage leave an important safety question unresolved.
Pharma & Biotech
Merck’s Keytruda-Padcev bladder cancer push moves closer to broader EU approval
Merck & Co.’s Keytruda plus Padcev has won a positive European regulatory opinion for perioperative treatment of resectable muscle-invasive bladder cancer regardless of cisplatin eligibility, potentially expanding an already important oncology franchise into a broader earlier-stage population.
Pharma & Biotech
Moderna and Merck’s personalized mRNA cancer therapy clears Phase 3 test, but the numbers still matter
INTerpath-001 met recurrence-free and distant metastasis-free survival endpoints in 1,137 patients, giving individualized mRNA cancer therapy its first positive Phase 3 readout.
Pharma & Biotech
Ingenia Therapeutics has two Prix Galien nominations, but its real test begins after the KOSDAQ IPO
Ingenia Therapeutics gains dual Prix Galien nominations as its KOSDAQ debut puts MK-8748, IGT-303 and the broader TIE2 pipeline under scrutiny.
Pharma & Biotech
Merck is licensing alimatravir before Phase 3 ends. Can a monthly HIV pill beat the access clock?
Merck’s alimatravir access plan covers 129 countries, but Phase 3 efficacy, pricing and regulatory execution will decide its HIV PrEP impact.
Pharma & Biotech
Gilead’s Trodelvy cleared a key EU hurdle, but can it really replace chemotherapy in first-line TNBC?
CHMP backs Trodelvy plus Keytruda for first-line PD-L1-positive metastatic TNBC, moving Gilead closer to an expanded EU label.