A B7-H3 Antibody Drug Conjugate Just Won a Second Phase 3, in a Second Tumour
A second positive Phase 3 in a second tumour makes Ris-Rez the only B7-H3 antibody-drug conjugate with late-stage wins across more than one cancer.
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J&J Won the Ruling on 22 July. Five Days Later It Agreed to Pay $5.5 Billion.
J&J agreed to pay $5.5 billion to resolve roughly 76,000 ovarian talc claims, five days after a court ruling that put plaintiffs in an untenable position.
Italy Ran an Innovation Test for Eight Years.
Italy graded new medicines full, conditional or not innovative for eight years. The 2025 reform abolished the middle grade, because almost nothing ever graduated.
A New Antibiotic Reached a Middle-Income Country Six Months After the US
Thailand approved a first-in-class oral antibiotic for gonorrhoea six months after the US, a benchmark for how fast new medicines can reach lower-income markets.
Argentina Just Made One Agency the Buyer for Five National Hospitals
Argentina published the decree completing its National Agency of Health Establishments, centralising the administration and procurement of five national hospitals.
Wet AMD’s Problem Was Never the Drug. It Was the Injections.
Susvimo won a CHMP recommendation as Europe’s first continuous-delivery wet AMD treatment, replacing monthly eye injections with two implant refills a year.
ADCs Graduated From Salvage to First Line, Twice in a Week
Enhertu with pertuzumab and Trodelvy with Keytruda both won CHMP opinions for first-line metastatic breast cancer, moving ADCs from last resort to standard.
Europe Backs the Cholesterol Class That Failed Four Times
Europe recommended approval for a CETP inhibitor, a class with four prior failures, on LDL-lowering trials. The outcomes trial that decides it has not read out.
The Cheapest Drug in Retina Just Became a Branded Product
LYTENAVA becomes the first FDA-approved ophthalmic bevacizumab for wet AMD, with 12 years of exclusivity, on a molecule already used in most first-line treatment.
Agilent Has Built an Annuity on Merck’s Clinical Programme, One Indication at a Time
Agilent won its eighth CE-marked companion diagnostic indication for a single PD-L1 assay, each one riding on a label expansion Merck paid to generate.