A Private Device Company Just Put Its Pivotal Trial Head to Head Against the Market Leader
VDyne treated the first patient in a pivotal trial randomising its tricuspid valve replacement head to head against Edwards’ commercially available EVOQUE.
By therapy area
Brazil Approved Five Semaglutides in a Day. Sandoz Announced One of Them.
ANVISA approved five semaglutide products in a single day, including the one Sandoz will sell. Ozempic’s Brazilian patent expired in March.
NICE Said Yes to the Lung Machine, and Then Attached Four Years of Conditions
NICE conditionally recommended the XVIVO perfusion system for NHS use, with four years of evidence generation and a hub model to end the postcode divide.
Abbott Is Not Testing Whether TriClip Works. It Is Building the File That Gets It Paid.
Abbott began a 1,000-patient, five-year post-market study of TriClip across 100 sites, generating the durability evidence payers and guidelines require.
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.
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.
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.