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.
The Brief
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.
China Stopped Excluding Patented Drugs From Its Price Cuts. Now the Bidder Signs for the Risk.
Eight patent-sensitive molecules were admitted to China’s price-cutting round on one condition: the bidder signs an intellectual property undertaking and carries the risk.
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.
China Approved the World’s First Once-Daily Oral Factor B Inhibitor, and a US Small-Cap Licensed It a Month Early
China approved Haisco’s ciprocopan for PNH, the world’s first once-daily oral complement Factor B inhibitor, a month after a US small-cap licensed ex-China rights.
Accord’s Denosumab Biosimilars Launch With Cigna Preferred Status Already Secured
Accord made two interchangeable denosumab biosimilars commercially available with Cigna preferred status already secured on the pharmacy benefit since 1 July.
One Robot, Three Ways In: Momentis Clears Multiport a Day After J&J Shrank the Footprint
Momentis won FDA clearance for multiport surgery, making Anovo the first robotic platform cleared for natural orifice, single-port and multiport approaches.
A Company Called StrokeDx Just Cleared a Device That Is Not Cleared to Detect Stroke
NeuraNova, formerly StrokeDx, won FDA clearance for a bedside device measuring cerebral fluid asymmetry, cleared as an adjunct rather than a diagnostic.