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.
Athithi Verma
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.
OrphanPulse Wk 30: CHMP Backs a Drug It Refused Twice
Nezglyal was refused in February 2024 and again in May. This week the same committee recommended it, and children with cerebral ALD get an oral option.
NeuroPulse Wk 30: Three Orexin Programmes in Two Weeks
Lundbeck’s Fast Track makes three orexin programmes in two weeks. Plus a Duchenne filing with a January date, and a CHMP slip caused by a contract manufacturer.
DealPulse Signal Wk 30: Three Billion-Dollar Deals, No Drugs
Dassault took a safety-data platform, Tempus took the diagnostics layer it already sold, Repligen took biopreservation tools. Three deals, no molecules.
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.