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.
Topics
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.
Dassault Paid $1.8B Cash for the Company That Processes 12 Million Safety Reports a Year
Dassault Systèmes will pay $1.8 billion cash for ArisGlobal, whose platform processes more than 12 million patient safety reports annually for 200 customers.
Trump Wants Generics Made in America by 2028. The Economics Say They Can’t.
Trump gave generic drugmakers until August 2028 before a 100% tariff, rising to 200% in 2029. The problem is the margin those drugs actually carry.
One Trial Miss Cut AstraZeneca’s Cushion Above $80bn to $800m
A drug worth $1.9bn of 2030 revenue cost AstraZeneca £19bn in a day, leaving roughly $800m of headroom above its $80bn goal with the risky readouts still ahead.