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.
By therapy area
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.
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.
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.
PRIMA Can Be Sold in 30 Countries Tomorrow. Reimbursement Is the Real Timeline.
Science Corp’s retinal implant won a CE mark for sale across 30 European countries, after trial patients gained a mean 25.5 letters of visual acuity.
Novo Is Suing Lilly Over a Head-to-Head Trial Lilly Won, Arguing the Result Went Stale
Novo Nordisk filed a Lanham Act suit over Lilly’s Zepbound ads, arguing a genuine head-to-head result became misleading once a higher Wegovy dose launched.
GSK Closed the Nuvalent Deal on 15 July. Seven Days Later, the FDA Approved the Drug.
GSK closed its Nuvalent acquisition on 15 July. The FDA approved Jideytro on 22 July, two months ahead of schedule, making it GSK’s first lung cancer drug.
A Geneva BCI Company Records Its First Human Neural Data, and Europe Gets a Serious Entrant
ABILITY Neurotech recorded human neural data for the first time during tumour surgery in Munich, its first step toward a long-term implantable brain-computer interface.