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.
Athithi Verma
A New Antibiotic Reached a Middle-Income Country Six Months After the US
Thailand approved a first-in-class oral antibiotic for gonorrhoea six months after the US, a benchmark for how fast new medicines can reach lower-income markets.
Argentina Just Made One Agency the Buyer for Five National Hospitals
Argentina published the decree completing its National Agency of Health Establishments, centralising the administration and procurement of five national hospitals.
Britain Thought It Had an Opt-Out. Washington Reads the Deal Differently.
Britain believed it had secured an exemption from the MFN reference basket. Washington reads the arrangement differently, and implementation is still being negotiated.
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.
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.