An FDA Panel Voted 9-3 Against Capricor on Cardiomyopathy and Never Voted on the Endpoint That Passed
The ballot was the outcome. A drug’s strongest dataset sitting off the voting question is not a footnote, it is the whole result.
Market Access
Revtorpyk Got Its NCCN Category 1 Listing Two Months Before Celcuity Can Sell a Single Vial
The reimbursement case is being built before the product exists. Two gates remain, and a guideline solves neither.
NICE Backed Aficamten the Same Day the MHRA Authorised It, at a Price It Will Not Disclose
Concurrent MHRA and NICE decisions collapse the usual access gap to zero. Then read the conditions, because that is where the guidance lives.
The Biosimilar Was Too Cheap to Sell. So the Price Went Up Fourfold.
Byooviz relaunched in the US at an average sales price of $1,190, roughly four times its previous level and above the originator it references.
AbbVie Took Two EU Approvals in One Day, Both for Diseases Payers Have Called Cosmetic
The European Commission approved RINVOQ for non-segmental vitiligo and, the same day, for severe alopecia areata, both in adults and adolescents aged 12 and over.
Brazil Approved Five Semaglutides in a Day. Sandoz Announced One of Them.
ANVISA approved five semaglutide products in a single day, including the one Sandoz will sell. Ozempic’s Brazilian patent expired in March.
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.
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 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.