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.
Month: July 2026
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.
J&J Paid $785 Million for a Look at Something That Has Never Been in a Human
J&J committed $785 million including a $465 million equity stake, plus an option to acquire Sail Biomedicines for $2.58 billion, on a preclinical in vivo CAR-T platform.
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.
Washington Removed the Cushion Under Part D, and Handed the Auditors an Algorithm
Washington ended the subsidy holding Part D premiums down, charged a record number of Medicaid fraud defendants, and put prosecutors’ analytics inside CMS.
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.
The Alzheimer’s Blood Test Just Moved Into the GP’s Office, Which Is the Whole Point
GPs in North West London are running C2N’s Alzheimer’s blood test before referral, testing whether accurate amyloid detection works in primary care.
A Private Device Company Just Put Its Pivotal Trial Head to Head Against the Market Leader
VDyne treated the first patient in a pivotal trial randomising its tricuspid valve replacement head to head against Edwards’ commercially available EVOQUE.
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.