Dr. Reddy’s Developed, Made and Filed the Rituximab. Fresenius Only Sells It.
Fresenius describes an end to end biopharma business. Dr. Reddy’s developed, made and filed this rituximab. Fresenius is only the channel.
Market Access
The 340B Rebate Pilot Is Back at Under 5.5% of Sales, Rebuilt to Survive the Court That Killed It
HRSA restarted the 340B rebate pilot at under 5.5% of sales, wrapped in 21 pages of answers to the court that vacated the first one.
Congress Exempted the Medically Frail. The Coding System Cannot Find Them.
Fewer than 500 of 10,000 rare diseases have an ICD-10 code. The Medicaid frailty exemption is verified against codes most patients never had.
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.
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.