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.
Athithi Verma
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.
KKR’s 51.8% Premium for Integer Is Measured From Before the Company Said It Was for Sale
KKR’s 51.8% premium for Integer is struck to the day before Integer said it was for sale. The 28.8% is what a holder actually gained.
Indivior’s Holders Take 56.5% and $1 Billion, Supernus Takes the Name, the CEO and the Building
Indivior holders take 56.5% and a billion in cash. Supernus takes the name, the CEO and the building. Equals describes the board seats only.
Curium’s CVR Waterfall Says It Trusts DEFINITY, Is Betting on Neurology, and Doubts Prostate
Curium locked 89.5% of consideration in cash and hung the rest on prostate. The CVR waterfall is the buyer’s own forecast, published.
DealPulse Signal Wk 31: One Buyer Paid Everything, Another Paid a Fifth
Two immunology deals, five days apart. argenx paid 100% on signing for Phase 1b. J&J paid 22% for preclinical. Both are correctly priced.
OrphanPulse Wk 31: The Panel Voted on a Process, Not a Drug
FDA advisers voted 9 to 3 against Capricor’s deramiocel, three weeks before PDUFA. The argument was not about biology. It was about which SAP counted.
NeuroPulse Wk 31: An Open-Label 77% Could Not Rescue a Missed Endpoint
FDA told NeuroPace its generalized epilepsy expansion is not approvable as filed. An open-label 77% cannot rescue a randomized endpoint that missed.
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.