The Year’s Two Largest Conjugate Deals Were Not ADCs, and Not Cancer Drugs
Buyers stopped paying for conjugate drugs and started paying for conjugate chemistry. The year’s two biggest cheques bought neither an ADC nor a cancer drug.
Oncology
ITM’s Complete Response Letter Names No Clinical Concern. It Names a Third-Party Facility.
COMPETE hit its endpoint and is published in The Lancet. The FDA did not touch any of it. What stopped the approval is a facility ITM does not own.
Imvanex Now Covers European Two-Year-Olds. The Children Carrying the Burden Are in Africa.
A type II variation in Brussels does nothing directly for a child in Kinshasa. What it does is unlock the procurement channels that reach one.
Replimune Won Accelerated Approval on 91 Evaluable Patients and a 24% Response Rate
CBER took a 24% response in 91 evaluable patients, one day after the same committee voted nine to three against Capricor. Measurement, not size.
NICE Backed Acalabrutinib and Venetoclax Without Obinutuzumab, and the Omission Is the Decision
AMPLIFY tested acalabrutinib and venetoclax with and without obinutuzumab. NICE recommended the doublet, which is a decision about infusions.
The EPO Revoked BMS’s 480mg Opdivo Patent Because the Trial Behind It Dosed by Weight
BMS claimed a 480mg flat dose. The only clinical example in its filed application dosed by weight. The EPO revoked the patent on added matter.
AstraZeneca Announced Nothing. The Market Charged It $24bn Anyway.
AstraZeneca closed 9% down on an unconfirmed report of Bristol Myers talks. Roughly $24bn gone, on a conversation neither company will admit to.
Pathos Put 6% Down on a Phase III ADC, and Alphamab Kept the Market It Can Actually Reach
Fresenius describes an end to end biopharma business. Dr. Reddy’s developed, made and filed this rituximab. Fresenius is only the channel.
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.
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.