OrphanPulse Wk 40: A First Approval in MCT8 Deficiency, and a Missed Pivotal Headed for Filing
One first approval, and one missed pivotal headed for filing anyway: the week tested what rare disease evidence can carry.
Athithi Verma
Merck and Daiichi Pulled an ADC Filing as GSK Paid $110 Million for a KRAS Payload
Crowded topoisomerase I ADCs face a higher bar, while money moves to RAS payloads, bispecific ADCs and discovery tools.
ICER Says AstraZeneca’s $10,950 Baxfendy Is Worth $1,400 to $2,500 a Year
ICER has handed payers the case for putting Baxfendy behind generics, and Mineralys gets its price anchor before launch.
Genentech Paid $100 Million for Alector’s Parkinson’s Enzyme but Not Its Brain Shuttle
Genentech bought the Parkinson’s enzyme and left the brain shuttle with Alector, which now funds its pipeline into 2029.
Shionogi Paid 29 Times Sales for IntraBio, 17 Days After AQNEURSA’s Second FDA Approval
Shionogi paid about 29 times sales for a drug that gained its second indication 17 days before the deal was signed.
CSL Paid $355 Million and Gave Up 45% of the Profits to Win a Claudin-1 Antibody
No development milestones and no royalty: CSL funds every trial through Phase 3 and gives Alentis 45% of the profits.
Merck Has 26 Months to Move Keytruda Patients to a Shot Protected Until 2043
Merck’s Keytruda defence turns on one number: how many US patients are on the one-minute shot when biosimilars ship.
Jaypirca’s 80% Win Over Chemo Opens a First-Line CLL Fight With Three BTK Rivals
Jaypirca reaches first-line CLL on a win over chemo, and now has to take share from three covalent BTK inhibitors.
IQWiG Finds Two Conflicting Studies and No Billing Code Behind AI Lung Cancer Reading
In Germany, AI lung reading is a cost radiologists carry and payers never see, and IQWiG wants outcome trials.
France Trades €100 Million in Price Relief for an Annual Review of Older Drugs
France has moved the reimbursement threat from price to presence: a competitor’s launch can now put an incumbent under review.