J&J Is Using Two Tecvayli Trials to Own Myeloma’s First Relapse Whether or Not Patients Had Darzalex
J&J’s frontline success with Darzalex is manufacturing the monotherapy market for Tecvayli at first myeloma relapse.
Antibody
Henlius Licensed a US pH-Switch Platform for Two T-Cell Engager Targets Without Disclosing Any Payment
Henlius bought a switch, not a molecule, and the deal discloses no dollar figure at all, not even a headline total.
Merck Moved Every Japanese Keytruda Indication to a One-Minute Injection on a Single Lung Cancer Trial
One exposure trial in lung cancer carried every Japanese indication. The contest is now minutes and millilitres.
India Got Three Different Access Mechanisms in Four Days
Three routes to patients in four days. In a market that pays out of pocket, not one announcement carries a price.
Japan Clears Five Products in a Day, Two With a Price Cut Attached
Five approvals, one calendar date, one November pricing round. The two expansions are the ones the system taxes.
Roche Paid $36.5 Million to Screen 300,000 Bispecific Combinations
Roche has not bought a molecule or a target. It has bought a search, and the pairing is an output rather than an input.
NICE Reversed on Enhertu Because the Threshold Moved, Not the Evidence
The clinical evidence did not change. NICE’s cost-effectiveness threshold did, as a term of a bilateral trade agreement.
The First Approval for Denecimig Came From Riyadh, Not Washington
One of the four Phase 3 studies is a safety-only switch from emicizumab. The commercial target was the incumbent, not the untreated.
ADCs Returned 0.46 in Relapsed Disease and 1.15 in the Front Line at WCLC
The dividing line is not the target or the payload. It is the setting: relapsed disease against chemotherapy, or the front line against chemo-IO.
CDA-AMC reverses course, backs Leqembi’s first ruling content still undisclosed
Four words carry the news: follows a reconsideration. CDA-AMC reached a different conclusion first, and neither release says what it was.