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.
By therapy area
Biocon Makes It, a Consultancy Holds the Licence, and Sandoz Sells It
Three parties, three functions, and Biocon holds only the middle one. Treat the caretaker MAH structure as the Japanese default, not the exception.
Abbott Cleared the First Dual Glucose and Ketone Sensor. FDA Judged Accuracy, Not Admissions.
The label says diabetes. The clinical argument is type 1. Coverage conversations start from 2.1 million people, not 40.1 million.
Three Proteins Flip the Tumour Sphere. Blocking Two of Them Flips It Back Toward Chemo-Resistance.
Blocking HER2 and HER3 impaired attachment, but pushed spheres into the state the same paper describes as chemo-resistant and pro-migratory.
DOJ Settled With the In-Home Vendor, Not the Health Plan, Over Four Medicare Advantage Codes
DOJ did not settle with a health plan. It settled with the in-home vendor that supplied the codes, and named the risk-share contract as the incentive.
Teva Faces New Probe in Turkey Over Conduct Flagged by EU
Not a new theory of harm. It is the European Commission’s Copaxone decision run a second time, with two of the same corporate entities named.
Japan Approved Orladeyo for Under-Twelves in an Open-Label Interim Analysis of 29 Children
The molecule has been approved in Japan since 2021. What is new is a formulation a two-year-old can swallow, and that is the commercial move.
A Dual MYC and GSPT1 Degrader Extended Survival by Over 300% in One Preclinical Model
The loop is the discovery, not the degrader. If GSPT1 supports MYC translation, a GSPT1-only degrader should permit MYC to recover.
China Will Pay One Price for 158 Conditions, Whatever the Hospital
Same disease, same payment across tiers. Of 31 DRG categories, 27 are internal medicine, where drug cost rather than theatre time drives the case.
France Funded Two Cancer Drugs the Same Week. One Was Rated Therapeutic Progress, One Was Not.
Listing is granted by indication, not by licence. Columvi is funded for one situation and refused for the rest of its authorisation.