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.
Antibody
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.
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.
Trodelvy Now Covers First-Line TNBC Across PD-L1 Status. The Two Regimens Are Not Equally Tolerated.
Serious adverse reactions ran at 38% in the combination trial against 26% in the monotherapy trial. Same drug, same line, different companion.
Canada Moved Two Cancer Drugs Forward in One Week. Neither Went the Normal Route.
One drug reached review only because payers filed for a manufacturer that had not. The other was recommended on evidence the committee called inconclusive.
In Ustekinumab Biosimilars, Approval Stopped Being the Hard Part
A biosimilar licence used to be the scarce asset. In ustekinumab it is the entry ticket, and the returns go to whoever solves supply and device.
Singapore Approved Both Blenrep Combinations. Korea Reimbursed Only the One With Survival Data.
Same drug, same week, two Asian markets. The regulator approved on progression-free survival. The payer funded only the regimen with overall survival data.
CMS Comments Close on a Rule That Retires the Small Biotech Exemption and Shuts the Hyaluronidase Route
QuickAccess read/Oncology/Antibody CMS Comments Close on a Rule That Retires the Small Biotech Exemption and Shuts the Hyaluronidase Route Athithi Verma· 19 August 2026· 2 min read· Synopulse The 60-day comment period on CMS-4215-P closed at 5pm on 17 August 2026. The proposed rule, published in the Federal Register on 16 June 2026, would codify … Read more
One Missed, One Published the Arm That Failed, One Disclosed a Verb
Three Phase 3 toplines in one day, and the detail released runs inversely to the strength of the result. One company disclosed no number at all.
Two TROP2 Conjugates Reached the Same Patients Ten Weeks Apart, and Payers Finally Have a Choice to Make
Until this summer every approved ADC held its indication alone. Two TROP2 conjugates now share one first-line population, and payers finally have a comparator.