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Korea adds Pergoveris pen to reimbursement rolls, vial already covered

September 2, 2026 by Athithi Verma
Korea adds Pergoveris pen to reimbursement rolls, vial already covered

This is a device listing, not an eligibility expansion. The indication is unchanged, and the criteria were relaxed back in April 2025.

Categories Access Read, Market Access, Peptide, Pricing & Reimbursement, Quick, The Brief Tags Merck Group, Pergoveris, South Korea

CDA-AMC reverses course, backs Leqembi’s first ruling content still undisclosed

September 2, 2026 by Athithi Verma

Four words carry the news: follows a reconsideration. CDA-AMC reached a different conclusion first, and neither release says what it was.

Categories Access Read, Antibody, Market Access, Neurology, Pricing & Reimbursement, Quick, The Brief Tags Alzheimer’s Disease, Amyloid, BioArctic, Biogen, Canada, Eisai, Lecanemab, Leqembi, Market Access, Pricing & Reimbursement

3 of 1,357 Cleared AI Devices Have Public Outcome Trials. The Study Has No Non-AI Comparator.

August 28, 2026 by Athithi Verma
3 of 1,357 Cleared AI Devices Have Public Outcome Trials. The Study Has No Non-AI Comparator.

The census counts publicly registered evidence, so it measures disclosure. Without a non-AI comparator it cannot show this is an AI problem.

Categories AI/ML, Diagnostics, Findings, Science Read, The Brief Tags 510(K) Clearence, AI Medical Devices, Clinical Validation, Evidence Standards, Radiology

Biocon Makes It, a Consultancy Holds the Licence, and Sandoz Sells It

August 28, 2026 by Athithi Verma
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.

Categories Approval, CI read, Oncology, Peptide, Quick, The Brief Tags Amgen, Biocon, Biosimilars, India, Japan, Market Access, MHLW, Pegfilgrastim, Sandoz

Abbott Cleared the First Dual Glucose and Ketone Sensor. FDA Judged Accuracy, Not Admissions.

August 28, 2026 by Athithi Verma

The label says diabetes. The clinical argument is type 1. Coverage conversations start from 2.1 million people, not 40.1 million.

Categories Access Read, Cardio-Metabolic, Digital Health, Quick, The Brief Tags Abbott, Continuous Glucose Monitoring, De Novo, Diabetic Keteacidosis, Libre Duo 10 Day, Type 1 Diabetes

Three Proteins Flip the Tumour Sphere. Blocking Two of Them Flips It Back Toward Chemo-Resistance.

August 27, 2026 by Athithi Verma
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.

Categories Antibody, Findings, Oncology, Science Read, The Brief Tags Colorectal Cancer, HER2, HER3, Peritoneal Metastasis, SorLA, University of Turku

Japan Approved Orladeyo for Under-Twelves in an Open-Label Interim Analysis of 29 Children

August 26, 2026 by Athithi Verma
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.

Categories CI read, Quick, Rare Diseases, Small Molecule, The Brief Tags berotralstat, BioCryst, Hereditary Angioedema, Japan, ORLADEYO, OrphanPacific, Paediatrics, Plasma Kallikrein, Pricing & Reimbursement

A Dual MYC and GSPT1 Degrader Extended Survival by Over 300% in One Preclinical Model

August 26, 2026 by Athithi Verma
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.

Categories Findings, Oncology, Science Read, Small Molecule, The Brief Tags AML, CSPT1, MD Anderson, MYC, Protein Degrader, venetoclax

China Will Pay One Price for 158 Conditions, Whatever the Hospital

August 26, 2026 by Athithi Verma
China Will Pay One Price for 158 Conditions Whatever the Hospital. Most of Them Are Drug-Led.

Same disease, same payment across tiers. Of 31 DRG categories, 27 are internal medicine, where drug cost rather than theatre time drives the case.

Categories Access Read, Cardio-Metabolic, Quick, Small Molecule, The Brief Tags China, DRG & DIP, Hospital Payment Reform, Market Access, NHSA, Pricing & Reimbursement

France Funded Two Cancer Drugs the Same Week. One Was Rated Therapeutic Progress, One Was Not.

August 26, 2026 by Athithi Verma
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.

Categories Access Read, Antibody, Oncology, Quick, The Brief Tags Accord Healthcare, Columvi, France, glofitamab, HAS, Henlius, Hetronifly, Liste en Sus, Market Access, Pricing & Reimbursement, Roche, Serplulimab
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Synopulse Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 24 2025

Synopulse Weekly Pulse – November 24, 2025

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