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.
Topics
Avulux Won a De Novo and Created the Category Its Competitors Will File Into
Going first through a De Novo builds the road behind you. Avulux owns the claim today and has created the category rivals will file 510(k)s into.
ASCO’s First ctDNA Guideline Found Few Instances of Clinical Utility. Residual Disease Got No Recommendation at All.
Most of the guideline concerns where ctDNA should not be used. The application carrying the largest commercial expectations got no recommendation.
RK-251 Was Tested Against One Cancer Cell Line. The Problem It Was Built to Solve Is Bioavailability.
FindingsScience read/Oncology/Small Molecule RK-251 Was Tested Against One Cancer Cell Line. The Problem It Was Built to Solve Is Bioavailability. Athithi Verma· 25 August 2026· 2 min read· Synopulse What they did A research article in the Journal of Medicinal Chemistry, published 23 July 2026 across pages 17342 to 17365. Kesarwani and colleagues at IIT … Read more
Roche Cleared an Alzheimer’s Blood Test With Three Result Categories. The Middle One Is Where PET Survives.
A three-way result means some patients resolve neither way, and those still go to imaging. Roche has not said how many land in the middle.
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.
Rett Syndrome Gets Its First EU Treatment. Thirty Pricing Negotiations Start Now.
First and only is not the same as available. One authorisation covers 30 jurisdictions, each of which now prices the drug separately.
NICE Backed a Weekly Insulin Before It Has a Licence, Then Told Prescribers to Pick the Cheapest Option
QuickAccess read/Endocrine & Metabolic/Peptide NICE Backed a Weekly Insulin Before It Has a Licence, Then Told Prescribers to Pick the Cheapest Option Athithi Verma· 25 August 2026· 2 min read· Synopulse NICE published final draft guidance recommending insulin efsitora alfa (Onswik), from Eli Lilly, for adults with type 2 diabetes. Given once weekly by pre-filled … Read more
Roche Paid $190 Million Up Front on a $2.3 Billion Headline for a Phase 1 Obesity Asset
https://synopulse.com/wp-content/uploads/2026/08/Roche-Paid-190-Million-Up-Front-on-a-2.3-Billion-Headline-for-a-Phase-1-Obesity-Asset.webp
FDA Moved a Class of Cancer Tests From PMA to 510(k). Fewer Than Five Parties Commented.
The order moves these tests from PMA to 510(k). One special control was deleted, and the predicate chain is where the change compounds.