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.
CI read
A Jury Convicted the Philips Engineer. The Approach Came as His Plant Was Closing.
The approach came in 2017 as Philips prepared to close the plant. A site closure is a knowledge event before it is a cost event.
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.
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.
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.
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.
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.
Two FDA Device Authorisations, Two Sets of Evidence Narrower Than the Headline
Aletta matches human phlebotomists only when it agrees to attempt a draw. Narwhal cleared on bench and animal data, citing a trial with a different probe.