In Brief: Tri-Med PYtest
This article was originally published in The Gray Sheet
Executive Summary
Tri-Med PYtest: Carbon-14 urea breath test for diagnosis of Helicobacter pylori is awaiting final FDA approval following March 7 submission of package insert clarifications requested by the agency in its Feb. 27 approvable letter to the firm. During February 1996 review of a new drug application for the test, FDA's Gastrointestinal Drugs Advisory Committee indicated that a confirmatory study of the diagnostic was inadequate because it did not generate appropriate control information ("The Gray Sheet" March 4, 1996, p. 17). Tri-Med says it submitted data on additional patients last fall to correct the deficiency...
You may also be interested in...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.