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Voyageur Pharmaceuticals Ltd V.VM

Alternate Symbol(s):  VYYRF

Healthcare Drug Manufacturers - Specialty & Generic
Voyageur Pharmaceuticals Ltd. is a Canada-based company engaged in the development of barium and iodine Active Pharmaceutical Ingredients (API) and offers high-performance imaging contrast agents. The Company is focused on vertically integrating the barium and iodine contrast market, and aims at producing its own barium, iodine, and endo fullerenes. The Company’s products include SmoothX, SmoothHD, SmoothLD, VisionHD, VisionLD and V-Gas. SmoothX (2%w/v) is a contrast medium for use in computed tomography (CT) of the gastrointestinal tract. VisionHD is a high-density (98% w/w) barium powder suspension tailored for double-contrast radiographic examination of the gastrointestinal tract, esophagus, stomach and duodenum. It also owns a 100% interest in the Frances Creek barium sulfate (barite) project, which is a rare grade mineral suitable for the pharmaceutical marketplace that is intended to replace the current synthetic products with quality imaging products.


TSXV:VM - Post by User

Voyageur Pharmaceuticals Ltd > Fantastic news for VM today
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Comment by lscfaon Feb 28, 2024 3:08pm
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Post# 35904654

RE:Fantastic news for VM today

RE:Fantastic news for VM todayYour 2 links make no sense without this one...

https://www.ropesgray.com/en/insights/alerts/2023/01/new-fda-reform-legislation-congress-gifts-a-fdora-for-the-holidays
  • Classification of Certain Products as Drugs. FDORA clarifies that any contrast agent, radioactive drug, or over-the-counter monograph drug is to be classified as a drug and not a device. This provision was enacted in response to Genus Medical Technologies, LLC v. FDA, 994 F.3d 631 (D.C. Cir. 2021) in which Genus, a manufacturer of the contrast agent barium sulfate, asserted that its product should be regulated as a device rather than a drug. The appeals court sided with Genus, determining that FDA violated the Administrative Procedure Act via the approach the agency used to determine that barium sulfate and other contrast agents could be regulated as drugs. This ultimately resulted in FDA announcing that certain products that had been regulated as drugs would be switched to being regulated as devices instead. FDORA now reverses course back to the pre-Genus status quo for these products.
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