Axplora`s Ursodeoxycholic Receives 5-Year Renewed Registration
Medac Gesellschaft`s Kolbam receive market authorisation in EU
Galmed Pharmaceuticals announced the FDA has approved an investigational new drug application for their ARRIVE study, in which the safety and efficacy of aramchol among patients with HIV-associated lipodystrophy and nonalcoholic fatty liver disease will be evaluated.
In the landmark case, Laboratoires CTRS v European Commission (Case T-452/14), the General Court of the European Union, by its judgment dated 11 June 2015, annulled the marketing authorisation for Kolbam (ASK Pharmaceuticals) in recognition of the orphan market exclusivity afforded to Orphacol (Laboratoires CTRS).
Sigma-Aldrich Corporation (NASDAQ: SIAL) announced today that the Cerilliant® brand within its Applied Diagnostics and Testing business segment has launched its new bile acid reference standards product line with ten certified Snap-N-Spike® solutions of the most routinely tested bile acids and their stable-labeled internal standards. These new solution certified reference materials (CRMs) consist of lithocholic acid, taurocholic acid and native and deuterium-labeled analogs of cholic acid, chenodeoxycholic acid, deoxycholic acid, and ursodeoxycholic acid.
Sanofi pays $245m for FDA priority review voucher
One, Two, Three . . . and They’re Out! FDA Issues Third Rare Pediatric Disease Priority Review Voucher, Triggering One-Year Sunset Clause
Asklepion`s Cholbam (Cholic Acid) Approved in USA For Bile Acid Synthesis Disorders