Salt Lake City, Utah federal court issues preliminary injunction against Prevose, Penn.-based HPF, Inc. in response to a complaint filed by Pharmanex, the Cholestin manufacturer says. Judge Dale Kimball orders that until the case comes to trial, Cholestene may not be marketed in its current packaging. The injunction follows an April 14 suit filed by Pharmanex asserting Cholestene packaging is deceptively similar to that of Cholestin. According to company data, Pharmanex has spent approximately $5 mil. on R&D for its red yeast rice dietary supplement for healthy cholesterol in addition to $1.8 mil. in litigation against FDA to protect the regulatory status of the product
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.
Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
