The European Medicines Agency is set to decide whether to back EU marketing approval for eight new drugs.
Eli Lilly/Almirall could this week learn whether the European Medicines Agency will recommend in favor of pan-EU marketing approval for lebrikizumab, their investigational treatment for moderate-to-severe atopic dermatitis and potential rival to Sanofi/Regeneron Pharmaceuticals’ blockbuster drug Dupixent (dupilimumab).
Lebrikizumab is among eight new products for which initial EU marketing authorization applications (MAAs) are listed as being up for...
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.
