Phase II development of lead phosphodiesterase-4 inhibitor compound for asthma, COPD discontinued, company announces April 25. Merck, which was developing a once-daily oral formulation under a collaborative agreement with Celltech, says it continues to study other PDE-4 inhibitor molecules for asthma and COPD, although "the timing for the development of these other molecules is not certain." Merck has demonstrated success with backup compounds where initial lead agents have failed in clinical trials - Singulair was a successor product to Venzair, Merck's first leukotrine antagonist asthma candidate whose development was halted due to clinical toxicity...
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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.
