Bristol-Myers Squibb/Sanofi-Synthelabo's Avapro (irbesartan) and Merck's Cozaar (losartan) share Sept. 17 supplemental approvals for treatment of diabetic nephropathy with elevated serum creatinine and proteinuria in patients with type 2 diabetes and hypertension. Avapro's supplemental approval was based on the IDNT trial, which FDA's Cardiovascular & Renal Drugs Advisory Committee felt did not provide sufficient evidence due to its "modest" p-value. Merck's Cozaar supplement was based on the RENAAL study, which the committee also did not feel was sufficient, as it failed to reach statistical significance. However, the advisory committee was in favor of approval when viewing the data from the two trials in conjunction. The firms reached an agreement to reference each other's studies in the sNDAs. Labeling refers only to their own studie
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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.’
Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.
The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.
