FDA's "Approved Rx Drug Products List with Therapeutic Equivalence Evaluations" supplement for Aug. 1984-Nov. 1984 incorrectly lists the patent expiration date for Diamox ("The Pink Sheet" Dec. 24, p. 10). The patent cited, #3584005 (not #3544005 as listed), is a process patent and therefore not valid for inclusion in FDA's listing. The list includes only chemical entity or use patents. Diamox will be deleted from future supplements
You may also be interested in...
FDA has heard from some manufacturers that additional time is needed to meet all of the requirements, “especially during the COVID-19 pandemic.” Prior to the pandemic, agency announced enforcement discretion during 2020 for compliance by firms with more than $10m in annual sales.
Data show Opdivo/Cabometyx combo bests Sutent for overall and progression-free survival and response endpoints in first-line RCC. Exelixis CEO says comparison to Sutent is standard control and allows better comparison to other combo regimens.
ES: Public Company Edition: Fifty biopharma companies launched initial public offerings in the US last year and there have been 52 so far in 2020, including Metacrine, Dyne, Athira and COMPASS.