Safety Of Anti-NGFs For Osteoarthritis Pain To Be Weighed By Advisory Panel
This article was originally published in The Pink Sheet Daily
The entire class of biologics has fallen under suspicion of worsening the very condition it is supposed to treat, and FDA has imposed clinical holds on ongoing trials.
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After well-publicized problems in Johnson & Johnson’s devices and consumer health divisions, in the words of a recent Deutsche Bank research note, “It’s pharmaceuticals’ time to shine.” Indeed, the diversified health care company expects to file 11 new drugs and over 31 line extensions by 2015. Though growth is now expected from J&J’s pharma business, less well understood is the role of biologics, both marketed and near to market, in driving that expansion and J&J’s increased focus on specialty products.
The three companies' decisions were spurred by concerns about potential for the bone disorder avascular necrosis.
Safety concerns require Pfizer to scupper two additional studies of its Phase III tanezumab, casting doubt on an entire class of new pain drugs.