Encore? FDA Could Come Close To Record 2012 NME Count This Year
This article was originally published in Pharmaceutical Approvals Monthly
With 19 novel agents approved so far in 2013 and a full slate of candidates under review, the recovery in novel agent approvals after the doldrums of the 2000s is likely to continue even if the agency falls short of last year’s 45 approvals. Watch for action on the first “breakthrough” therapies submitted and advances in hepatitis C treatment.
You may also be interested in...
Oncologists are the most restrictive physicians to pharma sales reps, according to a report by ZS Associates. Oncologists permit reps less than one visit a month to educate them about new drugs, but pharma continues to waste between $1 billion and $1.5 billion on infeasible sales calls.
Merck’s anesthesia reversal agent, which was deemed “not approvable” in 2008, faces another setback as FDA cancels its July 18 advisory committee meeting to allow more time to review clinical trial site inspection data.
Alzheimer’s community stakeholders are planning a unified response to a CMS Medicare coverage proposal that would, in their view, disastrously constrain use of PET imaging, and imaging agents like Lilly’s Amyvid, in the diagnosis and management of Alzheimer’s patients.