Funding, Deals & Partnerships: BIOLOGICS & MEDICAL DEVICES; BioMed e-Series; Medicine and Life Sciences Scientific Journal – http://PharmaceuticalIntelligence.com
In 2018, FDA approved an all-time record of 62 new therapeutic drugs (NTDs) [Not including diagnostic imaging agents, included are combination products with at least one new molecular entity as an active ingredient] with average Peak Sales per NTD $1.2Billion.
In 2018, FDA approved an all-time record of 62 new therapeutic drugs (NTDs) [Not including diagnostic imaging agents, included are combination products with at least one new molecular entity as an active ingredient] with average Peak Sales per NTD $1.2Billion.
Reporter: Aviva Lev-Ari, PhD, RN
BIOBUSINESS BRIEFS
2018 FDA approvals hit all-time high — but average value slips again
In 2018, the FDA approved an all-time record of 62 new therapeutic drugs (NTDs; see Fig. 1 for the definition and the difference compared with new molecular entities). This is consistent with the increase we predicted last year (Nat. Rev. Drug Discov.17, 87; 2018) and the overall resurgence of R&D in the last 5 years, with an average of 51 approvals per year in this period even with a low count in 2016. This is substantially more than the average of 31 approvals per year in the period 2000–2013 (Fig. 1).
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