Pink Sheet analysis of three years of novel US FDA approvals show the swiftest average time to approval in oncology, hematology, and antiviral divisions; neurology and hematology divisions contributed the most approvals.
The reorganization of the Office of New Drugs ongoing at the US Food and Drug Administration will break up one of the Center for Drug Evaluation and Research’s best-performing divisions in terms of both the number and speed of novel approvals.
Between 2016 and 2018, the Division of Hematology Products approved 19 new molecular entities and novel therapeutic biologics, tying with the Division of Neurology Products
The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.
US trade and tariff leverage might successfully push European and other countries to pay more for medicines, but if not, President Trump’s executive order includes potential US drug withdrawal and other options to entice industry to lower US prices.
Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.
