The US conditional approval pathway has enjoyed years of expansion, but now the FDA is trying to put the toothpaste back into the tube.
Amid ongoing pressure to reform the FDA’s fast-track pathway, signs emerge that the criticism is being heard.
Blockbuster sales are predicted for several projects nearing approval, from Biogen, Argenx, Fibrogen and others.
Though the stage is apparently set for Bristol’s contingent value right to pay out, the instrument trades at depressed levels.
The US regulator granted 14 accelerated approvals in 2019, fewer than in the previous two years, and the sector remains slow at conversions.
Vertex is due the first pivotal data on its cystic fibrosis triplets, while Global Blood Therapeutics will soon find out whether it can take a shortcut on voxelotor’s…