With only 18 novel drugs approved by the FDA so far this year, the influential US regulator looks set to dim the green lights in 2019.
Manufacturing issues prompt the US regulator to knock back projects from Nabriva and Heron Therapeutics, both of which insist that the problems are easily solvable.
An analysis of recent US drug sales confirms the growing role of licensing and acquisitions, though the biggest sellers conceal some interesting nuance.
May looks to be a fairly quiet month for US drug approvals, though Novartis's gene therapy should make headlines.
The price in value-based payment deals should by definition be justified, so why is patient cost-sharing part of the calculation? Spark covers this cost, but there is no…
A successful Mylan challenge would see generic entry within two years – though Biogen has fought off copycats before.
An Icer white paper provides ammunition for both PBMs and pharma before the next Capitol Hill hearing.
Many in the biopharma sector will rue the departure of Scott Gottlieb, an FDA commissioner who pursed a permissive path for novel drugs at the US regulator. Will his…