Amarin’s Vascepa and Allergan’s migraine project ubrogepant are the high-profile pending FDA approval decisions as the sector heads into the last month of the year.
Spending $95m to speed up the anaemia project’s path to approval could be worth the investment for Astrazeneca.
A US patent victory could give Amgen’s Enbrel another eight years’ patent exclusivity, but is the enthusiasm justified?
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.