Novel drug approvals head for a down year
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.
No news equals bad news for Nabriva and Heron
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.
If you want blockbuster sales, buy them in
An analysis of recent US drug sales confirms the growing role of licensing and acquisitions, though the biggest sellers conceal some interesting nuance.
Go or no go? Novartis, Sanofi and Regeneron await US verdicts
May looks to be a fairly quiet month for US drug approvals, though Novartis's gene therapy should make headlines.
Should gene therapy patients be asked to pay?
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…
After Alzheimer’s collapse, Biogen must win Tecfidera patent challenge
A successful Mylan challenge would see generic entry within two years – though Biogen has fought off copycats before.
Rebate ban would not necessarily equal savings, Icer says
An Icer white paper provides ammunition for both PBMs and pharma before the next Capitol Hill hearing.
The Gottlieb legacy: a surge in unproven treatments?
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…
Kickstarting ideas
Independent, data-driven daily news and analysis on pharma, biotech and medtech.