Zolgensma heads up spate of US approvals
The US FDA granted seven approvals in two days last week, including an eagerly awaited thumbs-up for Novartis’s gene therapy Zolgensma.
Mustang Bio sets its sights on 2021 approval
Its gene therapy is three years away from market, but Mustang is already thinking about outcomes-based pricing.
Pfizer shoots for a high price with tafamidis
Pfizer opts not to start a price war with Alnylam and Ionis, but could there be a pricing loophole?
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.
Peanut therapy makers face pricing pushback
An Icer report questioning the cost effectiveness of Aimmune and DBV's peanut allergy projects is yet another reason to be cautious about the companies'…
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…
China’s blueprint for a checkpoint blocker price war
A price war over anti-PD-(L)1 drugs is raging in China, less than a year after the first one was approved. When could the US see something similar?
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…
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