Latest From Andy Smith
Patient selection is held out as the Achilles heel of clinical trial success. But a surprise and fortunate finding in Pfizer’s gene therapy trial has already resulted in tightened recruitment criteria, thanks to genetic analysis.
What on earth would make a biotech company change the primary endpoint half way through a Phase III program and not discuss it with the FDA? There are at least two scenarios, neither of them good.
Many of the many biotech companies that raised money to develop and repurpose their molecules to address the pandemic have started to unwind those efforts. What will this mean for the sector’s valuation?
The stock price performances of the top two coronavirus vaccine producers are inversely correlated to their sales and pipelines. There seems to be an expectation of declining coronavirus vaccine sales for some, but not for others.
From clinical trials to in-person sales calls, the pharmaceutical value chain has been tested by the COVID-19 pandemic, but has held up. Nevertheless, recent friction within this chain may be more than a passing irritation.
It is not only gene therapy companies that have found European payers hard to convince of the value of their products. Amarin’s proposed European pricing may lead to another US company exit.