A first-line Keytruda study is nominally positive, but numerous questions remain before approval can be assured.
Merck & Co faces two US FDA decisions in June, and neither is an obvious guarantee of success.
The US FDA granted seven approvals in two days last week, including an eagerly awaited thumbs-up for Novartis’s gene therapy Zolgensma.
In the wake of two phase III glioblastoma failures this month, from Abbvie and Bristol-Myers Squibb, hopes dim for another big readout from Tocagen.
The group is desperately playing up mirvetuximab, but its future rests with a pair of earlier-stage projects.
The companies’ DS-8201 succeeds in breast cancer patients who had failed Kadcyla, and will go before the regulators later this year.
The Astrazeneca spinout is plugging data with its rare disease contender inebilizumab, but Alexion’s Soliris is one step ahead.
UK group bets billions on an Her2 project slated for late-line patients and those with lower expression of the target protein.
The companies’ decision to start a 1,500-patient Alzheimer’s disease study defies logic.