Go or no go? Sarepta’s gene therapy faces scrutiny
SRP-9001 heads for its month of regulatory probing, as vaccines from GSK and Pfizer, and Genmab and Abbvie’s bispecific, await FDA approval decisions.
Regulatory developments over the Christmas period
The FDA and Biogen come in for fierce Congressional criticism, and a handful of new cancer drugs are approved in Japan.
Ash 2022 movers – Glycomimetics shakes off its sickle cell past
Meanwhile, there was bad blood between cell therapy players and their investors.
Ash 2022 – toxicity still looms large for Regeneron’s bispecific
Another five treatment-related deaths, despite a dose regimen change, raise questions about whether odronextamab will be able to compete.
Not so fast for some accelerated approvals
The US conditional approval pathway has enjoyed years of expansion, but now the FDA is trying to put the toothpaste back into the tube.
Ash 2022 preview – Affimed and Aptose score
In oncology settings outside multiple myeloma investors have picked two early winners.