With list due 4 November, there may not be time for public comment. Meanwhile, where will biopharma find fill/finish capacity?

Lorbrena is approved as a second-line treatment for ALK-positive NSCLC but Pfizer believes data from the first-line Phase III CROWN study makes the drug a serious competitor to standard of care Alecensa in the first-line setting.

A new analysis of the ADAURA study shows that Tagrisso’s disease-free survival benefits in early stage EGFRm NSCLC are replicated for brain metastases, a common complication with a poor prognosis. Filings and OS data await.