Roche must believe that Blueprint Medicines’ Ret inhibitor pralsetinib has a safety edge over Lilly’s Retevmo.
Approval decisions are due for Jazz, Gilead and Galapagos in July, while Glaxo is preparing for a panel.
Crucial clinical data are expected in the third quarter for small to mid-sized players including Beigene, Turning Point, Intra-cellular and Immunovant.
Last month the FDA greenlit four oncology approvals early and the first GnRH antagonist in uterine fibroids.
June will be hectic for the US regulator, with many approval decisions due, including one for subcutaneous Arzerra in multiple sclerosis and Tazverik in follicular…
Astrazeneca’s Lynparza is due US approval decisions in prostate and ovarian cancers, while Bristol's Opdivo’s fate will be determined in lung cancer.
Launch phase is a challenging time for drug developers, so consider the likes of Biohaven, Esperion and, most recently, Urogen, as they brave locked-down markets.
Cellex wins the race to get the FDA’s buy-in for a blood test to pinpoint immunity.
Though the stage is apparently set for Bristol’s contingent value right to pay out, the instrument trades at depressed levels.