Roche pits its targeted cancer Blueprint against Lilly
Roche must believe that Blueprint Medicines’ Ret inhibitor pralsetinib has a safety edge over Lilly’s Retevmo.
Go or no go? Pandemic looms over FDA timelines
Approval decisions are due for Jazz, Gilead and Galapagos in July, while Glaxo is preparing for a panel.
Important catalysts approach for smaller biotechs
Crucial clinical data are expected in the third quarter for small to mid-sized players including Beigene, Turning Point, Intra-cellular and Immunovant.
US FDA approval tracker: several early decisions in May
Last month the FDA greenlit four oncology approvals early and the first GnRH antagonist in uterine fibroids.
Go or no go? A busy month ahead for US FDA decisions
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…
Go or no go? Oncology dominates upcoming decisions
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.
Covid-19 adds a new danger to drug launches
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.
FDA authorises the first Covid-19 antibody test
Cellex wins the race to get the FDA’s buy-in for a blood test to pinpoint immunity.
Holding a contingent value right in uncertain times
Though the stage is apparently set for Bristol’s contingent value right to pay out, the instrument trades at depressed levels.
