Go or no go? Covid-19 upstages US regulatory decisions
A Vantage analysis of FDA decisions expected in the next month and how the ongoing Covid-19 pandemic could affect these.
Will pending clinical readouts make it across the line?
Several key data readouts slated for the first quarter remain unannounced, from Roche, Lilly, Axsome and others, but the Covid-19 pandemic puts many at risk of delay.
Upcoming events – Fibroid data for Obseva, as Inventiva turns to Nash
Phase III data for Obseva's uterine fibroid project linzagolix need to prove its safety, while Inventiva tests its pan-PPAR agonist lanifibranor in Nash.
Go or no go? Ozanimod and Fintepla await FDA verdicts
Big approval decisions pending in March include ozanimod in multiple sclerosis, where Bristol-Myers is likely to win a green light, while the safety of Zogenix's…
Upcoming events – Filgotinib's ulcerative colitis data and serlopitant takes on pruritus
Gilead and Galapagos's filgotinib might not be a match for Rinvoq in ulcerative colitis, while Menlo needs to prove serlopitant works after previous setbacks.
US FDA approval tracker: a first for Aimmune
January saw Aimmune receive an FDA approval for Palforzia, a first for peanut allergy, alongside decisions for Blueprint Medicines and Horizon Therapeutics.
Go or no go? Esperion's double whammy and a look to priority reviews
Four assets with previous rejections are due FDA decisions in February, while those with priority review could become the next string of early approvals.
Upcoming events – Bayer and Merck look to vericiguat, and Akero bets on Nash
Bayer and Merck & Co need Vitality data to breathe life into vericiguat, while Akero awaits its first big test with the Nash project AKR-001.
Upcoming events – Pfizer's abrocitinib and Myovant's relugolix
Pfizer's abrocitinib heads against Dupixent in atopic dermatitis, while Myovant hopes to raise its Spirits.
