Phase III

Amgen Inc., of Thousand Oaks, Calif.; Allergan plc, of Dublin


Biosimilar candidate to Rituxan (rituximab, Roche Holding AG / Biogen Inc.)

CD20-positive B-cell non-Hodgkinlymphoma

Primary endpoint, an assessment of overall response rate by week 28, was within the prespecified margin for ABP-798 compared to Rituxan, showing clinical equivalence; safety and immunogenicity were comparable

Retrophin Inc., of San Diego


Small-molecule replacement therapy designed to pass the blood-brain barrier and be converted to phosphopantothenate

Pantothenate kinase-associated neurodegeneration

Missed primary and secondary endpoints as compared to placebo

Satsuma Pharmaceuticals Inc., of San Francisco


Dihydroergotamine (DHE) nasal powder


Dosed the first patient in its EMERGE efficacy trial for the acute treatment of migraine; the study will involve approximately 1,140 migraine patients in the U.S. with participants randomized (1:1:1) to receive 1 of 3 treatments: STS-101 DHE 3.9 mg, STS-101 DHE 5.2 mg or matching placebo and instructed to treat their next migraine attack of at least moderate pain severity with the allocated blinded study medication; top-line data is expected in the second half of 2020

Viiv Healthcare Ltd., of London

Cabotegravir and rilpivirine (Edurant, Johnson & Johnson) combination

HIV-1 integrase strand transfer inhibitor; non-nucleoside reverse transcriptase inhibitor

HIV-1 infection in patients whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine

Met the primary endpoint, showing that the long-acting regimen of cabotegravir and rilpivirine, injected every two months, was non-inferior to cabotegravir and rilpivirine administered every month at week 48


For more information about individual companies and/or products, see Cortellis.


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