The French firm’s Onivyde has succeeded as part of a combination regimen in chemotherapy-naïve pancreatic cancer patients, setting it up for a label expansion, but some experts are keen to see survival data in full before raising guidance.
Ipsen SA’s Onivyde (irinotecan liposome injection) has met the primary endpoint of overall survival (OS) in a Phase III trial in untreated pancreatic cancer patients, sparking filing plans, but potential sales depend on data yet to be released, some observers say.
The Phase III NAPOLI 3 trial set Onivyde plus oxaliplatin (Sanofi’s Eloxatin) and 5 FU/LV against gemcitabine (Eli...
FDA issued a complete response letter to Replimune’s BLA for a novel oncolytic immunotherapy for melanoma in a surprise to management and investors.
The French major is paying $1.15bn For the UK biotech and its bivalent candidate, VXB-241.
Chinese firms Junshi, Minghui and RemeGen rank among the world’s few players progressing antibody-drug conjugates combined with PD-(L)1/VEGF bispecific antibodies in Phase II trials for various cancers.
The biotech company is planning for Phase III based on positive topline results from Vibrance-1 in narcolepsy type 1 and remains optimistic about type 2 disease.
The biotech company is planning for Phase III based on positive topline results from Vibrance-1 in narcolepsy type 1 and remains optimistic about type 2 disease.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.
