AbbVie’s Rinvoq (upadacitinib) hit the mark as a maintenance drug for ulcerative colitis in a Phase III study. The company said more patients treated with Rinvoq in the 52-week study achieved clinical remission compared to placebo.
The U.S. Food and Drug Administration approved Bristol Myers Squibb’s oral drug Zeposia to treat adults with ulcerative colitis, a chronic inflammatory bowel disease.
The U.S. Food and Drug Administration approved AbbVie’s biologic therapy Humira (adalimumab) as a treatment for moderate-to-severe active ulcerative colitis in children aged 5 years and older.
Shares of Pandion Therapeutics soared more than 131 percent in trading after pharma giant Merck announced the acquisition of the autoimmune-focused company for up to $1.85 billion.
GlaxoSmithKline discontinued a Phase II clinical trial evaluating an anti-LAG3 cell depleting monoclonal antibody aimed at treating ulcerative colitis licensed from Australia-based Immutep Limited following an interim assessment of an Independent Data Monitoring Committee.
AbbVie’s Phase III induction study, U-ACHIEVE, of Rinvoq (upadacitinib) in moderate to severe ulcerative colitis hit the primary endpoint of clinical remission at week 8 and also met all ranked secondary endpoints.
Paris-based Ipsen secured Fast Track designation from the U.S. Food and Drug Administration for Onivyde (irinotecan liposome injection) for study patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen.
Bristol Myers Squibb’s experimental psoriasis drug deucravacitinib (BMS-986165) beat out Amgen’s Otezla (apremilast) in the POETYK PSO-1 Phase III clinical trial.
Roche Holding’s experimental drug etrolizumab did not fare well in late-stage clinical trials in treating people with moderate to severe ulcerative colitis, the Swiss drugmaker said.
U.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.