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.
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.
One day after Bristol Myers Squibb announced the commercial launch of the multiple sclerosis drug Zeposia (ozanimod), the company said the medication demonstrated statistically significant efficacy as a potential induction and maintenance therapy for ulcerative colitis.
A high dose of filgotinib, the JAK1 inhibitor under long-term development by Gilead Sciences Inc. and Galapagos NV, proved effective in a Phase IIb/III study as a treatment for patients with moderately to severely active ulcerative colitis.
The U.S. Food and Drug Administration approved Janssen’s Stelara (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis.