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2024 FEB 14 (NewsRx) -- By a News Reporter-Staff News Editor at Immunotherapy Weekly -- A new study on inflammatory bowel disease is now available. According to news reporting out [...]

2024 FEB 13 (NewsRx) -- By a News Reporter-Staff News Editor at Life Science Weekly -- Investigators publish new report on amyloid. According to news originating from Dublin, Ireland, by [...]

2024 FEB 12 (NewsRx) -- By a News Reporter-Staff News Editor at Respiratory Therapeutics Week -- New research on inflammatory bowel disease is the subject of a new report. According [...]

2023 DEC 22 (NewsRx) -- By a News Reporter-Staff News Editor at Health & Medicine Week -- Investigators discuss new findings in ulcerative colitis. According to news reporting from the [...]

NORTH CHICAGO, Ill: AbbVie has issued the following news release: AbbVie (NYSE: ABBV) today announced that it has submitted applications for a new indication to the U.S. Food and Drug [...]

Dublin: Research and Markets has issued the following news release: The 'Ulcerative Colitis (UC) - Market Insight, Epidemiology And Market Forecast - 2032' report has been added to ResearchAndMarkets.com's offering. [...]

The study verified the ability for Triastek's 3D Microstructure for Colon Targeting (3DμS-CT) to precisely target and release medication in the colon Nanjing, July 20, 2023 (GLOBE NEWSWIRE) -- https://www.globenewswire.com/Tracker?data=86YShXouoUJ3UWxNDjh9WAInf9AScfXm3st2xh-Uzv6XjPpUrlpablaC-r-TuiVdBEBXYwxdn--M4kXuUtzSPQ== [...]

Supporting You with UC Provides Patients with Resources to Help Manage Their UC and Tips on Ways to Communicate with Their Doctor PRINCETON, N.J. -- Bristol Myers Squibb (NYSE: BMY) [...]

* Positive Review from the Drug Safety Monitoring Board (DSMB) on the Ongoing Phase 2 Clinical Trial in Ulcerative Colitis. * Positive Opinion for Orphan Drug Designation from the European [...]

* Yuflyma is Celltrion USA's high-concentration (100mg/mL) and citrate-free formulation of Humira[R] (adalimumab) biosimilar JERSEY CITY, N.J. -- Celltrion USA today announced the launch of Yuflyma([R])(adalimumab-aaty), a high-concentration (100mg/mL) and [...]

At Digestive Disease Week (DDW) 2023, a comment was made following a presentation discussing the preliminary induction findings from QUASAR (NCT04033445), the Phase IIb/III trial evaluating Janssen's guselkumab (GUS) in ulcerative colitis (UC). A member of the audience questioned the talk's overall conclusion that GUS is a 'great therapy'. This individual's comment reflects an overarching belief within the field that treatments for inflammatory bowel disease (IBD) are entering an inflection point requiring active comparators, according to GlobalData, a leading data and analytics company. The attendant continued by pointing out that GUS was shown to only effect remission in less than a quarter of the treated patients (22.5%), with a moderate benefit over placebo of only approximately 12%. The commenter concluded the argument with the observation that GUS and many other IBD therapies do not meet the historical therapeutic standards, referencing a recent meta-analysis study that showed that treatments generally achieve a 20% delta over placebo. Observed from recent interviews of key opinion leaders (KOLs) within IBD conducted by GlobalData, the unmet need for more evidence to define the most efficacious therapy in the field has been echoed repeatedly. One such thought leader acknowledged the current status quo with companies being able to 'get away, so to speak, in the IBD field with these placebo-controlled trials'. Adding that the sole use of placebo is not the norm with other indications. Addressing this situation, not only improves the quality of care for the IBD patient population, but it also would benefit companies in a quickly evolving and expanding market. The significance of addressing this unmet need is of increased importance in light of recent bets within IBD and immunology through mergers and acquisitions, such as the purchase of Prometheus Biosciences by Merck for $10.8 bn, or the $2.4 bn offer by Lilly for Dice Therapeutics. In addition to the effect these strategic transactions will have on the market in the coming years, long-established agents such as Humira and Stelara are transitioning to legacy assets, providing the opportunity for the next generation of treatments to capture significant market share. The current situation would be best addressed through clinical asset evaluation through trials with active comparators, but of the eight late-stage pipeline agents at the beginning of 2023, only Lilly's mirikizumab and AstraZeneca's brazikumab were being evaluated against active comparators (ustekinumab and adalimumab, respectively), with the former programme ending following assessment of the competitive landscape. Original source: Global Data, website: http://www.energy.globaldata.com, Copyright Global Data 2023., market; mergers and acquisitions; research and development; adalimumab; adalimumab; brazikumab; gastrointestinal drugs; guselkumab; mirikizumab; monoclonal antibodies; Stelara; therapeutic antibodies; ustekinumab; AstraZeneca; Dice Therapeutics; Janssen; Lilly; Merck; Prometheus [...]

This is the first-ever long-duration data reported for an anti-TL1A antibody At the expected Phase 3 once-monthly subcutaneous dose in the overall population, RVT-3101 treatment resulted in improved Clinical Remission[sup.1] [...]

In ulcerative colitis patients with a clinical response to risankizumab induction treatment, a significantly higher proportion of patients treated with risankizumab (180 mg or 360 mg) achieved the primary endpoint [...]

AbbVie announced on 15 Jun 2023 positive top-line results from COMMAND, its Phase 3 maintenance study, showing risankizumab [SKYRIZI, 180 mg or 360 mg subcutaneous (SC)] achieved the primary endpoint of clinical remission (per Adapted Mayo Score) at week 52, as well as key secondary endpoints in adult patients with moderately to severely active ulcerative colitis. In the COMMAND maintenance study, patients from the Phase 2b/3 INSPIRE study who responded to induction treatment were re-randomized to receive risankizumab 180 mg SC, 360 mg SC or withdrawal from risankizumab treatment [risankizumab intravenous (IV) induction-only control group]. Approximately 75% of patients previously failed at least one advanced therapy (biologics, JAK inhibitors and/or S1P receptor modulators) for ulcerative colitis. A significantly higher proportion of patients who received risankizumab 180 mg or 360 mg achieved clinical remission at week 52: 40% and 38%, respectively, compared to 25% in the induction-only control group (p less than 0.01). In COMMAND, 51% of patients treated with risankizumab 180 mg and 48% of patients treated with risankizumab 360 mg achieved endoscopic improvement at week 52 vs 32% of patients in the induction-only control group (p less than 0.001). Additionally, significantly more patients treated with risankizumab 180 mg and 360 mg achieved histologic endoscopic mucosal improvement at week 52 compared to those treated with induction only: 43% and 42%, respectively, vs 23% (p less than 0.001). A significantly higher proportion of patients who received risankizumab 180 mg or 360 mg achieved steroid-free clinical remission compared to the induction-only control group at week 52 (40% and 37%, respectively, vs 25%; p less than 0.01). The safety profile of risankizumab in the 52-week, double-blind, placebo-controlled COMMAND study was consistent with the safety profile observed in previous studies across other indications, with no new safety risks observed. The most common adverse events observed in the risankizumab groups were colitis ulcerative, COVID-19, nasopharyngitis and arthralgia.1 Serious adverse events occurred in 5.2% and 5.1% of patients in the risankizumab 180 mg and 360 mg groups compared to 8.2% of patients in the control group. There was one death in the 360 mg group due to adenocarcinoma assessed as unrelated to study drug. There were no adjudicated major adverse cardiac events (MACE) and no adjudicated anaphylactic reaction events. Full results from the COMMAND study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal. Use of risankizumab in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities. Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. Original source: Abbvie, website: https://www.abbvie.com/, Copyright Abbvie Inc. 2023., joint venture; research and development; antiulcerials; monoclonal antibodies; risankizumab; therapeutic antibodies; AbbVie; Boehringer [...]

SAN DIEGO: Connect Biopharma Holdings Limited (CNTB) announced positive data at Week 48 from the Phase 2 trial (CN002) for icanbelimod, a once-daily, orally administered, selective sphingosine 1-phosphate receptor 1 [...]

(GlobeNewswire) - Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the Company), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through [...]

Icanbelimod demonstrated sustained clinical remission, a regulatory relevant efficacy endpoint, through Week 48 in 80% of patients who achieved clinical remission at Week 12 of the induction period. Icanbelimod continued [...]

2023 SEP 20 (NewsRx) -- By a News Reporter-Staff News Editor at Immunotherapy Weekly -- Current study results on ulcerative colitis have been published. According to news reporting out of [...]

2023 SEP 13 (NewsRx) -- By a News Reporter-Staff News Editor at Immunotherapy Weekly -- Investigators publish new report on ulcerative colitis. According to news reporting out of Rahway, New [...]

2023 SEP 13 (NewsRx) -- By a News Reporter-Staff News Editor at Immunotherapy Weekly -- AbbVie (NYSE: ABBV) announced that it has submitted applications for a new indication to the [...]

INDIANAPOLIS: Eli Lilly and Company has issued the following press release: Eli Lilly and Company (NYSE: LLY) announced today new investigational data for mirikizumab in patients with moderately to severely [...]

Late-breaking data from the Phase 3 QUASAR Induction Study show statistically significant and clinically meaningful improvements among ulcerative colitis patients, including bio-naȯve patients and those who have experienced treatment failure [...]

- First interim Phase 2 data of an IL-23p19 antagonist in pediatric patients - New analysis from the pivotal Phase 3 LUCENT-1 and LUCENT-2 studies INDIANAPOLIS, May 9, 2023 /PRNewswire/ [...]

Eli Lilly and Company announced on 9 May 2023 new investigational data for mirikizumab in patients with moderately to severely active ulcerative colitis (UC) that further support the efficacy and safety seen in previous pivotal studies. Lilly reported the first pharmacokinetic (PK), efficacy and safety data in 26 paediatric patients with moderately to severely active UC treated with mirikizumab. These interim results are from the Phase 2 SHINE-1 study (NCT04004611) and include data on all patients through induction at Week 12. The PK, safety and efficacy data were consistent with the adult Phase 3 LUCENT-1 study and support the planned paediatric Phase 3 studies in UC and Crohn's disease starting later this year. Importantly, this is the first data of any IL-23p19 antagonist in paediatric patients. Original source: Eli Lilly, website: http://www.lilly.com/, Copyright Eli Lilly and Company 2023., research and development; gastrointestinal drugs; mirikizumab; monoclonal antibodies; Eli Lilly and [...]

WALTHAM, Mass.: Morphic Therapeutic has issued the following news release: Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious [...]

WALTHAM, Mass.: Morphic Therapeutic has issued the following news release: Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious [...]

(GLOBE NEWSWIRE via COMTEX) -- - OLINGUITO Phase 3 program in adults with axial spondyloarthritis (AxSpA) to include two parallel studies to investigate the efficacy and safety of filgotinib in [...]

NEW YORK: Immunic, Inc. has issued the following press release: Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory [...]

Immunic (NASDAQ:IMUX) reported 50-week maintenance data from a Phase 2b study of vidofludimus calcium (IMU-838) for the treatment of patients with moderate to severe ulcerative colitis (UC) and noted that [...]