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2024 AUG 5 (NewsRx) -- By a News Reporter-Staff News Editor at Gastroenterology Week -- According to news reporting based on a preprint abstract, our journalists obtained the following quote [...]

CONCORD: Adiso Therapeutics has issued the following news release: Adiso Therapeutics, Inc., a clinical-stage biotechnology company committed to creating medicines that treat inflammatory diseases and improve the lives of patients [...]

(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 [...]

2023 JUL 7 (NewsRx) -- By a News Reporter-Staff News Editor at Health & Medicine Week -- Investigators discuss new findings in ulcerative colitis. According to news reporting from Wellington, [...]

SAN DIEGO, Jan. 09, 2023 (GLOBE NEWSWIRE) -- https://www.globenewswire.com/Tracker?data=maTKzhUgajGh0uCD1pGdC2A-vZkpRaIqKZDrMT-7FI0xpNfv3kLSfvibHyxX9QRWS13thUzNr5xYhi7XMx4mJ4K4DyZX9V3GfnjItx9lPAA=. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced feedback from the United States Food and Drug Administration [...]

HANGZHOU, China, Dec. 5, 2022 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as 'Lynk Pharmaceuticals'), an innovative clinical stage company, announced that it has dosed the first patient [...]

The rate of clinical remission was 47.9 percent in patients who received combination induction therapy with guselkumab and golimumab compared with either treatment alone (31.0 percent and 20.8 percent, respectively) [...]

The rate of clinical remission was 47.9 percent in patients who received combination induction therapy with guselkumab and golimumab compared with either treatment alone (31.0 percent and 20.8 percent, respectively) [...]

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on 10 Oct 2022 data from an ongoing analysis of a Phase 2a clinical trial showing adults with moderately to severely active ulcerative colitis (UC) who received 12 weeks of combination induction therapy with guselkumab and golimumab, followed by a transition to guselkumab alone for maintenance, achieved a clinical remission rate at week 38 of 47.9%, a higher rate than induction and maintenance treatment with either guselkumab alone (31.0%) or golimumab alone (20.8%). Patients had comparable rates of adverse events (AEs) across the treatment groups. Guselkumab alone, or the combination of guselkumab and golimumab are under clinical investigation and not approved for the treatment of adults with UC in the US. The VEGA study is the first randomized controlled trial to evaluate the efficacy and safety of combination therapy with an interleukin (IL)-23p19 subunit antagonist (guselkumab) and a tumour necrosis factor-alpha (TNFalpha) antagonist (golimumab) in UC. Detailed results were presented on 10 Oct 2022 as an oral presentation (OP087) at the United European Gastroenterology (UEG) Week 2022 congress taking place in-person in Vienna, Austria and virtually from 8-11 Oct 2022. In the VEGA study, patients with moderately to severely active UC were randomized (1:1:1) to receive combination therapy with guselkumab and golimumab, guselkumab monotherapy, or golimumab monotherapy. After endpoints were evaluated at week 12, patients in the monotherapy groups continued their initially assigned treatment, while patients randomized to the combination therapy group transitioned to guselkumab alone as a maintenance therapy. Patients remained blinded and received their respective therapies through the final efficacy assessment at week 38. Clinical remission, was assessed based on the modified Mayo score as well as the total Mayo score. Symptomatic remission, endoscopic improvement, endoscopic remission, histologic remission, and composite histologic-endoscopic endpoints, were also assessed at week 38 in an exploratory analysis. Safety was evaluated through week 50 (16 weeks after the final dose of study intervention at week 34). Patients who received combination therapy with guselkumab and golimumab followed by maintenance treatment with guselkumab achieved clinical remission at week 38 versus 31.0% (22/71) and 20.8% (15/72) of patients who received guselkumab or golimumab alone, respectively. Rates of clinical remission as defined by the total Mayo score at week 38 were similar to those based on the mMayo with 43.7% (31/71) in the combination therapy followed by guselkumab group achieving this endpoint, compared to either the guselkumab or golimumab monotherapy groups. Also, patients receiving combination therapy followed by guselkumab had the following outcomes at week 38:1. Endoscopic improvement and the composite histologic-endoscopic endpointg, were higher in patients who received combination therapy followed by treatment with guselkumab compared to patients who received guselkumab or golimumab alone. Endoscopic remission and histologic remission were higher in patients who received combination therapy followed by treatment with guselkumab compared to patients who received golimumab alone. Original source: Johnson & Johnson, website: http://www.jnj.com/, Copyright Johnson & Johnson Services Inc 2022., research and development; gastrointestinal drugs; golimumab; guselkumab; monoclonal antibodies; therapeutic antibodies; Janssen Pharmaceutical Companies; Johnson & [...]

CRANBURY: Palatin Technologies, Inc. has issued the following news release: Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of [...]

NEW YORK, Aug 03, 2022 (GLOBE NEWSWIRE via COMTEX) -- EQNX::TICKER_START (NasdaqGM:LABP), EQNX::TICKER_END NX-13 Demonstrated Favorable Safety and Tolerability Profile Across Range of Once-Daily Doses Results Indicate Promising Early Signals [...]

SAN DIEGO, July 18, Jul 18, 2022 (GLOBE NEWSWIRE via COMTEX) -- EQNX::TICKER_START (NASDAQ:RXDX), EQNX::TICKER_END - Global Phase 2 placebo-controlled trial enrolled twice as fast as the industry average, establishing [...]

2022 DEC 19 (NewsRx) -- By a News Reporter-Staff News Editor at Clinical Trials Week -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as 'Lynk Pharmaceuticals'), an innovative clinical stage [...]

CONCORD, Mass., April 13, 2022 /PRNewswire/ -- Adiso Therapeutics, Inc., a clinical-stage biotechnology company developing novel medicines targeting chronic inflammatory diseases, today announced that it has completed enrollment of its [...]

The VEGA Phase 2a proof-of-concept study shows 83.1 percent of patients who received combination therapy achieved the primary endpoint of clinical response and 36.6 percent of patients achieved clinical remission [...]

The VEGA Phase 2a proof-of-concept study shows 83.1 percent of patients who received combination therapy achieved the primary endpoint of clinical response and 36.6 percent of patients achieved clinical remission [...]

GHENT, Belgium: MRM Health, a clinical-stage biopharmaceutical company developing next-generation live microbiome consortia therapeutics, announced that the first patient received MH002 in a phase 1b/2a multi-center clinical trial in mild-to-moderate [...]

Bristol Myers Squibb announced on 23 Nov 2021 the European Commission has granted a Marketing Authorization for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Zeposia, an oral medication taken once daily, is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). Zeposia is the first and only oral S1P receptor modulator approved for UC, and represents a new way of treating this chronic immune-mediated disease. The approval was based on data from True North, a pivotal Phase 3 trial evaluating Zeposia as an induction and maintenance therapy versus placebo in adult patients with moderately to severely active UC. Key findings from the trial include: During induction at Week 10 (Zeposia N=429 versus placebo N=216) the trial met its primary endpoint of clinical remissiona as well as key secondary endpoints, including clinical responseb, endoscopic improvementc and endoscopic-histologic mucosal improvementd for Zeposia versus placebo, respectively. During maintenance at Week 52 (Zeposia N=230 versus placebo N=227) the trial met its primary endpoint of clinical remissiona as well as key secondary endpoints, including clinical response, endoscopic improvement, corticosteroid-free clinical remissione and endoscopic-histologic mucosal improvement for Zeposiaversus placebo, respectively. Decreases in rectal bleeding and stool frequency subscores were observed as early as Week 2 (ie, 1 week after completing the required 7-day dosage titration) in patients treated with Zeposia. In the induction and maintenance phases of the True North trial, the overall safety profile was consistent with the known safety profile for Zeposia and patients with moderate to severe UC. Zeposia is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, as listed in the Summary of Product Characteristics (SmPC); immunodeficient state; patients who in the last six months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization or New York Heart Association (NYHA) Class III/IV heart failure; patients with history or presence of second-degree atrioventricular (AV) block Type II or third-degree AV block or sick sinus syndrome unless the patient has a functioning pacemaker; severe active infections, active chronic infections such as hepatitis and tuberculosis; active malignancies; severe hepatic impairment (Child-Pugh class C); and during pregnancy and in women of childbearing potential not using effective contraception. The most commonly reported adverse reactions (greater than 5%) in controlled periods of the adult multiple sclerosis (MS) and UC clinical studies are nasopharyngitis, alanine aminotransferase (ALT) increased, and gamma-glutamyl transferase (GGT) increased. The most common adverse reactions leading to discontinuation were related to liver enzyme elevations (1.1%) in the MS clinical studies. Liver enzyme elevations leading to discontinuation occurred in 0.4% of patients, in UC controlled clinical studies. The overall safety profile was similar for patients with MS and UC. Original source: Bristol-Myers Squibb, website: http://www.bms.com/, Copyright Bristol-Myers Squibb 2021., regulations and rulings; research and development; antiulcerials; ozanimod; Zeposia; Bristol Myers [...]

STOCKHOLM, Aug. 24, 2021 /PRNewswire/ -- InDex Pharmaceuticals Holding AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has given clearance to start the phase III clinical [...]

STOCKHOLM: Index Pharmaceuticals has issued the following news release: InDex Pharmaceuticals Holding AB (publ) today announced that the Swedish Medical Products Agency (MPA) has given approval to start the phase [...]

STOCKHOLM, July 21, 2021 /PRNewswire/ --InDex Pharmaceuticals Holding AB (publ) today announced that the Swedish Medical Products Agency (MPA) has given approval to start the phase III clinical study CONCLUDE [...]

Ustekinumab (Stelara) is a blockbuster drug for the treatment of Crohn disease, ulcerative colitis, and psoriatic arthritis that brought in $5.24 billion in revenues for Janssen Pharmaceuticals in 2020, up [...]

The new data were presented at the International Human Microbiome Consortium Congress 2021 Results further support the benign safety profile of VE202 and identify an optimal dosing regimen Vedanta plans [...]

STOCKHOLM: Index Pharmaceuticals has issued the following news release: InDex Pharmaceuticals Holding AB (publ) today announced that the company has entered an agreement for services with global clinical research organization [...]

STOCKHOLM, March 30, 2021 /PRNewswire/ --InDex Pharmaceuticals Holding AB (publ) today announced that the company has entered an agreement for services with global clinical research organization (CRO) Parexel Biotech for [...]

- PRA023 is a TL1A antibody targeting both inflammation and fibrosis in patients with ulcerative colitis and Crohn's disease - - PRA023 is being developed to be used in combination [...]

2021 DEC 6 (NewsRx) -- By a News Reporter-Staff News Editor at Clinical Trials Week -- InDex Pharmaceuticals Holding AB (publ) announced that the first patient has been enrolled in [...]

- PRA023 is a TL1A antibody targeting both inflammation and fibrosis in patients with ulcerative colitis and Crohn's disease - - PRA023 is being developed to be used in combination [...]

(GlobeNewswire) - Kaleido Biosciences, Inc. (Nasdaq: KLDO) today announced that the first patient has been dosed in its clinical study evaluating Microbiome Metabolic Therapy (MMT) candidate KB295 in patients with [...]

LEXINGTON, Mass., Sep 29, 2020 (GLOBE NEWSWIRE via COMTEX) -- Kaleido Biosciences, Inc. (Nasdaq: KLDO) today announced that the first patient has been dosed in its clinical study evaluating Microbiome [...]

Roche has reported mixed top-line data from the Phase III clinical study programme of etrolizumab in patients with moderately to severely active ulcerative colitis. Across two studies, the drug as [...]

Bristol Myers Squibb Company (NYSE:BMY) today announced results from True North, a pivotal Phase 3 trial evaluating oral Zeposia (ozanimod) as an induction and maintenance therapy for adult patients with [...]

PRINCETON: Bristol Myers Squibb has issued the following press release: Bristol Myers Squibb (NYSE:BMY) today announced results from True North, a pivotal Phase 3 trial evaluating oral Zeposia (ozanimod) as [...]

Study met primary endpoints of clinical remission in induction at Week 10 and in maintenance at Week 52 Zeposia is the first oral sphingosine-1-phosphate (S1P) receptor modulator to demonstrate benefit [...]

2021 AUG 2 (NewsRx) -- By a News Reporter-Staff News Editor at Clinical Trials Week -- InDex Pharmaceuticals Holding AB (publ) announced that the Swedish Medical Products Agency (MPA) has [...]

-- PN-943 is safe and well tolerated with gut-restricted exposure; Phase 2 ulcerative colitis study initiation planned for early 2020 -- -- Pharmacodynamic data for PN-943 in healthy volunteers confirm [...]

Study Met All Primary and Secondary Endpoints PL-8177 is a Melanocortin Receptor 1 Agonist CRANBURY, N.J., April 4, 2019 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company [...]

2020 FEB 3 (NewsRx) -- By a News Reporter-Staff News Editor at Clinical Trials Week -- Investigators publish new report on Digestive System Diseases and Conditions - Ulcerative Colitis. According [...]