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🔷 This marks the first positive Phase III trial for the oral CELMoD Mezigdomide, with a safety profile consistent with prior studies.

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#ONCOnews #OncoAlert #OncEd #MultipleMyeloma #Hematology #Oncology #CancerResearch #ClinicalTrials #Phase3Trial

Bayer reveals data behind asundexian's stroke win Bayer's oral Factor XIa inhibitor asundexian can reduce the risk of a secondary ischaemic stroke by 26%, according to the OCEANIC-STROKE trial

#Bayer #asundexian #stroke #oralFactorXIainhibitor #FactorXIainhibitor #ischaemicstroke #OCEANICSTROKEstudy #antiplatelettherapy #InternationalStrokeConference #phase3trial #secondarystrokeprevention #anticlottingtherapies #OCEANICSTROKE #acutecoronarysyndromes #preventionofstroke
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🔷 The randomized study is designed to assess efficacy and safety versus placebo, with progression-free survival (PFS) as the primary endpoint.

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Data builds on Roche's dominance in primary progressive MS Roche looks on track to add oral BTK inhibitor fenebrutinib to treatment options for primary progressive multiple sclerosis.

#Roche #primaryprogressiveMS #MS #phase3trial #oralBTKinhibitor #fenebrutinib #primaryprogressivemultiplesclerosis #PPMS #Ocrevus #ocrelizumab #FENtrepidtrial #disabilityprogression #CD20targetingantibody #FENhance1trial #FENhance2trial #clinicalbenefit #diseasemodifyingtherapy
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Ultra-rapid insulin shows promise in phase 3 trial for type 1 diabetes - PharmaTimes BioChaperone Lispro demonstrates improved post-meal glucose control compared to Humalog

#Ultrarapidinsulin #phase3trial #type1diabetes #BioChaperoneLispro #THDB0206injection #postmealglucosecontrol #TonghuaDongbao #phase3clinicaltrial #ultrarapidinsulinformulation #HbA1creduction #bloodglucose #selfmonitoringbloodglucose #SMBG #diabetes #obesity
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Xeltis prepares for commercial launch after strong aXess trial results - PharmaTimes EU phase 3 data shows major gains in dialysis access performance

#nephrology #Xeltis #aXesstrialresults #aXessclinicaltrial #phase3trial #restorativevascularaccess #vascularaccess #haemodialyisis #primaryendpoint #endstagerenaldisease #haemodiaylisisvascularaccesstreatment #EndogenousTissueRestorationplatform #vascularaccess #dialysispatients
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Bluejay begins phase 3 trial of brelovitug for hepatitis D - PharmaTimes First patient enrolled in AZURE-2 study comparing brelovitug to Hepcludex

#Bluejay #BluejayTherapeutics #phase3trial #brelovitug #BJT778 #hepatitisD #AZURE2study #CHD #hepatitisDvirus #cirrhosis #livercancer #viralhepatitis #liverdisease #BreakthroughTherapydesignation #FDA #PRIMEdesignation #Orphanstatus #OrphanDrug #EMA
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Novartis shares slightly up after Ianalumab meets goals in Phase 3 trial Investing.com -- Novartis (NYSE:NVS) (SIX:NOVN) said its experimental antibody ianalumab, used in combination with eltrombopag, achieved the main goal in a phase 3 (VAYHIT2) study for patients with primary immune thrombocytopenia (ITP). The treatment significantly extended the time to treatment failure, measuring how long patients maintained safe platelet levels during and after therapy. Novartis shares climbed 0.5% in European trading. The Swiss drugmaker said the late-stage trial involved ITP patients who had previously received corticosteroids, and showed that ianalumab also prolonged the duration of safe platelet counts beyond the treatment period. ITP is a rare autoimmune condition in which the immune system destroys platelets, the blood cells needed for clotting. A key secondary endpoint was also met, with patients showing a notably higher rate of sustained platelet count improvements, according to Novartis. The company plans to present the results at an upcoming medical conference and include the data in regulatory submissions targeted for 2027. “While current treatments for ITP are generally effective in raising platelet counts, many patients require life-long treatment to maintain safe levels, which can create a lasting treatment burden,” said Adam Cuker, Professor of Medicine and Chief, Section of Hematology, University of Pennsylvania. “The results from VAYHIT2 are encouraging, as they suggest that ianalumab may support longer periods of disease control and reduce the need for continuous treatment.” Ianalumab is being studied as a potential therapy for multiple autoimmune diseases. On Monday, Novartis reported that the drug also met primary endpoints in two phase 3 trials in Sjoegren’s disease. The drug has been granted fast track status by the U.S. Food and Drug Administration, and Novartis said it will seek approval from regulators worldwide. If cleared, ianalumab could become the first targeted therapy for patients with Sjoegren’s disease. "Overall, we believe that the detailed data is needed to fully assess the strength of the efficacy benefit seen,” said Jefferies analysts in a note. Don't miss out on the next big opportunity! Stay ahead of the curve with ProPicks AI – 6 model portfolios fueled by AI stock picks with a stellar performance this year... In 2024 alone, ProPicks AI identified 2 stocks that surged over 150%, 4 additional stocks that leaped over 30%, and 3 more that climbed over 25%. That's an impressive track record. With portfolios tailored for Dow stocks, S&P stocks, Tech Stocks, and Mid Cap stocks, you can explore various wealth-building strategies. So if NOVN is on your watchlist, it could be very wise to know whether or not it made the ProPicks AI lists.

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Old COVID tweet lands Pfizer in new trouble with PMCPA Pfizer has been found to be in breach of the UK pharma industry's code of practice with posts on Twitter (now X), dating back to 2020

#pharmaindustry #socialmedia #pharmaceuticalindustry #Pfizer #PMCPA #COVID19vaccine #PrescriptionMedicinesCodeofPracticeAuthority #noncompliantpromotion #phase3trial #AssociationoftheBritishPharmaceuticalIndustry #ABPI #ABPIcode #socialmediaguidance #BioNTech
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Opthea raises solvency concerns after phase 3 trial fails Investing.com--U.S. and Australia-listed biopharmaceutical firm Opthea Ltd (NASDAQ:OPT) on Monday raised concerns over its ability to continue operations after a major phase 3 trial did not meet its primary endpoint. The biopharmaceutical firm said in a press release that its COAST Phase 3 trial to treat wet age-related macular degeneration, a serious eye condition, failed to meet its primary endpoint. The COAST trial is one of the biopharma firm’s two simultaneous phase 3 trials to develop treatments in the macular degeneration market. Both trials are tied to Opthea’s Development Funding Agreement, under which it received hundreds of millions of dollars in investment. Opthea said it in light of its phase 3 trial, it may be obligated to repay its DFA investors, and could be obligated to pay up to “four multiples” of the amounts invested into the company. Amounts could reach as high as $680 million, The company said its board and management were in active discussions with DFA investors, and that the company was unable to secure any additional non-equity funding or dispose of its assets without consent from its DFA investors. The company flagged a “material uncertainty” over its ability to continue as a going concern. It said it had an unaudited cash and cash equivalent balance of $113.8 million as of February 28. Opthea’s shares were on trading halt since March 14 and until at least March 31, or when the company can provide an update on its operations. The company has a market capital of about $738.8 million.

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Tris Pharma announces positive results from ALLEVIATE-1 trial of cebranopadol - PharmaTimes Phase 3 trial shows promising pain relief for acute pain patients

#painmanagement #healthcare #pain #TrisPharma #ALLEVIATE1clinicaltrial #cebranopadol #Phase3trial #painrelief #acutepain #abdominoplasty #primaryendpoint #reducingpainintensity #Painintensity #NRSscale #analgesia #opioids #painmanagement #NDAsubmission
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