Evidinno Outcomes Research Inc. ’s Post

In ONCO Life's featured interview of the principal investigator of GenFleet's KROCUS study, Dr. Rafael Rosell analyzed the favorable efficacy and safety of this first-line combination therapy. The phase II trial data of KROCUS Study, fulzerasib (KRAS G12C inhibitor) in combination with cetuximab (EGFR inhibitor), was orally presented at ASCO annual meeting in June. "Notably, in our study, about 32.5% of patients had brain metastases at the start of the treatment, which is particularly challenging as brain metastases usually correlate with poor survival and quality of life. Impressively, 70% of these patients showed a response without the need for brain irradiation. The ability to combine these new KRAS inhibitors with established treatments can potentially prolong survival significantly. This was evidenced in the KROCUS study, where we observed promising response rates and anticipate longer durations of response with these combinations." Please view the full text from page 7 of the online magazine, at the link of https://lnkd.in/gu9tW4XW For more of GenFleet's information, please visit the official website at

The U.S. FDA has approved Ocrevus Zunovo™ (ocrelizumab & hyaluronidase-ocsq) for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Developed by Genentech, a Roche Group member, Ocrevus Zunovo is the first subcutaneous injection option for multiple sclerosis, administered twice a year by a healthcare professional. This new method takes only 10 minutes. 💉 The approval is backed by data from the Phase III OCARINA II trial, which confirmed that subcutaneous Ocrevus Zunovo delivers safety and efficacy results similar to the traditional intravenous (IV) formulation. The study revealed 97% suppression of relapse activity and MRI lesions over 48 weeks. Additionally, over 92% of participants reported being satisfied with the new SC injection. 🚨 While Ocrevus Zunovo's safety profile is similar to the IV version, injection reactions were reported by 49% of patients after the first injection. These reactions were mild to moderate and did not lead to discontinuation. 🔬 Ocrevus Zunovo offers greater flexibility for both patients and healthcare providers, reducing treatment time while maintaining the proven benefits of Ocrevus. Genentech continues its dedication to developing innovative treatment options to further reduce the progression of multiple sclerosis, with many ongoing clinical trials designed to improve patient experiences and outcomes. #FDAApproval #MultipleSclerosis #OcrevusZunovo #RMS #PPMS #Genentech #Roche #Biopharma #HealthcareInnovation #MSAwareness #PatientCare #MedicalAdvancements #ClinicalTrials

Novo Nordisk’s semaglutide has achieved positive outcomes in a Phase 3 trial for metabolic dysfunction-associated steatohepatitis (previously known as nonalcoholic steatohepatitis).   The Essence trial demonstrated significant improvements in liver fibrosis and resolution of steatohepatitis, successfully meeting primary endpoints. With this breakthrough, Novo Nordisk aims to file for regulatory approval in the U.S. and Europe by 2025.   These promising results highlight the expanding role of GLP-1 therapies in many indications, including this complex field, which has limited treatment options.   Read more here: https://lnkd.in/ed5bvzDk   Find the clinical evidence for semaglutide on DRUGDOCS®: https://lnkd.in/gjy4C8QW   #MASH #NAFLD #GLP1 #LiverDisease

Zai Lab (NASDAQ: ZLAB, SEHK: 9688)'s partner, argenx, has received FDA approval for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo is the first and only neonatal Fc receptor (FcRn) blocker approved for CIDP, offering a once-weekly subcutaneous injection that takes 30 to 90 seconds. This approval is a significant milestone in providing effective and efficient treatment options for CIDP patients. The FDA's decision is backed by the robust data from the ADHERE Study, the largest clinical trial to date for CIDP. The results are impressive: · 69% of patients treated with VYVGART Hytrulo showed clinical improvement in mobility, function, and strength. · A remarkable 61% reduction in the risk of relapse compared to placebo. · 99% of trial participants elected to continue with the ADHERE open-label extension. The safety profile of VYVGART Hytrulo remains consistent with previous clinical studies and real-world use. #FDAApproval #VYVGART #CIDP #ClinicalResearch #HealthcareInnovation #Biotech #MedicalBreakthroughs #QimingPortfolio #QimingHealthcare

Join us in celebrating C. Ola Landgren, M.D., Ph.D., recipient of the Fierce 50 Breakthrough Honoree award for his groundbreaking work in advancing multiple myeloma treatment. Fierce 50 spotlights innovators and leaders driving the future of healthcare, pharma and biotech. Dr. Landgren’s journey began with an idea to improve diagnostic tools for detecting deeper remissions. Through over 15 years of rigorous research, collaboration and overcoming industry resistance, he proved the strong correlation between minimal residual disease (MRD) negativity and long-term progression-free survival (PFS). His efforts led to the FDA’s unanimous approval of MRD as a surrogate endpoint for accelerated drug approvals, a milestone that could reduce clinical trial timelines from a decade to just three years—enabling faster access to life-saving therapies for patients. This recognition honors Dr. Landgren’s unwavering commitment to improving patient outcomes. 🙌 Learn more: https://loom.ly/VcDfvvU. #OnlySylvester Fierce Pharma

💧 FDA grants breakthrough status to Roche’s Tina-quant Lp(a) test Developed in collaboration with Amgen, the Tina-quant Lp(a) test is designed to identify patients who could benefit from Lp(a)-lowering drugs that are presently in the development phase. The test measures Lp(a), a key marker for hereditary cardiovascular risk, in a person’s bloodstream. It is intended to be used for identifying patients with high levels of Lp(a) and a history of atherosclerotic disease. Amgen chief scientific officer and research and development executive vice president Jay Bradner said: “By combining Amgen’s deep legacy and expertise in cardiovascular disease with Roche’s diagnostic expertise, we can accelerate access to more standardised testing and equip more patients and healthcare providers with important information to better understand their risk for cardiovascular disease.” Read more online: https://lnkd.in/e6yJH4bm 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

Our new #BrainHealthTimeMatters is now available: https://lnkd.in/eDavWAg So many have made this work possible. Our thanks go to Alexion Pharma Germany GmbH and Merck Healthcare for sponsoring the launch of this report and helping bring this work to all; to Roche, MS Society and Horizon, now part of Amgen for their critical support towards the development of the report; to the panel of authors Helmut Butzkueven, Gavin Giovannoni, Sofia Arkelsten, Giancarlo Comi, Kathy Costello, Michael Devlin, Jelena Drulovic, Emma Gray, Jodi Haartsen, Anne Helme, Jana Hlaváčová, Elisabeth Kasilingam, Yaou Liu, Thomas Mathew, Saul Reyes, Jérôme de Sèze and Mitzi Joi Williams M.D., FAAN and to the many members of the Working Groups named in the report who brought expertise and evidence to shape and support the recommendations. We thank you and look forward the next steps - collaborating with you and further stakeholders to support the implementation of the recommendations. #BrainHealthTM #BrainHealth #MSTimeMatters, #NMOSDTimeMatters, #MOGADTimeMatters, #MSBH #OHPF, The Sumaira Foundation, Sumaira Ahmed, EMSP - European Multiple Sclerosis Platform, MS International Federation (MSIF), Can Do MS

It’s published 👏 a collaboration with over 60 experts across geography and disciplines. Delve in and see what it can mean for you and how you can support the implementation of recommendations for #MS, #NMOSD, #MOGAD and related disorders. MS Brain Health Oxford Health Policy Forum #MSBH #BrainHealthTM #NMOSDTimeMatters #MOGADTimeMatters

Out now: the updated 'MS Brain Health – time matters' report was launched at ECTRIMS yesterday! It highlights the importance of early diagnosis, timely treatment and holistic, person-centred care, along with the policy changes needed to improve long-term outcomes for those living with MS, NMOSD and MOGAD. #BrainHealthTM #BrainHealth #MSTimeMatters

Studies show that when it comes to liver disease treatment, Proton Density Fat Fraction is the best predictor of response. Livivos's proprietary non-invasive technology promises to deliver the accuracy of MRI PDFF in point-of-care settings. Follow our journey www.livivos.com Livivos, Inc #LiverScope #MASH #NASH #patientcentric #pointofcare #liverdisease #fattyliver #PDFF #NAFLD #rezdiffra #clinicaltrials #resmetirom Madrigal Pharmaceuticals Mazen Noureddin, MD, MHSc LiverScope is an investigational device. Limited by Federal (or United States) law to investigational use.