Agathe Le Lay

European regulatory authority adopts a positive opinion for an update of the Wegovy® label to reflect risk reduction of major adverse cardiovascular events Bagsværd, Denmark, 25 July 2024 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Wegovy® (semaglutide 2.4 mg) label to reflect data from the SELECT cardiovascular outcomes trial, demonstrating a risk reduction of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with established cardiovascular disease (CVD) and either overweight or obesity (initial BMI ≥27 kg/m2) without diabetes.

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Lundbeck today announced the advancement of the clinical development of amlenetug (Lu AF82422) for the treatment of MSA with the initiation of MASCOT, a randomized, double-blind, phase III trial. The trial builds on the encouraging results of the AMULET phase II trial showing consistent trend towards amlenetug slowing clinical progression in MSA patients despite the primary endpoint not meeting statistical significance and follows discussions with health authorities. “This is an important step forward in our commitment to addressing the unmet needs of patients with Multiple System Atrophy. We are hopeful about the potential of amlenetug to slow the clinical progression of this devastating disease and look forward to advancing its development through the MASCOT trial,” said Johan Luthman, EVP and Head of Research & Development at Lundbeck. Amlenetug is an investigational human monoclonal antibody (mAb) that recognizes and binds to all major forms of extracellular α-synuclein, thereby believed to prevent uptake and inhibit seeding of aggregation. Amlenetug may offer a potential treatment option that slows clinical progression for people with MSA. #clinicaltrials #MultipleSystemAtrophy #MSA #amlenetug #Lundbeck

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Novo Nordisk ready for PHUSE EU Connect 2024 - come and meet us ! 🙂 During the days we will be represented by a group of Clinical Data Scientists, Statisticians, Standard developers, and Specialists – all part of the Novo Nordisk Data Science organisation. 👍 In Novo Nordisk we believe that sharing knowledge and learnings, across the industry, expands everyone's capabilities for the benefit of the patients. This is one of the driving forces in our engagements striving for scientific excellence. To showcase this, we have the following contributions during this conference;  "Building CORE Strength: An Implementation Exercise" Stine Bertelsen, Addie Olsen in stream Poster Presentations (PP)  "Working with Omics Data – A Statistical Programmer’s Perspective" Adrian Czaban in stream Trends & Technology (TT)  "Status and News in OpenStudyBuilder" Martin Gram, Mikkel Traun in stream Poster Presentations (PP)  "Transcriptomics – A Demanding Data Analysis that Expands the Limits of Regulated Clinical Data Handling" Lea Hildebrandt in stream Data Handling & Data Engineering (DH)  "Mapping a Veeva SDS Specification to ODM-XML" Jørgen Iversen in stream Standards Implementation (SI)  "Optimising Workflow and Collaboration in a Pooled Coding Environment for Clinical Development" Louise Nørgaard in stream Scripts, Macros & Automation (SM)  "{r}amnog: Towards a Common, Open-Source Solution for Programming AMNOG-Style EU-HTA Analyses" Christian Olsen, Matthew Phelps in stream Open Source Technologies (OS)  "Why Are Old Wines Sometimes Tastier Than New Ones?" Henning Pontoppidan Föh in stream Trends & Technology (TT)  "How R Pharma? An Overview of How Our Industry Is Adopting the R Programming Language" Ari Siggaard Knoph in stream Open Source Technologies (OS)  "Digital Data Flow: Achieving Protocol Digitalisation and Clinical Research Interoperability Through Multi-Stakeholder Collaboration" Mikkel Traun in stream Data Standards & Governance (DS)  "Open Source and Regulatory Deliverables – Learnings from a Submission" Kristian Trøjelsgaard, Steffen Falgreen Larsen in a hands on workshop  "Leveraging the USDM Standard in OpenStudyBuilder for Enhanced Data Exchange" Nicolas DE SAINT JORRE in stream Data Handling & Data Engineering (DH)  "Hi. I Am a Chatbot. How Can I Help You? Enhancing the Reliability and Traceability of Large Language Models" Vicky Poulsen and Anja Vrecer in stream Machine Learning, AI and Large Language Models (ML) We have Lykke Pedersen taking on the role as streamchair in Data Handling & Data Engineering (DH) stream, and Henning Pontoppidan Föh taking on the role as streamchair in Analytical Risk-based Monitoring (AR) stream. If you are wondering what Novo Nordisk Data Science is all about please feel free to stop by at our booth in the exhibition area – you can find us in booth no 34.

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The demand for innovation in cancer care has never been greater, especially with an anticipated doubling of cancer cases in Sweden over the next 15 years. At BMS, we firmly believe that innovation should be diverse, inclusive and impactful throughout the patient journey. By bringing treatment closer to patients, hospitals can prioritize emergency care and research, benefiting patients, caregivers, healthcare professionals, and society at large. In the video below, I share some perspectives on the need to collaborate with many actors in the healthcare ecosystem and develop new solutions that benefit all Swedish patients. #BMSEmployee #gränbyprojektet #tillgängligcancervård #akademiskasjukhuset

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Yesterday I led several discussions on #PrecisionOncology at Nordic Precision Medicine Forum @MarinaTower Stockholm, Sweden. Precision oncology enables tailored prevention, diagnosis, treatment and follow-up based on the individual patient's uniqueness which includes the genetic profile, increased knowledge about the protein and specific patterns of biomarkers. These signatures allow them to divide cancer categories into far more precise types and subtypes. Individualized Treatment will be possible thanks to precision oncology. When doctors tailor treatments based sometimes on the DNA signature of an individual patient’s tumour, by analysing both tumour and blood samples, they can make informed decisions about the most effective therapies. As treatments become more effective, or precise, both for the patient and from a socio-economical point of view, it can reduce unnecessary suffering for patients with improved outcome. Traditionally, cancers have been classified based on the type of tissue or body part where they originate (like lung, brain, breast, or colon). However, now radical shift is underway. Eminent participants were: Henrik Gronberg, Professor, Senior physician, Cancer Researcher of the Year, the Swedish Cancer Society, 2022, Karolinska Institutet held a lecture on "ProBio, An outcome-adaptive and randomized multi-arm biomarkerdriven study with metastatic prostate cancer" Helena Ullgren, Specialist Nurse Oncology and palliative care, Karolinska Institut presented on "Cancer nursing in the era of precision medicine. Margareta Haag, Chairperson, Network Against Cancer & Nasim Bergman Farrokhnia, Senior Industry Advisor, Healthcare Executive, Global Healthcare and Life Science Team, Microsoft focused on "How to measure what we want to know and know what we want to measure from a patient's perspective". We finalized the morning discussing how we can achieve a more #patientcentric precision oncology in Sweden and the Nordics. I was representing #AllCan Sweden together with Margareta and Nasim. Important to understand how various actors are shaping the new landscape of Health care‼️ Thankful for my eminent participants and the excellent job they are all doing to pave way to better health and modernizing health care. Last but not least, saving lives ❤️ #BMSSweden #Cancer #precisiononcology #precisionmedicine #patient #research #innovation

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The results from this very recent Nordic survey (n=4000) on the knowledge and attitudes towards HIV/AIDS in the era of undetectable = untransmissible was presented last week at the Nordic HIV & Virology Conference in Stockholm. This poster won the Poster Award. The reason is because it shows that ... 51% claim being informed about HIV/AIDS and 71% agree HIV is a manageable chronic disease, still 40% believe transmission is possible under ART, 22% and 9% respectively still believe it is transmissible by kissing or sharing itmes such as plates or glasses! KNOWLEDGE and breaking entrenched (false) believes are probably the most important factors in eleviating stigmas...and it seems we still have some way to go. These data can help get the facts right and help improve awareness, education, and policies. #GileadNordics #MyCompany Janniche Hammer Susanne von Stockenström Juha Vuorte Ellen Moseholm Larsen Aurelie Miglar, Ph.D. Philippa Collins

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Looking forward to attend and share our learnings on building a Clinical Data Platform powered by AI at the Data 2030 Summit, thanks for the invitation Saranda Arifi. #data #ai #genai #FounData #NovoNordisk #DataScience

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Partnerships underpin our work to broaden patient access to medicines regardless of location and socio-economic factors. Joining forces means we can multiply competencies and capabilities to transform health systems in ways no single player could, thus accelerating our ability to meaningfully improve and extend people’s lives. As such, we partner with unwavering commitment, engaging for the long haul, and working alongside partners/communities to contribute complementary expertise and integrated solutions that address some of the world's most pressing global health challenges. Watch the video to hear my reflections on how we can forge robust #partnerships. #Health #Sustainability

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What is the difference between Ozempic and Wegovy? FDA Approved Labeled Indications: Semaglutide (Ozempic): 🟡 As an adjunct to diet and exercise to improve glucose control in adults with type 2 diabetes mellitus 🟡 Risk reduction of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction [MI], nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. Semaglutide (Wegovy): 🟢 As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥30 kg/m2 (obesity), or ≥27 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, dyslipidemia) 🟢 As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in pediatric patients ≥12 years of age with an initial BMI at the ≥95th percentile standardized for age and sex (obesity). 🟢 Risk reduction of major adverse cardiovascular events (cardiovascular death, nonfatal MI, nonfatal stroke) in adults with established cardiovascular disease and either obesity or overweight. Dr. Suzan Gharaibeh

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Nordic collaboration on pharmaceutical market access was recently reaffirmed in a series of meetings in Stockholm. The Working Group on Exchange of Information and Experience in the Medicines Area (WGEMA) and the Nordic Pharmaceutical Forum (NPF) met—together and separately—over three days in the Swedish capital.   WGEMA has attracted less attention than other cross-border collaborations in the region, such as the NPF and the Joint Nordic HTA Bodies (JNHB [formerly FINOSE]). Established by the Nordic Council of Ministers in 2017, WGEMA has been described as more strategic in its focus, whereas the NPF is more operational.   #WGEMA held its own annual meeting on 23rd September 2024. The agenda featured coverage of managed entry agreements, price comparison and health economics—including how the management of uncertainty in HTA decision making is evolving.   The following day, WGEMA convened with the NPF. The morning was devoted to discussions on preparedness for the growing challenge Alzheimer's disease will present to healthcare systems. A guest speaker shared the experience of the Wiener Gesundheitsverbund in Austria on working with different stakeholders in anticipation of the launch of new treatments. The afternoon programme included presentations on readiness for EU joint HTA, developing incentives for the use of generics and biosimilars, and how increased Nordic regulatory flexibility could boost access to new medicines and facilitate joint tendering.   On 25th September, the NPF held its own meeting. Among its achievements to date, the #collaboration lists the creation of a common framework for joint price negotiations for new medicines and the development of common environmental criteria for medicines that have been applied in joint tenders.   The programme on this occasion included presentations on cooperation between the regulatory agencies in the region, the #Nordic Council of Ministers’ health programme, the European Commission’s work on shortages and affordability of medicines, and proposals on how the Nordic countries can improve access to antibiotics. Future priorities for the NPF will include security of supply, joint procurement and price negotiations, horizon scanning, manufacturing, and environmental issues.   In a statement after the event, the NPF reflected that “the world around us is changing rapidly, and the medicines sector is becoming increasingly complex. Challenges in the sector are often common across national borders, and especially small countries with small markets such as the Nordics struggle to tackle these challenges alone. Therefore, we have a lot to gain by finding solutions together.”   The #NPF is “delighted that almost 10 years in, we’re still going strong, and working to develop our cooperation even further. We strongly believe that it makes sense for the Nordic countries to continue to move closer together on our way to becoming perhaps the most integrated pharmaceuticals region in Europe.”

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🔬 Latest pharma industry updates 👇 🤝 Lundbeck acquired Longboard Pharmaceuticals for $2.6B, gaining treatments for rare brain disorders that could become blockbuster products. 💰 Forbion raises over €2B across two funds, exceeding targets. 💔 Sage Therapeutics to lay off one-third of workforce after clinical setbacks; 5 senior executives depart. 💰 Inventiva secures €94.1M funding to complete Phase 3 MASH trial for lanifibranor; shares rise 41% amid potential €348M equity deal. 💰 Sanofi invests €300M in joint venture with Orano Med to develop lead isotope cancer therapies, expanding radiopharma. 🟢 AbbVie secures FDA approval for Parkinson's drug Vyalev after previous rejections. 🚫 FDA halts Novavax's flu and COVID-19 vaccine trials after serious adverse event; company investigating cause. 💉 Mpox vaccination begins in DRC and Rwanda amid rising cases; millions more doses expected by year-end. 💷 Eli Lilly and Company invests £279M in UK to launch Lilly Gateway Labs, supporting biotech startups and obesity prevention strategies. 🏭 Eli Lilly and Company also invests €200M in China to boost tirzepatide production for diabetes and obesity treatments amid growing demand. 💊 Novartis licenses cancer drug from Chengdu Baiyu Pharmaceutical for $70M upfront, up to $1.1B in milestones; expands pipeline. ❌ Molecular Templates announces liquidation and wind-up; shares plummet 73% following board approval. 🟢 FDA approves Novocure's Optune Lua for metastatic lung cancer, extending survival; first major advancement in over 8 years. 😮 Bright Minds Biosciences' stock surges inexplicably over 1,400% at first and then reports new investments, positive preclinical pain data and new collaborations. 📊 Johnson & Johnson raises annual revenue forecast, driven by strong cancer drug sales, notably subcutaneous Darzalex. 🧐 Over half of U.S. medical journal editors receive industry payments, according to a JAMA study. ⚖️ GSK sues Moderna over alleged infringement of mRNA lipid nanoparticle patents in COVID-19 vaccine; seeks royalties. 🟢 Valneva and LimmaTech Biologics AG's Shigella vaccine granted FDA Fast Track status; Phase II trials to start soon. 📊 Merck KGaA, Darmstadt, Germany lowers pharma growth forecast due to recent clinical failures in oncology and multiple sclerosis. ❌ EMA maintains decision not to renew PTC Therapeutics, Inc. Translarna's approval for Duchenne muscular dystrophy due to insufficient evidence. 🔄 INVO Bioscience merges with NAYA Biosciences, rebrands as NAYA, expanding from fertility into oncology and autoimmune treatments 💊 Indian pharma ready to supply generic weight-loss drugs like liraglutide to UK. 🔐 UnitedHealth Group lowers profit outlook due to $2.5B cyberattack costs impacting earnings.

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💡 New cancer strategy in Sweden and areas the government must prioritize to ensure good cancer care in the future. MSD debated this topic together with Karin Liljelund, Vice Chairman of the Lung Cancer Association, and Eva Backman, Chairman of the Cancer Association PALEMA. In the autumn of 2023, we conducted a series of round-table discussions together with political representatives from both regional and national levels, patient organizations, and healthcare professionals. It became clear that all parties in the Swedish healthcare system are calling for a greater focus on early detection and diagnosis, increased collaborations, and transparency in decision-making processes as well as increased patient influence. This would greatly benefit both the healthcare system and the individual patient. The updated cancer strategy is to be presented by the 30th of November at the latest, and we look forward to being part of the dialogue to create a new world-class cancer strategy. You can read the article here https://lnkd.in/dmtPqVZ5

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CTAD 2024, Clinical Trials in Alzheimer’s Disease, has started. - We have so much to do in the fields of Alzheimer’s, so if we have seen tremendous development in the last five years with for example improved diagnostics and anti-body treatments. This development has fueled the investments in the field, but the investment are still way to low, which is a shame, and bad health economically in a time where the societal cost for Alzheimer's are over one trillion US$, and are expected to triple in the coming thirty years. We at AlzeCure are proud to be here and present new data at the congress on our program NeuroRestore ACD856 which is presented by Cristina Parrado. Stay tuned on the data. #alzecure #ctad2024 #alzheimers #dementia #neurorestore

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Behandlingsrådet, The Danish Health Technology Council, evaluates new (or already widely used) health technology to assess the added value ✔️ The assessment includes: 🔵 clinical effectiveness and safety 🔵 patient perspective 🔵 organizational implications 🔵 health economics At ZEMA Pharma Consulting we are currently working together with a Health Economy Agency to introduce a new diagnostic technique into the market. ZEMA Pharma Consulting can help you with the strategic use of your data to obtain the best outcome 🚀 Book a free meeting with me today and hear what our experience is and how we can help your company: https://lnkd.in/dmqBfABS #ZEMAPharmaConsulting #HealthTechnology #ClinicalData

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Boston Programming Summit 2024 On the 12th of September Vertex Pharmaceutical and Novo Nordisk successfully hosted the "Boston Area Statistical Programming Summit 2024". This year’s summit was an event developed in a collaboration between Vertex Pharmaceuticals and Novo Nordisk with the scope of building a platform for cross company knowledge sharing, and thus establishing a knowledge sharing network, in the greater Boston area. We had 2 exciting high-level topics on the agenda - Automation and AI - with topics covered by an initial short presentation followed by a round table discussion among the participating companies. Novo Nordisk shared some of the learnings from establishing, governing and prioritization in the Data Science Automation Group (Alasdair Thomson as presenter), and there was a great discussion on this from the participating companies. Following this Vertex Pharmaceuticals presented some of their learnings with various automation initiatives (Rohit Dhanjal as presenter), and this presentation again spun of several great discussions and learnings for everyone attending. The AI topic was covered as a panel debate with 4 panelists representing different companies and perspectives: Vertex Pharmaceuticals with Todd Case as panelist representing medium sized pharma, Roche Genentech with Ning Leng as panelist representing a very technology progressed pharma company, Posit with Phil Bowsher as panelist representing a technology provider, and last but not least, Novo Nordisk with Kim Pedersen as panelist representing big pharma. From the discussions and perspectives given during the session it was evident that differences exist, but also that the new technology bring new opportunities along for everyone to benefit. However, with the new opportunities comes also concerns about the reliability of AI generated outputs, and the need for expert validation of output - at least until some experience base and trust have been established with the new technology. The event was designed as a ½-day event with the option of participating both virtually, and meeting face to face in the Novo Nordisk facilities in Lexington. Invitations was sent to contacts across 40 companies in the greater Boston area, and with 45 key roles / 21 companies attending it seems fair to say that there is a big interest in collaborating and sharing experiences and learnings. From this year’s organizing committee, we hope (and expect) that this will be the starting point for a yearly recurring "Boston Area Statistical Programming Summit" facilitating a closer collaboration and knowledge sharing across all the companies located in the greater Boston area. We can learn so much from each other but all journeys start with the first step ! A huge thank you to everyone that attended the summit and hope to see you engaging again next year! #collaboration #knowledgeshare #DataScience #NovoNordisk #Vertex

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Access trends for new medicines in Sweden are examined in the latest annual report by Quantify Research for Lif, the Swedish pharma association (tinyurl.com/bdfmeknk).   The study focused on 141 medicines approved by EMA from 2020 through 2022. Of these, 92 (65%) were listed as supplied in FASS, a database of drugs available in Sweden. Sixty-seven medicines—48% of the drugs approved by EMA and 73% of those available in Sweden—were nationally reimbursed. Some drugs that are on the market in Sweden but not nationally reimbursed may be covered regionally or available for patient purchase.   The mean time from EMA approval to listing in FASS was 33 days (median 16 days). The mean time from listing in FASS to national reimbursement was 269 days (median 214 days). However, mean times from FASS listing to national reimbursement were longer for orphan drugs (305 days), cancer therapies (337 days) and ATMPs (609 days).   Fifty-eight per cent of nationally reimbursed medicines were subject to subsidy restrictions—reimbursement only for certain sub-populations or for prescriptions written by specified physician specialties. Furthermore, 35% of nationally reimbursed drugs were subject to pricing agreements with the regions.   The 74 non-reimbursed medicines belonged to 56 companies: 32% lacked a Nordic presence and 45% had no medicines in the pharmaceutical benefits scheme. The authors suggest that “the large proportion of medicines from MAHs lacking Nordic presence might indicate that the system is perceived as complex, or that other sufficient treatment alternatives are already available.”   Forty-nine drugs (35% of those approved by EMA) were not yet available in Sweden. Twenty of these products were from companies that lacked a Nordic presence.   Of the 74 drugs not (yet) nationally reimbursed in Sweden, 25 (34%) have ongoing applications or a pending reimbursement decision, are planning to launch or are considering a launch in #Sweden (see accompanying figure). Thus, many of these products could be reimbursed in the future.   Conversely, 23 medicines have had negative decisions or recommendations, have had their applications withdrawn or are not expected to launch in Sweden. Most of these products are unlikely to be reimbursed.   The study also provides data on the use of tripartite negotiations involving the TLV, the manufacturer and the regions. This provision was introduced in 2014 to address situations such as questions regarding the use of a drug, its usefulness or uncertainty in relation to the patient population. There may be discussions related to price, subsidy restrictions or follow-up requirements. The manufacturer and the regions may negotiate a side agreement that allows the TLV to approve the company’s submission. Since the inception of the scheme, 78 negotiations have been conducted, of which 60 (77%) resulted in agreements. In the last four years, however, only 23 negotiations have been conducted, leading to 16 agreements. #marketaccess

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Lundbeck announced that Vyepti® (eptinezumab) met the primary and all key secondary endpoints in SUNRISE, a phase III pivotal clinical trial predominantly conducted in Asia evaluating the efficacy and safety in patients with chronic migraine. Based on the trial results Lundbeck plans to initiate discussions with relevant regulatory authorities with the aim of making Vyepti available for people suffering from migraine across Asia. “Millions of people in Asia suffer from frequent and severe migraine, yet very few utilize preventive therapy due to limitations in efficacy, safety and tolerability in currently available therapies,” said Johan Luthman, EVP and Head of R&D at Lundbeck. “I am very pleased with the outcome of the SUNRISE trial as patients in Asia also deserve more from their treatments, and these data show that Vyepti could be an important advancement in meeting the significant unmet need for patients to regain control of their lives. The results of the SUNRISE trial will be pivotal for our efforts to make Vyepti available for patients in Asia suffering from severe and disabling migraine”. The observed safety profile of Vyepti in the SUNRISE trial was generally similar to placebo, with the most common treatment-emergent adverse events (TEAEs) being COVID-19 and nasopharyngitis. The safety profile and the rates of TEAEs with Vyepti were consistent with previously reported trials. 👉 Vyepti® confirms efficacy in new phase III pivotal SUNRISE trial, meeting primary endpoint with statistically significant reductions in mean monthly migraine days compared with placebo 👉 Vyepti® met all key secondary efficacy endpoints in the SUNRISE trial, and the treatment was generally well tolerated 👉 Beginning day 1 after infusion, Vyepti® lead to statistically significant reductions in the risk of experiencing migraine compared to placebo In the SUNRISE trial, Vyepti met the primary endpoint showing statistically significant reductions in monthly migraine days (MMD) as compared with placebo. From baseline (average of 17 days) over weeks 1 through 12, mean reductions in MMDs were -7.5 for 300 mg and -7.2 for 100 mg compared to -4.8 days for placebo (p<0.0001 and p<0.0001 for 300 mg and 100 mg vs placebo, respectively). In addition, significantly greater proportions of patients achieved ≥50% reduction in monthly migraine days over weeks 1-12 with Vyepti 300 mg and 100 mg compared to placebo. Also confirming previous efficacy findings with Vyepti, more patients treated with Vyepti achieved ≥75% reduction in MMDs compared to placebo, and the SUNRISE trial confirmed early onset of preventive effects with significantly lower proportion of patients experiencing migraine on the day following infusion with Vyepti compared to placebo. #clinicaltrial #migraine #eptinezumab #Vyepti #Lundbeck

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Great news for MASH patients. More options means patients will one day get the right medications at the right times for them. Tailored care is the future. Novo Nordisk has announced promising results from part 1 of its phase 3 ESSENCE trial, which evaluated the impact of semaglutide 2.4 mg on liver health in patients with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis. The trial demonstrated significant improvements, with semaglutide showing superior efficacy in reducing liver fibrosis and resolving steatohepatitis compared to placebo, all without worsening either condition. These findings highlight semaglutide’s potential as an effective treatment option for the growing number of patients with MASH, and Novo Nordisk plans to seek regulatory approvals in the US and EU by mid-2025.

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