We’re hosting a virtual KOL event featuring Mark Sulkowski, MD, on July 18 to discuss the unmet need and current treatment landscape for patients with chronic #HepatitisB (CHB), positive data from the Phase 1b study of our CHB candidate, development plans and the chronic suppression regulatory pathway. Learn more: https://lnkd.in/e4yWu2ka
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Spending a very insightful morning discussing #mentalhealth at the 14th EPSA - European Pharmaceutical Students' Association Annual Conference at the European Parliament hosted by MEP Irena Joveva. Looking after your #mentalhealth should be an integral part of the way you treat your health and shouldn't be stigmatised or less normal then seeking any other kind of health support. Prevention, #education, #awareness, normalisation and #accesstocare need to be promoted when it comes to #mentalheath. Policy makers need to have this in mind while working on future policies, including #mentalhealth in all aspects of our lives.
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Counsel, Life Sciences Compliance and Regulatory Counseling Group at Porzio, Bromberg & Newman, P.C.
Check out the below article I co-authored about compliance considerations for clinical trial recruitment activities and communications. Let me know what you think!
Clinical trial sponsors face recruitment challenges, especially for rare diseases and complex therapies. In Clinical Leader, Michelle Axelrod and Noah Goldstein discuss practical compliance considerations for communications and payments related to recruitment. Read the article: https://bit.ly/3WfDkzc #ClinicalTrials #LifeSciences #FDA
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Highlighting the below from IQ DILI. Wonderful resources on this important topic. #dili
NOW AVAILABLE! The presentations from the May 2024 DILI Conference can be accessed on the IQ DILI website. IQ DILI was delighted to host this informative and engaging conference planned by a partnership of experts from AASLD, FDA, NIH, CIOMS, and IQ DILI. https://lnkd.in/ex9QNskY #DILI #hepatoxicity #iqdili
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On Wednesday, May 22nd, the @PharmaSUG is hosting an FDA panel with Helena Sviglin will offer her expertise in FDA Study Data Policy Framework. Y. Veronica Pei, MD, MEd, MPH, FACEP will provide an update to safety outputs, specifically Addressing Data Challenges in Drug Induced Liver Injury. And Stephen Wilson will speak about how volunteers drive this industry forward. #FDA #PharmaSUG #ClinicalTrials #DrugSafety #RegulatoryCompliance
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The time for Opioid Stewardship is Today! Listen in as I join the AHA in a 5 part series discussing how your healthcare center can develop its own Opioid Stewardship Program. It's time we give the right drug to the right patient for the right indication at the right dose for the right length of treatment and navigate opioid-related complications with the right treatments. #opioidstewardship #opioids #addiction https://lnkd.in/eQYPYVh5
Opioid Stewardship and Substance Disorders by Advancing Health
soundcloud.com
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I am very happy to start 2024 with this manuscript being published. Bringing rich and robust RWE in rare disease from our key questions to the publication can be a long and complex journey, but we learn so much along the way. Thank you to the team! Nadia Pillai, Audrey Muller, Rafael Sauter, Allan Lawrie, Fernando Exposto, Louise Raiteri, Neil Hamilton, David Kiely Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare disease characterised by obstruction of the pulmonary arteries. Left untreated, mortality is higher in CTEPH than in many common cancers. CTEPH is challenging to diagnose due to non-specific initial symptoms and patients often present at an advanced stage. We conducted a retrospective observational study to generate real-world evidence from a UK high-volume PH referral centre linked with data from the National Health Service (NHS) Hospital Episode Statistics (HES) database. Our results confirm that the economic burden of CTEPH is high and that health care resource use (HCRU) and costs are higher in intermediate-risk and high-risk patients. Our study supports the use of a risk stratification approach used in pulmonary arterial hypertension in a large cohort of patients with CTEPH, demonstrating differences in survival in the three risk bands at diagnosis. This study adds to a limited literature describing the economic burden of CTEPH, with data available prediagnosis and postdiagnosis and by risk status at diagnosis. Whether treatment strategies aimed at achieving, where possible, a low-risk profile in patients with CTEPH can improve patient outcomes requires further research. In addition, the diagnosis of CTEPH reduces unplanned HCRU (via A&E visits) among operated and not-operated patients, regardless of risk group, emphasising the importance of achieving a diagnosis and its positive impact on health-seeking behaviour.
Great to see this work evidencing the utility of risk stratification in CTEPH patients from the ASPIRE registry published. True team effort with thanks to all involved including Amélie Beaudet, Audrey Muller and colleagues at IQVIA.
Risk assessment and real-world outcomes in chronic thromboembolic pulmonary hypertension: insights from a UK pulmonary hypertension referral service
bmjopen.bmj.com
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Want to learn more about the safety & efficacy of immediate complete revascularisation (ICR) and staged complete revascularisation (SCR) in patients presenting with ACS? 🤳Join Hala K. and Mirvat Alasnag next Tuesday, April 16th, for a Live chat on the substudy of the #BIOVASC randomised trial (to be published in the new issue coming out April 15). 🕰️Tune in at 6:00 PM on you favorite social media channel! #EIJonAir!
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Journal of Cardiovascular Pharmacology Editor-in-Chief: George W. Booz, PhD Social Media Coord: Raffaele Altara, PhD
#CardiacInsights: Unraveling SNPiP's Therapeutic Potential #CardiovascularHealth #TranscriptomeAnalysis https://lnkd.in/eJ5Vnca3
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We found that 73.9% of deaths were directly due to or significantly contributed to by COVID-19 vaccination. Our data suggest a high likelihood of a causal link between COVID-19 vaccination and death. These findings indicate the urgent need to elucidate the pathophysiologic mechanisms of death with the goal of risk stratification and avoidance of death for the large numbers of individuals who have taken or will receive one or more COVID-19 vaccines in the future. This review helps provide the medical and forensic community a better understanding of COVID-19 vaccine fatal adverse events.
Clinical monitoring of C-19 product recipients is indicated for a period of at least one year after administration to ensure the absence of serious adverse events that may lead to death. Our Study: https://lnkd.in/g9MRmvht IronWillReport #MFScholar
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Earlier this week, the independent Data Safety Monitoring Board (DSMB) recommended that the Phase 2 clinical trial of ARG-007 in acute ischemic stroke patients continues with no modifications to the study protocol. Undertaking a review by an independent DSMB complies with Good Clinical Practice (GCP). The purpose of the DSMB is to monitor the rates of adverse events (AEs), endpoints, and study performance in the Phase 2 clinical trial of ARG-007. Read the follow announcement here ➡ https://lnkd.in/gPBJiEmR #ASX #AGN #ARG007 #stoke #clinicaltrial #strokeawarenes #lifesciencesaustralia
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