INTEGRA-D™ trial: 100% success in defibrillation tests for first 100 patients

Foley & Lardner LLP partner Kyle Faget authored the Clinical Leader article, “What The #FDA Says About Investigator Responsibilities in DCTs,” examining the U.S. Food and Drug Administration’s September 2024 guidance on conducting decentralized clinical trials (#DCTs) for drugs, biological products, and medical devices. #clinicaltrials

Actuate has amended its IND application with updated clinical data from its Phase 2 trial in first-line treatment of metastatic #pancreaticcancer, which showed a statistically significant improvement in median overall survival with the combination arm of elraglusib plus GnP versus GnP alone. These results are intended to support planned regulatory submissions with the FDA and EMA beginning later this year and continuing into early 2026. https://bit.ly/4moHC0V

📣 MHRA Updates Guidance on IVDs in Clinical Studies On 22 August, the MHRA issued updated guidance on the use of in-vitro diagnostic (IVD) devices in clinical studies. Key Updates Include: - Companion diagnostics in CTIMPs (Clinical Trial of Investigational Medicinal Products) must carry a UKCA or CE mark, or be analytically validated for that purpose. - New guidance and flowcharts provide clearer direction on the notification and application pathways for IVD clinical investigations. You can read the full MHRA update here: https://lnkd.in/gYXVP7SW   Whilst these updates provide greater clarity, they also raise expectations for compliance. At Elevation Strategic Development UK, we help sponsors and manufacturers stay ahead of evolving requirements with deep regulatory expertise, clinical study design knowledge, and MHRA submission experience. We provide strategic guidance and support with completing the MHRA checklist, ensuring studies and submissions meet the latest standards. Planning a study with an IVD or companion diagnostic? Now’s the time to align with the updated requirements. Contact us at info@elevationsd.com for help with clarity, precision, and practical insight. #Regulatory #MHRA #IVD #CDX #ClinicalStudies

📢 MHRA Updates Guidance on IVDs in Clinical Studies On 22 August, the MHRA released updated guidance for in-vitro diagnostic (IVD) devices in clinical studies — including new requirements for companion diagnostics and clearer pathways for IVD clinical investigations. Full update here 👉 https://lnkd.in/gYXVP7SW While the changes bring greater clarity, they also raise the bar for compliance. With deep regulatory expertise, clinical study design knowledge, and extensive MHRA submission experience, Elevation Strategic Development UK is the go-to team for navigating these evolving requirements. If you’re planning a study involving an IVD or companion diagnostic, now is the time to ensure your approach reflects the latest standards. Reach out to Elevation Strategic Development UK for clarity, precision, and practical insight. #MHRA #IVD #CDx #Regulatory #ClinicalStudies

📢 New Regulatory Update! 🏛️ Update from United Kingdom-MHRA - Medicines & Healthcare Products Regulatory Agency 🔍 Clinical trials that include an in vitro diagnostic device 🔗 For more details, read the full United Kingdom-MHRA announcement https://lnkd.in/dG4JMJky #ClinicalTrials #InVitroDiagnostic #RegulatoryGuidance

In Historical First, Colorado PDAB Sets First Upper Payment Limit In a landmark move, Colorado’s Prescription Drug Affordability Board (PDAB) has adopted a rule establishing an Upper Payment Limit (UPL) on Enbrel (Etanercept) — the first such limit approved anywhere in the country. With this decision, Colorado becomes the first state to cross the threshold from policy discussion to regulatory action. The rule now moves to Attorney General review and publication in the state register, marking the next steps toward implementation under the Board’s UPL plan.   🔹 Why This Matters 🔹 Colorado’s UPL rule will serve as the test case for how PDABs nationwide approach high-cost drugs, setting the tone for what future affordability measures could look like across the U.S.   📊 Stay Ahead of PDAB Developments. Our Healthcare Policy team produces a monthly PDAB Report that tracks and explains changes across every state in a clear, interactive format, so you can stay informed without getting lost in the details. To learn more or connect with our team, visit: https://lnkd.in/e2Gk2qsR

Science 37 and Catalent have announced a strategic partnership enabling direct-to-patient investigational medicinal product (IMP) delivery for clinical research. Through this collaboration, Catalent supports Science 37’s Direct-to-Patient Clinical Trial Site by providing reliable, efficient shipping and logistics services for study medications, ensuring rapid and secure delivery of IMPs across geographies and enabling patients to participate in clinical research from the comfort of their homes, regardless of their location. https://bit.ly/4ndqaOi

Will cracking down on drug ads help patients? According to Dr. Fugh-Berman and Judy Butler, there are better ways to curb rising prescription rates and drug use. Read now: https://lnkd.in/ewwuvcff In a new opinion piece, HAPI Program Co-Director Dr. Adriane Fugh-Berman and her colleague Judy Butler cover the executive order and FDA announcements made earlier this month and identity key challenges to their approach, proposing a more effective strategy for regulating drug ads. Read the full piece for free on Medpage Today: https://lnkd.in/ewwuvcff #DrugPolicy #PharmedOut #HealthJustice #PublicPolicy #HealthEquity #BigPharma

Science 37 and Catalent have announced a strategic partnership enabling direct-to-patient investigational medicinal product (IMP) delivery for clinical research. Through this collaboration, Catalent supports Science 37’s Direct-to-Patient Clinical Trial Site by providing reliable, efficient shipping and logistics services for study medications, ensuring rapid and secure delivery of IMPs across geographies and enabling patients to participate in clinical research from the comfort of their homes, regardless of their location. https://bit.ly/3VQdcK5

Science 37 and Catalent have announced a strategic partnership enabling direct-to-patient investigational medicinal product (IMP) delivery for clinical research. Through this collaboration, Catalent supports Science 37’s Direct-to-Patient Clinical Trial Site by providing reliable, efficient shipping and logistics services for study medications, ensuring rapid and secure delivery of IMPs across geographies and enabling patients to participate in clinical research from the comfort of their homes, regardless of their location. https://bit.ly/3Ikkbbg