Arrowhead Pharmaceuticals’ Post

Concept Medical Receives US FDA IDE Approval For Magictouch AVF Indication, Their Fifth US Clinical Study Approval For The Magictouch Portfolio. Concept Medical has been granted “IDE Approval” from the U.S. Food and Drug Administration (FDA) for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, to initiate a clinical study for the treatment of stenotic lesions of Arteriovenous Fistula in the Haemodialysis management of Chronic Renal Failure. This US FDA IDE approval allows Concept Medical to conduct pivotal clinical studies to gather safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in A.V. fistula & support a future pre-market approval (PMA) application in the USA. The complete article at the following link: https://lnkd.in/dU5pS-Qx

For manufacturers of #medicaldevices in the #EU. 🇪🇺 The European Medicines Agency #EMA has issued an updated guidance to clarify the process for health technology developers to determine applicability of the Health Technology Assessment Regulation #HTAR and potential joint clinical assessment #JCA requirements. Under HTAR, certain submissions will require JCA. EMA's updated pre-authorization procedural advice outlines the timeline and process. Starting in 2025, developers of specific medicines, including cancer treatments and cell therapies, will need to declare HTAR applicability during the letter of intent #LOI submission. This facilitates parallel pre-submission phases for EMA and relevant HTA bodies. The applicability requirement will progressively encompass other medicinal products over the coming years. The European Commission has also initiated a consultation on EMA and HTA body cooperation under HTAR. This consultation seeks input on information sharing and planning processes for joint assessments, including patient and expert identification. The consultation period concludes on July 24th. Find the draft here 👉 https://lnkd.in/gmAnkey4 If you have any questions or need support regarding the EU HTA Regulation and its implications for the assessment of your medical devices, we are here to offer guidance and expertise. Let's navigate this landscape together to ensure the effective evaluation and implementation of medical devices. Feel free to contact us ☞ meetus@taoexcellence.ch #ClinicalTrials #MedicalAffairs #EUHealthcare #medtech #medtechindustry #regulatoryaffairs #healthcareinnovation #regulatorycompliance #EUHTA #healthcare #healthtechnologyassessment #ehealth #medicaldevices #publichealth

Regulatory update 🔔: The European Medicines Agency's Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for #ClinicalTrials across the EU. This platform will enable stakeholders to exchange views on all aspects of clinical research, including clinical trial design, conduct, statistical analysis, proposals for regulation optimisation, transparency of data, and patient engagement. Learn more in the March edition of our Monthly Regulatory Round-up:https://buff.ly/4a8BpRv #AdvancedTherapies #CellTherapy #GeneTherapy #ATMPs

🚩 Embracing Change and Collaboration: The Future of IVD Regulation ✍️ The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is at the forefront of a significant shift in the regulation of high-risk in vitro diagnostics (IVDs). Moving away from a static list-based approach, the MHRA is adopting a dynamic risk-based classification system (A to D), aligning with global standards and fostering innovation. 💡 This transition, however, presents challenges, particularly in bridging the regulatory gap for high-risk IVDs. To address this, the MHRA proposes: 1. Common specification requirements for evaluating high-risk IVDs, ensuring consistency and reliability. 2. A mandate for manufacturers to monitor safety and effectiveness post-market**, leveraging these common specifications. 3. The integration of COVID-19 tests into the new system, streamlining the approval process. ‼️ As stakeholders in the healthcare industry, we must recognize the **critical role of CROs in this evolving landscape. CROs bring specialized expertise and resources that are invaluable for navigating complex regulatory waters, especially when it comes to: ♦️Developing robust evaluation strategies that meet the MHRA's common specifications. ♦️Implementing comprehensive post-market surveillance to ensure ongoing compliance and patient safety. ♦️Adapting quickly to regulatory changes, such as the inclusion of COVID-19 diagnostics. 🧭 The deadline for public commentary is June 14th. Let's join the conversation and collaborate with CROs to ensure that our regulatory framework not only protects public health but also encourages the development of innovative diagnostic solutions. #HealthcareInnovation #IVDRegulation #CROCollaboration #MHRA #PublicHealth https://lnkd.in/eA7G9nen

This morning, we have released an update on our Phase 2 trial in acute ischaemic stroke (AIS) patients. Highlights from this exciting update include: ➡ Manufacturing and release testing of GMP grade ARG-007 drug product has been successfully completed, ready for patient dosing in the upcoming Phase 2 clinical trial. ➡ Gold Coast Hospital and Royal Brisbane & Women’s Hospital have now been included as trial sites, now confirming the ten clinical trial sites to be involved in dosing stroke patients in the Phase 2 trial. ➡ Site initiation visits will commence this month, enabling clinical trial sites to be ready to start recruiting and dosing patients into the trial. ➡ Dosing of first patients in the Phase 2 trial is on track to commence in March 2024. All the details of this announcement can be found here: https://bit.ly/42AxQQZ #ASX #AGN #stroke #clinicaltrials #clinicaltrialupdate #ARG007

In a recent draft guidance @US_FDA recommends that sponsors developing investigational medical products enroll an adequate number of trial participants from under-represented populations and prepare a diversity plan - learn more at this #ASCPT2024 Pre-con! https://bit.ly/2rTP1zy

When it comes to using IVDs (to guide treatment for personalised medicine) companies or innovators will need to define a gold standard for the type of indication and prepare a regulatory strategy to define its advantages. Get in touch with IDEA Regulatory to see how we can help you with your regulatory strategy today. https://lnkd.in/ecYRkxyZ #strategy #invitrodiagnostics #medtech #IVDR #regulatoryaffairs #regulatory #personalisedmedicine

Today is International Clinical trials day! As a team with patients, site staff, regulatory agencies and all a sponsor team we work together to contribute the access to safer and better treatments! I’ve been contributing with Clinical Research for More than 20 years and this is just the beginning! Lets celébrate and continue reimagining medicine together! Novartis Argentina #clinicaltrials #novartis #reimaginingmedicinetogether #internationalclinicaltrialsday

One of the popular FDA expedited pathway for MAA is "breakthrough therapy designation" which is eligible for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies aiming to bring innovative medicines to patients faster. In the below, we can interpret how this expedited pathway was used extensively during COVID time.

STAY TUNED on EU HTA - 7 ********************************   🌍 Health Technology Assessment (HTA) Regulation: Where We Stand 🌍   The application of the Regulation on Health Technology Assessment (#HTA) is progressing, although several key Implementing Acts are still awaited. The first Implementing Act, related to #JCA for medicinal products, was published in May 2024, but we are still waiting for additional acts that will provide clarity on: 1 - Conflict of interest management. 2 - Cooperation by exchange of information with the European Medicines Agency (EMA). 3 - Joint scientific consultation for medicinal products 4 - Joint scientific consultation for medical devices 5 - Joint clinical assessment for medical devices   With the implementation of JCA for oncology medicines and Advanced Therapy Medicinal Products (#ATMPs) scheduled for January 2025 and in line with the initially planned timelines, we expect a gradual release of additional Implementing Acts over the coming months, with a particular focus likely in the autumn. These acts will be crucial for ensuring a harmonized approach to HTA across the EU, promoting innovation, and improving patient access to new therapies.   Stay updated with our latest #insights on this evolving regulatory landscape. With our expertise and extensive experience, we are well-equipped to support our clients.   #HealthTechnologyAssessment #HTA #EURegulation #JCA #JointHTA