Satya (Nanu) Das, MD, MSCI’s Post

The Breakthrough Therapy Designation, which will expedite the development and regulatory review of TAR-200 in this setting, is based on findings from the phase 2b SUNRISE-1 trial. https://lnkd.in/gNfsQyq2

The data come from the phase 1/2 RESET-Myositis clinical trial (NCT06154252) and the phase 1/2 RESET-SLE clinical trial (NCT06121297). Cabaletta Bio https://lnkd.in/eKuUpSx8

oday. MAIA announced that an abstract about its Phase 2 THIO-101 clinical trial named “A phase 2, multicenter, open-label, dose-optimization study evaluating telomere-targeting agent THIO sequenced with cemiplimab in patients with advanced #NSCLC: Updated results” was accepted for poster presentation at the #ASCO24 Annual Meeting taking place May 31-June 4, 2024, in Chicago, Illinois. The poster is scheduled for presentation on June 3, 2024, from 1:30pm to 4:30pm CST. More information can be found in the press release here: https://bit.ly/4dL9ngY #NSCLC

The last patient in Cohort 2 of the ADX71149 (JNJ-40411813) Phase 2 #epilepsy clinical study has been randomized. We remain on track to announce top-line results in the second quarter of 2024. A reminder that this comes after the recommendation of an independent Interim Review Committee (IRC) convened by our collaboration partner to continue the study following review of unblinded data from Part 1 of patient Cohort 1. #drugdevelopment #clinicalstudies #allostericmodulator https://lnkd.in/eR3vPySv

Attralus has received Breakthrough Therapy Designation for our pan-amyloid diagnostic PET imaging candidate 124I-evuzamitide (AT-01) for cardiac amyloidosis from the US FDA. ✳ Read the press release – https://lnkd.in/egNHUjnT. ✳ 124I-evuzamitide (AT-01) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration for positron emission tomography (PET) imaging in patients with suspected or known cardiac amyloidosis. ✳ FDA granted BTD for 124I-evuzamitide (AT-01) based on clinical data from Attralus-sponsored and investigator-initiated studies evaluating the use of 124I-evuzamitide in patients with cardiac amyloidosis, representing experience in more than 200 trial participants. #amyloidosis #rarediseases

🫀✨Positive momentum for the team at Amplitude Vascular Systems as they announce successful #IDE approval to begin their POWER-PAD-II pivotal trial toward their pulsatile intravascular #lithotripsy (IVL) therapy, the PULSE IVL system. Founded at the University of Michigan and now operating in the Boston seaport, Amplitude Vascular Systems has been aggressively developing a new standard in #coronary and #peripheral intravascsular low intensity, high-frequency balloon based lithotripsy attacking intimal and medial calcified vessels. With $28M+ in recent Series B financing alongside yesterday’s IDE approval, AVS looks to aggressively move closer toward successful FDA clearance and brining the PULSE IVL to the US market. “We are proud to be one of the first companies to conduct a peripheral intravascular lithotripsy pivotal IDE trial in the USA. The IDE approval marks our most significant clinical milestone to date as we approach FDA clearance and market availability for the Pulse IVL system, which is designed to easily deliver therapy across complex calcified lesions and reduce overall procedural costs.” - Mark Toland, Amplitude Vascular Systems Board Chairman #medicalinnovation #vascularsolutions #interventionalmedicine #bioelectronics The Mullings Group Vascular News

Ophthopedia Update:Drug Approval for the Treatment of Geographic Atrophy: How We Got Here and Where We Need to Go: To discuss the clinical trial results leading to the FDA approval of anti-complement therapies for geographic atrophy (GA), perspectives on functional data from the GA clinical trials, and how lessons from the FDA approval may guide future directions for basic and clinical research in AMD. #Ophthalmology #Ophthotwitter #Scicomm

PharmAbcine is very delighted to announce that the Phase 1 safety data from intravitreal 3mg single-dose of PMC-403 in patients with neovascular age-related macular degeneration has been approved by the Safety Review Committee. The clinical study will progress to the fourth single-dose group of 4mg and first multiple-dose group of 3mg in parallel. Macular degeneration is a leading cause of blindness caused by aging-related damage to the retina. PMC-403 is a novel TIE2-activating antibody with the mechanism of stabilizing pathological and leaky blood vessels. Once Phase 1 clinical study is completed successfully with promising data, PMC-403 can potentially be a new treatment option for macular degeneration patients worldwide. For more information please see the link below: Press Release Link: https://bit.ly/4csyrIP #PharmAbcine #PMC_403 #TIE2 #MacularDegeneration #ClinicalStudy

The EU IVDR applies to all in vitro diagnostic devices used within the EU. The regulation became applicable in the EU on 26 May 2022 and has changed the landscape for the laboratory testing component of clinical trials. Laboratories and clinical trial sponsors are now discovering firsthand the consequences of using IVDs off-label, relying on in-house developed IVDs, and working with central testing facilities outside of the EU. Pieter Bogaert, PhD, and Paulussen Anne share why it’s becoming increasingly clear that laboratories and clinical trial sponsors must collaborate closely to reach compliance with the EU IVDR in this Regulatory Focus peer-reviewed article: https://bit.ly/3VjMHhf

The EU IVDR applies to all in vitro diagnostic devices used within the EU. The regulation became applicable in the EU on 26 May 2022 and has changed the landscape for the laboratory testing component of clinical trials. Laboratories and clinical trial sponsors are now discovering firsthand the consequences of using IVDs off-label, relying on in-house developed IVDs, and working with central testing facilities outside of the EU. Pieter Bogaert, PhD, and Paulussen Anne share why it’s becoming increasingly clear that laboratories and clinical trial sponsors must collaborate closely to reach compliance with the EU IVDR in this Regulatory Focus peer-reviewed article: https://bit.ly/3VjMHhf