JEITO’s Post

GPCR Therapeutics is thrilled to announce a significant out-licensing agreement with Bridge Biotherapeutics, Inc. focused on the development and commercialization of a combination therapy involving our CXCR4-LPA1 inhibitor method, to aid our pursuit of innovative treatments for Idiopathic Pulmonary #Fibrosis (IPF). The scientific basis for this approach was recently published in the peer-reviewed journal 'Cell Communication and Signalling,' (https://lnkd.in/exTvdTxP) highlighting the potential of this innovative treatment for fibrotic diseases like IPF. We are excited about the prospects this collaboration brings and the opportunity to explore new avenues in IPF treatment alongside Bridge Biotherapeutics. IPF is a chronic lung condition causing scarring, making breathing progressively difficult. With no current treatment to halt or reverse scarring, our joint efforts aim to revolutionize IPF treatment and improve outcomes for patients. 📝 Read our press release: http://gpcr.co.kr/news/ 🔗 Learn more about our platform technology: https://lnkd.in/eH8YveC8 #BioTech #LungDisease #LungHealth

Struggling with the “Double-blinded placebo-controlled randomized controlled clinical trial for patients with Anal Intraepithelial Neoplasia (AIN),” Frantz Viral Therapeutics, a joint venture between Georgetown University Medical Center and Frantz Medical Group, faced numerous challenges while dealing with the trial phases. Moving ahead, they reached out to us with their concern over the ongoing challenges and sought help through Jeeva Clinical Trials Inc.'s eclinical solutions to accelerate their research. Learn how we accepted the challenges and, through our efficient and innovative solutions, assisted them in fulfilling their objectives from this case study: https://hubs.la/Q02gg2dj0 #RCT #clinicaltrials #AIN #healthtech #casestudy #randomizedclinicaltrial

Discounts for the Neuromodulation Summit 2024 expire this Friday! 📢 Check out the full event guide now: https://ter.li/rw1ht3 This exclusive conference is industry’s must-attend meeting to join the community of 80+ experts in neuromodulation to share crucial insights into: ✅ How the CDRH is accelerating patient access to innovation ✅ How to overcome regulatory and clinical challenges to receive funding ✅ How the adoption of invasive and non-invasive devices differs ✅ How to choose which submission type is the best first step Joined by the likes of FDA, LivaNova, Axonics, Inc., Cognito Therapeutics, Inc., Neuspera Medical Inc., ClearPoint Neuro, Inc. and many more - this is not one to miss! Save up to $400 on your pass and join them in Boston this June: https://ter.li/wummg3

In this whitepaper, IQVIA’s David Duque and Elizabeth Allen consider recent changes designed to accelerate the early clinical drug development process. Discover how adaptive trial designs in early phase non-oncology clinical trials, together with the integration of digital tech, are reducing risk and improving patient safety. Download now. https://bit.ly/41pdlX0 #drugdevelopment #clinicaltrials #patientsafety

Humacyte made significant strides in the second quarter of 2024 to further our mission to improve patient’s lives and transform the practice of medicine. Laura Niklason MD and PhD, founder and CEO of Humacyte and Dale Sander, Chief Financial Officer, Chief Corporate Development Officer, Treasurer shared our Q2 2024 results on August 13th, 2024. FDA Extends Review of ATEV™ BLA for Vascular Trauma: The FDA notified Humacyte that additional time is needed to complete the review of the Biologics License Application (BLA) for the acellular tissue engineered vessel (ATEV) in vascular trauma, a first-in-class product granted Priority Review. Humacyte remains confident in the approvability of ATEV. ATEV Shows Positive Patency Results in Phase 3 Hemodialysis Access Trial: Topline results from the V007 Phase 3 trial (N=242) demonstrated ATEV's positive functional patency at 6 and 12 months (co-primary endpoints; p=0.0071) and significantly longer hemodialysis duration over 12 months (p=0.0162) compared to autogenous fistula, the current standard of care. ATEV Receives 3rd RMAT Designation for Advanced PAD: The FDA granted ATEV its third Regenerative Medicine Advanced Therapy (RMAT) designation for treatment of advanced peripheral artery disease (PAD), recognizing its potential impact for patients facing amputation. Progress in CABG and BioVascular Pancreas Programs: Humacyte reported progress across its pipeline, including promising preclinical results for the BioVascular Pancreas in type 1 diabetes, and positive 6-month primate data on ATEV remodeling for coronary artery bypass grafts. We are proud of these milestones and look forward to sharing more at upcoming medical meetings. Thank you to our dedicated team and partners for making these advancements possible! View the full press release here: https://lnkd.in/eTYJcP6H The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. #Humacyte #BiotechInnovation #Biotech $HUMA

We are pleased to share good news from AIM ImmunoTech (NYSE American: AIM), one of our featured companies at B2i Digital. AIM was granted two new US patents for their drug Ampligen! What does this mean? Put simply - it strengthens and extends AIM’s rights to use Ampligen for treating cancers and chronic fatigue/ME until 2039-2040. Key takeaways: - One patent covers unique combos of Ampligen with other drugs for pancreatic, kidney, colon cancers, etc., where it could improve outcomes. - The second patent is for precision methods to treat ME/CFS with Ampligen tailored to specific patients, a significant development for this neglected disease. With sole rights extended, AIM can further develop these approaches with Ampligen, either alone or with partners through 2039-2040. Click here if you would like to watch a video of CEO Thomas Equels discussing the issuance of these two key patents. https://lnkd.in/dpuHBi-A Congratulations to the team at AIM ImmunoTech, including CEO Thomas Equels, COO Peter Rodino III, Chief Scientific & Medical Officer David Strayer, and CFO Robert Dickey! As a featured company, we at B2i Digital are proud to see your progress in pioneering new therapies. These new patents are outstanding achievements that bode well for the future. Keep up the great work! Featured Company Profile: https://lnkd.in/eTNN4849 #LongCOVID #chronicfatigue #clinicaltrials #biotech #immunotherapy #Ampligen #MECFS #patents

The Oncology Community is being flooded with the promise of shorter turn around times with Liquid Biopsy tests. The reality is that prior authorization continues to be a barrier for test initiation. The speed in which a test can be approved is now the limiting factor in time-to-result and ultimately, time-to-treatment. According to the ASCO article, on average: - Takes a payer 5 business days to respond to a prior authorization request. - Prior authorization request is escalated beyond the staff member who initiates it 34% of the time. - Prior authorizations are perceived as leading to a serious adverse event for a patient with cancer 14% of the time. - Prior authorizations are “significantly” delayed (by more than 1 business day) 42% of the time Spesana Authorize is ensuring that molecular testing results are delivered in the fastest time possible by minimizing financial exposure to the patient, laboratory, and healthcare delivery entity. Spesana Authorize also supports prior authorization for drug treatments and other therapeutic pathways. Spesana continues tear down silos and remove barriers to ensure that the delivery of innovative NGS testing solutions and life changing pharmaceuticals are not impacted by the delays of the prior authorization process. https://lnkd.in/gwRn6DDV #precisionmedicine #priorauthorization #moleculardiagnostics #timetoresult #timetotreatment #spesana #authorize #healthequity #cdx #liquidbiopsy #ngs #costofhealthcare #laboratory #payers #pmwc #jpm2024

NMD Pharma A/S breaks new ground in neuromuscular diseases and Sophion Bioscience‘s instruments were part of their research from the start. From early on, Sophion’s #AutomatedPatchClamp instruments have been an important part of NMD Pharma’s research and data package. “The whole platform that Sophion offers can help you understand channel function better, cheaper and faster than if you had to do it another way – you get the whole package with Sophion,” says Martin Broch-Lips, Head of Biological Research at NMD Pharma A/S. Read the full 𝗡𝗠𝗗 𝗣𝗵𝗮𝗿𝗺𝗮 𝗰𝘂𝘀𝘁𝗼𝗺𝗲𝗿 𝗰𝗮𝘀𝗲 𝘀𝘁𝗼𝗿𝘆 here: https://lnkd.in/dp2MGSGu With an NMD670 orphan drug designation and achievement of a Phase IIa study in patients with myasthenia gravis, NMD Pharma has developed into a clinical stage biotech company focused on discovering and delivering life-transforming therapies for people living with neuromuscular diseases. #NMDPharma #QPatchCompact #PatchClamp #AutomatedPatchClamp #IonChannels #DrugDiscovery #Electrophysiology #Sophion

Time is ticking – how prepared are you for the EU HTA Regulation? One year out from full implementation for oncology products, ATMPs and certain medical devices, join us for a webinar to explore what we know so far and what further developments we can expect on the road to January 2025. Find all the details of our webinar and instructions to register at this link: https://buff.ly/3trhI7c #LumanityPerspectives #EUHTARegulation #HTA #HEOR

One week to go before the American Heart Association Annual meeting (#AHA23) kicks off in Philadelphia. On behalf of our people at Cardiomedex, I am very excited to be sharing the latest results showing the clinical relevance of the diet-Induced Obese NASH Hamster for evaluating drugs targeting HFpEF during the poster session “The Next Generation of Heart Failure Research” on Sunday November 12th, from 3:30-4:45PM (poster #2223) This model shows severe heart failure with preserved ejection fraction (HFpEF) related to evident hepatocellular ballooning and portal/bridging (stage 2-3) fibrosis and develops alterations in kidney function as characterized by our subsidiary company Physiogenex. This preclinical model provides a unique opportunity to evaluate the efficacy of drugs targeting HFpEF in a clinically relevant model. If you are attending #AHA23, I would love to connect and share ideas. Otherwise, contact us online to set-up an appointment and/or discuss your drug development projects with us: https://lnkd.in/eWkX9McT #AHA23 #cardiovascular #heart_failure #HFpEF #NASH #MASH #preclinical #innovation #proof_of_concept