MCRA’s Post

Dr. Douglas Jennings, PharmD, FACC, FHFSA, LIU Pharmacy Professor & Director of our pioneering Advanced Heart Failure & Heart Transplant Pharmacy Fellowship, has co-authored two international expert consensus documents with the ISHLT - International Society for Heart and Lung Transplantation. These documents address a critical need by providing guidance in the area of heart failure-related cardiogenic shock management. Link to second article in comments #academia #pharmacy #pharmacist #faculty #ISHLT #futureofpharmacy

#heartdisease #cardiology #surgery https://lnkd.in/gPC2KMSQ An #injectable #hydrogel can mitigate damage to the right ventricle of the heart with chronic pressure overload, according to a new study published March 6 in Journals of the American College of Cardiology: Basic to Translational Science. The study, by a research team from the University of California San Diego, Georgia Institute of Technology and Emory University, was conducted in rodents. In 2019, this same hydrogel was shown to be safe in humans through an FDA-approved Phase 1 trial in people who suffered a heart attack. As a result of the new preclinical study, the FDA approved an investigational new drug application for the Emory and Georgia Tech researchers to start a clinical trial with the hydrogel in pediatric patients in the coming months, once institutional approvals are received. In this case, the injectable hydrogel is intended for children born with a condition that leaves them with an underdeveloped, nonfunctional left ventricle. The disorder, known as hypoplastic left heart syndrome, comprises less than 4 percent of congenital heart defects. But it is responsible for 40 percent of deaths associated with heart defects in newborns. Patients with the disorder have a 35 percent survival rate.

CONGRATULATIONS!! And thanks to all those who worked so diligently to complete enrollment in the DEEPER REVEAL clinical trial (NCT05358353). The study evaluates the Reflow Spur™ Stent, a unique clinical solution intended to provide stent-like results while leaving no metal behind. It was designated a Breakthrough Device by the FDA (for investigational use only). Designed for use in patients with critical limb-threatening ischemia (CLTI), Spur Retrievable Scaffold Therapy (RST) features a stent with radially self-expanding spikes that treat the diseased vessel wall before being retrieved. Read the press release: https://lnkd.in/g-pm2Fds #clinicaltrials #CLTI #interventionalcardiology #vascularsurgery #angiology #peripheralarterydisease #RST #clinicalstudies #medicaldevices

June in #neuromodulation: Last month saw one of the largest ever European Series-A rounds for a #MedTech company as Amber Therapeutics landed a huge $100m to help progress their "Amber-UI" pudendal nerve stim system towards FDA approval; at which point it would become the first fully implantable adaptive neuromod therapy for women with mixed urinary incontinence. Amber also hit the press when a UK boy received a “Picostim” brain implant at Great Ormond Street Hospital to control #epilepsy seizures in a world first. In Sept 23 Amber acquired Bioinduction and its Picostim DyNeuMo platform, on which Amber’s closed-loop neuromod therapy for mixed urinary incontinence is being developed. Plenty happening last month at Cala Health too as they named a new CEO along with earning Medicare coverage for their TAPS therapy for essential tremor (ET). Chief Product Officer Deanna Harshbarger was promoted to CEO with immediate effect, whilst CMS delivered a positive Medicare local coverage determination for TAPS, a wrist worn non-invasive device that delivers transcutaneous afferent patterned stimulation (TAPS) therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease. Neurolief announced positive results from a clinical trial evaluating their non-invasive neuromod device for treatment-resistant depression (TRD), designed for clinic and at-home treatment. Neurolief’s double-blind, randomized, placebo-controlled, multi-center clinical trial enrolled 124 patients across multiple centers in the U.S. and Israel. Key findings include a significant reduction in depression symptoms compared to the control group with Neurolief’s neuromodulation. A substantial portion of patients achieved full remission from depression symptoms. PathMaker Neurosystems Inc. secured $2.16m from the US DoD to fund a clinical trial using its MyoRegulator investigational neuromod device to treat people with amyotrophic lateral sclerosis (ALS). Elsewhere, CIONIC unveiled three new centers of excellence on the east coast to aid patient mobility and #neurorehabilitation through the use of their FDA-cleared “neural sleeve”, and Neuromod Devices' “lenire” device became a treatment option through the VA for 2.9 million veterans living with tinnitus as a result of them being awarded a Federal Supply Schedule (FSS) Contract from the US Government, making Lenire the first bimodal neuromod device to achieve this. Finally, CEFALY Technology launched headaches.com to increase awareness for Patients and Healthcare Providers of effective non-invasive neuromod therapies available for treating migraines. H2 in play....

For cardiology department, antiarrhythmic drugs #cardiology #clinicalpharmacy #clinicalpharmacy #pharmacy #arrhythmia #pharmacology

Vintage Wednesday - Three Decades in IVD and Counting! Three decades I've journeyed, my path so clear, July 17th this week, marks the day I hold dear. In the realm of In vitro Diagnostics (IVD) my heart finds its place, With Immunoassays and Molecular Diagnostics, I've found my grace. In vials and tubes, a symphony hums, Precision dances, where insight comes. Each test a verse, each result a tale, In the art of healing, where futures unveil. Through Clinical Marketing and Knowledge Management profound, My dedication and passion in this field have been crowned. Autoimmune testing by Immunofluorescence microscopy brightly dawn, In 2000, it’s legacy was beautifully drawn. Markers for Sepsis, for Rheumatoid's early fight, In 2003, PCT and Anti-CCP brought to light. Luminex based HLA DNA Typing, in 2007 did appear, A revolutionary advance, a future so clear. In Rheumatology, Dermatology, Critical Care’s might, Nephrology, Neuroimmunology, Gastroenterology’s insight. Expanding the business, with a manifold scope, In Immunoassays, we've given new hope. Innovative promotions, for clinicians to see, In specialties broad, we built our marquee. From Cardiology to Gynecology’s embrace, Critical Care Medicine, Neurology’s grace. Gratitude I extend, heartfelt and true, To clinicians, laboratorians, and decision-makers too. In South Asia’s realm, your support has been key, Guiding me forward, setting my spirit free. Colleagues past and present, steadfast and dear, Your companionship and support, I always endear. To my mentors, like lighthouses, shining bright, Like Modern-day ATCs, guiding my flight. So here’s to the future, with gratitude so wide, In the realm of IVD, where I’ll continue to stride. Through days, weeks, months, and years, with your support so grand, Together we’ll achieve much more, and always hand in hand. #ivd #clinicaldiagnostics #immunoassays #diagnostics #biomarkers #gratitude #appreciation #mentors #productlaunches #marketing #clinicalmarketing #Knowledgemanagement

📢Attention pharmacy students!  This is your chance to win a trip to Athens to attend the 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗣𝗹𝗮𝘀𝗺𝗮 𝗣𝗿𝗼𝘁𝗲𝗶𝗻 𝗖𝗼𝗻𝗴𝗿𝗲𝘀𝘀 (𝗜𝗣𝗣𝗖) organised by the Plasma Protein Therapeutics Association (PPTA). A 2-Day conference packed with insightful discussions, research presentations and networking opportunities. 🧬 Plasma-derived medicinal products (PDMPs) have improved the lives of patients living with a rare disease such as primary-immunodeficiency, bleeding disorders, neurological disorders and hereditary angioedema. Did you also know that plasma components can be used as supportive treatment in trauma cases, liver disease, cardiac surgery, and in some cases, pregnancy complications? Write an article (600-800 words max.) showing the importance of PDMPs in Rh Incompatibility. 📅 You have until 𝟱𝘁𝗵 𝗼𝗳 𝗺𝗮𝗿𝗰𝗵 to send your article to:  NourFeriel.Khodja@pptaglobal.org and MGeorgiou@pptaglobal.org 🏆 The winning article will be published in the Source magazine of PPTA.

#MedTech News roundup to keep you updated this Thursday.   Medtronic's innovative acquisition, Penditure, obtained from Syntheon LLC, stands out as an FDA-cleared heart implant designed to mitigate stroke risks during atrial fibrillation in cardiac surgery. Unlike its counterparts by Abbott and Boston Scientific, Penditure distinguishes itself through a swift deployment process. Supported by a 2021 study revealing a 42% reduction in ischemic strokes with left atrial appendage closures, Medtronic is poised for a comprehensive postmarket study in 2024, involving the evaluation of this groundbreaking device in 150 patients.   https://lnkd.in/g7iBDbs4   Orthofix Medical named Massimo Calafiore as its new CEO, effective early 2024 pending LimaCorporate's acquisition by Enovis. Calafiore, a seasoned industry professional with a background as LimaCorporate's CEO and NuVasive's executive VP, will bring extensive orthopedic and spine experience to the role. The appointment follows the departure of the previous leadership in September due to misconduct, resulting in a 30% decline in Orthofix shares.   https://lnkd.in/gcjPNbkn   A piece of insider news from the pharmaceutical side: Stanford University researchers, with Novo Nordisk, developed a drug delivery system potentially reducing GLP-1 drug dosing to a few times yearly. Published in Cell Reports Medicine, the hydrogel system sustained therapeutic Liraglutide levels in rats for 42 days. Human trials are expected in 1.5-2 years. The system could have broader applications, including CAR-T cell therapy, glaucoma drugs, and COVID-19 vaccines.   https://lnkd.in/gcjPNbkn #MedTechNews #MedicalDevices #HealthcareInnovation #MedTechIndustry #HealthTech #HealthcareTechnology #MedDeviceNews #HealthcareNews #MedTechTrends

Genentech’s Subcutaneous Ocrevus One-Year Data Demonstrates Near-Complete Suppression of Clinical Relapses and Brain Lesions in Patients With Progressive and Relapsing Forms of MS – Results from the Phase III study showed that subcutaneous (SC) injection was consistent with IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeks – – The twice-yearly, 10-minute SC injection has the potential to expand the usage of Ocrevus to treatment centers without IV infrastructure or with IV capacity limitations – – U.S. FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024 – “Updated results from OCARINA II further underline the potential benefits of subcutaneous Ocrevus for patients with both relapsing and progressive forms of MS,” said Scott Newsome, D.O., lead author, Johns Hopkins University School of Medicine. “Patients treated with subcutaneous Ocrevus experienced appropriate B-cell suppression and impressive near-complete suppression of new inflammatory disease activity. These results demonstrate the potential of subcutaneous Ocrevus as a treatment option that can be matched to the individual needs of people with MS and healthcare professionals.” Additional data continued to show that the safety profile of Ocrevus SC injection was consistent with the well-established safety profile of Ocrevus IV infusion. No new safety signals were identified for Ocrevus SC. The most common adverse events in the Ocrevus SC group were injection reactions (51.5% of all exposed patients), including erythema (34.8%; skin redness or irritation), pain (17.2%), swelling (9.4%) and pruritus (5.6%; skin itching), all of which were either mild or moderate and none of which led to treatment withdrawal. A total of seven serious AEs were experienced by three (2.6%) and four (3.4%) patients in the Ocrevus SC injection and IV infusion groups, respectively. The OCARINA II abstract was selected as an abstract of distinction by the AAN, based on the quality of the study and the interest to the neurology community. https://lnkd.in/eShr75YM

📢 Exciting updates from the world of cardiology clinical trials (Oct 16-30, 2023)! 🩺❤️ 1️⃣ SWAP-6 Study (1): Investigated: Drug-drug interaction between cangrelor and prasugrel in PCI patients. Patients: 77 Results: Concomitant use of prasugrel with cangrelor increased platelet reactivity after stopping cangrelor infusion, indicating a drug-drug interaction. 🚫💊 2️⃣ REACTION Study (2): Investigated: Relationship between hemoglobin glycation index (HGI) and 5-year major adverse cardiovascular events (MACEs). Patients: 9791 Results: U-shaped correlation between HGI values and MACE risk. Both low and high HGIs increased MACE risk. 📈❤️ 3️⃣ HOST-EXAM Study (3): Investigated: Benefits of clopidogrel in high-risk subgroups after PCI. Patients: 5403 Results: Clopidogrel showed a lower rate of primary composite endpoint than aspirin monotherapy. Benefits consistent across risk groups. 💊🎯 4️⃣ Clinical Risk Scores Study (4): Investigated: Prognostic performance of five clinical risk scores for MACE. Patients: 4551 Results: HEART, GRACE, and T-MACS scores, along with unstructured ICJ, performed well for predicting 30-day MACE. 📊🔍 5️⃣ Rosuvastatin vs. Atorvastatin Study (5): Investigated: Efficacy and safety of rosuvastatin vs. atorvastatin in coronary artery disease patients. Patients: 4400 Results: Comparable efficacy for both drugs. Rosuvastatin had lower LDL cholesterol but higher risk of diabetes onset and cataract surgery. 🩸💉 6️⃣ TWILIGHT Study (6): Investigated: Dyspnea-related ticagrelor discontinuation after PCI. Patients: Not specified Results: Dyspnea led to ticagrelor discontinuation in 1 in 10 patients, mostly early after PCI. 🚫💨 7️⃣ Uric Acid Levels Study (7): Investigated: Association between uric acid levels and clinical outcomes in heart failure patients. Patients: 1943 Results: Serum UA levels at admission were positively associated with risk of clinical outcomes, especially readmission. J-shaped relationship observed. 📉🔬 Stay updated with the latest in cardiology! 💓🔬 #CardiologyUpdates #ClinicalTrials #HeartHealth #ResearchMatters