Fixing a broken heart: Exploring new ways to heal damage after a heart attack

medicalxpress | April 23, 2019

For people who survive a heart attack, the days immediately following the event are critical for their longevity and long-term healing of the heart's tissue. Now researchers at Northwestern University and University of California, San Diego (UC San Diego) have designed a minimally invasive platform to deliver a nanomaterial that turns the body's inflammatory response into a signal to heal rather than a means of scarring following a heart attack. Tissue engineering strategies to replace or supplement the extracellular matrix that degrades following a heart attack are not new, but most promising hydrogels cannot be delivered to the heart using minimally invasive catheter delivery because they clog the tube. The Northwestern-UC San Diego team has demonstrated a novel way to deliver a bioactivated, biodegradable, regenerative substance through a noninvasive catheter without clogging.

Spotlight

The Medicines for Europe annual Pharmacovigilance Conference is a unique event where a broad range of stakeholders congregate to work together towards a common goal: to support access for EU citizens to safe medicines with an effective pharmacovigilance policy. The 11th Pharmacovigilance Conference will once more see leading experts and regulators discussing the future direction of EU pharmacovigilance.

Spotlight

The Medicines for Europe annual Pharmacovigilance Conference is a unique event where a broad range of stakeholders congregate to work together towards a common goal: to support access for EU citizens to safe medicines with an effective pharmacovigilance policy. The 11th Pharmacovigilance Conference will once more see leading experts and regulators discussing the future direction of EU pharmacovigilance.

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RESEARCH

Ora, Inc. Launches the Ora EyecupTM, a Revolutionary Ophthalmic Research Technology at Eyecelerator 2022

Ora, Inc. | September 29, 2022

Ora, Inc., the world's leading ophthalmology clinical research firm, has formally launched a revolutionary mobile research platform, Ora EyeCupTM, which promises to transform patient data capture through high-resolution imaging, artificial intelligence (AI) analysis, and real-time patient feedback. The Ora EyeCupTM, a finalist in the Most Valuable Clinical Technology Award category at the Reuters Events Pharma Awards USA 2022, will be presented by Dr. Gustavo De Moraes, Chief Medical Officer at Ora, at this year’s Eyecelerator Conference in Chicago, IL, September 29th. The Ora EyeCupTM platform is a powerful combination of hardware and software — a smartphone attachment and software application which allows patients to take high-resolution images of their eyes and track disease signs and symptoms remotely. With over 138,000 images captured to date, 98% are considered gradable by researchers and AI. Post-capture processing utilizes AI-powered image analysis for precise clinical assessments of ocular redness, tear film stability, and corneal health. Along with this, the Ora EyeCupTM ensures protocol adherence through compliance assurance diaries for both symptom tracking and therapy dosing. “At Ora, our technologists have spent the past two years developing this revolutionary system to capture patient data and provide a deeper understanding of therapeutic effect. The result is a trailblazing technology that captures high quality therapeutic data and improves the likelihood of study success.” Dr. De Moraes About Ora, Inc. Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 40 years, we have proudly helped our clients earn more than 55 product approvals and create vision beyond what they see. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora's pre-clinical and clinical models, unique methodologies, and global regulatory strategies have been refined and proven across thousands of global projects. We bring together the world's most extensive and experienced team of ophthalmic experts, R&D professionals, and operations management to maximize the value of new product initiatives. Think ophthalmology, think Ora.

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BUSINESS INSIGHTS

Novavax Submits Application to the U.S. FDA for Emergency Use Authorization for Novavax COVID-19 Vaccine,

Novavax, Inc. | August 16, 2022

Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that it submitted an application to the U.S. Food and Drug Administration for Emergency Use Authorization of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 as a homologous and heterologous booster in adults aged 18 and older. "It's important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations. Based on the data presented to the FDA's VRBPAC and the CDC ACIP, we believe our vaccine offers a broad, long-lasting immune response against a range of variants." Stanley C. Erck, President and Chief Executive Officer, Novavax Authorized Use The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. About the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) The Novavax COVID-19 Vaccine, Adjuvanted is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. The Novavax COVID-19 Vaccine, Adjuvanted contains purified protein antigen and can neither replicate, nor can it cause COVID-19. The Novavax COVID-19 Vaccine, Adjuvanted is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations. About Matrix-M™ Adjuvant Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response. About Novavax Novavax, Inc. is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 Vaccine, Adjuvanted, the company's COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including in the U.S., European Union and with the World Health Organization. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine candidate in a Phase 1/2 clinical trial, which combines the Novavax COVID-19 Vaccine, Adjuvanted and NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is also evaluating an Omicron strain-based vaccine as well as a bivalent format Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

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PHARMA TECH

GNS and Servier Announce AI Collaboration to Advance Multiple Myeloma Drug Discovery and Clinical Development

Servier Group and GNS | August 25, 2022

GNS, the leader in the use of "Digital Twins" and Causal AI & biosimulation technology for biopharmaceutical drug discovery and development, and Servier, a global pharmaceutical group, today announced a collaboration to advance drug discovery, translational, and clinical development efforts in Multiple Myeloma (MM). "This collaboration furthers Servier's goal to accelerate its drug discovery and clinical development efforts through AI and biosimulation and other digital initiatives. We believe GNS' Digital Twin and unique causal AI models will help our research and early development group improve our understanding of MM disease biology and, ultimately, transform our drug discovery and clinical development process". Claude Bertrand, EVP of Research and Development at Servier "We are delighted to collaborate with Servier to help advance research in MM and leverage our Gemini Digital Twin models to help uncover novel insights and reveal the hidden biological circuity of this disease," said Joe Donahue, Chief Business Officer at GNS. "Working together with the outstanding Servier team, we hope to make a difference in the lives of patients with MM." The collaboration will address key questions about how MM progresses in different patient subpopulations, including discovering what are the most synergistic pathways for new combination therapies and will help Servier gain insights that can advance their translational and clinical development efforts. This work will initially leverage the GNS Gemini Digital Twin for MM developed using the rich clinico-genomic data from the Multiple Myeloma Research Foundation CoMMpass study. GNS' MM Digital Twin leverages the rich patient multi-modal data generated by MMRF to create a transparent, accurate, quantified representation of complex biological mechanisms, revealing new circuitry of human disease. By conducting biosimulations, which are essentially computational experiments, one can discover new drug targets and disease mechanisms, and can also determine which drug candidates are more effective than others and why certain molecular profiles of patients lead to better and more durable response. Ultimately, the MM Digital Twins will radically change how Pharma R&D is conducted by helping to accelerate the identification of new targets and target combinations, new biomarkers, and enabling the in silico design of better trials. About Servier Group Servier is a global pharmaceutical group governed by a Foundation. With a strong international presence in 150 countries and a total revenue of 4.7 billion euros in 2021, Servier employs 21,800 people worldwide. Servier is an independent group that invests over 20% of its brand-name revenue in Research and Development every year. To accelerate therapeutic innovation for the benefit of patients, the Group is committed to open and collaborative innovation with academic partners, pharmaceutical groups, and biotech companies. It also integrates the patient's voice at the heart of its activities. A leader in cardiology, the ambition of the Servier Group is to become a renowned and innovative player in oncology. Its growth is based on a sustained commitment to cardiovascular and metabolic diseases, oncology, neuroscience and immuno-inflammatory diseases. To promote access to healthcare for all, the Servier Group also offers a range of quality generic drugs covering most pathologies. About GNS GNS is the leader in the application of Causal AI and simulation technology to discover and validate novel drug targets, simulate clinical trials, and help pharmaceutical and biotech companies discover and develop new medicines faster. GNS' patented AI uncovers new insights from multi-omics and real-world data leading to the discovery and prioritization of novel biological targets, and more efficient clinical trials with patients who are likely to respond to therapies. The Gemini Digital Twin models across oncology, auto-immune diseases, and neurology enable the simulation of disease progression and drug response at the individual patient level to simulate clinical trials in diverse patient cohorts.

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