BUSINESS INSIGHTS, PHARMA TECH
businesswire | April 19, 2023
Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, announced that the U.S. FDA has renewed its licenses to the DILIsym® software platform, the flagship quantitative systems toxicology (QST) software for predicting and investigating drug-induced liver injury (DILI). The one-year renewal provides continued access to DILIsym software for authorized FDA employees across all FDA divisions.
Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the DILI-sim Initiative, commented, “The FDA’s renewal of these licenses endorses the value of DILIsym software in both predicting liver safety liabilities and defining the underlying mechanisms, which are critical to evaluating risk. The recent signing of the FDA Modernization Act 2.0 by President Biden, which encourages the FDA to limit animal use in drug development, should be a positive catalyst for greater utilization of DILIsym software in drug development. In my role as Chair of the SAB, I am very excited about the direction of the public-private partnership that is guiding further development of the DILIsym platform that will benefit many key stakeholders.”
Dr. Brett A. Howell, President of the DILIsym Services division at Simulations Plus, added, “Given the effect of rising costs on providing vital healthcare, the use of novel simulation technologies to improve the efficiency of drug development is more critical than ever. An important first step is ensuring that regulatory agencies have the most advanced technology tools to fulfill their essential mission. We are delighted the FDA has opted to renew once again and will continue using DILIsym and other Simulations Plus tools to enable reviews and enhance regulatory science.”
DILIsym software results support crucial drug development decisions by predicting potential DILI risk of new drug candidates. The modeling also identifies the biochemical events that lead to DILI caused by a drug and can thereby predict certain subgroups of patients at increased risk for DILI from that drug. The information from DILIsym modeling serves to help guide go/no-go decisions on major drug development projects, potentially avoiding the disastrous financial effects of failed clinical trials, or better, providing assurances that DILI will not be an insurmountable obstacle to regulatory approval. For the past 13 years, DILIsym Services, a division of Simulations Plus, has coordinated the DILI-sim Initiative, which is a public-private partnership that has guided development of the DILIsym software package. DILIsym is available to the pharmaceutical and chemical industries for direct use to predict and understand liabilities via membership in the DILI-sim Initiative consortium and/or commercial licenses. The DILIsym Services division also routinely uses DILIsym for comprehensive consulting services on safety-related issues.
Companies interested in a free trial version of the DILIsym software can request it here.
About Simulations Plus
Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI)/machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide.
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BUSINESS INSIGHTS, PHARMACY MARKET
Businesswire | May 02, 2023
COEUS, a leading healthcare communications, technology, talent, and consulting firm delivering a variety of services and platforms to all stakeholders in the healthcare ecosystem, announced today that it has completed a major rebranding. Following nearly 14 years of both organic growth and acquisitions, all business units have been combined to form one entity: COEUS.
Since the company’s inception in 2009, the company sought to build a suite of services capable of providing end-to-end solutions for drug and therapy manufacturers ranging from preapproval, through launch, and eventual loss of exclusivity.
“A little over 13 years ago, we started this company with just one employee. After a series of acquisitions, the hiring of more than 140 people, and the creation of numerous distinct business units all coming online at different times, we felt it was a necessary part of our evolution to consolidate the business units to one entity capable of servicing all clients,” stated Marc Hixson, CEO, COEUS. “Our clients have routinely told us that our experts, our strategic vision of what healthcare should be, and our commitment to leveraging — and building — technologies that improve the biotech, pharmaceutical, and payer audiences truly sets COEUS apart. It’s time to let the rest of the industry in on it.”
Through the rebranding, the company has redesigned its logo, launched an entirely new website and reinvented all its marketing collateral to reflect the company’s new identity.
As part of the consolidation, COEUS has appointed Jodie McVan to the position of Chief Commercial Officer. In her new role, Jodie will oversee the day-to-day operations, staffing, and the management of existing offerings, as well as drive the creation of new services and products for the consulting and agency business.
“With the combination of end-to-end service offerings for manufacturers, our technology platforms and services for manufacturers and payers alike, and industry leading talent and deep subject matter expertise, COEUS is well-positioned to efficiently deliver world-class service to our clients,” stated Jodie McVan, Chief Commercial Officer, COEUS. Visit 1COEUS.com to explore the new website and brand.
About COEUS
Established in 2009, COEUS is a leading healthcare consulting, communications, technology, and talent firm. The company offers clients a variety of services, as well as SaaS technology platforms, for various stakeholders throughout the healthcare ecosystem including all payers and emerging or more established drug manufacturers. Leveraging the deep knowledge and experience of the company’s many subject matter experts, COEUS works on all drug types with a particular focus on cell and gene therapies, rare diseases, and oncology. The company also has unique expertise in the creation and management of value-based agreements by leveraging COEBRA™, the company’s evidence and outcomes adjudication platform. In its 13-year history, the company has supported the launch of more than 120 pharmaceutical brands and has worked with more than 300 pharma clients including many top global pharmaceutical manufacturers.
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PHARMACY MARKET
PRNewswire | May 19, 2023
Asieris Pharmaceuticals a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced a strategic collaboration with UroViu Corporation ("UroViu"). Asieris Pharmaceuticals will obtain exclusive global rights to UroViu's patented technology of portable single-use cystoscope in the field of fluorescent imaging.
Under the agreement, Asieris Pharmaceuticals will use this patented technology in combination with specific optical imaging agents to conduct research on the application of non-white light imaging technology in the diagnosis and postoperative monitoring of None-Muscle Invasive Bladder Cancer (NMBC). At the same time, Asieris Pharmaceuticals will be responsible for the global commercialization of the sterile single-use fluorescent Cystoscope.
Previously, Asieris Pharmaceuticals entered a cooperation agreement with UroViu in 2021 for the exclusive registration and commercialization rights of its portable single-use flexible white light cystoscopy system in mainland China, Taiwan, Hong Kong and Macau.
"There is still a huge unmet need for more accessible and safer fluorescent cystoscopy in the diagnosis and surveillance of bladder cancer."Dr. Susan Wang, Senior Vice President of Global Business Development & Strategic Partnership of Asieris said, "We are thrilled to deepen and expand our collaboration with UroViu which enabling us not only to broaden our technology portfolio, but also to expedite the implementation of Asieris' integrated strategy for bladder cancer diagnosis and treatment, aiming to provide more effective disease management options for bladder cancer patients."
"We are excited about the possibilities that our expanded Partnership with Asieris will create. Our unique and expanding portfolio of single use endoscopic products are fulfilling UroViu's promise to greatly improve both the patient and provider experience, elevate the standard of care in a field with rapidly advancing technologies," said Bruce OuYang, Founder and CEO of UroViu.
About Asieris
Asieris Pharmaceuticals founded in March 2010, is a global biopharma company specializing in the discovery, development and commercialization of innovative drugs that treat genitourinary tumors and other related diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing, and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.
The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.
Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet medical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.
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