Sanofi, Regeneron's Libtayo hits hot streak with EU green light, NICE backing

Sanofi | July 02, 2019

Sanofi and Regeneron’s Libtayo is two for two in the last two days-with European officials, that is. One day after the European Commission cleared the PD-1 drug to treat cutaneous squamous cell carcinoma, England’s cost watchdog signed off on an access agreement for the product in adults whose disease can’t be treated with surgery or radiotherapy. But it’s not an outright win for Libtayo at the National Institute for Health and Care Excellence (NICE). The cost-effectiveness gatekeeper will add the product to its Cancer Drugs Fund rather than cover it for routine use on the National Health Service. And as usual, the gatekeeper has some conditions. Patients should receive Libtayo until their disease progresses or they reach the two-year mark-whichever comes sooner, NICE said.

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Farmacon Global Partners With Validcare for Performance-Based Clinical Research Solutions

Validcare | February 17, 2022

“Validcare’s partnership with Farmacon Global will literally redefine clinical trial success from patient-centric design through database lock,” said Patrick McCarthy CEO Validcare. The Validcare platform accommodates site-based, hybrid and decentralized clinical trials and establishes key performance indicators to ensure study success. “Partnering with Validcare allows our sponsors to quickly identify and implement ROI generating activities like increased patient enrollment and site set up, while facilitating easier communication with principal investigators and on-going participation. This is especially critical for clinical trials in Latin America where Farmacon Global is uniquely positioned for delivering on-time and on-budget studies. Our focus has always been on the voice of the patients enrolled in a study. Today through our Validcare partnership we can offer the empirical results of better access and data integrity with our trial participants through e-CRF, e-diaries and more efficient RWE data being applied at a whole new level,” Tylosky concluded. Sara Tylosky CEO Farmacon Global Validcare will provide critical infrastructure to power Farmacon Global along with relevant metrics and KPIs. “Together, we provide proven processes, tools and technology to overcome the obstacles that typically cause clinical trial delays and failures,” said McCarthy. “We are excited to reset sponsor expectations and execute clinical trials on time and on budget.” About Validcare Founded by experts with more than 20 years of industry experience, Validcare offers the leading solution for best practices in streamlining research for regulatory compliant, life-improving products. Validcare brings a decade of experience powering clinical trials and value-based care models spanning pharma, med device and supplement market segments. About Farmacon Global Farmacon Global is a strategic CRO of medical consultants, providing solutions to accelerate clinical trials in emerging markets – with a specialty in Latin America and emerging markets with in-place medical associates and KOL alliances. Specialties include rare disease, cancer, immunology and infectious disease

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Vivera Partners with NINDS of NIH to Identify Potential Stuttering Treatments

Vivera Pharmaceuticals, Inc. | May 18, 2022

Vivera Biosciences, a division of Vivera Pharmaceuticals dedicated to the research and development of innovative medical technologies and pharmaceutical therapies, is pleased to announce its collaborative progress on a Cooperative Research and Development Agreement with the National Institute of Neurological Disorders and Stroke an Institute within the National Institutes of Health that aims to foster and advance cutting-edge neuroscience research to reduce the burden of neurological disease. The collaboration aims to identify therapeutic agents for the potential treatment of stuttering disorders, estimated to affect approximately 70 million people worldwide. Stuttering, also referred to as childhood-onset fluency disorder, is a neurological condition characterized by speech disfluencies, which can be disabling to patients affected. While there are currently no FDA-approved therapies for stuttering, in recent years, much has been discovered to understand the underlying neurological basis for the disorder. Scientists at Vivera and NINDS have discovered differences in the structure and function of the areas of the brain that regulate the timing and initiation of speech related to stuttering. These neurological revelations and the potential to develop related therapeutics inspired the partnership between Vivera and NINDS. The initiative is unique because of the individuals it will be led by: Vivera Biosciences' Investigator, Gerald A. Maguire, M.D., D.F.A.P.A., and NINDS' Principal Investigator, Shahriar SheikhBahaei, Ph.D. Both are persons who stutter and doctors who have dedicated their careers to understanding the disorder they share with millions of others and one they are working to develop novel treatments for. "I am grateful to the NIH, NINDS, and Vivera Biosciences for supporting this translational collaborative research with my friend and colleague, Dr. SheikhBahaei, as we potentially develop therapeutics to assist our stuttering community," said Dr. Maguire. Dr. Maguire is a world-renowned clinical researcher. He has over three decades of experience as an academic psychiatrist and has served as principal investigator for numerous studies involving investigational medications for various neuropsychiatric disorders, specializing in stuttering. "This collaboration may be an initial step toward developing novel and personalized therapeutic approaches for changing the course of the disorder for people who stutter," Dr. SheikhBahaei. Dr. SheikhBahaei's graduate studies focused on how astrocytic networks control activities of respiratory motor circuits within the brainstem. He currently leads the Neuron-Glia Signaling and Circuits Unit at NINDS, whose goal is to understand how different glial and neural cell types in the brain contribute to the neural circuits controlling voluntary speech production to enhance the ability to intervene in motor control disorders like stuttering. "Vivera is confident in our choice in partnership with NIH," said Vivera's Chief Medical Officer, Stephen J. McColgan, M.D., M.B.A. "Since day one, Vivera has been dedicated to the research and development of patient-centric treatments," said Paul Edalat, CEO of Vivera. "This partnership with NIH and NINDS is about bettering the lives of people who stutter, further solidifying the Company's commitment to our mission." About Vivera Pharmaceuticals Vivera Pharmaceuticals is an innovative, science-driven pharmaceutical company located in Southern California. The Company has global exclusivity to license the patented and patent-pending TABMELT® sublingual drug delivery system for pharmaceutical use and holds its own issued patents on ZICOH®, a smart dose-controlled electronic medical device. The Company has also received a Notice of Allowance for its portable telemedicine station, MDZone. With multiple divisions, including its pharmaceutical, neurosciences, medical technology, biosciences, and advanced diagnostics divisions, Vivera Pharmaceuticals is vertically integrated with patented technology, manufacturing capabilities, and distribution for its products.

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BUSINESS INSIGHTS

Long Island University Extends Partnership with Dassault Systèmes to Innovation and Research in Life Sciences

Long Island University | March 23, 2022

Long Island University announced a new research and innovation partnership with Dassault Systèmes in life sciences. The partnership will focus on research with high societal impact to advance the fields of pharmaceutical sciences, precision medicine and health care in the digital age. Research includes precision medicine using "Virtual Twins," or exact digital models of human anatomy being developed by LIU and Dassault Systèmes; pandemic preparedness and the digitization of healthcare; innovation in medical devices; and telemedicine through the "Internet of Things," or the exchange and analysis of data between physical objects that are connected digitally. In addition, the partnership aims to provide a platform for technology transfer, or the sharing and transformation of inventions and scientific outcomes into commercialized products or services that benefit society. "Long Island University is at the forefront of revolutionizing health care training and research in higher education with our ongoing partnership with Dassault Systèmes. We are investing in opportunities and technology to ensure our students become future leaders and innovators in emerging industries." President Kimberly R. Cline As part of this commitment to students, LIU has also been designated as a Dassault Systèmes 3DEXPERIENCE Edu Center of Excellence. Dassault Systèmes created the global 3DEXPERIENCE Edu Centers of Excellence program in October 2021. The program is aimed at providing students, professionals, learners, businesses and governments with a network of centers dedicated to experiential, lifelong learning with its 3DEXPERIENCE platform that enables the current and future workforce to accelerate the digital transformation of industry. "At Dassault Systèmes, we have the profound belief that the virtual world extends and improves the real world helping to address today's social and environmental challenges," said Rama Kondru, Ph.D. co-CEO of Medidata, a Dassault Systèmes company. "This strategic initiative with LIU brings enormous opportunities since it is helping to prepare the next generation of life science experts to innovate in tomorrow's more sustainable economy, transform healthcare, and solve some of the biggest medical challenges in areas such as cancer and Alzheimer's disease." LIU is the second Center of Excellence in the U.S. in addition to Purdue University, which opened as a Center of Excellence in Advanced Composites in 2020. Additional centers have been established in France, Mexico, Germany, Switzerland, Brazil and India, and focus on various industry sectors. "Earning the distinction of being named a 3DEXPERIENCE Edu Center of Excellence is a testament to Long Island University's standing as a preeminent academic institution," said LIU Board of Trustees Chair Eric Krasnoff. "We are proud to partner with Dassault Systèmes to create an ecosystem where students, faculty and industry partners can collaborate on real-world, impactful learning." The University's extended and ongoing partnership with Dassault Systèmes, world leader in 3D design and engineering software, is in line with its vision to advance academic excellence through innovation, provide extraordinary and distinctive experiences to students, and create solutions for a sustainable global future. Forged in 2019, the partnership provides LIU students with hands-on experience using cutting-edge artificial intelligence and digital engineering technologies, and to collaborate on multidisciplinary research in the life sciences. "The LIU-Dassault Systèmes research partnership is centered on solving real-world problems through an integrated approach to education while simultaneously developing the future workforce for precision medicine, healthcare and pharmacy," said Dr. Randy Burd, senior vice president for academic affairs at LIU. "We look forward to using Dassault Systèmes' incredible technology to expand and enhance life sciences, liberal arts, humanities and performing arts degree programs throughout the University." In 2021, the University opened a state-of-the-art simulation laboratory that allows students to use Dassault Systèmes' patented 3D, augmented reality and virtual reality software to conduct experiential research, education and training. The laboratory is used in several areas of study, including artificial intelligence, robotics, virtual reality gaming, cybersecurity, data analytics, and drug discovery and development. LIU also employs Dassault Systèmes' cloud-based 3DEXPERIENCE platform in classrooms across the University. "LIU has entered a truly transformative niche in higher education by aligning with a digital healthcare industry that is on the rise," said Dr. Mohammed Cherkaoui, vice president for academic affairs at LIU. "We are honored to work with Dassault Systèmes, combining its content expertise and research tools to become a global leader in the innovation of healthcare." About Long Island University Long Island University, founded in 1926, continues to redefine higher education, providing high quality academic instruction by world-class faculty. Recognized by Forbes for its emphasis on experiential learning and by

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BUSINESS INSIGHTS

MRM Proteomics, Inc. and Agilent Technologies, Inc.: A Collaboration for Progress

MRM Proteomics, Inc. | February 04, 2022

MRM Proteomics, Inc. (MRMP) and Agilent Technologies Inc. are excited to announce their new co-marketing agreement aimed to further advance the capabilities of quantitative proteomic applications and thereby help the scientific community make impactful, novel scientific discoveries. This new partnership will provide a complete solution for quantitative protein and metabolite analysis. Agilent’s advanced expertise and state-of-the-art mass spectrometry technology, along with MRMP’s leadership and experience in peptide and metabolite quantitation will enable the development of new tools and technologies to advance the field of multi-omics. MRMP has developed an array of easy-to-use assay kits designed for “absolute” protein and metabolite quantitation in clinical and/or research biological samples, incorporating Agilent’s robust and sensitive HPLCs and mass spectrometers for analyte separation and detection. The new Agilent 6495C LC/MS Triple Quad, coupled online to an Evosep One HPLC system, allows for higher multiplexity, enabling a greater number of metabolites and proteins to be quantified in significantly less time. Via this partnership, MRMP is excited to develop novel kits specifically designed for the Agilent/Evosep platform, including biological pathway- and disease-specific kits, useful to those in the multi-omics field. Additionally, MRMP commits to hosting regular hands-on and virtual workshops focused on teaching innovative techniques in targeted quantitative proteomics. Participants will learn the essentials of proteomics workflows, sample preparation methodologies, Agilent’s LC/MRM-MS set-up, and data analysis using the popular, open source and readily available Skyline software™. Training in the operation of the Evosep LC system will be included in these programs. Quote from Jennifer Gushue, Associate Vice President of Mass Spectrometry Marketing “The new targeted proteomics workflows that have been developed through our collaboration with MRM Proteomics and Evosep will improve quantification of protein targets in clinical research and accelerate drug development in sample limited environments,” said Jennifer, “This collaboration highlights the capabilities of our 6495 LC/MS Triple Quadrupole as a winning combination with Evosep and MRM proteomics for targeted proteomics and our commitment to driving answers for the toughest analytical challenges.” “We are impressed with the scanning speed of the Agilent 6495C triple quad MS and the quantitation accuracy that has been repeatedly demonstrated with the MRM Proteomics kits. This combined workflow demonstrates great potential for future clinical research studies.” Dr Nicolai Bache, Head of Applications, Evosep

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