Novartis sues as Amgen tries to cancel migraine tie-up

Novartis | April 05, 2019

Novartis and Amgen have become embroiled in a legal row over rights to the migraine prevention drug Aimovig, as sales of a new class of injected drugs begin to mount. Amgen’s Aimovig (erenumab), was already close to the end of its clinical development process two years ago this month when Novartis expanded a marketing agreement over the drug, building on a neurology pact dating back to 2015. Aimovig was approved in the US last May and under the agreement, Novartis co-markets the drug in the US, and markets the drug exclusively in Canada and the rest of the world, except for Japan, where Amgen still has rights. It’s this deal that Amgen wants to walk away from, sparking a legal dispute between the US pharma and Novartis that looks set to run and run. Amgen has said Aimovig’s launch has been a huge success, with sales of $95 million in Q4 alone.

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Cytel and GSK Advance Clinical Trial Design with Solara

Cytel | February 09, 2023

On February 7, 2023, Cytel Inc., a provider of statistical software and advanced analytics in the life sciences industry, announced that GSK, one of the world's top biopharmaceutical firms, signed a three-year strategic agreement to increase GSK’s deployment of the clinical strategy platform Solara (R). This agreement will contribute significantly to the future development of the Solara platform. The platform can help GSK effectively align on trial goals, traverse trial uncertainties, and create pressure-tested clinical trial designs that reduce costs and expedite speed up to the market. GSK began using Solara in early 2022 and has already profited from the platform in a variety of study design projects. Over 300 users have adopted Solara at the top 20 biopharma firms worldwide since its initial debut in 2021. It is also the recipient of the 2022 Fierce Life Sciences Award for Technology Innovation. Solara blends Cytel's proprietary algorithms evolved over three decades with enormous cloud computational capacity to overcome limits in clinical trial planning and design. Clinical development teams use Solara to quickly generate thousands of trial models representing thousands of design variants. These are used to pressure-test dozens of trial uncertainties, including treatment effect and enrollment rate. The platform's high-speed processing capabilities simulate tens of millions of modeled events that might occur during trial execution in minutes. In addition, Solara's visualizations make it simple to review results and quantify scientific and business trade-offs. The user-friendly interface and dynamic visualization of Solara provide a common language and workspace to facilitate a more data-driven and collaborative trial design process across clinical development functions. About Cytel Founded in 1987, Cytel is the leading provider of statistical tools and advanced analytics for the design and execution of clinical trials. It helps life sciences decision-makers to realize the full potential of their products. Its 30 years of global expertise in consulting, data-driven analytics, and industry-leading software helps biotech and pharmaceutical firms transform insight into confident decisions, from navigating uncertainty to establishing value. The company has an unwavering dedication to scientific rigor and operational excellence, which is directed via its offices in the United Kingdom, North America, Europe, and Asia.

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BUSINESS INSIGHTS, PHARMA TECH

Elligo Introduces AI-Driven Clinical Research Study Technology to Expedite Trials

Elligo Health Research | January 25, 2023

On January 24, 2023, Elligo Health Research®, the leading healthcare-enabling research organization, presented the DataAI Connect, a new data and technology platform that will facilitate data-driven, rapid clinical research. DataAI Connect, a scalable, end-to-end data platform, optimizes the clinical research workflow by decreasing human error and rapidly digesting patient data to speed up clinical studies. Elligo has created an industry-first AI-driven platform that sources, processes, analyses, and distributes patient real-world data (RWD) by bringing together data, processes, and clinical expertise. That means an end-to-end solution that solves clinical trial issues directly rather than being an add-on technology. The platform is adaptable and reusable, and it includes the following An RWD repository of electronic health records (EHRs) and clinical data storage that incorporates EHR, clinical trial, and patient data for analytics, artificial intelligence (AI), and research A comprehensive medical records retrieval and analytics solution that transforms data into searchable, actionable insights and personalized patient journey information within minutes using NLP, ML, and clinical experience. A data-driven protocol development service that puts designs to the test in the real world. Elligo's Chief Data Officer, Michael Ibara, commented, "The application of AI approaches to healthcare and clinical study data is moving from the moon-shot approach to more practical applications." He added, "An example of this approach is the process of getting patients' medical records, which involves manual, non-scalable activities such as getting accurate information on patients' providers, asking sites to track down records, and having humans triage hundreds of pages of medical records. The judicious and intelligent application of natural language processing (NLP), machine learning (ML), and other AI approaches increases speed, accuracy and quality, while removing the burden from the sites and patients." (Source – Business Wire) About Elligo Health Research Founded in 2016, Elligo Health Research® is a leading healthcare-enabling clinical research organization. With access to known patients and their HIPAA-compliant healthcare data, its IntElligo® Research Stack technology and eSolutions Research Accelerator PatientSelect approach expedite clinical trials through healthcare. Elligo's Site Solutions, combined with the largest Known Patient Access Network, enable healthcare practices and research sites to engage in clinical studies. Its services expedite the development of novel pharmaceutical, biotechnology, medical device, and diagnostic products through the adaptive involvement of known patients and clinicians.

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BUSINESS INSIGHTS, PHARMA TECH

Certara Acquires AI Company Vyasa to Boost Scientific Innovation

Certara | January 05, 2023

Certara, Inc. announced the acquisition of Vyasa Analytics, LLC, which offers scalable deep-learning software that enables life sciences enterprises to make predictions and answer complicated queries across structured and unstructured bio-medical data. The acquisition will improve Certara's software by giving its end-to-end platform cutting-edge artificial intelligence (AI) features. Certara said it was excited to announce that it had bought Vyasa, a cutting-edge company that would improve its software platforms and give it more options across many product lines. It went on to say that by introducing AI into its product line, the company is establishing capabilities that will allow it to maintain its leadership in biosimulation use cases in drug research and development. Established in 2017, Vyasa software offers businesses a revolutionary artificial intelligence-powered platform that allows them to integrate and analyze material across their company data landscape. LAYAR is a flexible, modular data fabric that can be used to analyze numbers, words, and pictures. It is Vyasa's most important product. It uses artificial intelligence to help people make better decisions during all stages of drug development. About Certara Certara, a pharmaceutical manufacturing firm with headquarters in Princeton, is focused on accelerating the creation of medications by transforming the traditional drug discovery and development process utilizing its biosimulation software, technology, and services. There are around 2,000 biopharmaceutical businesses, academic institutions, and regulatory bodies from 62 countries among its clientele.

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