Gilead demonstrates non-inferiority of Descovy to Truvada for HIV PrEP

Pharmaceutical Technology | November 07, 2019

Gilead Sciences has published data from the Phase III 96-week DISCOVER trial in which Descovy (emtricitabine 200mg and tenofovir alafenamide 25mg) demonstrated non-inferiority to another Gilead drug Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg) for pre-exposure prophylaxis (PrEP). The DISCOVER study only evaluated men and transgender women who have sex with men and are at risk of sexually acquiring human immunodeficiency virus (HIV) infection. Descovy is currently only approved for at-risk adults and adolescents at risk of sexually acquired HIV-1 infection, except individuals at risk from vaginal sex, because the drug is yet to be evaluated for efficacy in this patient population. Gilead has committed itself to carrying out clinical trials of Descovy in cisgender women and adolescent females at risk of sexually transmitted HIV-1 infection in Africa. Results from the DISCOVER trial showed that eight of the 2,670 people in the Descovy group experienced an incident of HIV infection, compared to 15 of the 2,665 participants in the Truvada group.

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Parexel and Veeva Collaborate to Speed-Up Clinical Trials

Parexel, Veeva Systems | May 04, 2021

Parexel and Veeva Systems announced a strategic partnership today to accelerate clinical trials through technological and process innovation. The unique partnership blends the best of each company's expertise through thousands of tests worldwide – Parexel as a pioneering CRO and Veeva as the technological innovator powering trials – to boost study performance and bring innovative therapies to patients faster. Parexel is standardizing Veeva's suite of clinical operations software, including Veeva Vault eTMF, Vault CTMS, and Vault Study Startup, as part of the agreement to streamline operations. Parexel's clients will now have access to Veeva Vault CDMS for clinical data storage as a free product. The companies will work together to continually develop Veeva's cloud technology and Parexel's clinical trial delivery processes based on the insights from sponsors, sites, and patients. Parexel will provide early access to and give feedback on Veeva's clinical products, such as innovations to support sites and patients in decentralized clinical trials (DCT), risk-based quality management (RBQM), and community-based sites. "By implementing Veeva's clinical solutions, we can streamline trial procedures, increase performance, and make trial implementation and attendance simpler for promoters, locations, and patients," Parexel CEO Jamie Macdonald said. "Through this extended relationship with Veeva, we hope to have more value to customers and have a much greater effect on the lives of patients." "We're happy to work with Parexel to fuel customer success and accelerate clinical research innovation," said Peter Gassner, Veeva's founder, and CEO. "By working together, we will help our customers get new vaccines, diagnostics, devices, and therapies to patients in need" About Parexel Parexel encourages the development of new innovative drugs to improve patient health. It provides services to clients in the life sciences and biopharmaceutical industries all over the world to help them transform scientific discoveries into new treatments. The therapeutic, technological, and functional ability is underpinned by a strong conviction in what we do, from decentralized clinical trials to regulatory advisory services to exploiting real-world insights. An independent council for Informa Pharma Intelligence voted Parexel the "Best Contract Research Organization" in December 2020. About Veeva Systems Veeva is the world's leading provider of cloud software for the life sciences industry. Veeva represents over 975 clients, ranging from the world's leading pharmaceutical firms to new biotechs, and is dedicated to innovation, product excellence, and customer success. Veeva is committed to balancing the needs of all stakeholders, including customers, employees, shareholders, and the industries it serves, as a Public Benefit Corporation.

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PHARMA TECH

Bayer and Mammoth Biosciences to Collaborate on Novel Gene Editing Technology

Bayer and Mammoth Biosciences | January 10, 2022

Bayer AG and Mammoth Biosciences, Inc., which is harnessing the diversity of nature to power the next-generation CRISPR products, announced a strategic collaboration and option agreement for the use of Mammoth’s CRISPR systems to develop in vivo gene-editing therapies. Mammoth Biosciences’ groundbreaking gene-editing technology is a key enabling technology, as well as a stand-alone therapeutic modality. It will significantly enhance Bayer’s efforts to develop transformative therapies for patients faster and strengthen the company’s recently established new cell and gene therapy platform. Under the terms of the agreement the two companies will start their collaboration with a focus on liver-targeted diseases. “Bringing together Mammoth’s novel CRISPR systems with our existing gene augmentation and our induced pluripotent stem cell (iPSC) platforms will allow us to unleash the full potential of our cell and gene therapy strategy. Partnering with Mammoth’s cutting edge scientific team is a fundamental pillar for our company to improve the lives of patients suffering from conditions that are currently still difficult to treat.” Stefan Oelrich, Member of the Board of Management, Bayer AG and President of the Bayer’s Pharmaceuticals Division “We’re excited to be working together with Bayer, building on the technology leap of our novel CRISPR systems, along with Bayer’s expertise in successful drug development,” said Dr. Peter Nell, Chief Business Officer and Head of Therapeutic Strategy at Mammoth. “This joint effort has the potential to benefit patients by developing CRISPR-based approaches for the clinic with the appropriate urgency, while ensuring scientific excellence and safety.” Cell and gene therapies are the next step in the evolution of drug development. By addressing the root cause of diseases, they are potentially capable of permanently reversing diseases with a one-time treatment. Gene editing serves as a key enabler for cell therapies when used outside the living body and allows therapeutic targeting of a wide range of genetic diseases with a high unmet medical need when used inside the living body. Mammoth Biosciences’ proprietary toolkit of ultra-small Cas enzymes, including Cas14 and Casɸ, allows for expanded high-fidelity gene editing to be combined with targeted systemic delivery. Under the agreement, Bayer gains access to this novel gene-editing technology, which offers the potential of an advanced in vivo applicability due to the ultra-compact size of these novel CRISPR systems. Under the terms of the agreement, Mammoth Biosciences will receive an upfront payment of USD 40 million and is eligible to receive target option exercise fees as well as potential future payments in the magnitude of more than one billion USD upon successful achievement of certain research, development, and commercial milestones across five preselected in vivo indications with a first focus on liver-targeted diseases. In addition, Bayer will pay research funding and tiered royalties up to low double-digit percentage of net sales. The companies are also exploring work on ex vivo projects on a nonexclusive basis. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. About Mammoth Biosciences Mammoth Biosciences is harnessing the diversity of life to power the next generation of CRISPR products. Through the discovery and engineering of novel CRISPR systems, the company is enabling the full potential of its platform to read and write the code of life. Mammoth aims to develop permanent genetic cures through best-in-class in vivo and ex vivo therapies and to democratize disease detection with on-demand diagnostics. By leveraging its internal research and development and exclusive licensing to Cas12, Cas13, Cas14, and Casɸ, Mammoth can provide enhanced diagnostics and genome editing for life science research, healthcare, agriculture, biodefense and more. Based in the San Francisco Bay Area, Mammoth Biosciences is co-founded by CRISPR pioneer and Nobel Laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington. The firm is backed by top institutional investors including Redmile Group, Foresite Capital, Senator Investment Group, Sixth Street, Decheng, Mayfield, NFX, and 8VC.

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PHARMA TECH

Capacity and Citeline Connect Partner for AI-Powered Clinical Trial Recruitment Experience

Capacity | August 12, 2021

Capacity, an AI-powered support automation platform, today announces its partnership with Citeline Connect, the all-in-one clinical trial recruitment platform developed by Informa Pharma Intelligence. The companies partnered to launch Moderna's clinical trial recruitment website with an AI-powered chatbot to provide a comprehensive experience for potential study participants. This partnership enables customers like Moderna to create engaging clinical trial recruitment websites. With the power of Capacity's chatbot and support automation software alongside Citeline Connect technology, users are able to actively complete registration and pre-screening through an easy-to-use interface. "Our work with Citeline Connect is reflective of our ultimate goal at Capacity, leveraging a company's existing knowledge base with support automation to help teams do their best work," said David Karandish, CEO of Capacity. "As we see relief from the COVID-19 pandemic on the horizon, there is still a way to go before we are in the clear. In working with Citeline Connect, we're honored to have the opportunity to provide helpful technology for healthcare providers, researchers, and patients." Capacity and Citeline Connect's first-of-its-kind work will enhance the patient experience. With user-friendly technology, Capacity's chatbot provides an expansive knowledge-base and user-friendly solution. "We are proud of our ability to create more opportunities for the public to engage with important clinical trials," said Chris Venezia, chief commercial officer at Citeline Connect. "Working with Capacity is a no-brainer to provide an extensive solution that meets the needs of potential patients and the clinical trial sponsors. They make it easy for both potential and current study participants to ask questions, find clinical trial information, and begin their study enrollment journey" This partnership comes on the heels of Capacity's growth and recognition across industries. Capacity was recognized as the "Adaptive Learning Innovation of the Year" in the 2021 EdTech Breakthrough Awards, as a "Tech 100 Mortgage Winner" by HousingWire, and was a 2021 FinTech award winner for the "Most Innovative Financial Services Machine Learning UI Solution - North America" by Wealth and Finance International. Capacity was also recognized by Knowledge Management World as one of the top 100 companies that matter most in knowledge management, and secured $12M in Series C funding late last year to continue innovating solutions for its customers. About Capacity Capacity is an AI-powered support automation platform that connects your entire tech stack to answer questions, automate repetitive support tasks, and build solutions to any business challenge. Capacity was founded in 2017 by David Karandish and Chris Sims, and is part of the Equity.com incubator.

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