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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Drug development and production are challenging, however, high throughput characterization systems can greatly accelerate discovery programs. Using a proprietary discovery and development platform technology, Avitide enables its partners to rapidly advance candidate molecules to the clinic and achieve faster and more predictable bioprocess development timelines.

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BUSINESS INSIGHTS

DiMe Releases Toolkits to Improve Sensor Data Integration and Power Better, Faster Global Healthcare and Research

Digital Medicine Society | July 18, 2022

Today, the Digital Medicine Society released the Sensor Data Integrations Toolkits, four comprehensive toolkits to guide data producers, processors, and consumers to use the influx of data from the increased use of wearables and digital sensing products at scale. These resources are based on the Sensor Data Integrations project, comprised of healthcare leaders from Amazon Web Services Oracle, the Moffitt Cancer Center, Takeda, the US Department of Veterans Affairs and more. These toolkits will help realize the promise of sensor generated data to drive better decisions, faster, to improve healthcare delivery and research. The project team will conduct a demo of the toolkits during a live launch event on July 18 at 10:30 am ET, featuring Micky Tripathi, the National Coordinator for Health Information Technology at the US Department of Health and Human Services. The surge of data from sensor technologies is far outpacing the industry's ability to collect, store, analyze, protect, and use this data effectively for patient care and research. The number of US patients using remote patient monitoring devices is expected to surpass 70 million by 2025. Between 2022 and 2028, the global market for wearable technology is expected to grow around 18.5 percent, reaching $380.5 billion. The number of unique digital endpoints being used in industry sponsored trials of new medical products increased by over 950% between October 2019 and May 2022. The number of sponsors using these products in medical product development increased from 12 to 96 in the same timespan. And while the ability to discern high-quality sensor data suitable for clinical decision making is increasing rapidly, the ability to access these data is constrained by a current dependence on individual point solutions. "Sensor generated data, captured during people's daily lives, offer the opportunity to redefine how we measure health and disease. This opportunity powers the possibility of using high quality, high resolution flows of data to reimagine our approach to healthcare and research, leveraging more complete information to improve individual clinical decisions, decisions about the effectiveness of new medical products, and broader policy and public health decisions. DiMe's new Sensor Data Integrations Toolkits provide action-oriented resources to help data producers, processors, and consumers come together to create a sensor data ecosystem suitable for scale." DiMe CEO Jennifer Goldsack AWS has contributed customer feedback and technical expertise to ensure the toolkit meets the needs of today's modern healthcare system. "Across every industry, we see companies trying to accelerate their path to the cloud," said Lita Sands, Head of Solutions Life Sciences at AWS. "Timelines are getting quicker while the data collected is increasing exponentially – there is a clear and significant need for how to effectively and securely collect and use this information at scale. DiMe's new toolkits are a lifeline to organizations working with sensor data. They offer a comprehensive starting point for data producers, processors, and consumers to help build an integrated pipeline to support better and faster decision making." The development of these toolkits builds on DiMe's previous pre-competitive initiatives, such as The Playbook, the essential guide for developing and deploying digital clinical measures to advance patient care, clinical research, and public health. The Sensor Data Integrations Toolkits go further to ensure that high quality sensor data can be used at scale to improve patient care and speed efficient medical product development. The DiMe community is currently working on additional projects related to taking digitally generated data to scale and will be releasing additional resources over the coming months. DiMe is not only committed to creating and disseminating new digital health approaches and tools, but also sharing user experiences with the broader community. We encourage Sensor Data Integrations Toolkits users to contribute to Dime's "Resources in Action" case study hub by sharing how you are using resources to further the safe, effective, equitable, and ethical use of digital medicine to redefine healthcare and improve human health. The leading organizations from across the global healthcare, research, and digital health innovation sectors that collaborated with DiMe to create these open-access resources are AWS, Elevance Health, Evidation, US Food and Drug Administration (FDA), Human First, Institute of Electrical and Electronics Engineers, Medable, Moffitt Cancer Center, Open mHealth, Oracle, Savvy, Takeda, and US Department of Veterans Affairs (VA). About the Digital Medicine Society DiMe is a global non-profit and the professional home for all members of the digital medicine community. Together, we tackle the toughest digital medicine challenges, develop clinical-quality resources on a technology timeline, and deliver these actionable resources to the field via open-source channels and educational programs. Join us to advance the ethical, effective, equitable, and safe use of digital medicine to redefine healthcare and improve lives.

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BUSINESS INSIGHTS

Sanofi Global Health launches nonprofit Impact® brand for 30 medicines in low-income countries

Sanofi | July 05, 2022

Sanofi Global Health announces the launch of Impact®, a new brand of standard of care medicines produced by Sanofi dedicated for nonprofit distribution to at-risk populations in the world’s most impoverished countries. The Impact® brand, which includes insulin, glibenclamide and oxaliplatin amonst others, will enable the secure distribution of 30 Sanofi medicines in 40 lower-income countries. Considered essential by the World Health Organization, the medicines cover a wide range of therapeutic areas, including diabetes, cardiovascular disease, tuberculosis, malaria and cancer. The launch of the Impact® brand is among the steps taken since the formation last year of Sanofi Global Health, a nonprofit unit within the company aiming to increase access to healthcare through the distribution of medicines, and the building and bolstering of local healthcare systems in countries with among the lowest per capita GDP. Sanofi Global Health is the first and only global initiative to provide access to such a broad portfolio of medicines in so many countries and across multiple therapeutic areas while funding local support programs and strengthening local inclusive businesses. “At Sanofi, we believe we have a responsibility to make a difference for the health of those most in need, and we know we have the ability and the ambition to bring about lasting change. With critical medicines, relentless drive and impactful partnerships, we can take our innovation beyond the lab and use it to strengthen health systems and access to medicines for those most vulnerable communities of patients. Sanofi Global Health aims to improve the lives of millions of people who now cannot get the help they need. Sanofi’s renewed purpose is to chase the miracles of science to improve people’s lives. And our quest to make life better for all people must include helping to provide better access to care and quality medicines for underserved populations.” Paul Hudson Chief Executive Officer, Sanofi The company also announces the establishment of an Impact fund that will support startup companies and other innovators that can deliver scalable solutions for sustainable healthcare in underserved regions. By providing inclusive businesses financing and technical assistance, the fund will complement the GHU mission of leveraging global, regional and local investment to support the training of healthcare professionals and aiding communities in running sustainable care systems. The announcements come as Sanofi gathers key global health stakeholders to discuss how to build effective end-to-end health programs that are embedded in the communities in which they serve, to best reach, treat and manage patients’ health effectively and sustainably. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

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PHARMA TECH

Gerresheimer and Zollner enter into a strategic partnership for electronically controlled medtech systems from a single source

Gerresheimer AG | August 18, 2022

Gerresheimer AG and Zollner Elektronik AG are pooling their market-leading pharmaceutical and medical technology expertise under a strategic partnership. Starting immediately, they will offer pharmaceutical, healthcare and biotech companies their conceptual design, development and manufacturing capacities for drug delivery and medical technology systems, including complete electronics, from one single source. Gerresheimer serves as the central point of contact for customers. The market-leading partners combine the expertise of Gerresheimer in innovative devices for the administration of medicines and medical technology systems with the globally established electronics expertise of Zollner. Together they want to further develop their expertise in the healthcare sector and open up new markets. With this strategic partnership, Gerresheimer and Zollner are counting on the global trend toward electronic, digitally controllable and connected drug delivery and diagnostic systems. These include insulin pens, inhalators, like for people suffering with asthma, Point-of-Care systems and medicine pumps. The demand for medical and pharmaceutical devices with electronic components mostly for the treatment of chronic illnesses will significantly increase in coming years. According to studies, the market for digital and connected solutions for the treatment of diabetes alone is expected to grow to around EUR 11bn by 2025. Zollner Elektronik AG is one of the world's largest manufacturing service providers for electronic and mechatronic components (Electronic Manufacturing Services or EMS). It generated revenues of around 1.9 billion Euros with just over 12,000 employees at 23 locations in Germany and abroad, 18.3% of that in the area of Healthcare & Life Sciences. "The future belongs to digital treatment support with electronic systems and connected platforms. The partnership with Zollner helps us provide our pharma customers with innovative one-stop medtech solutions. For patients, using these solutions means better treatment and enhanced quality of life. At the same time, the healthcare system also benefits by way of permanently reduced treatment costs." Dietmar Siemssen, CEO of Gerresheimer AG "Digitalization of medical devices is advancing at a very fast tempo. At Zollner, we are happy to have found an ideal partner in Gerresheimer for the expansion of our successful Healthcare & Life Sciences efforts," says Markus Aschenbrenner, Managing Board Member at Zollner. "Together we will expand access to existing markets, exploit new growth markets and support our mutual customers along the entire life cycle of the products." Zollner and Gerresheimer have collected much cooperation experience in numerous projects. The electronics specialist in Zandt already supplies Duesseldorf-based Gerresheimer with components and assemblies for medicine pumps in Parkinson's therapy. Gerresheimer and Zollner are now further developing this cooperation and will act as equal partners for the healthcare system of the future. Through the integration of concept design, development and manufacturing, the products of both sides can be brought to market faster and more efficiently. Also gained is permanent, secure access to electronic components. The cooperation initially covers the development of inhalers for chronic lung disease sufferers, autoinjectors, ophthalmology systems and drug pumps, as well as contract manufacturing for these and similar devices.

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