SmartSkin Technologies and PDA | October 06, 2022
SmartSkin Technologies and Parenteral Drug Association, Inc. announced a partnership to integrate SmartSkin’s data collection technologies with PDA’s aseptic processing and visual inspection training.
SmartSkin is recognized by leading pharmaceutical brands as an innovator. Its technology helps the industry adapt faster and improve production quality by providing timely data from the container’s perspective inside the production process — from the washer to warehousing. This previously unavailable information enables data-driven decisions, improving efficiency, lowering costs, and reducing waste.
Built on a reputation of scientifically reliable and compliant industry best practices, PDA's hands-on aseptic processing and visual inspection training courses provide new and experienced pharmaceutical professionals with practical information and implementable solutions related to these critical manufacturing operations.
“PDA’s training curriculum is widely acknowledged as the gold standard for the pharmaceutical industry. We have been working closely with them for the past several months and are thrilled to have our technology included as part of their training. We have been working hard to understand all aspects of sterile products, aseptic processing, and how to improve quality in pharmaceutical manufacturing. PDA training will ensure industry professionals understand what is now possible.”
SmartSkin CEO, Evan Justason
“We are always looking to integrate new technologies into our training courses to provide meaningful hands-on experience to our attendees. Smartskin’s technology to protect the integrity of containers across the fill-finish process will enhance the aseptic processing and visual inspection training courses, making them even more unique and valuable,” said PDA VP of Education, David Talmage.
SmartSkin discussed manufacturing and quality assurance issues at the 2022 PDA/FDA Joint Regulatory Conference in Washington earlier this month and showcased its latest product innovations to PDA and FDA members. SmartSkin will also be attending the upcoming PDA Universe of Pre-Filled Syringes and Injection Devices show in Palm Springs, CA, October 18-19.
The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information. The PDA creates awareness and understanding of important issues facing the pharmaceutical and biopharmaceutical community and delivers high-quality, relevant education to the industry. Since its founding in 1946 as a nonprofit organization, PDA has been committed to developing scientifically sound, practical technical information and expertise to advance pharmaceutical/biopharmaceutical manufacturing science and regulation, so members can better serve patients.
About SmartSkin Technologies
SmartSkin Technologies, Inc. is based in Fredericton, New Brunswick, Canada. The company’s patented Quantifeel™ solutions fuse innovative sensors, deep analytics and artificial intelligence to provide global manufacturers with actionable data on the forces their containers experience during the filling and packaging process. By identifying previously undetectable adverse or abnormal operating conditions, workers are able to better control the process, preventing product defects and costly downtime. SmartSkin’s technology is in use around the world and has earned a reputation as a world leader in IIoT productivity solutions across multiple industries. SmartSkin was honored with the “Best Manufacturing Innovation” at the 2020 PharmaPack Awards in Paris.
Teva Pharmaceuticals | November 21, 2022
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced a new collaboration with HealthSnap, a leading full-service Virtual Care Management Platform for chronic disease management.
The collaboration will enable more consumers to have access to Teva’s Digihaler® system, a digital health platform designed to enable patients to have more informed treatment discussions with their healthcare providers through personalized care. The collaboration will enable healthcare providers to better integrate patient data into their workflows, supporting proactive remote care across large populations.
The platform can be used to monitor and manage large populations by a network of health systems. It can capture objective and actionable data for asthma patients, thereby creating the mechanism for personalized care.
“Digital health platforms will succeed only by seamlessly integrating multiple data sources into workflows and systems like electronic medical records (EMR). We believe in building an ecosystem and are delighted to partner with HealthSnap as we seek to expand the reach of our platform, and continue to shape digital therapeutics and the integrated care landscape,” said Manny Montalvo, Senior Vice President, Head of Digital Health & Innovation at Teva. “We believe that the future of healthcare is in predictive and preventative care, which is a significant paradigm shift from the standard of care today. That is why we will focus our collaboration and our services on facilitating this change, to help providers deliver better care and help patients manage their condition.”
“With a rich heritage of delivering innovative medicines, alongside technology development capabilities, Teva is uniquely positioned to help the healthcare ecosystem move toward greater integration of objective health data, and create meaningful population-scale solutions to help patients and providers. We envision broad utilization of our platform by consumers, healthcare providers and other technology organizations. In respiratory care, our long-term vision is ambitious and clear: harnessing the power of technology and therapeutics to predict asthma attacks.”
Montalvo continued, “Over the past few years, through a talented and continuously evolving in-house team we have built a robust technology arm within Teva to continue exploring ways to improve patient outcomes. Through our vision for connected therapy, we strive to be at the nexus between patients, healthcare providers, technology, and the future of medicine, exploring new ways for digital health to serve as an economically sustainable solution for small and large healthcare provider organizations, offering timely, data-driven solutions to benefit patients. Our hope is that by working with HealthSnap and other capable companies in this space, we will fulfill our mission of improving the lives of patients, and do so by improving the health and effectiveness of our healthcare system – and we’re just getting started.”
“By partnering with Teva, HealthSnap is expanding its reach to patients with respiratory diseases, allowing them to receive personalized care based on their data. HealthSnap is continuously seeking partnerships and we look forward to delivering quality at home programs with this new and exciting collaboration with Teva,”
Samson Magid, Co-Founder and CEO of HealthSnap
Teva Pharmaceutical Industries Ltd. has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com
About Teva Digital Health
Teva aims to be a global leader in personalized, predictive care, continuously investing in platforms and regulatory-compliant systems that will help change the nature of digital health as we know it. Teva’s proprietary software platform Digihaler® – developed and maintained in-house by a team of research specialists and programmers – is built into a series of FDA-approved inhalers, currently marketed in the U.S., and with plans to expand to Europe in 2023.
HealthSnap is an integrated Virtual Care Management Platform that helps healthcare organizations improve patient outcomes, reduce utilization, and diversify revenue streams. From chronic disease-agnostic Remote Patient Monitoringand Chronic Care Management to AI-guided care coordination, virtual care delivery, automated care management billing, population analytics - and so much more, HealthSnap is the simplest way to manage chronic conditions remotely.
BioMarin Pharmaceutical Inc. | November 24, 2022
BioMarin Pharmaceutical Inc. announced advancements in the U.S. Food and Drug Administration review of the Biologics License Application of ROCTAVIAN™ for adults with severe hemophilia A. The Company was recently notified by the FDA that after further consideration, at this time, the Agency no longer plans to hold an advisory committee meeting to discuss the BLA for ROCTAVIAN that is currently under review. Previously, the FDA communicated to the Company that it did intend to hold an advisory committee meeting but did not specify a date. The Company also remains on track to host the scheduled FDA Pre-Licensure Inspection (PLI) of BioMarin's gene therapy manufacturing facility located in Novato, CA.
"The review of a BLA is a dynamic process, and we appreciate FDA's ongoing engagement as we work toward delivering a potentially transformative treatment choice to those patients with severe hemophilia A. We look forward to further dialogue with the Agency as it reviews our application."
Hank Fuchs, M.D., President of Worldwide Research and Development at BioMarin
About valoctocogene roxaparvovec
The FDA granted Regenerative Medicine Advanced Therapy designation to valoctocogene roxaparvovec in March 2021. RMAT is an expedited program intended to facilitate development and review of regenerative medicine therapies, such as valoctocogene roxaparvovec, that are expected to address an unmet medical need in patients with serious conditions. The RMAT designation is complementary to Breakthrough Therapy Designation, which the Company received for valoctocogene roxaparvovec in 2017.
In addition to the RMAT Designation and Breakthrough Therapy Designation, BioMarin's valoctocogene roxaparvovec also received orphan drug designation from the EMA and FDA for the treatment of severe hemophilia A. Orphan drug designation is reserved for medicines treating rare, life-threatening, or chronically debilitating diseases. The European Commission (EC) granted conditional marketing authorization to valoctocogene roxaparvovec gene therapy under the brand name ROCTAVIAN™ on August 24, 2022.
Robust Clinical Program
BioMarin has multiple clinical studies underway in its comprehensive gene therapy program for the treatment of severe hemophilia A. In addition to the global Phase 3 study GENEr8-1 and the ongoing Phase 1/2 dose escalation study, the Company is also conducting a Phase 3, single arm, open-label study to evaluate the efficacy and safety of valoctocogene roxaparvovec at a dose of 6e13 vg/kg with prophylactic corticosteroids in people with severe hemophilia A. Also ongoing is a Phase 1/2 Study with the 6e13 vg/kg dose of valoctocogene roxaparvovec in people with severe hemophilia A with pre-existing AAV5 antibodies (Study 270-203) and a Phase 1/2 Study with the 6e13 vg/kg dose of valoctocogene roxaparvovec in people with severe hemophilia A with active or prior Factor VIII inhibitors.
About Hemophilia A
People living with hemophilia A lack sufficient functioning Factor VIII protein to help their blood clot and are at risk for painful and/or potentially life-threatening bleeds from even modest injuries. Additionally, people with the most severe form of hemophilia A often experience painful, spontaneous bleeds into their muscles or joints. Individuals with the most severe form of hemophilia A make up approximately 50 percent of the hemophilia A population. People with hemophilia A with moderate or mild disease show a much-reduced propensity to bleed. Individuals with severe hemophilia A are treated with a prophylactic regimen of intravenous Factor VIII infusions administered 2-3 times per week or a bispecific monoclonal antibody that mimics the activity of Factor VIII administered 1-4 times per month. Despite these regimens, many people continue to experience breakthrough bleeds, resulting in progressive and debilitating joint damage, which can have a major impact on their quality of life.
Hemophilia A, also called Factor VIII deficiency or classic hemophilia, is an X-linked genetic disorder caused by missing or defective Factor VIII, a clotting protein. Although it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous mutation, a new mutation that was not inherited. Approximately 1 in 10,000 people have hemophilia A.
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening genetic diseases and medical conditions. The Company selects product candidates for diseases and conditions that represent a significant unmet medical need, have well-understood biology and provide an opportunity to be first-to-market or offer a significant benefit over existing products. The Company's portfolio consists of eight commercial products and multiple clinical and preclinical product candidates for the treatment of various diseases.
UCB, Inc. | September 02, 2022
UCB, a global biopharmaceutical company, today announced that it will present 20 abstracts across its dermatology portfolio at the 31st European Academy of Dermatology and Venereology (EADV) Congress in Milan, Italy, September 7-10. The abstracts, accepted for poster presentation, underscore UCB's commitment to delivering innovative solutions that aim to address the unmet needs of people living with dermatological diseases.
"We are proud to present new data from our expanding dermatology portfolio at the 31st EADV Congress. At UCB, our ambition is to transform the lives of people living with severe diseases such as psoriasis and psoriatic arthritis, and the strength of scientific data at this year's congress reaffirms our long-standing commitment to raising standards of care," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.
Key data to be presented on UCB's investigational product bimekizumab include new results from the BE BRIGHT open-label extension study evaluating maintenance of response with bimekizumab through three years in patients with moderate to severe plaque psoriasis who responded at week 16 during Phase 3 clinical studies. New analysis of pooled safety data from up to three years of treatment with bimekizumab in the treatment of moderate to severe plaque psoriasis across Phase 2 and 3 clinical trials will also be presented. Bimekizumab is an investigational product; its efficacy and safety have not been established for any indication in the U.S. and it is not approved by the U.S. Food and Drug Administration (FDA).
For CIMZIA® (certolizumab pegol), data to be presented include three-year data from three Phase 3 trials evaluating the association of patient-reported outcomes (Dermatology Life Quality Index, DLQI 0/1) with relative skin clearance improvements (Psoriasis Area and Severity Index, PASI) in subgroups of adult patients with moderate to severe plaque psoriasis.
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB).