Johnson and Johnson aims to torpedo thousands of talc cases with one high-stakes hearing

Johnson and Johnson faces about 14,200 lawsuits alleging harm from talc, and Monday marks its next big test. In a New Jersey courtroom, the drugmaker plans to challenge expert evidence set to be presented at trial and the judges decision will determine the fate of most of the outstanding lawsuits. That evidence is key to 85% of the cases grouped for consideration in J&J's home state. If the court decides the plaintiffs' expert evidence can't be used in court, then "there's nowhere for these cases to go," a lawyer for J&J told the Wall Street Journal. Apparently, the company has high hopes for the outcome. "[W]hen folks have a chance to really look at the facts in these cases, they see that the product is safe and that the company acted responsibly," CFO Joe Wolk told analysts on the company's Q1 earnings call last week. The talc plaintiffs argue J&J's products caused them to develop cancer and that the company hid the risks from the public. Meanwhile, at a federal court in Delaware, J&J on Friday fell short in its attempt to combine 2,400 state lawsuits from around the country in the court where several units for its supplier Imerys filed for bankruptcy.

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FORTREA SELECTS COGNIZANT AS ITS TECHNOLOGY TRANSFORMATION PROVIDER

PR Newswire | January 05, 2024

Cognizant and Fortrea, a leading global provider of clinical development and patient access solutions to the life sciences industry, today announced that Cognizant has been selected as Fortrea's strategic technology transformation provider. By partnering with Cognizant, Fortrea aims to continue advancing its mission and delivering solutions to its pharmaceutical, biotechnology and medical device customers – and to the patients those customers serve – within the confines of a sound and secure digital infrastructure. Over the four-year agreement, Cognizant is expected to transform Fortrea's global technology environment. Cognizant's approach to the project is expected to bring the speed and agility necessary for the deployment of the next generation hybrid cloud and platforms required for a new era of digital innovation for Fortrea. The state-of-the-art technologies and services are designed to empower Fortrea to transform into a "born digital" organization, enabling a seamless digital experience with agility and efficiency across many different touchpoints. In June 2023, Fortrea successfully completed its spin-off from its former parent company in a move designed to enhance its agility; capitalize on growth opportunities in phase I-IV clinical trials and patient access; and extend its leading positions in oncology, clinical pharmacology and partnership models. In 2024, Cognizant will play a fundamental role in the exit from Fortrea's Transition Service Agreements with its former parent company, facilitating a smooth switch and the establishment of the global Fortrea infrastructure, application management, and end-user services. Cognizant's strategic services are expected to elevate Fortrea's data and analytical capabilities with the goal of setting new standards in the CRO industry and driving modernization required to support Fortrea's global operations. Fortrea also expects to benefit from Cognizant's robust life sciences and healthcare technology experience to help address the evolving needs of its customers, including some of the industry's leading enterprises. "Today's announcement reflects Fortrea's renewed organizational agility following our spin-off," said Alejandro Martinez Galindo, Chief Information Officer of Fortrea. "We are selectively investing in clinical applications and platforms that give us and our customers an advantage in the race to bring life-changing treatments to patients faster. As we build the infrastructure that's essential to supporting these platforms and quickly delivering the insights our customers rely on, we have the opportunity to be 'born digital.' Our new modern ecosystem will be designed to speed decision making with innovation in clinical development. Cognizant's deep expertise will help make our vision a reality." "Cognizant is proud to partner with Fortrea as they leverage technology to build a world-class culture of excellence that benefits customers, patients, employees and shareholders," said Cognizant EVP, Software and Platform Engineering, Prasad Sankaran. "With our deep domain expertise in clinical trial platforms, medical administration automation and secure collaboration, we can help Fortrea fortify its position as an independent, best-in-class digital, global Contract Research Organization." "We're looking forward to bringing Cognizant expertise from across our service portfolio to support Fortrea's goal of providing a seamless digital experience for their customers. And we expect our work together will help Fortrea achieve a step-change from the legacy systems common across the industry, to a fully digital ecosystem leveraging the latest technology, which should result in better customer experiences and greater efficiency," said Cognizant EVP & President of the Americas, Surya Gummadi. About Cognizant Cognizant engineers modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast-changing world. Together, we're improving everyday life. About Fortrea Fortrea is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea's solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team of about 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

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SHL Medical partners with SteriPack Group to set up final assembly service

PR Newswire | January 25, 2024

SHL Medical, a world-leading solutions provider of advanced drug delivery systems and SteriPack Group, renowned global supplier of secondary packing and final assembly services to the pharmaceutical industry, enter a non-exclusive strategic partnership. Together, they aim to establish a pre-validated final assembly service at the SteriPack facility in Poland, enhancing the overall flexibility of supply chain strategies for their customers. In addition to SHL Medical's existing final assembly, labeling, and packaging¬ services in the United States, this collaboration extends high-quality CMO options to Europe. Markus Puusepp, SHL Medical's Chief Growth Officer, expressed enthusiasm about the partnership, stating "This partnership is a significant addition to the Molly platform value proposition. We share common values with SteriPack, from focus on the customer to a commitment to quality, making the decision to collaborate straightforward." Recognizing the importance of flexibility and time-to-market, especially in clinical production, the partnership with SteriPack will offer SHL Medical's customers highly flexible and personalized final assembly and packaging solutions. This is particularly beneficial for small batch handling in clinical supply and niche markets like rare diseases. Emphasizing the comprehensive capabilities of the Molly platform, SHL Medical aims to deliver right-sized solutions that ensure improved service, faster timelines, and a more streamlined supply chain for its diverse customer base. John Ward, SteriPack Group's VP Pharmaceutical Solutions commented "SteriPack Group looks forward to supporting SHL Medical and their customers in providing quality and flexible solutions to a fast- moving market. With an emphasis on creating service solutions designed around specific customer requirements, this partnership will make the process of working with the Molly platform an easy decision." About SHL Medical As a world-leading solutions provider of advanced drug delivery systems, SHL Medical is the partner of choice for many leading pharma and biotech companies. Driven by its company purpose – Enabling Patients' Independence – SHL Medical offers patient-centric solutions for the design, development, and manufacturing of autoinjectors, pen injectors, as well as innovative specialty delivery systems for large-volume and high-viscosity formulations. It also offers final assembly, labeling, and packaging solutions for its drug delivery systems. In response to the rising trend in home therapy, SHL Medical has increased its developmental work in the digital healthcare sector to help improve the drug delivery ecosystem. Located across Switzerland, Taiwan, Sweden, and the US, SHL Medical's global team of experts collaborate seamlessly as one team in utilizing its comprehensive in-house manufacturing capabilities. Its solutions offer customization and optimization for each project while proactively weaving sustainability-driven measures into its designs and processes to contribute to a cleaner earth. About SteriPack Group SteriPack Group is a globally renowned contract packing and manufacturing organisation serving the pharmaceutical and medical device sectors respectively. With a strong emphasis on innovation, quality and compliance, SteriPack's services to the pharmaceutical industry include device design and development, final assembly, labelling, secondary packing, serialisation and aggregation of injectable formats including vials, pre-filled syringes, and autoinjectors. SteriPack's tailored customer-focused solutions make it an ideally suited supplier for small to medium-sized batch volumes required for a growing market of targeted therapies as well as clinical trials. Its proven capabilities in cleanroom assembly and labelling as well as secondary packing services for drug delivery systems and medical devices, combined with significant investment into growing cold chain storage capacity, have helped to make it a trusted partner to top global pharmaceutical companies.

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AION Labs Welcomes Amiti as Strategic Partner to Accelerate Israel's Position as a Leading Hub for Transformative AI-Powered Drug Discovery Innovation

PR Newswire | January 09, 2024

AION Labs, the first-of-its-kind venture studio spearheading the adoption of AI technologies and computational science to solve therapeutic challenges, announced today a new strategic partnership with Amiti Ventures, one of the leading early-stage venture capital firms in Israel. The partnership further strengthens the alliance of global leaders in pharma, biotech, and technology investment, expanding its offering as a venture studio and partner for new startups. "With a proven track record of identifying the best teams for the mission and investing early in the most innovative deep tech startups that shape the future, Amiti Ventures will bring important complementary capabilities and expert investor knowledge to the AION Labs partnership," said Mati Gill, CEO of AION Labs. "We thank Amiti for its vote of confidence in our model of innovation for groundbreaking AI and computational biotech ventures. We further appreciate Amiti's recognition that Israel's ecosystem is poised to lead the world in bringing AI and biotech together to solve our biggest drug discovery challenges." By joining forces with Amiti, AION Labs is enhancing its expertise and capabilities in the deep tech and computational technology domains, areas that are critical to the success of biotech innovation. Amiti's extensive experience and track record in these fields will bring invaluable investor knowledge and insights to AION Labs, enabling it to more effectively develop and support early-stage startups focused on AI and computational biology. Amiti's first investment in the venture studio will entail investment in DenovAI Biotech's Seed round of funding. Launched in 2022, DenovAI is developing an AI-powered biophysics solution for de novo antibody and protein design. AION Labs builds and invests in early-stage startup teams focused on AI and computational biology in drug discovery and development, offering them top-notch resources and mentorship while working closely with them to develop new technologies that meet the most significant challenges in the pharmaceutical industry. The partnership with Amiti Ventures will help AION Labs to advance healthcare towards patient-centric precision medicine and create a significant contribution to the health and well-being of humankind by helping to bring new treatments to market faster and more efficiently. "We believe that AION Labs is uniquely positioned to identify the biggest challenges to accelerate drug discovery and development and then evaluate the best computational bio approaches and entrepreneurs," said Ben Rabinowitz, Founder and Managing Partner of Amiti Ventures. "AION Labs' venture studio model bridges the gap between outstanding academic research, huge leaps forward in generative AI, and the biggest challenges and opportunities in the development of new medicines, and we look forward to working closely with our new partners to make this a reality. "We also have been amazed by the can-do spirit of the AION Labs team," added Rabinowitz. "It is that readiness to create, pull themselves up by the bootstraps and forge ahead with amazing innovation that makes AION and Israel's entire startup ecosystem so special." About AION Labs AION Labs is a first-of-its-kind alliance of Astrazeneca, Merck, Pfizer, Teva, the Israel Biotech Fund, Amiti Ventures, and Amazon Web Services (AWS), powered by BioMed X with the support of the Israeli Government via the Israel Innovation Authority, that have come together with one clear mission: to create and adopt groundbreaking new AI technologies that will transform the process of drug discovery and development in order to contribute to the health and well-being of all people world-wide. AION Labs is a unique venture hub where brilliant innovators and scientist-founders convene from around the world to solve the biggest R&D challenges guided by years of accumulated know-how, data and experience in pharma. The lab leverages its partners' wealth of knowledge and a new multidisciplinary mindset with the ingenuity, agility and innovative power of Israel's startup ecosystem, to develop strong companies with clear long-term strategies, that will pave the way to the future of healthcare. AION Labs cultivates innovation from within; its unique venture creation process bridges the gap between outstanding academic research in the field of AI and the biggest R&D needs in the discovery and development of new medicines for the benefit of patients.

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