Jazz, Alexion and Lundbeck to pay $122m to settle kickback probe

Jazz Pharmaceuticals | April 08, 2019

Drugmakers Jazz Pharmaceuticals, Lundbeck and Alexion Pharmaceuticals have agreed to pay a total of $122.6m to settle allegations of paying kickbacks via copay assistance foundations. The US Department of Justice (DOJ) said that the companies violated the False Claims Act by paying patients under Medicare and the Civilian Health and Medical Program (ChampVA) through purportedly charitable organisations. These charitable foundations allegedly subsidised the copays with financing from the companies. The Anti-Kickback Statute restricts drugmakers from offering or paying, directly or indirectly, in the form of money or any other thing of value to motivate Medicare or VA patients to buy their medicines.

Spotlight

Welcome to Pharmaprojects’ 2023 review of trends in pharmaceutical R&D. For over 30 years now, I’ve been taking an annual look at the evolution of pharma R&D, and in this article, I’llexamine the state of play at the start of 2023.

Spotlight

Welcome to Pharmaprojects’ 2023 review of trends in pharmaceutical R&D. For over 30 years now, I’ve been taking an annual look at the evolution of pharma R&D, and in this article, I’llexamine the state of play at the start of 2023.

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RESEARCH, BUSINESS INSIGHTS

Allucent Extends Medidata Clinical Cloud Usage to Expedite New Drug Development

Medidata Solutions | March 13, 2023

Medidata, a leading provider of innovative software solutions for clinical trials that streamline the clinical trial process, reduce time and cost, and accelerate the development of new treatments, recently announced that Allucent, a contract research organization (CRO) that brings innovation to biopharma firms, is expanding the global use of Medidata's Clinical Cloud to enhance its clinical trial operations offering. This agreement extends Allucent's current usage of Medidata's technology, which includes eCOA, Rave EDC, RTSM, and Rave Imaging, supporting crucial development areas such as rare and orphan indications, oncology and cell and gene therapies. As part of the deal, Allucent's team achieved 100% Rave EDC certification, reinforcing their dedication to quality and providing clients with industry-leading technology. Allucent is a sponsor of Medidata NEXT London and will give a presentation on data analytics for early-phase oncology trials. The presentation will cover how working with Medidata has helped them apply visualization techniques and strategies to extract the total value of information for all stakeholders. Medidata is a Dassault Systèmes company poised to drive the digital transformation of life sciences in the age of personalized medicine with its 3DEXPERIENCE platform. This platform is the first end-to-end scientific and business solution, from research to commercialization. Medidata's head of Global Sales, Janet Butler, commented, "Allucent is leveraging the power of the Medidata Clinical Cloud to solidify their position at the forefront of clinical technology." She further emphasized, "Their work with novel therapies requires agile, patient-centric solutions. We are proud to build on our eight-year collaboration to advance the digital transformation of life sciences and deliver clinical innovations to help reach their goals." (Source – Business Wire) About Medidata Solutions Medidata Solutions is a New York-based global provider of cloud-based software solutions for clinical trials. Its platform, the Medidata Clinical Cloud, enables pharmaceutical, biotechnology, medical device companies, and academic research organizations to manage all aspects of clinical trials, including study design, data capture, management, and analysis. Medidata's platform can capture real-time data from multiple sources, including electronic health records and wearable devices, to monitor patients closely, identify potential safety issues earlier, and make informed decisions about trial design and treatment protocols. The platform also features advanced analytics tools like machine learning and artificial intelligence algorithms to help researchers analyze and interpret their data. In 2019, Dassault Systèmes, a global leader in 3D design software and simulation solutions, acquired Medidata, further enhancing its platform.

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BUSINESS INSIGHTS, PHARMACY MARKET

Shields Health Solutions and Nemours Children’s Health, Delaware Partner to Enhance Specialty Pharmacy Services for Pediatric Care

Shields Health Solutions | March 17, 2023

Shields Health Solutions (Shields), the premier specialty pharmacy accelerator in the country, announced that it has partnered with Nemours Children’s Health, Delaware, to collaborate in developing a specialty pharmacy program that will provide patients with complex, chronic conditions access to specialized pharmacy services designed to lower costs, expand treatment options, enhance medication management, and improve overall health. Shields will provide Nemours Children’s Health new support services through its partnership to meet the unique needs of patients with complex chronic conditions. Now, specialty pharmacy liaisons will work with patients on-site in clinics, offices, and pharmacies, among other locations, guiding patients who fill their prescriptions with Nemours Children’s. These liaisons work with teams of experts to assist patients and families with a multitude of tasks, including health insurance prior authorizations or securing financial assistance to help overcome one of the significant barriers to care. These expanded patient support services, combined with access to recently approved and newly available drugs, will give Nemours’ patients greater availability for onsite treatment options. Shields currently partners with nearly 80 health systems around the country and has helped their patients reduce co-pays, promptly receive medication delivery, often within two days, and improved medication adherence greater than 90 percent on average. Nemours Children’s Health is one of the largest multistate pediatric health systems in the country and provides award-winning care to more than 38,000 specialty patients. The complete health system includes two free-standing children's hospitals and a network of more than 70 primary, specialty and urgent care practices. US News & World Report ranked Nemours Children’s Hospital, Delaware among the 10 best children’s hospitals in the Mid-Atlantic region and recognized Nemours Children’s Hospital, Florida for excellence in orthopedics and endocrinology. “Nemours’ commitment to outstanding care for children with chronic diseases aligns with Shields core mission,” said Stephen Davis, Senior Director of Health System Strategy. “Specialty pharmacy services provide challenges for all patient populations, but pediatric patients have unique needs that require tremendous support. We are proud to provide that support for patients at Nemours Children’s Health and help them achieve the best possible health outcomes.” “As Nemours Children’s Health works toward creating the healthiest generations of children, it is imperative to address social determinants of health including access to medications that are affordable, said,” said Robert J. Mullen, BS, PharmD, RPh, Vice President, Patient Operations, Delaware Valley, at Nemours Children’s Health, Delaware. “Specialty pharmacy services can cause many challenges for the complex patients that Nemours Children’s cares for on a daily basis. We are proud to be partnering with Shields Health Solutions to help ease the burden for families acquiring prescription medication for their children and in turn achieve better health outcomes.” About Shields Health Solutions Shields Health Solutions (Shields) is the premier specialty pharmacy accelerator in the country. The Shields Performance Platform, an integrated set of solutions, services and technology, is intentionally designed to elevate payer and drug access for specialty pharmacies, elevate health outcomes for complex patients, and elevate growth throughout the entire health system. As the foremost experts in the health system specialty pharmacy industry, Shields has a proven track record of success including access to over 80 percent of all limited distribution drugs (LDDs) and most (health insurance) payers in the nation; and a clinical model proven to lower total cost of care by 13%. In partnership with more than 70 health systems across the country through national-scale collaboration, Shields has a vested interest in delivering measurable clinical and financial results for health systems.

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PHARMA TECH

Leading Pharmaceutical Company in Brazil Chooses ValGenesis iRisk to Redefine and Automate Risk-Based Validation Processes

prnewswire | May 30, 2023

ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems announced that a leading pharmaceutical company in Brazil selected ValGenesis iRisk to redefine and automate the company's risk-based validation processes. ValGenesis iRisk is the world's most advanced risk management platform, used by top pharmaceutical companies across the world. With corporate origins in Japan, the company draws upon a rich legacy of innovation and a pipeline of robust therapeutics that are enhancing the lives of millions of people across the globe. Working to keep pace with ever-changing business and regulatory landscapes, the company chose ValGenesis iRisk because it enhances business performance and business process excellence across end-to-end product and process lifecycles. On this compliant platform, experts can analyze, visualize, query, and compare risk over different products, processes, production sites, and more, sharing a continuous flow of risk communications between relevant stakeholders to get products to market more quickly and safely. "Brazil is the largest pharmaceutical market in Latin America, and we are happy that more companies are turning to ValGenesis for risk-based validation solutions that enforce a structured and consistent approach to risk, " says Steve Reynolds, Chief Revenue Officer at ValGenesis. "ValGenesis iRisk is able to deliver on these stringent requirements simply, efficiently, and very cost-effectively." ABOUT VALGENESIS ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.

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