Humana calls Mallinckrodts Acthar a billion-dollar golden goose in 700M Dollars fraud lawsuit

FiercePharma | August 12, 2019

Mallinckrodt is getting burned on all sides as federal prosecutors scope out the drugmakers controversial H.P. Acthar Gel marketing and price hikes. Now, one of the largest U.S. insurers is looking to pile on. Humana overpaid for Acthar by 700 million dollars because of Mallinckrodts widespread campaign to stifle competition and pay doctors and patients to choose the pricey med, the insurer said in a new federal lawsuit in California. Humana accused Mallinckrodt of a complex, multipart scheme involving monopoly, bribery, racketeering, fraud, and other deceptive and unfair practices to fuel the drugs skyrocketing price increases and induce physicians to boost prescriptions. Mallinckrodt acquired Acthar in 2014 as part of a $5.6 billion purchase of Questcor, which has landed the U.K. drugmaker in a raft of legal problems since its buyout. Humana did not provide a statement on the lawsuit, citing a "longstanding policy not to comment on pending litigation." A Mallinckrodt spokesman could not be reached for comment by press time.

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In the world of commercial research and science, there’s probably no undertaking more daunting—or more expensive—than the process of bringing a new medicine to market. For a new compound to make it from initial discovery through development, testing, and clinical trials to finally earn regulatory approval can take a decade or more.  Learn how Novartis and Microsoft are coming together using AI and leading research capabilities to advance medicine.

Spotlight

In the world of commercial research and science, there’s probably no undertaking more daunting—or more expensive—than the process of bringing a new medicine to market. For a new compound to make it from initial discovery through development, testing, and clinical trials to finally earn regulatory approval can take a decade or more.  Learn how Novartis and Microsoft are coming together using AI and leading research capabilities to advance medicine.

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BUSINESS INSIGHTS

Curia and Replicate Bioscience Enter Strategic Collaboration to Create Groundbreaking Development Platform for Self-Replicating RNA (srRNA)

Curia | June 10, 2022

Curia, formerly AMRI, a leading contract research, development and manufacturing organization, and Replicate Bioscience, a company pioneering ways to prevent drug resistance in cancer and to treat autoimmune and inflammatory disorders and other diseases using self-replicating RNA (srRNA), today announced that they will collaborate on a robust development platform for Replicate’s srRNA therapeutics. As part of the collaboration, Curia’s experienced process development team will support the GMP production of Replicate Bioscience’s srRNA vectors up to eight-liter scale (8L), which can be used in Phase 1 through pivotal clinical trials. Curia’s global mRNA development and manufacturing facility is ISO-13485 certified and located near Boston, Massachusetts. This facility also supports innovators engaged in vaccine and other mRNA therapy development and manufacture through Phase 2 and 3, including GMP assays. Additional Curia facilities support manufacture of srRNA through commercial production scales. “Replicate’s approach to srRNA is unique, in that we create our own virally-derived synthetic vectors to customize srRNAs to deliver specific proteins,” said Replicate Co-founder and Chief Development Officer Andrew Geall, Ph.D., who previously has set up srRNA CMC frameworks for companies including Novartis, Synthetic Genomics, and Precision Nanosystems. “This customization has important therapeutic. advantages—versatility of application, lower dosing, and longer duration of therapeutic effect compared to other RNA modalities—but requires built-for-purpose processes to solve the challenges of manufacturing longer RNAs. Curia’s unprecedented expertise in process development and end-to-end integration of longer RNAs makes them a perfect partner for us as we transition from research into clinical development and the production of our srRNA for trials in patients.” “The manufacture of these longer mRNAs is more technically challenging than non-replicating mRNAs and to date we have succeeded with mRNAs up to 16,000 bases. Curia’s platform offers versatility and streamlined manufacturing times that can handle such complex molecules. Our collaboration with Replicate Bioscience is enabling us to create entirely new methods of manufacturing longer RNAs. We have built our platform from the ground up, using our combined experience in biologics and chemistry to create end-to-end solutions covering mRNA synthesis, lipid synthesis, formulation, and liquid nanoparticle fill-finish. We are proud to apply our capabilities and expertise to support the Replicate Bioscience team and its innovative approach.” Norman Garceau, Ph.D., Vice President, Global R&D Technology, Curia About Curia Curia, formerly AMRI, is a leading contract research, development and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s 3,700 employees at 29 locations across the U.S., Europe and Asia help its customers advance from curiosity to cure. Learn more at CuriaGlobal.com. About Replicate Bioscience Replicate Bioscience, an ATP company, is designing and delivering srRNA immunotherapies to revolutionize the practice of medicine and improve and save lives. Replicate applies advanced srRNA technology in its work to prevent drug resistance in cancers. The company is also developing srRNA injections for sustained therapeutic protein expression to treat autoimmune and inflammatory disorders and other conditions. Replicate believes that srRNA will bring about the next big breakthroughs in RNA therapeutics and is working to realize the promise of srRNA for all patients.

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PHARMACY MARKET

Stevanato Group Announces Expansion of Corporate Headquarters

Stevanato Group | November 18, 2021

Stevanato Group, a global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries, today announced the expansion of its corporate headquarters with the construction of a new facility in Piombino Dese, Italy to advance operations and growth of the Company. The new 6,750 square meter facility is expected to support the optimization of Stevanato Group’s industrial footprint, with about 2,500 square meters dedicated to increasing the production of high-value products. In addition to hosting offices, the Italian analytical services site, and R&D space, it is also expected to include new glass syringe forming lines devoted to boosting the production of EZ-fill® solutions, which are pre-sterilized drug containment solutions that reduce total cost of ownership and time-to-market for pharmaceutical companies. “We are very proud of the global growth and evolution that Stevanato Group has achieved over the recent years, and we are always exploring new opportunities and ways to meet our customers’ needs. Further increasing our production capabilities here at home through this new space we expect to be able to bridge capacity demands while our exciting projects in the U.S. and China are underway. Importantly, this expansion is further validation of the hard work of our employees, the demand for our innovative products and the continued growth of our business, and we expect it to allow us to be well positioned to build on our current momentum and advance development initiatives that are expected to directly benefit all of our customers and stakeholders around the world.” Franco Moro, CEO of Stevanato Group Construction of the new building began in September 2021. The Company expects to install and validate new lines in the second quarter of 2022, and expects industrial production to begin between late second quarter and early third quarter of 2022. Stevanato Group’s new flagship building represents an important development in its 2020-2023 Industrial Plan, including efforts to meet increasing global demand for premium products. As part of these efforts, the Company recently operationalized two additional lines for EZ-fill® vials and syringes manufacturing in Italy and, in 2022, plans to add two more lines devoted to EZ-fill® syringes as well as one dedicated line for Alba® syringes, the breakthrough solution for biologics. The expansion underway is part of the Company’s expected plans to triple production of EZ-fill® pre-fillable sterile syringes by 2023 and to increase production of EZ-fill® sterile vials and cartridges 19x by 2023, compared to 2016 numbers. Stevanato Group’s new building also marks the Company’s ongoing dedication to and investment in the local Piombino Dese community, where it has been headquartered for more than 60 years. The new building is expected to act as the counterpart to another facility at the Piombino Dese headquarters, recently completed in 2020, also used for the production of syringes and that hosts solar electric panels. These panels produce 160kWp of electricity per year and are intended to provide electricity to both buildings, as Stevanato Group remains committed to sustainability. To that end, the new building is also intended to have a partial recovery system enabling it to reuse water used for washing in production. About Stevanato Group Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients. Forward-Looking Statements This press release may include forward-looking statements. The words "expected", "expects", “intended”, "plans" and similar expressions (or their negative) identify certain of these forward-looking statements. These forward-looking statements are statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, the size and use of the plant, the construction and timing of its plant, impact of the plant of the Company’s business and results of operations and the nature of the plant once complete. The forward-looking statements in this press release are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which the Company will operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements of the Company to be materially different from those expressed or implied by such forward looking statements. Many of these risks and uncertainties relate to factors that are beyond the Company's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behavior of other market participants, the actions of regulators and other factors such as the Company's ability to continue to obtain financing to meet its liquidity needs, changes in the political, social and regulatory framework in which the Company operates or in economic or technological trends or conditions. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements.

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BUSINESS INSIGHTS

With Veeva eConsent, Celerion is changing the consent experience for clinics and patients

Veeva Systems | October 07, 2021

Veeva Systems (NYSE: VEEV ) announced that Celerion has launched Veeva eConsent , a MyVeeva for Patients solution, to provide electronic consent for its Phase I clinical trials obtain. With Veeva eConsent, Celerion is moving from manual and paper-based consent forms to a fully digital process. The company uses Veeva eConsent for several studies and has already given their consent to more than 200 test subjects. Covid-19 limited the time we could spend with attendees. So we needed new and digital ways to advance our studies while meeting regulatory requirements for proper consent, - Staci McDonald , Executive Director, Scientific Clinical Operations at Celerion . An easy-to-use solution that can keep pace with our fast-paced environment and improves the participants' understanding of the study processes. The implementation of the solution went smoothly, and the feedback from the study teams, on-site staff and participants was positive. " Celerion, a leading global provider of early clinical research services, uses Veeva SiteVault to digitally create, manage and distribute informed consent (ICF). Patients can then securely access the eConsent document and complete the consent process via a mobile device. This simplifies the comparison of documents and reduces the administrative effort for the locations. Thanks to a seamless flow of information, Celerion has a complete overview of the status of consent and can thus improve study compliance and monitoring. Celerion is driving industry collaboration by leveraging digital solutions that enable patient-centric, paperless clinical trials, Veeva eConsent improves the process of informed consent for everyone Stakeholders by providing an intuitive and digital experience for patients and easy collaboration with locations and IRBs for sponsors. - Tim Davis , vice president, MyVeeva for Patients at Veeva Systems. About Veeva Systems Veeva is the world's leading provider of cloud software for the life science industry. Veeva is committed to innovation, product quality and customer success, serving more than 1,000 customers from the world's largest pharmaceutical companies to emerging biotech companies. As a not-for-profit, Veeva is committed to aligning the interests of all stakeholders, including customers, employees, shareholders and the industries it serves.

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