Pharmaceutical companies limit competition from generic alternatives by producing their own, new report says

Mic | August 09, 2019

Generic drugs are supposed to be affordable. They are a service to people who cant afford the name brands but still need essential medications for everything from pain relief to allergy prevention. Big drug companies already have the ability to keep these cheaper alternatives off pharmacy shelves for years, but a new report from Kaiser Health News identified a way that drug makers are now using a workaround known as "authorized generics" to limit competition from generic alternatives while keeping prices high and turning a profit. Typically when a generic version of a drug comes to market, it is only made available after a company's patent protection has expired. That protection lasts for 20 years. After that, other companies can produce alternative versions of the medication. These drugs typically have the same active ingredients, purpose of use, dosage form, strength and intended effect for people who use them but may have slightly different aspects about them. For example, Flonase is a popular brand-name allergy medication but generic alternatives of the drug, fluticasone propionate, are produced and made available under labels like CVS or Walgreens. Generics can use different inactive ingredients to create a different flavors or bring down the cost with cheaper fillers. These modifications have to be tested and approved by the United States Food and Drug Administration before they are allowed to be sold to consumers.

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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PHARMACY MARKET

Elixir announces the next wave of innovation for pharmacy benefits technology platform

Businesswire | May 29, 2023

Elixir, a pharmacy benefit management company owned by Rite Aid has announced details of the next release of its Laker Software technology platform. The upcoming enhancements include new automated workflows, a customer service tool and modernization of the user interface. "Already a leader in the industry, Laker Software is going from good to great,” said Jeff Mallad, VP, PBM Technology Sales for Elixir. "Elixir’s technology platform is one of the fastest and most reliable pharmacy claims systems available—and it’s about to become turbo-charged! We’re modernizing the future of pharmacy benefits to support our customers’ business growth, the digital world and cost reduction.” The upgrade will include a range of advanced functionalities that are designed to help customers better manage their pharmacy claims adjudication data and streamline workflows. The new features will allow users to access and share data more efficiently, collaborate more effectively, and improve productivity. For more than 20 years, the Laker Software platform has been a leading technology solution and one of only a few that can manage multiple lines of business including Medicare, Medicaid and Exchange Commercial payers Adjudication and claims processing for 340B pharmacies Prescription savings card programs Workers’ compensation Built on a resilient, scalable architecture, the Laker Software platform is a 100% virtualized environment. The platform processes millions of paid claims per year and is SOC 1 Type 2 certified. It has multiple levels of data security and redundant backup systems. Laker Software provides a full set of robust capabilities, including Claims Processing/Adjudication Call Center Plan Set Up Eligibility Accumulator Accounts Payable/Receivable Prior Authorization Reporting Customers will begin to beta test some of the platform’s newest features shortly, and other enhancements will follow as the next generation of Laker Software evolves. Customers can expect to see improvements in cost reduction due to automation, solutions for improved plan design and channel management, and advanced analytics and statistical analyses. This is in addition to a cloud-based infrastructure and redesigned user interface, allowing for even more flexibility and a better customer experience. "Elixir is committed to investing in innovative solutions to meet the evolving needs of the pharmacy benefits industry,” said Mallad. “In addition to our Laker platform, customers can rely on our full suite of pharmacy benefit services to custom design their ideal solution. We support your business, enable your growth and help you succeed in every segment of the pharmacy lifecycle." About Elixir Elixir, a fully owned subsidiary of Rite Aid Corporation, is a pharmacy services provider that offers pharmacy benefit management services, Medicare-approved prescription drug plans, mail and specialty pharmacy solutions, and prescription discount programs. With the unique ability to optimize the full pharmacy care experience, Elixir is crafting solutions for today’s pharmacy benefits challenges.

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BUSINESS INSIGHTS, PHARMACY MARKET

Enanta Pharmaceuticals Receives FDA Fast Track Designation for EDP-323, its Oral, L-Protein Inhibitor in Development

Businesswire | April 10, 2023

Enanta Pharmaceuticals, Inc. a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDP-323, Enanta’s L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV). "Receiving Fast Track designation from the FDA underscores EDP-323’s potential as a once-daily, oral therapeutic for the treatment of this deadly virus and reflects the pressing need for a highly potent, direct antiviral to treat RSV, particularly for high-risk populations,” said Scott T. Rottinghaus, M.D., Senior Vice President and Chief Medical Officer of Enanta Pharmaceuticals. “Given that EDP-323 has shown sub-nanomolar potency against several RSV-A and RSV-B strains in vitro and is not expected to have cross-resistance to other classes of inhibitors, we believe it could be used as a monotherapy or in combination with other RSV mechanisms to potentially broaden the addressable RSV patient populations or the treatment window. We believe this designation will be a valuable component of our clinical and regulatory strategy as we progress EDP-323 in development.” The Fast Track program is designed to accelerate the development and review of products such as EDP-323, which are intended to treat serious diseases and for which there is an unmet medical need. Fast Track designation enables more frequent communication with the FDA and eligibility for FDA programs such as priority review and rolling review, if relevant criteria are met. EDP-323 is being evaluated in a Phase 1 double-blind, placebo-controlled study designed to assess its safety, tolerability, and pharmacokinetics (PK). Enanta plans to present new preclinical PK data at the European Congress of Clinical Microbiology and Infectious Diseases in April and expects to report topline data from the Phase 1 study this quarter. EDP-323 is supported by in vitro data demonstrating a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B, with consistent potency across a range of RSV clinical isolates in various cell types. In a mouse model of RSV infection, EDP-323 treatment was associated with dose-dependent decreases in viral load in the lung, reduced lung immunopathology and decreases in pro-inflammatory cytokines, including IFNγ, TNFα, and IL1β. Additionally, EDP-323 has favorable oral bioavailability with good plasma exposures across preclinical species and pharmacokinetic properties supporting once-daily, oral dosing in humans. These data indicate that EDP-323 is a potent inhibitor of RSV replication and has the potential to be a best-in-class, once daily, oral antiviral treatment for RSV. About Enanta Pharmaceuticals, Inc. Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections. Enanta’s research and development programs include clinical candidates for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 and hepatitis B virus. Enanta is also conducting research on a single agent targeting both RSV and human metapneumovirus.

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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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