PHARMA TECH

Phio Pharmaceuticals Announces Three Poster Presentations at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting

Phio Pharmaceuticals Corp | October 26, 2020

Phio Pharmaceuticals Corp. a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL™) therapeutic platform, today announced three upcoming poster presentations discussing INTASYL compounds, including posters being delivered by two development partners, AgonOx, Inc. and the Helmholtz Zentrum München, at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2020), to be held virtually from November 9-14, 2020.

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.

Related News

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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PHARMA TECH

USFDA Accepts BioMarin's sNDA to Expand Use of VOXZOGO

BioMarin Pharmaceutical Inc. | March 08, 2023

On March 7, 2023, BioMarin Pharmaceutical Inc., a global biotech company focused on improving lives via genetic discovery, announced that the US FDA has accepted its supplemental New Drug Application (sNDA) for VOXZOGO® (vosoritide) for injection to expand the treatment of achondroplasia in children under the age of 5. Achondroplasia is a common form of disproportionate short stature. The FDA has set an action date of October 21, 2023, for the sNDA. The sNDA is supported by data from a Phase 2 double-blind, randomized, placebo-controlled clinical trial, which showed similar safety and efficacy profiles in children under five years of age compared to those aged five years and older. The European Medicines Agency (EMA) also validated BioMarin's application for VOXZOGO in January to treat children under the age of 2. If approved, VOXZOGO could be prescribed for over 1,000 additional children from birth for achondroplasia. VOXZOGO is the first EMA and FDA-approved treatment for achondroplasia with open bone growth plates. The treatment uses a new class of therapy, C-type natriuretic peptide (CNP) analog, which promotes bone growth by acting as a positive regulator of the signaling pathway downstream of the fibroblast growth factor receptor 3 gene (FGFR3). The drug is approved in the EU, Brazil, and Australia for children aged two years and above with epiphyses (bone growth plates) and in Japan for children from birth who have achondroplasia with open growth plates. BioMarin has enrolled 250 children with achondroplasia in seven clinical studies in eight countries to evaluate the safety and efficacy of VOXZOGO. About BioMarin Pharmaceutical Inc. BioMarin is a leading biotechnology firm established in 1997 with a mission to transform people's lives by using genetic discovery. The company creates targeted therapies that address the underlying cause of genetic disorders to improve the quality of life for individuals with rare genetic diseases. It has developed eight first or best-in-class treatments and has a range of product candidates to address various genetic disorders using the same science-based approach. As BioMarin continues to create new and innovative solutions, it has the potential to impact the lives of even more people. The company is committed to prioritizing patients and their needs in its approach to drug development.

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PHARMACY MARKET

Xeris Biopharma Announces Research Evaluation Collaboration and Option Agreement With Regeneron for XeriJect™

businesswire | April 03, 2023

Xeris Biopharma Holdings, Inc. a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapeutic areas, today announced that it has entered into a platform research evaluation collaboration and option agreement with Regeneron Pharmaceuticals, Inc. Under the terms of the agreement, Xeris will use its proprietary drug-formulation platform, XeriJect™, to develop ultra-highly concentrated, ready-to-use, small volume subcutaneous injections of two undisclosed monoclonal antibodies developed by Regeneron. Xeris will receive an upfront payment and potential milestone payments for preclinical achievements. Regeneron has an option to commercially license the Xeris technology for such molecules and nominate additional molecules for reformulation and potential commercialization. Specific financial terms of the agreement were not disclosed. “We are excited to be working with Regeneron on a platform collaboration basis, which builds on our prior feasibility studies and reflects the significant progress and investment we have been making into the development of XeriJect™,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “Through our novel drug-formulation platform, we aim to provide our biologic development collaborators with the competitive advantage of delivering a significantly improved patient and provider experience through stable, ready-to-use, ultra-highly concentrated, small-volume subcutaneous injection formulations. This agreement with Regeneron is another in a series of collaborations Xeris has recently undertaken with top pharmaceutical and biotechnology companies.” About XeriJect™ Xeris’ drug-delivery system, XeriJect, provides innovative, ready-to-use, viscoelastic pharmaceutical suspensions that have the potential to improve drug delivery, lower treatment burden and improve patients' lives across a broad range of therapeutic categories. XeriJect suspensions maximize drug loadings at >450mg/mL, enable small volume subcutaneous injections, do not settle on storage and are ready-to-use. The suspensions use FDA-approved excipients and leverage known manufacturing processes. XeriJect formulation technology is well suited for drugs and biologics including large molecules such as proteins, monoclonal antibodies, and vaccines. The technology is protected by an extensive patent estate, trade secrets and know-how, and it is available for licensing. About Xeris Xeris is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing differentiated and innovative products across a range of therapies. Xeris has three commercially available products: Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; Keveyis®, a proven therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris has a diverse pipeline of development and partnered programs using its formulation sciences, XeriSol™ and XeriJect™, to support long-term product development and commercial success.

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