Business Insights, PHARMACY MARKET
PRNewswire | August 09, 2023
Verista, a leading business and technology services company offering specialized solutions for the life sciences industry, is delighted to announce a new partnership with Sware. This collaboration underscores Verista's commitment to its clients to provide advanced and innovative digital validation solutions, helping them realize Pharma 4.0.
By incorporating Sware's Res_Q platform, clients can enhance, streamline, and optimize the flow of content and data, effectively addressing the challenges posed by static documents and disjointed workflows in the validation discipline. Together, Verista services and Res_Q provide a powerful combination, offering customers a comprehensive and efficient risk-based approach to validation processes in the life sciences industry.
"In this partnership, Verista will drive the efficient execution of digital transformations with Res_Q enabling clients to modernize their processes and leverage the latest regulated technologies in compliant ways," says Manny Soman, CEO of Verista. "We are delighted that Verista and Sware share the same goal to reduce and manage validation efforts while helping clients unleash the full potential of digital transformation to bring their products to market more quickly and safely."
"Digitizing the validation process is crucial for compliance-focused life sciences companies to be able to meet stringent global regulatory requirements, but digitizing processes means much more than putting paper processes on glass," says Bryan Ennis, Co-Founder and CEO of Sware. "Our partnership with Verista couples our deep digital technology expertise with robust industry experience to deliver the most comprehensive, intelligent and digital validation solutions on the market today."
ABOUT VERISTA
Verista is a leading business, technology and compliance company that enables clients to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from clinical to commercialization, manufacturing and distribution. Verista's experts continually deliver consistent, safe, and high-quality results across the product development lifecycle in the areas of enterprise and lab solutions, technology solutions, manufacturing solutions, and regulatory compliance and product management.
ABOUT SWARE
Sware is changing how the life sciences industry manages validation – helping companies deliver safer therapies through better technology. Sware provides one validation solution crafted specifically for the entire life sciences industry. Res_Q by Sware automates validation – effortlessly navigating through each step of the validation process for both GxP and non-GxP systems.
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Business Insights, PHARMACY MARKET
Businesswire | August 07, 2023
Mind Medicine Inc a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today that it has entered into a license agreement with Catalent, a leader in enabling the development and supply of better treatments for patients worldwide, to access Catalent’s proprietary Zydis® orally disintegrating tablet (ODT) technology.
Under the terms of the licensing agreement, Catalent has granted MindMed access to its Zydis technology for the development of MindMed’s lead product candidate MM-120 (lysergide D-tartrate), which is a proprietary, pharmaceutically optimized form of lysergide. The agreement also provides MindMed with exclusive rights for the use of the Zydis technology to develop all salt and polymorphic forms of lysergide in the United States, United Kingdom, and European Union among other key territories. Zydis ODT is a unique, freeze-dried, oral solid dosage form that disperses almost instantly in the mouth, without the need for water. Zydis is also recognized as one of the world’s best performing ODTs and has well-established advantages over conventional oral dosage forms, including improved patient compliance, adherence and convenience.
“We aim to develop best-in-class brain health treatments that have the potential to reach patients in need and are pleased to be working with Catalent, a global CDMO leader with broad, deep-scale expertise in delivery technologies, and multi-modality manufacturing capabilities to reach this objective”, said Robert Barrow, Chief Executive Officer and Director of MindMed. “ODT formulations have the potential to result in enhanced bioavailability and more rapid absorption, which could ultimately culminate in a shorter treatment session for MM-120. We believe that the Zydis ODT delivery technology, when incorporated into our MM-120 product candidate, represents an optimized pharmaceutical product that has the potential to enhance our competitive advantage in the marketplace and continue to expand our intellectual property estate. If granted, based on our current and ongoing applications that incorporate the Zydis ODT platform, MM-120 would benefit from numerous patents with first expiration dates beginning in 2042.”
“Catalent has a proven track record in working with partners to bring novel therapies through the clinic and to market quickly and we look forward to working with MindMed in the development of this potentially life-changing new product candidate,” said Tom Hawkeswood, President, Division Head of Pharma Product Delivery at Catalent. “The Zydis technology platform has been shown to be very versatile and effective in developing easy-to-administer dose forms for innovators, and its superiority over other ODTs has been illustrated by its use in the launch of more than 36 products in over 60 countries.”
MindMed is currently conducting a Phase 2b trial evaluating MM-120 for the treatment of generalized anxiety disorder (GAD) with topline data expected in the fourth quarter of 2023. This Phase 2b trial is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The participants are randomized to receive a single administration of 25 µg, 50 µg, 100 µg or 200 µg of MM-120 or placebo. The primary objective is to determine the reduction in anxiety symptoms four weeks after a single administration of MM-120, compared across the five treatment arms. Key secondary objectives, measured up to 12 weeks after the single administration, include assessments of anxiety symptoms, safety and tolerability, as well as other measures of efficacy and quality of life. More information about the trial is available on our website (mindmed.co), the trial website (anxietyresearchstudy.com) or on clinicaltrials.gov (identifier NCT05407064). In addition, MindMed is in the process of initiating a Phase 1 pharmacokinetics bridging study to support advancement of the MM-120 ODT formulation into pivotal clinical trials.
About MindMed
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.
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Business Insights
PRnewswire | July 28, 2023
TriRx Pharmaceutical Services, LLC, a Contract Development and Manufacturing Organization (CDMO), welcomed the UK Government's recent announcement on England's second Investment Zone, focused on Life Sciences in the Liverpool City Region.
TriRx Speke Ltd. is the first investor and is well-positioned to further advance its capabilities by adding upstream technologies to manufacture monoclonal antibodies to an existing large-scale biotech purification facility. The current facility has significant capacity to support the high-growth large-molecule pharmaceutical market. Monoclonal antibodies (also referred to as mAbs) are a type of immunotherapy that work by blocking certain diseases from affecting healthy cells and are used to treat numerous types of diseases including cancers, arthritis and skin conditions. This additional investment to augment the TriRx facility at Speke will foster economic growth, create high-value jobs and complement the existing Speke Biopharmaceutical cluster in the region.
"We are delighted to be expanding our capability in this critical immunotherapy area, to become a worldwide center of technical excellence located in the UK in the monoclonal antibody development and manufacturing field to serve the human and animal pharmaceutical markets," said Tim Tyson, Chairman and CEO of TriRx.
About TriRx Pharmaceutical Services:
TriRx Pharmaceutical Services is a global contract development and manufacturing organization (CDMO) serving global pharmaceutical, biopharmaceutical and animal health markets. Headquartered approximately 50 miles outside of New York City in Norwalk, Connecticut, TriRx operates facilities in multiple regions providing state-of-the-art laboratory, manufacturing, packaging, warehousing, and technical service capabilities. Founded and led by a team of pharmaceutical industry executives, who have served as both contract service providers and outsourcing customers, TriRx has a profound and multifaceted understanding of client needs. It has the knowledge and commitment to deliver an exceptional experience on every project, consistently meeting or exceeding quality standards, regulatory requirements, on-time-in-full (OTIF) delivery, and all other customer requirements and expectations.
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