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MELBOURNE, Australia, July 9, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that its next-generation PSMA[1] PET[2] imaging agent, Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), has been granted a permanent Healthcare Common Procedure Coding System (HCPCS) code by the U.S. Centers for Medicare & Medicaid Services (CMS). Effective from 1 October 2025, CMS and commercial health insurers will recognise the HCPCS Level II code A9616 assigned for reimbursement of Gozellix. The assignment of the code is a significant milestone supporting provider billing and reimbursement for Gozellix, and a further step toward receiving Transitional Pass-Through (TPT) payment status. After radiolabelling with 68Ga, Gozellix is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected biochemical recurrence (BCR) based on elevated serum prostate-specific antigen (PSA) level. With its extended shelf-life and flexible production options, Gozellix overcomes many of the logistical barriers that have historically limited access to PSMA-PET imaging. Telix believes receiving a HCPCS code will support clinical adoption of Gozellix and expanded access to PSMA PET imaging. Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, said, "Being granted a HCPCS code marks a significant step forward in Telix's mission to improve access to precision medicine imaging for prostate cancer patients across the United States, regardless of their location. It is also an important enabler for commercial scale-up and reimbursement of Gozellix in the U.S. as we bring our next-generation PSMA PET imaging agent to market." About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX). Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix's first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA[3]. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook. [1] Prostate-specific membrane antigen. [2] Positron emission tomography. [3] Telix ASX disclosure 21 March 2025. Telix Investor RelationsMs. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com Telix Investor Relations (U.S.) Annie Kasparian Telix Pharmaceuticals Limited Director Investor Relations and Corporate Communications Email: annie.kasparian@telixpharma.com This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices Cautionary Statement Regarding Forward-Looking Statements You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix's business; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. Trademarks and Trade NamesAll trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties. ©2025 Telix Pharmaceuticals Limited. All rights reserved.
TOKYO, July 9, 2025 /PRNewswire/ -- Visitors to the Watson-Marlow Fluid Technology Solutions booth W15-2 at INTERPHEX Tokyo 2025 (July 9-11 at Tokyo Big Sight, Japan) can learn more about the new WMArchitect Interchangeable Parts service as well as how recently advanced manufacturing of BioClamp is bringing sustainability benefits to users. Steven Lin, Sales Engineer; Faith Tang, Head of APAC Marketing; Hirotoshi Watanabe, Engineer; Hironobu Kirii, Sales Leader The single-use sanitary BioClamp®, from BioPure, has been re-engineered in both its design and manufacturing process. Visitors to booth 15-2 can discover how BioClamp is manufactured to be 13% lighter than the previous model, with a 26% reduction in carbon dioxide emissions across the full lifecycle of the product. BioClamp is one of multiple innovative solutions WMFTS offers for pharmaceutical and biotechnology companies, including expert services, peristaltic pumps, tubing, assemblies, and valves. Competitive bulk order prices are available due to the highly efficient manufacturing methods of BioClamp, which securely attaches sanitary fittings and is ideal for single-use critical fluid transfer lines. Following the release of WMArchitect™ single-use solutions last year, the Interchangeable Parts service allows users to reduce single-use component supply limitations by incorporating pre-qualified, alternative components into their single-use assemblies. The versatile service eliminates the disruption of reduced stock and potential for production shutdown, as well as avoiding the need to evaluate substitute parts quickly in time-sensitive incidents. This service meets industry best practices and has been developed according to industry working group consensus on interchangeability of components. According to Market Data Forecast, the Asia Pacific biopharmaceuticals market was valued at $44.3 billion in 2023 and is expected to be worth $78.69 billion by 2029 with a CAGR of 10.05 per cent from 2024 to 2029. Jacky Chan, WMFTS APAC Division Director, said: "Asia is poised to become a manufacturing powerhouse for biopharmaceutical with the macro trends of the rise of decentralised clinical trials (DCTs), personalised medicine, cell and gene therapy (CGT), the expansion of mRNA technologies, and focus on biosimilars. Watson-Marlow Fluid Technology Solutions is here to support the growth of pharma manufacturing by providing an end-to-end biopharmaceutical fluid management solution from a single supplier including the newly launched Interchangeable Parts service. This improvement in supply agility avoids regulatory compliance interruptions when component availability is disrupted. Meanwhile BioClamp is re-engineered to support our customers' sustainability journey in reducing carbon footprint." Akira Uozumi, Regional General Manager of Northeast Asia Region, said: "Our peristaltic pumps and compatible fluid path solutions are renowned in the pharmaceutical and biotechnology sectors. Visitors to our booth at INTERPHEX Tokyo will be able to discover more about our solutions for upstream, downstream and final fill/finish applications. For example, BioPure delivers high-purity fluid transfer components designed to maintain sterility and integrity in biopharmaceutical manufacturing meanwhile Flexicon offers scalable, aseptic filling solutions that maintain sterility and accuracy, ideal for sensitive drug production." The team who are present at the booth are Hironobu Kirii, Sales leader; Steven Lin, Sales Engineer; Suzuki Sales Leader, and Faith Tang, Head of APAC Marketing. Faith Tang is holding a media briefing to the Japanese media at the booth on July 9 afternoon to explain BioClamp and new WMArchitect Interchangeable Parts service to the market. Visit WMFTS at stand W15-2 at INTERPHEX Tokyo to learn more about its innovative fluid management solutions for life sciences applications. Any further enquiries please contact WMFTS Japan team at info.jp@wmfts.com and +81 3 5918 8101, +81-3-3967-8161.
SHANGHAI, July 9, 2025 /PRNewswire/ -- Duality Biotherapeutics' ("DualityBio", HKEX:09606) partner Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, today announced the first patient has been dosed in the Phase 1 portion of a Phase 1/2 clinical study evaluating AVZO-1418/DB-1418, a potential best-in-class, novel EGFR/HER3 bispecific antibody-drug conjugate (ADC), in patients with advanced solid tumors. On January 7th, 2025, DualityBio and Avenzo announced that they have entered into an exclusive license agreement, pursuant to which Avenzo will develop, manufacture and commercialize AVZO-1418/DB-1418, a potential best-in-class EGFR/HER3 bispecific ADC, globally (excluding Greater China). The Phase 1/2 first-in-human, open-label clinical study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-1418/DB-1418 as a single agent and in combination therapy in patients with advanced solid tumors. About DualityBio Duality Biotherapeutics (HKEX:09606) is a clinical-stage biotech company dedicated to the discovery and development of next-generation ADCs to treat cancer and autoimmune diseases. DualityBio has successfully built several cutting-edge ADC technology platforms with global intellectual property rights. Leveraging a robust pipeline, DualityBio is conducting multiple global clinical trials across 17 countries and has enrolled over 2,000 patients for multiple clinical-stage ADC candidates. Additionally, DualityBio has established strategic collaborations with global MNCs and leading biotech innovators. As a global ADC powerhouse, DualityBio is developing novel ADCs, including bispecific ADC candidates, novel-payload ADC candidates, and autoimmune ADC candidates. For more information, please visit www.dualitybiologics.com.
SEOUL, South Korea, July 9, 2025 /PRNewswire/ -- As Southeast Asia's health and wellness market rapidly evolves, consumer expectations are shifting toward multifunctional solutions that go beyond basic digestion. Gut health is now understood as the foundation for immune support, skin clarity, mental balance, and even healthy aging. Among the key microbiome species for gut health, Bifidobacterium bifidum and B. animalis subsp. lactis have emerged as central players in this transformation. BiomeNrich PRO G814, PRO G952 Recognizing this growing need for targeted probiotic innovation, CJ BIO has introduced two new Bifidobacterium strains under its advanced BiomeNrich™ PRO G814 (Bifidobacterium bifidum) and PRO G952 (B. animalis subsp. lactis). Unveiled at Vitafoods Europe 2025, these two human-origin strains reflect CJ BIO's strategy to provide diverse solutions for customers seeking innovative probiotic ingredients for gut health. Their introduction brings new scientific diversity and formulation potential to Southeast Asian partners seeking to meet the region's growing demand for premium gut health ingredients. The inclusion of Bifidobacterium introduces new clinical potential — especially in targeting life stage –specific microbiome challenges such as age-related declines in Bifidobacterium levels, which are associated with gastrointestinal discomfort. BiomeNrich™ PRO G814 and PRO G952 are rooted in over 30 years of scientific research, supported by clinical trials and historical use. The safety of the products has been recognized by the U.S. FDA through GRAS (Generally Recognized as Safe) and NDIN (New Dietary Ingredient Notification), as well as being listed in the QPS (Qualified Presumption of Safety) in Europe. Additionally, their usability is supported by certifications, including Halal and Kosher status, catering to religious needs in the Southeast Asian market. These additional measures have been taken to ensure seamless integration into a wide range of finished products for dietary supplements and functional foods. Beyond safety and regulatory readiness, these strains offer unique advantages in formulation and health outcomes. What sets them apart is not only their clinical performance, but also their origin and quality control. Both strains are isolated from healthy, breastfed infants and selected for their ability to: Strongly adhere to human intestinal epithelial cells Survive in high-acid and bile conditions Deliver measurable benefits for digestive and immune functions BiomeNrich™ reflects our commitment to holistic, gut-organ axis innovation — with these new Bifidobacterium strains representing our next step in enabling partners to formulate with purpose and precision. For more details on clinical performance, origin, application formats, and formulation compatibility:https://online.cjbio.net/bnr_bifido_pr About CJ BIO Taste & Nutrition Business CJ BIO is a business unit of CJ CheilJedang, part of CJ Group—an international company founded in South Korea in 1953 with businesses across Food & Food Service, Bio & Pharma, Entertainment & Media, and Retail & Logistics. CJ BIO is a global leader in fermentation-based bio-products, offering science-driven solutions such as BiomeNrich™ and AMINATURE® for nutrition and wellness. Leveraging its global manufacturing network and microbial fermentation expertise, CJ BIO also provides clean-label taste solutions like TasteNrich® to support innovation in the food and nutrition industries. CONTACT: Soohyun Paik (sh.paik@cj.net) +82-2-6740-1209
ASHEBORO, N.C., July 9, 2025 /PRNewswire/ -- Technimark, a world leader in manufacturing for healthcare, consumer packaging, and industrial sectors, today launched a new brand identity to reflect the company's transformation into a global manufacturing leader, known for its reliability and excellence. This new brand identity reflects Technimark's core values: innovation, quality, service, sustainability, and trust. It also underscores the company's expanded presence in the healthcare sector, its continued leadership in consumer packaging, and its unwavering focus on operational excellence and customer success. "This is more than a new look — it's a statement of who we are today and where we're going tomorrow," said Kris Peavy, Chief Commercial Officer and President of Healthcare. "Our new brand identity reflects our value as a true solutions partner. We work side-by-side with our customers to overcome challenges and unlock breakthrough results." Trent Ingle, Director of Marketing and Communications, said: "We want to use the brand to highlight the human impact we make, from life-saving medical devices to the products we all use every day. Simply put, we make what makes life better — and our new brand shows how we do it." "Our products must deliver a positive impact for people and planet. We have a responsibility to make what the world depends on in the most sustainable way," said Katie Distler, Technimark's Chief Sustainability Officer. "From our Innovation Center, where we find the most efficient ways to manufacture products, to replacing virgin resin with recycled resins made at our recycling and reprocessing facility, Wellmark, sustainability is our obligation — and it's at the forefront of everything we do." With this rebrand, Technimark affirms its promise to deliver solutions that drive performance, reduce risk, and help customers succeed in an increasingly complex world. See it in action at technimark.com. About Technimark Technimark is a global manufacturing solutions partner for the healthcare, consumer packaging, and specialty industrial sectors, specializing in precision injection molding, value-added assembly, and contract manufacturing, including medical devices. Technimark provides customized, end-to-end solutions focused on technology and innovation that improve quality, lower risk, and reduce costs. With facilities in the United States, Mexico, United Kingdom, Ireland, Germany, and China, Technimark leverages its global footprint to deliver high-quality products worldwide. See the Technimark difference at technimark.com. Contact: Trent IngleDirector of Marketing and Communicationscommunications@technimark.com
A recognized pioneer in metabolomics, Metabolon is the most experienced and trusted metabolomics partner in the life sciences industry MORRISVILLE, N.C., July 8, 2025 /PRNewswire/ -- Metabolon, Inc., the global leader in providing metabolomics solutions advancing a wide variety of life science research, diagnostic, therapeutic development, and precision medicine applications, proudly announces its 25th anniversary—a milestone that marks a quarter-century of scientific innovation and transformative contributions to health, wellness, and life sciences through the power of metabolomics. Founded in 2000, Metabolon pioneered the field of metabolomics by unlocking the potential of small molecules to drive breakthrough discoveries across clinical research, drug development, precision medicine, and beyond. Today, Metabolon is the industry's leading metabolomics service provider with over 25 years of experience delivering high-quality data and actionable insights to researchers worldwide. Metabolon continues to push the boundaries of scientific innovation with integrated bioinformatics tools and ground-breaking metabolomics services – no other metabolomics provider has as many workflow patents as Metabolon. Why is Metabolon the industry's best-in-class metabolomics service provider? Extensive Scientific Track Record: Metabolon has contributed to over 4,000 peer-reviewed publications, making Metabolon the most-published metabolomics service provider globally. These scientific publications include high-impact studies across oncology, neuroscience, immunology, cardiometabolic disease, and beyond. Since its founding, Metabolon has completed over 15,000 customer projects and processed more than 1.8 million samples. Industry Gold Standard: Metabolon's platform combines ultra-high-performance liquid chromatography/tandem accurate mass spectrometry (UHPLC/MS/MS) with the world's most extensive proprietary biochemical reference library that contains over 5,400 metabolites spanning 85+ metabolic pathways.Our platform supports the world's leading population health research initiatives, including CLSA (Canadian Longitudinal Study of Aging), EPIC (European Prospective Investigation into Cancer) Norfolk Study, FinnGen, Genomics England Ltd., HELIOS (Health for Life in Singapore), IMPACC (ImmunoPhenotyping Assessment in a COVID-19 Cohort), MVP (Million Veteran Program), TOPMed (Trans-Omics for Precision Medicine), TwinsUK (UK Adult Twin Registry), and others, to drive discoveries with the potential to translate into improved clinical outcomes, health equity, and precision interventions. As the global industry standard, Metabolon's services allow for broad scientific collaboration and support data and research longevity. Unrivaled Data Quality: Metabolon projects are backed by rigorous QC protocols, ISO 9001:2015 certification, CLIA and CAP certifications, and robust standard operating procedures, ensuring data reproducibility and consistency across thousands of studies globally. No other metabolomics vendor carries as many certifications or quality control measures. Trusted by Leading Organizations: Metabolon serves thousands of clients worldwide, including the majority of the top pharmaceutical, biotechnology, and academic institutions. Metabolon empowers these organizations to shorten development timelines, accelerate pipeline progression, and support evidence-based decisions for clinical asset optimization. "Reaching our 25th anniversary is a tremendous honor and a testament to the passion and expertise of our global team and partners," said Rohan Hastie, Ph.D., President and CEO of Metabolon. "From the start, our mission has been to decode the biological language of metabolites to transform science and medicine. We're proud of what we've achieved and excited for what's ahead as we continue shaping the future of health through metabolomics." To learn more about Metabolon's Global Discovery Panel, please visit: https://www.metabolon.com/services/untargeted-metabolomics/global-panel/ About Metabolon Metabolon, Inc. is the global leader in metabolomics, with a mission to deliver biochemical data and insights that expand and accelerate the impact of life sciences research and complement other 'omics' technologies. With 25 years of experience, 15,000+ client projects, 4,000+ scientific publication references, and ISO 9001:2015, CLIA, and CAP certifications, Metabolon has developed industry-leading scientific, technology, and bioinformatics techniques. Metabolon's Global Discovery Panel is powered by the world's largest proprietary metabolomics reference library. Metabolon's industry-leading data and translational science expertise help customers and partners address some of the most challenging and pressing questions in the life sciences, accelerating research and enhancing development success. The company offers scalable, customizable multiomics solutions, including metabolomics and lipidomics, that support customer needs from discovery through clinical trials and product life-cycle management. For more information, please visit www.metabolon.com and follow us on LinkedIn and Twitter. About MetabolomicsMetabolomics, the large-scale study of all small molecules in a biological system, is the only omics technology that provides a complete current-state functional readout of a biological system. Metabolomics helps researchers see beyond the genetic variation of individuals, capturing the combined impact of genetic and external factors such as the effect of drugs, diet, lifestyle, and the microbiome on human health. By measuring thousands of discrete chemical signals that form biological pathways in the body, metabolomics can reveal important biomarkers, enabling a better understanding of a drug's mechanism of action, pharmacodynamics, and safety profile, as well as individual responses to therapy. Logo - https://mma.prnasia.com/media2/1671125/Metabolon_Inc_Logo.jpg?p=medium600
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