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Business Wire
6 days ago
- Business
- Business Wire
Orano Med Inaugurates Expansion of its U.S. Research and Development Center in Texas
PARIS--(BUSINESS WIRE)--Orano Med, a subsidiary of the Orano Group and a pioneer in radioligand therapies in oncology, today inaugurated the expansion of its main Research and Development Center located in Plano, Texas (USA). This strategic facility is dedicated to developing novel radiopharmaceuticals and conducting preclinical research focused on targeted alpha therapies using lead-212 (212 Pb), an innovative and promising approach against various types of cancer. The site hosts the R&D teams of Orano Med as well as those of its subsidiary Macrocyclics, a manufacturer of customized chelating agents. 'The expansion of our R&D center enhances our ability to develop lead-212-based radioligand therapies by giving our teams the resources they need to advance a growing pipeline of drug candidates through to the clinic." Share With an investment of over $5 million, Orano Med has expanded its R&D Center by approximately 11,000 ft². The expansion includes around 5,000 ft² of new laboratory space, enabling the advancement of a growing pipeline and doubling the Good Manufacturing Practice (GMP) production capacity for early clinical trial supply. In addition, about 5,500 ft² of new office space has been added to accommodate the site's growing team, whose headcount has doubled over the past four years. Overall, this represents about a 50% increase in space compared to the pre-existing facility. Julien Torgue, Chief Scientific Officer of Orano Med, stated: 'The expansion of our R&D center enhances our ability to develop lead-212-based radioligand therapies by giving our teams the resources they need to advance a growing pipeline of drug candidates through to the clinic. With an integrated platform, cutting-edge equipment and a focused scientific strategy, we are well positioned to support both our internal developments and collaborations with partners.' Orano Med's R&D platform is fully integrated, combining cutting-edge equipment and a highly experienced team to advance the development of next-generation cancer therapies. The company can carry out the full range of preclinical development studies, including in vivo and Chemistry, Manufacturing and Controls (CMC) studies, onsite. Orano Med conducts both in-house research programs and collaborative developments with biotech and pharmaceutical partners. This integrated approach ensures a rapid and reliable transition from research to clinical phases. While the primary mission of the research and development center is therapeutic development, the facility also serves as production hub for lead-212 based drug candidates for early-stage clinical trials in the U.S. This expansion demonstrates Orano Med's strong commitment to innovation and leadership in the field of radioligand therapies, accelerating the development of new treatment options for patients worldwide. A celebration was held on-site with local teams and Orano Med's Executive Committee to mark this important milestone. During the event, Orano Med also unveiled the new name of the facility: Drug Development and Preclinical Unit (DDPU) – George de Hevesy Center Arnaud Lesegretain, President and Chief Executive Officer of Orano Med, added: 'This expansion marks an important step in Orano Med's growth at our Plano site, which has played a key role since the inception of the company 15 years ago. It reinforces our world-class R&D capabilities in the U.S. and strengthens our ability to deliver innovative targeted alpha therapies by supporting early-stage development in a fully integrated environment.' About Orano Med Orano Med, a subsidiary of the Orano Group, is a clinical-stage biotechnology company which develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (212 Pb), an alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha-Emitter Therapy (TAT). AlphaMedix, its most advanced asset in clinical development for GEP-NETs tumors, received Breakthrough Designation from the FDA in 2024. The company is advancing several potential treatments using 212 Pb combined with various targeting agents through clinical and preclinical studies. Orano Med has 212 Pb manufacturing facilities, laboratories, and R&D centers in France and in the US. It is expanding its GMP-manufacturing capacities for 212 Pb radiolabeled pharmaceuticals in North America and Europe and building a unique, independent, and fully integrated industrial platform to serve the needs of patients globally. For more information, please visit: About Orano As a recognized international leading operator in the field of nuclear materials, Orano delivers solutions to address present and future global energy and health challenges. Its expertise and mastery of cutting-edge technologies enable Orano to offer its customers high value-added products and services throughout the entire fuel cycle. Every day, the Orano group's 17,500 employees draw on their skills, unwavering dedication to safety and constant quest for innovation, with the commitment to develop know-how in the transformation and control of nuclear materials, for the climate and for a healthy and resource-efficient world, now and tomorrow. Orano, giving nuclear energy its full value. About Targeted Alpha Therapy Targeted alpha therapy (TAT) relies on a simple concept: combining the ability of biological molecules to target cancer cells with the short-range cell-killing capabilities of alpha-emitting radioisotopes. Alpha decay consists of the emission of a helium nucleus (alpha particle) together with very high linear energy transfer and a range emission of only few cell layers, resulting in irreparable double strand DNA breaks in cells adjacent only to area of alpha emission. This approach results in an increased cytotoxic potential toward cancer cells while limiting toxicity to nearby healthy cells. As a result, alpha emitters are considered as the most powerful payloads to be found for targeted therapies.
Barnama
25-06-2025
- Business
- Barnama
Fortrea, Emery Pharma Team Up On Rifampin Safety Testing For Clinical Trials
BUSINESS KUALA LUMPUR, June 25 (Bernama) -- Fortrea, a global contract research organisation (CRO), has announced a strategic collaboration with Emery Pharma to provide rapid impurity testing of rifampin used in drug-drug interaction (DDI) studies. In a statement, Fortrea said the partnership will enable testing for 1-methyl-4-nitrosopiperazine (MNP), a nitrosamine impurity, ensuring levels remain below the acceptable intake limit set by the United States Food and Drug Administration (FDA). Fortrea Chief Medical Officer and President of Clinical Pharmacology Services, Dr Oren Cohen said the partnership would help accelerate early-phase clinical trials by providing certified rifampin for use in DDI studies and enhance data quality. 'This collaboration reflects our shared commitment to smarter study design and greater participant safety,' he said. Meanwhile, Emery Pharma Chief Executive Officer, Dr Ron Najafi said the collaboration would contribute to safer and more efficient drug development, adding that the company specialises in solving complex analytical challenges in compliance with regulatory standards. Fortrea selected Emery Pharma based on its expertise in analytical and bioanalytical testing under current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) standards. The new testing service is now available to Fortrea customers involved in clinical pharmacology trials, with study designs tailored to FDA requirements. Rifampin, a widely used antibiotic and a preferred agent in DDI studies due to its safety and tolerability, had previously come under scrutiny after the FDA found that MNP levels in tested batches exceeded acceptable limits. However, the agency revised its guidance in 2023, allowing the continued use of rifampin under updated thresholds.
Barnama
25-06-2025
- Business
- Barnama
Fortrea & Emery Pharma Announce Strategic Collaboration To Deliver FDA Compliant Drug-drug-interaction Studies Using Rifampin
DURHAM, N.C., June 25 (Bernama) -- Fortrea (Nasdaq: FTRE) (the 'Company'), a leading global contract research organization (CRO), today announced a strategic collaboration with Emery Pharma, a leading analytical and bioanalytical CRO providing testing services under current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP), to provide rapid lot-by-lot, 1-methyl-4-nitrosopiperazine (MNP) testing of rifampin, the preferred drug for drug-drug interaction (DDI) studies, to certify impurities are below the Acceptable Intake (AI) Limit set by U.S. Food and Drug Administration (FDA) guidelines. Fortrea has selected Emery Pharma due to its strong capabilities in analytical and bioanalytical testing in support of Fortrea's global clinical programs. Emery Pharma's expertise in this area supports Fortrea's ability to offer rifampin as an agent for inducing the CYP3A4 isoenzyme in DDI studies. The collaboration announced today allows sponsors to conduct DDI assessments using rifampin, which is frequently named as the preferred agent in these studies, due to its safety and tolerability profile.
Yahoo
25-06-2025
- Business
- Yahoo
BASFY's New GMP Site Set Up to Innovate Through Customer Collaboration
BASF SE BASFY, in alignment with its commitment to providing innovative solutions in the biopharma and pharmaceutical ingredients industries, has launched a new Good Manufacturing Practice ('GMP') Solution Center in Wyandotte, MI. It will make the supply of bioprocessing ingredients and excipients for biopharma applications reliable. The state-of-the-art facility ensures high quality standards, clean room packaging and high-sensitivity analytical testing to help BASF expand its existing network of GMP sites in close collaboration with consumers to customize product development. These sites will harness innovation to address dynamic needs in biopharma and pharmaceutical industries. Installed with improved capabilities, BASFY will be able to regulate parameters more tightly and validate control systems for higher productivity. The initiative underscores BASF's drive for excellence through innovation and unique products. It highlights the company's ability to adapt with respect to ever-changing customer needs. The GMP site would play a key role in collaboration with customers worldwide. BASFY stock is up 0.3% over the past year against the industry's 23.2% decline. Image Source: Zacks Investment Research BASFY currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the Basic Materials space are Akzo Nobel N.V. AKZOY, Newmont Corporation NEM and Balchem Corporation BCPC. While AKZOY and NEM currently sport a Zacks Rank #1 (Strong Buy) each, BCPC carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank stocks here. The Zacks Consensus Estimate for Akzo Nobel's current-year earnings is pegged at $1.67 per share, implying a 19.3% year-over-year increase. Its earnings beat the Zacks Consensus Estimate in three of the trailing four quarters while missing once. The Zacks Consensus Estimate for NEM's current-year earnings is pegged at $4.18 per share, indicating a 20.1% year-over-year earnings beat the Zacks Consensus Estimate in three of the trailing four quarters and missed once, with an average surprise of 32.41%. NEM's shares have gained 39.6% in the past year. The Zacks Consensus Estimate for BCPC's 2025 earnings is pegged at $5.15 per share, indicating a rise of 31% from year-ago levels. The company's earnings beat the consensus estimate in two of the trailing four quarters while missing the rest. Its shares have gained 3.5% in the past year. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Newmont Corporation (NEM) : Free Stock Analysis Report BASF SE (BASFY) : Free Stock Analysis Report Akzo Nobel NV (AKZOY) : Free Stock Analysis Report Balchem Corporation (BCPC) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
24-06-2025
- Business
- Yahoo
Cosmos Health Enters U.S. Market with Strategic Made-in-America Manufacturing, Mitigating Tariff Risks; Executes Agreement with New Jersey-Based DolCas Biotech
CHICAGO, June 24, 2025 (GLOBE NEWSWIRE) -- Cosmos Health Inc. ("Cosmos Health" or the 'Company'') (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today its entry into the U.S. market and the launch of U.S.-based manufacturing through a strategic agreement with DolCas Biotech LLC ('DolCas'), a New Jersey-based developer and manufacturer of clinically studied nutraceutical ingredients. Cosmos Health is set to commence production in the United States at GMP-certified (Good Manufacturing Practice) facilities, marking a significant milestone in the Company's operational expansion. This move not only mitigates tariff exposure and cross-border logistical risks but also enhances production control beyond its existing European footprint, positioning Cosmos to scale efficiently in the global healthcare market. The agreement strengthens Cosmos Health's position in the premium nutraceuticals space and supports its broader strategy to expand its portfolio with scientifically backed, high-efficacy ingredients, while also leveraging DolCas's expertise in clinically validated formulations and vertically integrated manufacturing. K. Gnaneshwar Rao, CEO at DolCas Biotech, commented: 'We are thrilled to partner with Cosmos and are eager to build on this collaboration with a wide range of innovative products that will benefit both companies. Cosmos, under the visionary leadership of CEO Greg Siokas, has built an impressive portfolio of brands and products. His forward-thinking approach aligns perfectly with our values and ambitions. We see this as the beginning of a strong, strategic partnership and look forward to supporting Cosmos' continued growth in the United States and globally.' Greg Siokas, CEO of Cosmos Health, stated: 'We are proud to reach this important milestone as we commence production in the United States through our agreement with DolCas Biotech, a partner widely recognized for its commitment to quality and innovation. This strategic move strengthens our supply chain, enhances production oversight, and positions Cosmos for scalable global growth. It also reduces exposure to tariff-related risks, adding resilience amid shifting trade dynamics.' About DolCas Biotech LLCDolCas Biotech LLC is a U.S.-based developer and marketer of branded, science-backed nutraceutical ingredients, founded in 2007 as an extension of Orcas Naturals founded in 1993. Its portfolio includes, among others, clinically supported products such as Curcugen® (turmeric), Ginfort® (ginger), Morikol® (marine collagen), and TruOliv® (olive polyphenols). Through its dedicated manufacturing arm in India, the company maintains full vertical integration and strict control over ingredient quality. Its facilities are GMP-certified, FDA-registered, and UL-audited, underscoring a strong commitment to regulatory excellence and product integrity. About Cosmos Health Health Inc. (Nasdaq:COSM), incorporated in 2009 in Nevada, is a diversified, vertically integrated global healthcare group. The Company owns a portfolio of proprietary pharmaceutical and nutraceutical brands, including Sky Premium Life®, Mediterranation®, bio-bebe®, C-Sept® and C-Scrub®. Through its subsidiary Cana Laboratories S.A., licensed under European Good Manufacturing Practices (GMP) and certified by the European Medicines Agency (EMA), it manufactures pharmaceuticals, food supplements, cosmetics, biocides, and medical devices within the European Union. Cosmos Health also distributes a broad line of pharmaceuticals and parapharmaceuticals, including branded generics and OTC medications, to retail pharmacies and wholesale distributors through its subsidiaries in Greece and the UK. Furthermore, the Company has established R&D partnerships targeting major health disorders such as obesity, diabetes, and cancer, enhanced by artificial intelligence drug repurposing technologies, and focuses on the R&D of novel patented nutraceuticals, specialized root extracts, proprietary complex generics, and innovative OTC products. Cosmos Health has also entered the telehealth space through the acquisition of ZipDoctor, Inc., based in Texas, USA. With a global distribution platform, the Company is currently expanding throughout Europe, Asia, and North America, and has offices and distribution centers in Thessaloniki and Athens, Greece, and in Harlow, UK. More information is available at as well as LinkedIn and X. Forward-Looking StatementsWith the exception of the historical information contained in this news release, the matters described herein, may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements preceded by, followed by, or that otherwise, include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could", are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. These statements, involve unknown risks and uncertainties that may individually or materially impact the matters discussed, herein for a variety of reasons that are outside the control of the Company, including, but not limited to, the Company's ability to raise sufficient financing to implement its business plan, the impact of the war in Ukraine, on the Company's business, operations and the economy in general, and the Company's ability to successfully develop and commercialize its proprietary products and technologies. Readers are cautioned not to place undue reliance on these forward- looking statements, as actual results could differ materially from those described in the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's filings with the SEC, which are available at the SEC's website ( The Company disclaims any intention or obligation to update, or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Relations Contact:BDG Communicationscosm@ while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
