EMA approves Bayer’s NTRK-targetting Vitrakvi for children and adults

Pharmaceutical Technology | September 24, 2019

Bayer has announced that the European Medicine Agency (EMA) has licensed its Vitrakvi (larotrectinib) in adults and children with solid tumours displaying Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. The indicated patients must also have either locally advanced or metastatic disease, or be in a situation where there are no adequate treatment options or surgical resection is likely to cause severe morbidity. This makes Vitrakvi the first tumour agnostic drug to be approved in the European Union (EU), which means it can be used against multiple tumour types with the same, rare genetic alteration. NTRK gene fusion occurs when the NTRK gene fuses with an unrelated gene, leading to an altered TRK protein, which has oncogenic drivers encouraging the spread and growth of cancer cells.

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Learn about the industry’s first pharmaceutical supply chain solution that is reducing the cost of care and ensuring access to critical medications for hospitals and health systems.

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Evolution Health Announces Revolutionary Technology Platform to Transform Stakeholder Engagement and Actively Measure Their Impact for Pharmaceutical

prnewswire | September 01, 2023

Evolution Health Group (EHG), a leading name in medical communications, pharmaceutical strategic marketing, and digital solutions, unveiled its game-changing technology platform, 360Connex®, set to redefine the landscape of stakeholder engagement. The primary objective of this robust platform is to enable enterprises to scale and target their engagement initiatives effectively. With a focus on efficiency, transparency, and actionable insights, organizations can now make data-driven decisions and foster stronger relationships with their stakeholder communities. This state-of-the-art platform is geared towards three core functionalities Management, Monitoring, and Measurement of Stakeholder Engagement: Through an intuitive interface and innovative technologies, enterprises can now efficiently manage, track, and measure the impact of their interactions with their key stakeholders, streamlining the collaboration process and helping teams focus their resources and strategies to ensure maximum impact on the business. Facilitation of Speaker Programs: The platform offers tools that will not only simplify the coordination and execution of speaker programs, but also ensure they meet the highest standards of content delivery and engagement. Application of Advanced Analytics: By harnessing the power of artificial intelligence, machine learning, and advanced automation technologies, EHG's 360Connex® platform offers unprecedented insights and optimization opportunities. This ensures that engagement activities are not only scaled, but also aligned with the dynamic needs of the stakeholder community. The platform is designed to meet the differing needs of emerging organizations through the largest of enterprises. "The healthcare community is rapidly evolving, and traditional methods of engagement are no longer sufficient. Our new technology platform bridges the gap, empowering enterprises to create more impactful, meaningful, and measurable interactions with their key stakeholders in a cost-effective way that ensures ongoing transparency and accountability," commented Carolyn Vogelesang Harts, one of the Managing Partners of Evolution Health Group. The unveiling of 360Connex® comes at a pivotal moment in the healthcare industry. As interactions between enterprises and healthcare professionals become increasingly intricate, there is a pressing need for systems that simplify processes and provide actionable insights. EHG's 360Connex® platform is the answer to this pressing demand. This innovation is poised to usher in a new era of insight-driven engagement, ensuring that healthcare companies not only keep pace with, but also anticipate the needs of, their diverse professional audiences. About Evolution Health Group Founded in 2005 and based in Pearl River, NY, Evolution Health Group stands at the forefront of pharmaceutical strategy, marketing, and digital solutions for global healthcare companies. EHG provides distinctive services through three main divisions; Evolution Medical Communications for medical and scientific strategy, blulava, for technology and digital solutions, and Maestro360 for speaker program logistic management.

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Pharma Tech

WCG Announces Partnership with Mint Medical to Support Imaging in Oncology Clinical Trials

PRNewswire | June 29, 2023

WCG, one of the world's leading providers of solutions that measurably improve the quality, efficiency, and safety of clinical research, recently announced a partnership with Mint Medical to leverage its mint Lesion™ radiology platform for oncology trials. The mint Lesion™ software is used for standardized and computer-assisted review of medical imaging according to defined protocols, guidelines, and workflows. Compliant and highly configurable, mint Lesion™ is a trusted imaging software for oncology clinical trials, offering quick deployment and more than 20 standardized and configurable response criteria templates out of the box. Through this partnership, WCG will combine its suite of clinical trial management solutions: operational processes, quality systems, imaging solutions, technology, and expansive reviewer network with mint Lesion's™ verified, read-ready platform, structured reporting, and site-specific workflows for a best-in-class solution for oncology trials. "The combination of WCG and Mint Medical offers a powerful solution to the market. WCG's teams are experts in study management and have a proven record of managing international clinical trials across all therapeutic areas and indications, including oncology," said Terri Moench, president, WCG Clinical Research Solutions. "Our ISO-certified processes ensure the processing of participant images received from sites are meticulously planned, implemented, and monitored for success. Combine that with mint Lesion™, a technology built to keep pace with changing requirements and the demand for new response criteria, and you have a solution that is unmatched in the industry." "WCG impressed us with their swift and sound implementation of our groundbreaking technology," said Matthew Hayden, executive director of Clinical Research Operations, Mint Medical. "After just one in-person meeting we crafted a fully operational, fully compliant reading platform that was built and ready for live trial use in just one month. Through this collaborative endeavor, we have forged a dynamic partnership that ensures rapid adaptability to our customers' evolving needs and requirements." About Mint Medical Mint Medical GmbH located in Heidelberg/Germany was founded in 2010 as a spin-off of German Cancer Research Center. The company commits itself to developing innovative software solutions in the field of medical imaging and combines image assessment and reporting in one system by considering guidelines for each clinical application context. A particular focus is currently being set on the field of oncology where the software platform mint Lesion™ is applied in clinical routine and clinical trials. Customers of Mint Medical are radiological practices, (university) hospitals, cancer centers, (Imaging) CROs, as well as pharmaceutical and biotech companies all over the world. In addition to the headquarters in Germany, the company has a subsidiary, Mint Medical Inc., in New Jersey, USA. About WCG WCG is a global leader of solutions that measurably improve and accelerate clinical research. Biopharmaceutical and medical device companies, contract research organizations (CROs), research institutions, and sites partner with us for our unmatched expertise, data intelligence, and purpose-built technology to make informed decisions and optimize study outcomes, while maintaining the highest standards of human participant protection. WCG raises the bar by pioneering new concepts, reimagining processes, fostering compliance and safety, and empowering those who perform clinical trials to accelerate the delivery of medical therapies and devices that improve lives.

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Pharmacy Market

Ardelyx Announces Acceptance of New Drug Application for Tenapanor for Hyperphosphatemia in China

Globenewswire | July 14, 2023

Ardelyx, Inc. a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that a New Drug Application (NDA) for tenapanor has been accepted for review by China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the control of serum phosphorus in adult patients with chronic kidney disease on hemodialysis. This acceptance triggers a $2 million milestone payment to Ardelyx under the terms of the license agreement between Ardelyx and its collaboration partner in China, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma). A potential approval of the NDA submission in China is expected by the end of 2024. “The NDA acceptance for tenapanor for hyperphosphatemia in China marks a significant step forward in Ardelyx’s commitment to bringing our novel therapies to patients with unmet medical needs and our desire to expand internationally alongside best-in-class partners who complement our capabilities and share our mission,” said Mike Raab, president and chief executive officer of Ardelyx. “I commend our collaboration partner, Fosun Pharma, on the impressive clinical results they generated which demonstrate the important role that tenapanor can play in offering a new treatment option for patients with hyperphosphatemia. We look forward to further collaboration as Fosun Pharma brings this treatment to patients.” Under the terms of its agreement with Fosun Pharma, Ardelyx received an upfront payment of $12 million and is eligible to receive additional developmental and commercialization milestones of up to $110 million and tiered royalty payments on net sales ranging from the mid-teens to 20 percent. Fosun Pharma has the exclusive rights to market and sell tenapanor in China, Hong Kong and Macau. About Ardelyx, Inc. Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx’s first approved product, IBSRELA® (tenapanor) is available in the United States and Canada. Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories. About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company continuously enriches its innovative product pipeline through independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma improves the research and clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class) new drugs as well as accelerates the R&D and launch of innovative technologies and products.

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