New prostate cancer test could diagnose five years earlier

Pharmatimes | June 27, 2019

Researchers at the University of East Anglia and the Norfolk and Norwich University Hospital have developed a urine test, dubbed PUR (Prostate Urine Risk), to diagnose aggressive prostate cancer and predict whether patients will require treatment up to five years earlier than standard clinical methods. The revolutionary test also identifies men who are up to eight times less likely to need treatment within five years of diagnosis. The University says that it hopes the breakthrough “could help large numbers of men avoid an unnecessary initial biopsy and repeated invasive follow-ups for 'low risk' patients on active surveillance.” Previous urine biomarker tests have been designed specifically for single purposes such as the detection of prostate cancer on re-biopsy (PCA3 test). But, this new test uses four PUR signatures to provide a simultaneous assessment of non-cancerous tissue and risk groups (low, intermediate and high-risk) to show how aggressive the cancer is. Lead author Shea Connell from UEA’s Norwich Medical School, explained that “Prostate cancer is more commonly a disease men die with rather than from. Unfortunately, we currently lack the ability to tell which men diagnosed with prostate cancer will need radical treatment and which men will not. “Current practice assesses a patient’s disease using a PSA blood test, prostate biopsy and MRI. But up to 75% of men with a raised PSA level are negative for prostate cancer on biopsy. Meanwhile 15% of patients who do not have a raised PSA are found to have prostate cancer – with a further 15% of these cancers being aggressive.

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ApiJect Announces Investment by Royalty Pharma and Jefferies

ApiJect Systems Corp. | May 19, 2022

ApiJect Holdings, Inc., the parent company of ApiJect Systems, Corp., a medical technology public-benefit corporation transforming the fill and finish and delivery of injectable vaccines and medicines, announced today that it had completed a $111 million private round of investment. This investment round values ApiJect at approximately $300 million. The new round was led by Royalty Pharma and Jefferies Financial Group (NYSE: JEF), which acquired a revenue interest in addition to equity. Jefferies and ApiJect's other lenders also converted all of their debt into ApiJect equity, such that following this transaction, ApiJect has no debt on its balance sheet. The funds will be used for continued development of ApiJect's proprietary Blow-Fill-Seal (BFS) plastic prefilled injection system, to deploy its equipment and proprietary technologies to licensees, and for general working capital purposes. Royalty Pharma and Jefferies are represented on ApiJect's Board of Directors, along with ApiJect co-founders Jay Walker and Marc Koska, and Hanjin In, the CEO of Tae-Chang Industrial Co., Ltd., ApiJect's South Korean cannula supplier. ApiJect is developing an innovative portfolio of drug delivery devices using high-speed BFS manufacturing, which is recognized by the FDA as an advanced aseptic process that forms, fills and seals a single unit dose in a continuous, automated manufacturing step. BFS technology greatly reduces the risk of contamination and error during one of the most critical steps of drug production. BFS is cost-efficient for short and long runs, and highly suitable to scale quickly in order to meet unexpected spikes in demand such as for a rapid response to population-scale health emergencies. Advancements developed by ApiJect for temperature management now enable BFS manufacturing of a vast array of sterile injectable drugs, including ultra-cold mRNA vaccines. "This is an important day for injection device innovation, and, with that, the future health of billions of people throughout the world. The investment provided by Royalty Pharma and Jefferies supports further development of an injection technology that can scale rapidly and efficiently to meet global demand for injectable medicines." ApiJect Chief Executive Officer Jay Walker Mr. Walker further said: "We welcome Royalty Pharma's commitment to the ApiJect mission. Royalty Pharma has a proven track record in selecting successful partners and in assisting in advancing its partners' goals. We could not ask for a better strategic partner from within the pharma industry. In Jefferies, we have a partner that has been with us from virtually the beginning of ApiJect." "We are delighted to form this win-win partnership with ApiJect," said Pablo Legorreta, Royalty Pharma's Founder and Chief Executive Officer. "The global pandemic highlighted the clear unmet need for a new kind of prefilled syringe that can be rapidly produced to respond to public health threats, and at massive scale that would be capable of delivering hundreds of millions, potentially billions, of doses to people in the U.S. as well as globally. ApiJect is developing a truly innovative technology, that could transform the manufacturing and delivery of life-saving injectable drugs in a way that would also make these medicines safer and more readily accessible for patients around the world." "We are proud of our association with ApiJect and believe strongly that their solutions will be a positive gamechanger in many of the most critical aspects of improving health globally," said Rich Handler, CEO of Jefferies. The first potential device made on the ApiJect Platform is the Prefilled ApiJect Injector, a single-dose prefilled injector designed to efficiently deliver a 0.5mL dose into a patient with a simple squeeze of the BFS container by the healthcare professional. This new type of prefilled injector will be ApiJect's first product submitted for regulatory review and approval. The Prefilled ApiJect Injector and its manufacturing process include An aseptically filled single-dose container, designed to enable efficient and intuitive injection administration. A pen-needle-style hub that turns the BFS container into an injection device. Innovations in temperature management to expand the range of medicines and vaccines suitable for BFS packaging. ApiJect recently launched its Technology Development Center in the greater Orlando area to bring to the U.S. critical capabilities for device design and engineering, and BFS mold development, as well as for small-scale manufacturing of single-dose, prefilled injectors and other injectable devices. Its purpose is to dramatically reduce the time and processes necessary for product development. ApiJect's Technology Development Center supports the company's existing fill-finish lines at its manufacturing partner site in South Carolina, which currently has the capacity to produce up to 540 million single-dose prefilled injectors annually. About ApiJect Systems ApiJect Systems, Corp., is a public-benefit medical technology company working to use our platform to bring more prefilled, single-dose injections to patients everywhere. The ApiJect Platform enables pharmaceutical and biotech companies to design scalable prefilled injectors and efficiently fill-finish them with their injectable drug products. This can be done either on one of their own Blow-Fill-Seal packaging lines with ApiJect-licensed technology, or at one of ApiJect's world-class manufacturing partners.

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Pneuma Systems collaborates with West Pharmaceutical Services, Inc. to improve the patient experience

Pneuma Systems Corporation | April 08, 2022

Medical technology company, Pneuma Systems Corporation, has entered a multi-faceted business collaboration with West Pharmaceutical Services, Inc. with the goal of improving the patient's experience with drug therapy. West is a leading global manufacturer in the design and production of technologically advanced, high-quality, integrated containment and delivery systems for injectable medicines. Pneuma Systems Corporation has developed a family of fluid flow technologies that are aimed at scientific and medical applications. The global intravenous pump market segment is expected to reach USD 20.5 billion over the next five years. Pneuma will provide a novel closed-loop fluid flow control platform that West will use to develop drug delivery solutions for pharmaceutical companies and clinical end users. West will provide technical and financial support to Pneuma and access to the emerging West Digital Platform, designed to improve transmission of data and other information. "West's almost century-long commitment to the development of drug delivery systems dovetails with our cutting-edge flow control technology. West's latest foray into a broad digital architecture is very important to us. When you improve both fluid flow and information flow, the result is an improvement in workflow, which results in higher levels of patient safety and lower costs," said Pneuma CEO Jeffrey Carlisle. "We are aiming at disruptive improvements in workflow." "We are excited about our collaboration with Pneuma and the potential of their technologies to address a variety of flow control challenges to drive improvements in healthcare. At West our mission is to improve patient lives not only through our products and services but also by investing in small innovative companies and offering our deep technical and commercial expertise to help them bring their transformation technologies to the market," Scott Young, VP Venture & External Collaboration at West Pneuma Systems, together with its strategic partners, plans to install PneumaDrive™ technology-based infusion devices in infusion centers, home care, and acute care settings around the world. The low cost PneumaDrive™ technology can replace existing infusion pumps and automate "gravity drip" infusions, providing patients with a safer and easier experience. About Pneuma Pneuma Systems is a New Hampshire based company founded by Jeffrey Carlisle, also Founder of the recently acquired Ivenix. Pneuma is dedicated to improving fluid flow, information flow, and workflow for the IV therapy process. About West West Pharmaceutical Services, Inc. is a leading provider of innovative, high-quality injectable solutions and services. As a trusted partner to established and emerging drug developers, West helps ensure the safe, effective containment and delivery of life-saving and life-enhancing medicines for patients. With approximately 10,000 team members across 50 sites worldwide, West helps support our customers by delivering over 45 billion components and devices each year.

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Agilent Announces the Innovative Seahorse XF Pro Analyzer

Agilent Technologies Inc. | January 25, 2022

Agilent Technologies Inc. announced the release of the Agilent Seahorse XF Pro Analyzer, featuring new pharma-oriented workflow solutions incorporating advanced experimental design and analysis tools. With enhanced performance, more robust and efficient workflows, and an optimized user experience, the XF Pro enables operators at any skill level to access the most advanced cellular metabolism analysis technology for understanding cellular fate, fitness, and function. Preclinical therapeutic discovery workflows place high demands on cellular analysis, with immunology and disease researchers increasingly using rare, ex vivo, and genetically engineered cells to build better disease models. To address the increasing interest in monitoring live cells in real-time, the new XF Pro Analyzer incorporates a suite of hardware and software enhancements that improve measurement performance and data interpretation. These enhancements will make it easier to identify novel drug targets, validate target effect on cellular function, optimize disease models, and determine drug safety and antitumor potential of T cell therapies. “With dedicated workflow solutions the XF Pro provides enhanced performance and customer experience, particularly within pharma and biopharma therapeutic development, and toxicity programs. This underlines Agilent’s commitment towards developing intentional end-to-end solution-focused innovations that continue to lead the way for applied analytical and research applications, including direct metabolic analysis.” Richard Fernandes, associate vice president and general manager of Agilent’s Cell Analysis, Seahorse, Luxcel, and microplates businesses "The launch of the XF Pro is very much a customer-driven event. Through collaboration and intentional conversations with our customers and key opinion leaders, we recognized the need for a live-cell metabolic analysis platform which makes sophisticated analysis even more accessible for both experienced users as well as novices,” added Chris Braun, associate vice president of Marketing for Agilent’s Cell Analysis Division. “Primarily targeting the pharma/biopharma sector, but beneficial to all our customers, the XF Pro incorporates critical metabolic insights into researchers’ discovery workflows to facilitate even higher quality data where it matters most.” The XF Pro Analyzer is expected to enhance critical aspects of live-cell analysis, particularly for researchers working in immunotherapy, early drug discovery, and preclinical safety assessment. By delivering better precision at a low oxygen consumption rate (OCR), the XF Pro Analyzer allows analysts to confidently interrogate more immune cell types, as well as cell types that are bioenergetically compromised. The instrument also features pharma-tailored workflows for harnessing robust cellular metabolism measurements while handling suspension cell types, along with simplified automation enablement and analytical instrument qualification (AIQ). About Agilent Technologies Agilent Technologies Inc. is a global leader in the life sciences, diagnostics, and applied chemical markets, delivering insight and innovation that advance the quality of life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.32 billion in fiscal 2021 and employs 17,000 people worldwide.

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PHARMA TECH

Aquavit Further Prevails Against Counterfeiters in U S Following its Recent Victory in Europe

Aquavit Pharmaceuticals, Inc | March 22, 2022

Aquavit Pharmaceuticals, Inc continues to succeed in its intellectual property cases against counterfeiters both domestically and abroad. Following a recent win against counterfeiter U-BioMed, Inc. across the European Union, the U.S. Southern District Court of New York adopted Judge Lehrburger's recommendations that any sanctions related to U-BioMed's deletion of its Instagram account, which blatantly exploited Aquavit's AQUAGOLD product illegally, be folded into the pre-existing sanctions requiring U-BioMed to pay Aquavit's reasonable legal fees and costs associated with the sanctions-related motions. The Court further reinforced Lehrburger's preview award ordering U-BioMed to pay attorney fees and costs to Aquavit in compensatory damages. U-BioMed's continuous violation of the court's order in 2019 has to date accumulated the court's coercive sanction to millions of dollars. "The depths to which counterfeiters have gone to exploit Aquavit's patented technology, confuse customers, and attempt to trick the legal system(s) is criminal, especially with FDA regulated medical devices. It is of the utmost importance that we protect our physicians from liability and misinformation and continue to keep our patients safe." Sobin Chang, CEO of Aquavit Aquavit's victorious claim against U-BioMed with the European Union Intellectual Property Office (EUIPO) has set a significant milestone. The court acknowledged that U-BioMed knowingly and intentionally filed an infringing trademark application with the EUIPO for the mark "AQUAGOLD Fine Touch". "The counterfeits appear almost identical to the naked eye; however, they do not contain the microchannels as they claim and are often made of regular steel that are not biocompatible under the FDA's medical device material guidelines. Furthemore, they infringe on our 'repeated motion' drug delivery utility patent (U.S. Patent No . 10,980,865) for any drugs, components or biologics." says Dr. David Shafer, Aquavit's Chief Medical Technology Officer. The EUIPO has declared U-BioMed's actions to be willful and done purposefully in an effort to confuse consumers with Aquavit's already existing AQUAGOLD products being sold globally. The EUIPO issued a cancellation of U-BioMed's infringing mark, upheld Aquavit's application for a declaration of invalidity, and held U-Biomed accountable for the legal costs in the European Union. About Aquavit Aquavit is a high-tech pharmaceutical company that provides a comprehensive range of innovative pharmaceutical, biotech and medical device technologies. Aquavit focuses on personalized medicine to improv.

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