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FDA approves Thermo Fisher's NGS-based companion diagnostic for targeted therapy in patients with grade 2 IDH-mutant glioma < Back FDA Approves NGS-Based Companion Diagnostic for Targeted Therapy in Grade 2 IDH-Mutant Glioma Patients FDA approves Thermo Fisher's NGS-based companion diagnostic for targeted therapy in patients with grade 2 IDH-mutant glioma Thermo Fisher Scientific has announced that the U.S. Food and Drug Administration (FDA) has approved its next-generation sequencing (NGS)-based companion diagnostic for the first targeted therapy aimed at patients with Grade 2 IDH-mutant glioma, a rare and challenging form of brain cancer. This milestone approval marks a significant step forward in the treatment of this patient population, offering new hope for personalized and more effective therapy options. The FDA approval pertains to Thermo Fisher’s Oncomine Dx Target Test, which is designed to identify patients with Grade 2 glioma who have mutations in the isocitrate dehydrogenase (IDH) gene. These patients can now be matched with a targeted treatment specifically designed for their genetic profile. This companion diagnostic is the first of its kind for this particular subtype of glioma, which is typically difficult to treat due to its aggressive nature and location in the brain. In a statement, Dr. Marc Tremblay, Vice President of Clinical Research at Thermo Fisher Scientific, emphasized the importance of the approval, noting, “The approval of the Oncomine Dx Target Test represents a major advancement in personalized cancer care, enabling oncologists to more effectively identify patients who are eligible for a targeted therapy. This is a step toward transforming the way we approach glioma treatment by focusing on genetic drivers rather than traditional treatment regimens.” IDH-mutant gliomas are a genetically distinct subgroup of gliomas, a type of brain tumor, and are characterized by mutations in the IDH gene. These tumors are generally slower-growing than other forms of glioma but can still be challenging to treat due to their location and the difficulty in achieving complete surgical resection. The approval of a targeted therapy for this condition represents a significant advancement in precision medicine, allowing for a more individualized treatment approach that may improve patient outcomes. The Oncomine Dx Target Test leverages Thermo Fisher’s expertise in NGS technology to analyze tumor DNA and identify genetic mutations that can guide treatment decisions. By detecting IDH mutations in glioma patients, the diagnostic test ensures that only those most likely to benefit from the targeted therapy are selected, thus optimizing treatment effectiveness and reducing unnecessary side effects. The targeted therapy, which was developed in conjunction with the companion diagnostic, is designed to block the oncogenic effects of the IDH mutation, potentially slowing tumor growth and improving survival in patients with this specific genetic alteration. The approval of this diagnostic test provides a critical tool for oncologists in selecting appropriate treatments and personalizing care for glioma patients. Thermo Fisher Scientific’s NGS-based diagnostic is part of a broader trend in oncology toward more precise, gene-targeted treatments. The company continues to expand its portfolio of companion diagnostics, supporting the growing field of precision medicine and helping to bridge the gap between genetic insights and effective clinical therapies. The approval of the Oncomine Dx Target Test is expected to significantly impact the treatment landscape for Grade 2 IDH-mutant glioma, improving the quality of care and offering new treatment options for patients who previously had limited therapeutic choices. Author BioFocus Newsroom Previous Next

WuXi Biologics has bolstered its manufacturing capacity by installing three 5,000-liter single-use bioreactors. < Back WuXi Biologics Enhances Manufacturing with New Single-Use Bioreactors WuXi Biologics has bolstered its manufacturing capacity by installing three 5,000-liter single-use bioreactors. WuXi Biologics has bolstered its manufacturing capacity by installing three 5,000-liter single-use bioreactors. These bioreactors, now operational at their drug substance manufacturing facility, are expected to significantly enhance the company’s GMP production capabilities. The implementation of single-use technology is key to increasing flexibility, reducing contamination risks, and ensuring quicker batch turnovers. This expansion underscores WuXi Biologics' dedication to meeting the growing global demand for biologics and providing high-quality manufacturing services to their clients. For more details, view the official press release . Author BioFocus Newsroom Previous Next

Universities help commercialize life science research by turning discoveries into market-ready innovations through patents, spin-offs, and industry partnerships. < Back The Role of Universities in Commercializing Life Science Research Universities help commercialize life science research by turning discoveries into market-ready innovations through patents, spin-offs, and industry partnerships. Did you know that CRISPR technology , one of the most transformative breakthroughs in genetic engineering, was born in a university lab? What started as a quest to understand bacterial immune systems evolved into a revolutionary tool for precise DNA editing. This journey from academic curiosity to a world-changing application underscores the pivotal role of universities in advancing life sciences research. Universities serve as hotbeds of innovation, nurturing ideas that push the boundaries of knowledge. Beyond discovery, these institutions bridge the gap between fundamental research and practical application, ensuring groundbreaking insights become transformative technologies. By fostering partnerships, patenting discoveries, and supporting startups, universities amplify their impact, shaping industries and improving lives. This article looks into the commercialization of life sciences research within universities, exploring the pathways from lab to market, the success stories that inspire innovation, and the challenges that require creative solutions. The Importance of Academic Research in Life Sciences Catalysts for Innovation Academic research is the foundation of breakthroughs in life sciences , driving advancements in healthcare, biotechnology, and diagnostics. Universities foster curiosity-driven research that lays the groundwork for transformative technologies: CRISPR-Cas9 Gene Editing : Initially discovered through studies of bacterial immune systems, this tool has revolutionized genetics, enabling unprecedented precision in DNA modification. DNA double helix : The iconic discovery by Watson and Crick formed the basis for modern molecular biology and biotechnology. Such discoveries often take decades to mature into practical applications. On average, 17 years elapse from initial research to commercialization, yet the long-term rewards are substantial. Transforming Healthcare University research drives critical advancements in medicine, such as: New treatments and vaccines : The Oxford/AstraZeneca COVID-19 vaccine, developed in record time , is a prime example of university-industry collaboration saving millions of lives. Diagnostics : Innovations like liquid biopsies enable early detection and monitoring of diseases, reshaping healthcare paradigms. Biotechnology products : Bioengineered foods enriched with essential nutrients address global nutritional challenges, showcasing the broad impact of academic research. The commercialization process Bridging academia and industry Technology Transfer Offices (TTOs) are pivotal in transforming research into market-ready innovations. Established at most research-focused universities, TTOs ensure discoveries transcend academic journals to benefit society. Core functions of TTOs: Patenting : TTOs guide researchers in securing intellectual property rights, ensuring discoveries are protected and commercially viable. Market research : By evaluating market potential, TTOs align innovations with industry needs. Licensing : TTOs negotiate agreements, granting companies the rights to develop and market university-owned technologies. Spin-off support : TTOs assist in forming new companies to commercialize research when direct licensing isn't feasible. Networking : Connecting researchers with industry experts and investors expands the ecosystem necessary for innovation. Funding : Many TTOs provide seed funding , addressing the critical "valley of death" where early-stage projects often stall. Patents and licensing Patents are the cornerstone of research commercialization, protecting novel inventions and making them attractive to investors. The Bayh Dole Act of 1980 transformed this landscape by allowing universities to retain ownership of federally funded research. Since its enactment: University-filed patents increased substantially between 1980 and 2009. Licensing revenues have fueled further research and development. Spin-offs and startups based on patented technologies have flourished, exemplified by advancements like CRISPR-Cas9 and mRNA vaccines. Spin-Off Companies When licensing isn’t viable, universities often foster spin-offs—new companies dedicated to commercializing academic discoveries. There are several key steps in spin off creation: Identifying opportunities : Researchers and TTOs assess the commercial potential of discoveries. Building a business case : This involves crafting a strategy, identifying funding sources, and securing stakeholder buy-in. Securing IP : Robust intellectual property protections form the foundation for successful commercialization. Launching the company : Spin-offs often start in university incubators, benefiting from mentorship and initial funding. Examples of Success: Genentech : A pioneer in recombinant DNA technology, Genentech’s university roots catalyzed the biotech industry. Moderna : Founded on mRNA research , Moderna’s COVID-19 vaccine is a testament to the transformative power of university-led innovation. Challenges and Opportunities Addressing the "Valley of Death" Funding gaps between research and commercialization—known as the " valley of death "—pose significant barriers. Proposed solutions include: Proof-of-Concept Grants : Targeted funding to support early-stage projects. University Venture Funds : Internal funding mechanisms to de-risk innovations. Bridging cultural and skill gaps Diverging priorities between academia (publishing) and industry (profitability) can hinder partnerships. Solutions include: Entrepreneurial training : Programs such as NSF Innovation Corps train researchers in business fundamentals. Collaborative networks : Formalized university-industry partnerships ensure alignment of goals. Navigating regulatory complexities Compliance with stringent regulations requires expertise and resources. Universities can address this by engaging regulatory consultants and creating in-house teams to guide commercialization efforts. Conclusion Universities are vital engines of innovation in the life sciences, transforming foundational research into real-world applications that improve lives and drive economic growth. Despite challenges, strategic initiatives like enhanced TTOs, targeted funding, and strengthened industry partnerships are paving the way for more efficient commercialization. By fostering environments where academic discoveries thrive, universities will continue to be at the forefront of life sciences innovation, shaping a healthier and more sustainable future for all. Author Ramya Nadig , freelance contributor Previous Next

< Back Kandu Health and Neurolutions Merge to Transform Stroke Recovery Kandu, Inc. merges Kandu Health and Neurolutions to create an innovative, integrated approach to stroke recovery, combining advanced technology with personalized, at-home care. Kandu Health and Neurolutions have announced their merger, creating a new company—Kandu, Inc.—aimed at transforming stroke rehabilitation. The merger combines Neurolutions’ innovative brain-computer interface (BCI) technology with Kandu’s AI-driven telehealth services to provide a more integrated, accessible solution for stroke recovery. This move is expected to significantly improve care for stroke survivors, offering continuous, at-home rehabilitation and support. The newly formed Kandu, Inc. has also secured $30 million in financing, co-led by Ally Bridge Group and AMED Ventures, which will help expand its services. The company will use this funding to further enhance its telehealth platform, provide better caregiver support, and continue developing its groundbreaking technology for motor recovery. Neurolutions’ FDA-cleared IpsiHand® System, a BCI device that helps stroke survivors regain motor function, has already proven effective in improving limb movement for patients in the chronic phase of recovery. By merging with Kandu Health, the companies now offer a more comprehensive care model that combines cutting-edge technology with personalized rehabilitation at home. Kandu, Inc. aims to fill a gap in stroke recovery care, where patients often face fragmented treatment and high readmission rates. The merger brings together telehealth rehabilitation, therapy monitoring, and support for both patients and caregivers, helping to improve patient outcomes and quality of life. “This merger positions us to lead in stroke recovery,” said Leo Petrossian, CEO of Neurolutions, who will head the new company. “We now have the opportunity to offer stroke survivors the tools they need to enhance their recovery and regain independence.” With the merger, Kandu, Inc. is already seeing positive results. Early reports show that many patients who received its services achieved independent living within 90 days, with reduced hospital readmissions compared to traditional rehabilitation models. The company’s approach focuses on making stroke recovery more effective and accessible, offering a holistic and personalized care plan that goes beyond just medical treatments. Kandu, Inc. is set to redefine stroke rehabilitation by combining cutting-edge technology with patient-centered care, improving the recovery process for survivors and providing crucial support for their families. Author BioFocus Newsroom Previous Next

< Back 13th – 14th November, 2025 Philadelphia, PA 5th Investigator-Initiated Trials Summit As investigator-initiated trials grow more intricate, your team needs the most up-to-date strategies on building successful IITs, forecasting budgets, achieving study milestones, and brainstorming innovative KPI strategies. Save the date for November 13-14 for DGE’s 5th Investigator Initiated Trials conference! Back by popular demand, our all-new agenda provides answers to your most urgent questions about the best practices for reviewing, selecting, and funding research investigators! Previous Register now Next

< Back 12th December, 2024 Cambridge, MA 2024 Advancing Drug Development Forum This forum is designed to allow free-flowing dialogue and plenty of time has been woven throughout the day to assure interactive quality networking. The forum strives to attract and stimulate dialogue with key opinion leaders in biotech and pharma, executive leadership, senior directors, consultants, and a close network of CROs and CDMOs to further explore together novel solutions, promising technology breakthroughs and hearing how the entrepreneurial industry leaders are introducing and incorporating novel approaches in small molecule drug development, changing timelines and ROIs. Hear for yourself, how you can speed up your timelines and improve your product quality. Previous Register now Next

< Back World Health Summit 11th - 13th October, 2026 Berlin, Germany From Crisis to Resilience: Innovating for Health. ! Widget Didn’t Load Check your internet and refresh this page. If that doesn’t work, contact us. Previous Next

Bayer Pharmaceuticals implements leadership streamlining amid restructuring efforts. < Back Bayer Pharmaceuticals Shakes Up Leadership Structure Bayer Pharmaceuticals implements leadership streamlining amid restructuring efforts. Bayer Pharmaceuticals , a key player in the pharmaceutical industry, has recently announced significant leadership restructuring aimed at streamlining operations and enhancing efficiency. This strategic move comes amidst ongoing efforts to optimize organizational structure and adapt to evolving market dynamics. The restructuring initiative involves a reshuffling of executive positions within Bayer Pharmaceuticals, with the aim of fostering greater collaboration and alignment across various departments. By consolidating leadership roles, the company seeks to facilitate faster decision-making processes and improve overall agility in responding to market demands. This development follows Bayer's earlier announcement of plans to restructure its pharmaceutical division, focusing on key therapeutic areas and reallocating resources to support innovation and growth. The streamlined leadership team is expected to play a pivotal role in driving these strategic objectives forward. The restructuring efforts underscore Bayer's commitment to remaining competitive in the rapidly evolving pharmaceutical landscape. By simplifying its organizational hierarchy and optimizing leadership functions, the company aims to enhance operational efficiency and accelerate the pace of innovation. In a statement regarding the leadership streamlining, Bayer Pharmaceuticals emphasized its dedication to delivering impactful healthcare solutions and improving patient outcomes. The company remains focused on advancing its pipeline of innovative therapies and strengthening its position as a leader in the pharmaceutical industry. As Bayer Pharmaceuticals continues to navigate the challenges and opportunities presented by the healthcare market, the streamlined leadership structure is poised to facilitate greater agility and effectiveness in pursuing strategic goals. Through ongoing innovation and operational excellence, Bayer remains committed to driving positive change and making meaningful contributions to global healthcare. Author BioFocus Newsroom Previous Next

< Back Dopamine as an Addiction? Can you be addicted to dopamine? The short answer is no. However, despite this common misconception, dopamine does play a key role in addiction behavioural patterns. Dopamine is a neurotransmitter and hormone associated with pleasure. Now, these two bodily messengers are similar but there is a difference between neurotransmitters and hormones . Neurotransmitters are chemicals released within the brain, which can then influence the body, whereas hormones are chemicals released within the body which coordinate different bodily functions. As a neurotransmitter, dopamine acts as a chemical messenger within the brain, communicating between nerve cells and the rest of your body, stimulated when experiences associated with pleasure and reward occur. This release of dopamine occurs from the ‘reward centre of the brain’ which plays a role in motivation, reward processing and reinforced learning . As a hormone, dopamine is released from a gland situated near the kidneys called the adrenal gland and from the hypothalamus within the brain as a neurohormone. When something pleasurable happens to us, dopamine is released and we feel the pleasure . Changes in neural connectivity that occur when dopamine is released can lead us to develop habits as this increased connectivity helps us to repeat actions. Dopamine functions on the body Dopamine can affect several bodily functions such as mood, sleep, arousal, insulin production and the slowing of gut movement. When released as a hormone, dopamine can influence the ‘fight or flight response’ , a way our body deals with perceived or real stressful events. Most notably, dopamine is involved in our brain’s reward and pleasure pathways. So, what is dopamine’s involvement with addiction? With dopamine being released from the reward centre of the brain, associated with motivation and reward processing, this can reinforce a behaviour if it is pleasurable, making you want to do it more often and drive you to seek out that pleasure. This can create strong urges and over time it may take more of the stimulant , whether that be drugs, gambling or nicotine to trigger this dopamine and ‘feel good’ response. Experts believe this is due to dopamine playing a role in tolerance levels and its involvement with addiction. Tolerance is built, meaning the user would need to take more of a substance to get the same effects. Triggering the reward centre of the brain too frequently can result in it becoming overwhelmed and releasing high amounts of dopamine. The overstimulated reward centre tries to resolve this issue by decreasing dopamine production and reducing the number of dopamine receptors (these allow the effects of dopamine to occur). These changes can cause the addictive substance/behaviour to have less of an impact on the reward centre, requiring more of it to get a response from the brain and therefore release of dopamine. Despite being involved with addiction, there is no need to worry. Lots of experiences can trigger this ‘feel good’ response associated with dopamine, such as eating great food, having sex, exercising, achieving goals and listening to good music. Addiction can be influenced by a variety of different factors such as genes, your age, the people around you, your home life and hardships. So, to answer our original question: can you be addicted to dopamine? No, sources say you cannot be addicted to dopamine itself. But, due to its pleasurable and motivating effects on the body when released, it does play a highly prominent role in the addiction to any dopamine-boosting activities. Author Mia Butterworth-Brooks , freelance contributor Previous Next

< Back 17th March, 2026 Philadelphia, PA Hub and Specialty Pharmacy Models East Optimizing Hub and Specialty Pharmacy Models to Advance Patient Access and Support. A leading access-focused event that brings together life sciences professionals to explore evolving hub operations, specialty pharmacy strategies, and patient support innovations. As part of Access USA, this summit convenes pharma manufacturers, hub service providers, specialty pharmacies, payers, technology partners, and market access leaders for expert sessions, peer benchmarking, and actionable insights. Attendees will gain critical perspectives on AI-enabled patient engagement, regulatory shifts, distribution optimization, gross-to-net alignment, and cross-channel collaboration that enhance operational efficiency and improve patient outcomes. Previous Register now Next

< Back 17th March, 2026 Philadelphia, PA Patient Assistance & Access Programs Championing patient access, affordability & support across the healthcare ecosystem. The Patient Assistance & Access Programs (PAP) Conference is the leading industry event dedicated to advancing patient access, affordability, and support strategies within the life sciences and healthcare community. Taking place March 17–19, 2026 (with pre-conference workshops on March 16) at the Sheraton Philadelphia Downtown, PAP unites pharma, patient advocacy organisations, health clinics, policy experts, and technology innovators to tackle today’s most pressing access challenges. Attendees will engage in robust keynotes, benchmark discussions, expert panels, and collaborative sessions focused on program optimisation, shifting policy landscapes, cutting-edge technology, and enhancing patient outcomes. PAP serves as an essential platform for sharing best practices, building cross-stakeholder partnerships, and accelerating equitable access to therapies and support services. Previous Register now Next

The funding will fuel ongoing clinical trials of VXB-241, a bivalent vaccine targeting both respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). < Back Vicebio Secures $100 Million to Develop Innovative Respiratory Virus Vaccines The funding will fuel ongoing clinical trials of VXB-241, a bivalent vaccine targeting both respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). British biotech company Vicebio has raised $100 million in Series B funding as it advances the development of its novel vaccines targeting multiple respiratory viruses. The funding will fuel ongoing clinical trials of VXB-241 , a bivalent vaccine targeting both respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). A key data readout from this Phase 1 trial is expected next year. Vicebio will also use the funds to develop VXB-251, a trivalent vaccine that adds parainfluenza virus 3 (PIV3) to the RSV and hMPV targets. Both vaccines are based on Vicebio’s proprietary “molecular clamp” technology, which stabilizes viral proteins, making vaccines easier to manufacture, store, and administer. The technology was developed by researchers at the University of Queensland, Australia, and licensed to Vicebio. The company's innovative vaccines are designed to be delivered in ready-to-use, prefilled syringes. CEO Emmanuel Hanon, Ph.D., highlighted the significance of the funding, emphasizing that Vicebio’s technology could bring next-generation respiratory virus vaccines to the market. With RSV vaccines from major players like GSK, Pfizer, and Moderna already available, Vicebio hopes to differentiate itself by targeting both RSV and hMPV, a niche not yet filled by existing vaccines. However, competition looms, especially from AstraZeneca, which recently acquired Icosavax and its RSV-hMPV combo vaccine, IVX-A12, that is close to entering Phase 3 trials. As the RSV vaccine market grows more crowded, Vicebio’s success may hinge on its ability to demonstrate the advantages of its molecular clamp technology. Author BioFocus Newsroom Previous Next