< Back LIVX 2026 8th – 10th December, 2026 Dubai, UAE Hosting the most powerful global ecosystem for longevity, biotech, and investment. ! Widget Didn’t Load Check your internet and refresh this page. If that doesn’t work, contact us. Previous Next

Innovative GLP-1 and amylin receptor agonist shows up to 22% weight reduction in early-stage study. < Back Novo Nordisk Unveils Promising Weight Loss Results from Amycretin Clinical Trial Innovative GLP-1 and amylin receptor agonist shows up to 22% weight reduction in early-stage study. Novo Nordisk has announced promising results from its phase 1b/2a clinical trial of amycretin, a novel once-weekly subcutaneous treatment for individuals with overweight or obesity. Amycretin is a unimolecular GLP-1 and amylin receptor agonist designed to aid weight loss. The trial assessed the safety, tolerability, pharmacokinetics, and efficacy of amycretin in 125 participants. The primary endpoint focused on treatment-emergent adverse events, which were consistent with those observed in incretin-based therapies. The most common side effects were gastrointestinal, predominantly mild to moderate in severity. Participants began with an average body weight of 92.7 kg. Those treated with amycretin experienced significant weight reductions: 1.25 mg dose (20 weeks): 9.7% weight loss 5 mg dose (28 weeks): 16.2% weight loss 20 mg dose (36 weeks): 22.0% weight loss In contrast, placebo recipients saw weight gains of 1.9%, 2.3%, and 2.0% over the same periods. Martin Lange, Novo Nordisk's executive vice president for Development, expressed optimism: "We are very encouraged by the subcutaneous phase 1b/2a results for amycretin in people living with overweight or obesity. The results seen in the trial support the weight-lowering potential of this novel unimolecular GLP-1 and amylin receptor agonist, amycretin, that we have previously seen with the oral formulation." Building on these findings, Novo Nordisk plans to advance amycretin's clinical development for adults with overweight or obesity. Amycretin represents a new class of treatment, combining GLP-1 and amylin receptor agonism, and is being developed for both oral and subcutaneous administration. Novo Nordisk, founded in 1923 and headquartered in Denmark, is a global healthcare leader aiming to combat serious chronic diseases. The company employs approximately 72,000 people across 80 countries and markets its products in around 170 countries. Author BioFocus Newsroom Previous Next

IGM Biosciences is discontinuing its lead autoimmune programs, imvotamab and IGM-2644, following disappointing clinical results, and implementing a 73% workforce reduction while reevaluating its strategic direction. < Back IGM Biosciences Halts Lead Autoimmune Programs, Cuts Workforce by 73% IGM Biosciences is discontinuing its lead autoimmune programs, imvotamab and IGM-2644, following disappointing clinical results, and implementing a 73% workforce reduction while reevaluating its strategic direction. IGM Biosciences , a clinical-stage biotechnology company, has announced a major shift in its strategic direction, discontinuing its lead autoimmune programs and implementing significant workforce reductions. The company cited disappointing interim results from clinical studies as the primary reason behind its decision. Key Programs Discontinued The company’s lead program, imvotamab, a CD20 x CD3 bispecific IgM antibody, was being developed to treat rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Phase 1b trials revealed inconsistent and insufficient B cell depletion, a critical mechanism for the treatment of these autoimmune conditions. The company also discontinued its IGM-2644 program, a targeted effort to develop therapies for autoimmune and inflammatory diseases. Workforce and Financial Impact In response to these developments, IGM Biosciences announced a 73% workforce reduction, affecting approximately 144 employees. This restructuring is intended to conserve resources as the company re-evaluates its strategy. As of December 31, 2024, IGM reported $183.8 million in cash and investments, which will support the transition. Strategic Reevaluation Underway Dr. Mary Beth Harler, CEO of IGM Biosciences, expressed gratitude to the patients, investigators, and employees who contributed to the discontinued programs. She acknowledged the difficult but necessary decision to halt these projects and emphasized the company’s commitment to identifying new pathways to address unmet medical needs. IGM is now focused on assessing internal opportunities and exploring potential strategic alternatives to maximize shareholder value. Industry Implications The decision reflects the challenges of translating innovative therapeutic approaches into consistent clinical success. Analysts suggest that the company’s focus on IgM antibody technology, though promising, has struggled to deliver the required efficacy in autoimmune indications. Looking Forward While the discontinuation of these programs marks a setback, IGM’s proprietary IgM platform remains a potential asset for addressing other medical conditions. The company is expected to provide further updates as it refines its strategic priorities. This announcement follows a broader industry trend of biotech firms reassessing pipelines and conserving cash amid uncertain economic conditions and rising development costs. Author BioFocus Newsroom Previous Next

< Back CAR-T Therapy Drives Multi-Disease Remission Single treatment induces sustained remission across three autoimmune conditions, signalling expansion beyond oncology. A single administration of CD19-targeted CAR-T therapy has induced sustained, treatment-free remission across three severe autoimmune diseases, marking a significant inflection point in the clinical trajectory of engineered cell therapies beyond oncology. The findings, published in Med , describe a patient with refractory autoimmune haemolytic anaemia (AIHA), immune thrombocytopenia (ITP), and antiphospholipid syndrome who achieved rapid and durable remission following CAR-T infusion. Fourteen months post-treatment, the patient remains symptom-free and off all medication, despite previously failing nine lines of therapy. A Convergence of Three Refractory Diseases The clinical significance of the case lies not only in the severity of the individual conditions, but in their simultaneous presentation. The patient’s disease profile represents a convergence of B cell-mediated autoimmune pathologies, each associated with substantial morbidity and limited treatment durability. Prior to CAR-T intervention, the patient required continuous transfusion support and intensive pharmacological management, with no sustained response. The ability of a single therapeutic intervention to resolve all three conditions highlights a key mechanistic insight: these diseases, while clinically distinct, share a common immunological driver. Mechanism: Targeted Immune System Reset CAR-T therapy operates by engineering autologous T cells to recognise and eliminate CD19-expressing B cells, which are central to autoantibody production. In this case, depletion of pathogenic B cell populations resulted in: Rapid disappearance of circulating autoantibodies Restoration of normal haematological parameters Elimination of transfusion dependence within weeks Crucially, subsequent B cell reconstitution appeared to favour naïve, non-pathogenic populations, suggesting a functional “reset” of the immune system. This concept of immune reprogramming represents a fundamental departure from conventional immunosuppressive strategies, which typically require chronic administration and do not address underlying immune dysfunction. From Oncology to Autoimmune Disease CAR-T therapies have established clinical utility in haematological malignancies. Their application in autoimmune disease, however, represents a rapidly emerging frontier. Early clinical signals across multiple indications, including lupus and systemic sclerosis, have demonstrated the potential for deep and durable remission following a single treatment. What differentiates this case is the simultaneous resolution of multiple autoimmune conditions, extending the therapeutic hypothesis beyond single-disease targeting toward systemic immune recalibration. Clinical Significance and Limitations Despite the strength of the response, the study remains a single-patient case report and should be interpreted as hypothesis-generating rather than definitive evidence. Key limitations include: Lack of controlled clinical data Limited follow-up duration Uncertainty around long-term relapse risk Nevertheless, the findings align with a growing body of evidence suggesting that CD19-directed CAR-T therapy can induce deep remission in B cell–driven autoimmune diseases. Implications for Biopharma and Bioprocessing From an industry perspective, the implications extend well beyond clinical efficacy. Expansion of Addressable Markets The successful application of CAR-T in autoimmune disease significantly expands the potential patient population, moving beyond niche oncology indications into large, chronic disease segments. Manufacturing Pressure Unlike oncology use cases, broader autoimmune adoption will require: Increased manufacturing capacity Reduced cost of goods Streamlined, scalable production models Shift Toward One-Time Therapies If validated in larger trials, CAR-T could redefine treatment paradigms by replacing chronic immunosuppression with single-administration, potentially curative interventions. What Comes Next Multiple clinical trials are now underway to evaluate CAR-T therapies across a range of autoimmune indications, including lupus, multiple sclerosis, and vasculitis. However, key questions remain: Durability of remission beyond current follow-up periods Long-term safety and immune competence Optimal patient selection and treatment timing Author BioFocus Newsroom Previous Next

< Back 12th – 14th November, 2024 Boston, MA PMC Annual Personalized Medicine Conference The Annual Personalized Medicine Conference is designed to provide attendees with an opportunity to develop collaborative solutions to shared challenges in personalized medicine. Participants will exchange views with leading business executives, clinicians, journalists, and patient advocates in an intimate conference setting. Previous Register now Next

< Back 6th – 9th May, 2024 San Jose, CA SynBioBeta 2024 Where Global Leaders Shape the Future of Synthetic Biology. SynBioBeta 2024: The Global Synthetic Biology Conference brings the world’s leading innovators, investors, and industry pioneers to Silicon Valley from May 6–9, 2024. With 180+ expert-led sessions, 20+ curated networking experiences, and 200+ sponsors and exhibitors, this four-day event convenes over 2,500 attendees to explore the breakthroughs transforming science, industry, and society. Organized across four core themes and 18 in-depth tracks, SynBioBeta 2024 is the premier platform for advancing collaboration, accelerating innovation, and shaping the future of synthetic biology. Previous Register now Next

< Back 30th June – 3rd July, 2024 Rotterdam, Netherlands ECB2024 The Dutch Biotechnology Association (NBV) is pleased to host the World’s two longest running biotechnology Congresses, ECB2024 and IBS2024, at their annual meeting, NBC-24, in the Netherlands. Previous Register now Next

Astellas Pharma partners with AveXis to develop and commercialize AVXS-101, a promising gene therapy for Spinal Muscular Atrophy (SMA), aiming to expand treatment options for this rare and life-threatening genetic disorder. < Back Astellas and Avexis Collaborate on Gene Therapy for Spinal Muscular Atrophy Astellas Pharma partners with AveXis to develop and commercialize AVXS-101, a promising gene therapy for Spinal Muscular Atrophy (SMA), aiming to expand treatment options for this rare and life-threatening genetic disorder. Astellas Pharma Inc. (TSE: 4503) has announced a strategic partnership with AveXis, Inc., a Novartis company, to advance the development and commercialization of a gene therapy for Spinal Muscular Atrophy (SMA). The collaboration, aimed at expanding treatment options for this rare and debilitating neuromuscular disease, underscores Astellas’ commitment to addressing unmet medical needs in the field of genetic disorders. Under the terms of the agreement, Astellas will obtain exclusive rights to collaborate with AveXis on the continued development of AVXS-101 , a gene therapy for SMA. The partnership will focus on both the clinical development and the potential commercialization of this promising therapy in key global markets. Breakthrough Gene Therapy for SMA SMA is a rare genetic disorder caused by mutations in the SMN1 gene, leading to the degeneration of motor neurons, severe muscle weakness, and loss of motor function. It is one of the leading genetic causes of infant mortality, with an early onset of symptoms often resulting in significant health complications and, in many cases, premature death. AVXS-101 is an investigational one-time gene therapy designed to address the underlying cause of SMA by delivering a functional copy of the SMN1 gene to motor neurons, potentially halting disease progression or improving motor function. The therapy has already shown promising results in clinical trials, demonstrating significant improvements in motor function for patients with SMA, particularly for those with the most severe forms of the disease. If successfully commercialized, AVXS-101 could provide a transformative treatment option for SMA patients, offering hope for those affected by the condition and their families. Astellas' Commitment to Gene Therapy The collaboration with AveXis marks a significant milestone in Astellas’ growing portfolio of gene therapies. "Astellas is excited to partner with AveXis on this innovative gene therapy for SMA," said Yoshihiko Hatanaka, President and CEO of Astellas. "This collaboration reflects our ongoing commitment to advancing transformative therapies that address the root causes of diseases and bring meaningful improvements to patients’ lives." Astellas brings substantial expertise in developing and commercializing cutting-edge treatments, particularly in the field of rare diseases. The company’s experience in gene therapies, combined with AveXis’ leadership in SMA treatment development, positions the partnership to accelerate the availability of new, potentially life-changing options for SMA patients. Terms of the Partnership While the full financial details of the collaboration were not disclosed, the agreement includes both upfront payments and performance-based milestones, along with royalty payments based on future sales. Astellas will work closely with AveXis to progress AVXS-101 through further clinical development, regulatory approvals, and potential market entry. The collaboration is expected to facilitate the global expansion of gene therapies for SMA, with a focus on bringing the treatment to patients in regions such as the U.S., Europe, and Japan, where Astellas has a strong commercial presence. About Spinal Muscular Atrophy (SMA) SMA is a genetic disorder that affects approximately 1 in 6,000 to 10,000 live births worldwide. It leads to progressive muscle weakness and atrophy, primarily affecting infants and young children, with varying degrees of severity. Without early intervention, SMA can lead to respiratory failure and loss of motor function. However, with early diagnosis and treatment, patients can experience significant improvements in motor skills, mobility, and quality of life. About Astellas Pharma Astellas Pharma Inc. is a global pharmaceutical company dedicated to improving the health of people around the world. With a focus on research and development in areas such as oncology, immunology, neuroscience, and rare diseases, Astellas is committed to bringing innovative therapies to patients. The company works to meet the unmet medical needs of patients, aiming to improve their quality of life and achieve better health outcomes. About AveXis (now Novartis Gene Therapies) AveXis, a Novartis company, is a leader in gene therapy with a focus on developing transformative treatments for patients with serious neurological genetic disorders. The company is particularly known for its work in SMA, where its groundbreaking gene therapy has shown to provide significant improvements in clinical outcomes. AveXis remains at the forefront of innovation in gene therapies for rare diseases. Author BioFocus Newsroom Previous Next

CHO Playbook Gibco™ CHO Cell Culture Solutions for Biomanufacturing The success of biopharmaceutical manufacturing relies on a controlled, scalable and high-yield production process. Cell culture is an essential component in the manufacture of vaccines, therapeutic proteins and antibodies. So, to maintain product consistency and improve quality, researchers must fine tune at each step to maximize the potential of the cell line. This compendium offers guidance and solutions for the culturing of Chinese hamster ovary (CHO) cells for robust large-scale biomanufacturing. To learn more about how you can unlock your edge in cell therapy, visit: thermofisher.com/performance First name Last name Country Email Company Job title Do you work on protein therapeutics? Choose an option Are you interested in learning more about scaling up your cell culture process? Choose an option I acknowledge and agree to the use of my contact information to receive messages about offerings by BioFocus, its brands, affiliates and/or third-party partners, consistent with the BioFocus Privacy Policy View privacy policy. Read playbook

Aim higher to reach new peaks. Preparing your cell culture workflow to scale for success. As workflows scale up toward clinical and commercial production volumes, failures or unexpected outcomes can result in costly delays for biologics developers. This article shares how to proactively consider factors such as the medium and feed system, the manufacturing workflow, and the choice of supplier, to help reduce the risk of delays, mitigate unforeseen costs, and rapidly deliver the needed therapeutic to patients. Learn more on how you can aim higher, reach new peaks, and scale your processes with confidence, download now. First name Last name Country Email Institution City Would you like to have a Thermo Fisher Scientific bioprocessing specialist contact you for a quote, demo, sample, or to provide technical support? Choose an option I acknowledge and agree to the use of my contact information to receive messages about offerings by BioFocus, its brands, affiliates and/or third-party partners, consistent with the BioFocus Privacy Policy Read article

< 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 Sanome Partners With NHS Trusts to Deploy AI-Powered Clinical Intelligence for Earlier Infection Detection MEMORI, a CE-marked AI clinical decision support tool, is being rolled out at two UK NHS hospitals to help clinicians spot hospital-acquired infections sooner. Sanome , the London-based health tech company behind MEMORI, an AI-powered clinical decision support tool that helps clinicians detect hospital-acquired infections (HAIs) earlier, has announced two major hospital partnerships to improve patient care. Earlier this year, MEMORI became the UK’s first multimodal Class IIb CE-marked AI Software as a Medical Device for infection prediction. The Royal Hospital for Neuro-disability and East Kent Hospitals University NHS Foundation Trust have each selected Sanome’s MEMORI platform to support earlier detection of HAIs and clinical decision-making. This comes at a time when health services prepare for soaring pressures during the winter months, with rising admissions, workforce shortages, and seasonal infection spikes placing clinicians under mounting pressure to take swift and decisive action to prevent serious conditions like hospital-acquired infections from escalating. HAIs remain one of the most serious and costly challenges facing the NHS, contributing to over seven million additional patient bed days and £2.7 billion in annual care costs. Early detection is critical for preventing deterioration, easing clinical pressures, and improving patient outcomes. MEMORI analyses real-time patient data using explainable clinical AI to identify emerging infection risk, with early studies showing the potential to surface life-threatening HAI predictions up to three days earlier than standard practice. By flagging high-risk patients sooner and providing clear, actionable insights, the platform helps clinicians recognise deterioration earlier and deliver the right care at the right moment. Embedded directly within electronic patient records (EPRs), MEMORI brings these insights into clinicians’ existing workflows, enabling earlier, more confident decision-making. The Royal Hospital for Neuro-disability, one of the UK’s leading specialist centres for long-term and complex neurological conditions, will become the first specialist neuro facility to embed MEMORI into routine patient care. Patients with complex neurological conditions are among the most vulnerable to infections and associated complications; in fact, more than six in ten of those admitted to intensive care units contract at least one HAI during their stay. Through integration with the PatientSource EPR, MEMORI will support earlier detection across four wards initially, enabling clinicians to intervene sooner for a highly vulnerable patient population where timely action is essential. In addition to the deployment of MEMORI in specialist neurological care, East Kent Hospitals University NHS Foundation Trust, one of England’s largest acute trusts, is also partnering with Sanome to integrate real-time AI insights directly into its EPR system to support early recognition of deteriorating patients. This collaboration lays the groundwork for a scalable new model for safe, secure access to real-time NHS data, supporting thousands of patients across multiple hospital sites. “Partnering with leading healthcare organisations like the Royal Hospital for Neuro-disability and East Kent Hospitals University NHS Foundation Trust marks another major step towards bringing earlier, data-driven infection detection into everyday care for every patient,” said Benedikt von Thüngen, Founder and CEO of Sanome. “Working closely with clinicians, we’ve co-created a platform that not only flags those at risk but fits seamlessly into existing workflows. Our aim is to equip frontline teams with the actionable insights they need to intervene sooner and protect patients, at the same time relieving pressure on already-stretched resources.” Bedside go-live dates at both sites in specialist neurological care are scheduled for the coming months, with additional NHS deployments planned throughout 2026 as Sanome continues to expand its footprint across UK healthcare. Author BioFocus Newsroom Previous Next