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Strategic move boosts the Swiss pharmaceutical company's shares. < Back Roche Accelerates Anti-Obesity Drug Development to Rival Eli Lilly and Novo Nordisk Strategic move boosts the Swiss pharmaceutical company's shares. Roche , a leading Swiss pharmaceutical company, is expediting the development of its anti-obesity drugs to compete with industry giants Eli Lilly and Novo Nordisk in the rapidly expanding market. This move follows the unveiling of promising data for a new weight-loss pill. Thomas Schinecker, Roche’s CEO, disclosed to the Financial Times that the company’s first anti-obesity treatments are expected to reach the market "significantly faster than people are expecting," potentially by 2028. These treatments, part of an up to $3.1 billion acquisition of biotech firm Carmot Therapeutics last year, include a weight-loss injection entering phase II trials and a pill that demonstrated a 6.1% weight reduction compared to a placebo after four weeks. The Carmot acquisition could yield approximately seven drugs, with several in early development stages, though Roche has disclosed details for only three assets so far. Recent data from the weight-loss pill boosted Roche's shares by 6% on the day of the announcement, while shares of Novo Nordisk and Eli Lilly declined amid concerns about potential competition from Roche. Goldman Sachs analysts project that the obesity market will exceed $130 billion by 2030, with multiple companies vying to introduce their treatments. Roche faces the challenge of catching up with established players like Novo Nordisk and Eli Lilly, whose drugs Wegovy and Mounjaro have achieved approximately 15% and 20% weight loss, respectively, in trials lasting over a year. Other pharmaceutical companies, including Boehringer Ingelheim and Pfizer, are also aiming to enter the obesity drug market. Shares of US biotech Viking Therapeutics surged by 30% after announcing plans to advance an obesity pill to late-stage trials. Schinecker highlighted the scalability of Roche’s weight-loss pill, which is synthetically manufactured rather than derived from natural peptides, as is the case with Novo Nordisk’s pill. This synthetic approach could potentially streamline production and distribution processes. Barclays analyst Emily Field remarked that while Roche’s early data is promising, it remains uncertain whether the company can disrupt the head start held by Novo Nordisk and Eli Lilly. "If you look at what’s disclosed, it’s better than pretty much everything at four weeks. But there’s a lot we don’t know," she noted, referring to the lack of detailed information on potential side effects like nausea and vomiting. Since taking over as CEO in March 2023, Schinecker has overseen a significant restructuring at Roche, including cutting 25% of underperforming drugs in development. The company is now focusing on a more selective but promising portfolio of drugs, including those targeting obesity and Alzheimer’s disease. "That creates room for new starts and things that we can bring in from the outside so that you don’t carry projects for too long and then you find resources that you could put to much more effective use to develop new medicines," Schinecker explained. Roche’s strategic shift follows a series of research setbacks, such as the recent failure of a late-stage trial for its lung cancer drug tiragolumab to show superior survival rates compared to Merck's Keytruda. Schinecker expressed optimism that Roche’s obesity drugs might also be used in combination with the company’s other treatments for obesity-related conditions. He highlighted the success of Vabysmo, a blockbuster eye treatment developed with subsidiary Genentech, which generated CHF 1.8 billion ($2.1 billion) in sales in the first half of the year and shows promise in treating diabetic macular edema. Buoyed by strong sales of Vabysmo and the multiple sclerosis drug Ocrevus, Roche raised its expected earnings per share growth for 2024 to the high single-digit range, up from previous guidance of a mid-single-digit increase. Author BioFocus Newsroom Previous Next

In a landmark advancement for genetic medicine, the NHS is set to offer a revolutionary gene therapy, Casgevy, to patients with transfusion-dependent beta thalassaemia. < Back NHS Introduces Groundbreaking Gene Therapy for Beta Thalassaemia In a landmark advancement for genetic medicine, the NHS is set to offer a revolutionary gene therapy, Casgevy, to patients with transfusion-dependent beta thalassaemia. The new therapy, developed by Vertex Pharmaceuticals and CRISPR Therapeutics , marks a significant milestone in the treatment of this severe genetic blood disorder. Casgevy has been approved by the National Institute for Health and Care Excellence (NICE) and will be available from August 7. It is anticipated to benefit around 460 patients in England. Beta thalassaemia, a condition where the body produces insufficient haemoglobin, affects approximately 2,300 people in the UK, predominantly those of Mediterranean, Asian, or Middle Eastern descent. The disorder often leads to severe anaemia, necessitating lifelong blood transfusions and reducing life expectancy to around 50 years. Casgevy offers a potential cure by employing CRISPR gene-editing technology. The treatment involves extracting stem cells from a patient's bone marrow, modifying the genes in a lab to produce functioning haemoglobin, and reinfusing the corrected cells back into the patient. This process reprograms the cells to produce foetal haemoglobin, bypassing the genetic defect that hampers adult haemoglobin production. In clinical trials, 93% of patients did not require blood transfusions for at least a year post-treatment. "This is a historic moment for people living with beta thalassaemia," said Amanda Pritchard, NHS Chief Executive. "This therapy offers a life free from regular transfusions and the debilitating symptoms of the disorder, promising a longer and healthier life." The gene-editing tool CRISPR, which won the Nobel Prize for Chemistry in 2020, is integral to this treatment. It precisely targets and edits the DNA responsible for the haemoglobin switch from foetal to adult forms. This innovative approach not only addresses the symptoms but also targets the root cause of beta thalassaemia. The therapy's introduction follows a thorough evaluation by NICE, which considered both its costs and benefits. While the listed price of Casgevy is £1.65 million per patient, NHS England has negotiated a lower price to make it accessible. The treatment will be available at seven specialist centres across the UK, ensuring it reaches those in need efficiently. "This transformative treatment offers patients a life-changing opportunity, enabling them to repair their own cells and embrace a future free from the challenges of their condition," stated Romaine Maharaj, Executive Director of the UK Thalassaemia Society. This gene therapy not only represents a breakthrough for beta thalassaemia but also paves the way for future treatments of other genetic disorders, such as sickle cell anaemia, which is currently under negotiation for NHS approval. The rollout of Casgevy by the NHS signifies a new era in the treatment of genetic blood disorders, providing hope and improved quality of life for many patients. This advancement underscores the potential of gene therapy to address and potentially cure debilitating conditions, marking a significant achievement in medical science. Author BioFocus Newsroom Previous Next

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< Back Training the Immune System to Outlast Cancer Personalized RNA vaccines show long-term promise in pancreatic cancer, new study reports. Pancreatic cancer, particularly pancreatic ductal adenocarcinoma (PDAC), is one of the deadliest forms of cancer, with limited treatment options and a high rate of recurrence after surgery. However, a new study published in Nature reports that personalized RNA vaccines can train the immune system to fight back, potentially delaying or even preventing the return of the disease. One of the biggest hurdles in cancer treatment is getting the immune system to recognize and attack cancer cells. Cancer vaccines aim to do just that by targeting specific proteins, or "neoantigens," that are unique to the tumor. But in pancreatic cancer, which has relatively few mutations, this has been particularly challenging. The new study, led by researchers at Memorial Sloan Kettering Cancer Center, tackles this problem head-on with a novel approach: personalized RNA vaccines designed to prime the immune system to recognize and destroy cancer cells. A Personalized Approach The researchers conducted a phase I clinical trial involving 19 patients who had undergone surgery to remove their pancreatic tumors. After surgery, patients received a combination of treatments: a single dose of atezolizumab (an immune checkpoint inhibitor), followed by a personalized RNA vaccine called autogene cevumeran , and then a standard chemotherapy regimen known as mFOLFIRINOX. The vaccine was tailor-made for each patient, targeting up to 20 unique neoantigens—mutated proteins found only in their tumors. The goal was to train the immune system, specifically CD8+ T cells, to recognize and attack any remaining cancer cells, reducing the risk of recurrence. The results were striking. At a median follow-up of 3.2 years, patients who responded to the vaccine—meaning their immune systems produced a strong T cell response—had significantly longer recurrence-free survival compared to non-responders. In fact, the median recurrence-free survival for responders had not yet been reached, while non-responders had a median survival of just 13.4 months. Even more impressive was the longevity of the immune response. The vaccine-induced T cells were estimated to persist for an average of 7.7 years, with some clones potentially lasting for decades. These T cells not only stuck around but also remained functional, retaining their ability to recognise and attack cancer cells. This is a critical finding, as long-lasting immunity is essential for preventing cancer from coming back. How does it work? The vaccine works by introducing RNA sequences that encode the neoantigens into the body. These RNA sequences are packaged in lipid nanoparticles, which help deliver them to immune cells. Once inside, the immune cells use the RNA to produce the neoantigens, effectively training the immune system to recognize and attack cancer cells that display these same proteins. The study also revealed that the vaccine-induced T cells were mostly "de novo," meaning they were newly generated in response to the vaccine rather than pre-existing in the body. This is important because it suggests that the vaccine can kickstart an immune response even in patients whose immune systems haven’t naturally recognized the cancer. Using advanced single-cell RNA and TCR sequencing, the researchers tracked the behavior of these T cells over time. They found that the T cells went through several phases: first proliferating rapidly, then contracting, and finally settling into a long-lasting memory state. Importantly, these memory T cells retained their ability to kill cancer cells, even years after vaccination. In patients who experienced a recurrence, the tumors showed signs of "clonal pruning," meaning that the cancer cells targeted by the vaccine were largely eliminated. This suggests that the vaccine-induced T cells were actively working to keep the cancer in check. What does this mean for patients? For patients with pancreatic cancer, these findings are a beacon of hope. The study shows that it’s possible to generate a strong, long-lasting immune response against a cancer that has historically been very difficult to treat. While the results are still early and need to be confirmed in larger trials, the potential is enormous. The personalized nature of the vaccine is particularly exciting. By targeting the unique mutations in each patient’s tumor, the vaccine can potentially be adapted to treat a wide range of cancers, not just pancreatic cancer. This approach could be especially beneficial for cancers with low mutation rates, where traditional immunotherapy has struggled to make an impact. The researchers are already planning the next steps. A global randomized trial, called IMCODE 003, is underway to further test the efficacy of the vaccine in a larger group of patients. If successful, this could pave the way for a new era of personalized cancer vaccines, offering hope to patients with some of the most challenging forms of the disease. This study represents a significant leap forward in the fight against pancreatic cancer. By harnessing the power of personalized RNA vaccines, researchers have shown that it’s possible to train the immune system to recognize and attack cancer cells, potentially preventing recurrence and improving survival. While there’s still much work to be done, the results are a promising step toward a future where cancer vaccines could become a standard part of treatment, offering new hope to patients worldwide. Author BioFocus Newsroom Previous Next

Read the essential strategies and considerations for scaling up biologics and our run down of the top 10 companies supporting biologic scale up. < Back Essential Strategies for Scaling Up Biologics Read the essential strategies and considerations for scaling up biologics and our run down of the top 10 companies supporting biologic scale up. Biologics are revolutionising healthcare. Characterised as pharmaceutical drugs that are produced from biological systems, biologics such as therapeutic proteins, monoclonal antibodies (mAbs), and vaccines are providing highly targeted and effective treatments for conditions where patients have historically had few effective options. Recent research by Nova One Adviser values the global biologics market at $511 billion, projected to reach $1,375 billion by 2033. The ability for biopharma companies to efficiently scale the manufacturing of this type of therapeutic is paramount to realising this market value. Predictably though, scaling up is complex, and requires the implementation of critical strategies and considerations to ensure the process is efficient, cost-effective, and compliant with regulatory standards. Here, we take a look at the essential strategies for biologic scale-up, and provide a run-down of the top 10 premier companies specialising in biologic scale-up solutions. Scale up strategies and considerations Process development and optimisation A critical step in scale up is developing and refining media and feed strategies to maximize yield, titers, and cell density. It is also important to consider how the media and feed strategy translates to large-scale bioreactors. Ensuring bioreactor processes can maintain consistency from lab to pilot and production scales is imperative to achieving succesful scale up. Using optimized cell lines to enhance productivity and product quality is vital to ensure successful scale up. Cell lines are cultures of animal cells that can be propagated repeatedly, and in some cases indefinitely. Mammalian systems have higher levels of native folding, post-translational modifications, and more functional activity than other systems meaning they are more closely representative of a physiologically relevant environment for producing proteins for human use. Chinese hamster ovary cells (CHO) are the gold standard for protein production due to high productivity, the ability to allow for post-translational modifications, and low virus susceptibility. Additionally, they can grow in serum-free and chemically defined media, which helps ensure reproducibility between different batches, and they can also easily grow in large-scale cell culture. Quality control and assurance Developing robust analytical methods to ensure product quality and consistency, and ensuring all processes comply with regulatory requirements, including Good Manufacturing Practice (GMP) standards is paramount. Validation processes should be conducted to demonstrate that the process consistently produces a product meeting its predetermined specifications and quality attributes. Technology transfer It is important to have a thorough, well-planned technology transfer program that features detailed product information, process-related documentation, material transfer agreements, facility fit assessments, training requirements, and regulatory considerations. This will help protect against unwanted surprises and instead facilitate a seamless transfer between development and manufacturing stages. Scale-Up equipment and infrastructure Deciding between single-use bioreactors and traditional stainless steel systems is a key decision that biopharmaceutical manufacturers must make. The decision involves a myriad of different factors that should be considered across areas such as sustainability, flexibility, scale, quality, and cost/speed. In recent times, single-use technologies (SUT) has become more widely adopted, contributing to increasing process intensification due to SUT’s advantage of being more flexible, cost-effective, sustainable, and possessing lower risk of cross-contamination when compared to more traditional stainless steel systems. An additional consideration for equipment and infrastructure is the implementation of automation and advanced control systems in order to maintain optimal and harmonized conditions during production. Real-time monitoring of the bioprocessing workflow allows for precise control of process parameters, which is critical for success. Supply chain management Reliable sourcing of high-quality raw materials is a vital component of scaling up because any impurities in the raw materials, when scaling up to large bioreactors, can be amplified, in doing so influencing performance parameters and causing lot-to-lot inconsistencies. It is important when choosing a manufacturing supplier to ensure they have global redundancy in manufacturing supply as pauses in the manufacturing process are highly costly. In recent times, the unprecedented demand for bioproduction materials, combined with significant disruption to global supply chains, has placed an increasing importance on ensuring a robust raw material supply to meet timelines and avoid costly delays. Risk management Developing contingency plans for potential risks, such as equipment failure or supply chain disruptions is crucial as is the use of scale-down models to identify and mitigate risks before full-scale production The Top 10 Companies Supporting Biologic Scale-Up Lonza Lonza has a strong reputation in the industry. It offers comprehensive biologics development and manufacturing services, including cell line development; process development; commercial manufacturing; mammalian and microbial production; cell and gene therapy manufacturing, drug production services including formulation, fill and finish. Thermo Fisher Scientific With an extensive global footprint, Thermo Fisher Scientific provides comprehensive services for biologics development and manufacturing, including cell line development, process optimisation, cell culture media, bioreactors, purification systems, fill/finish, analytical testing services, and large-scale production. WuXi AppTec WuXi AppTec provides end-to-end solutions for biologics development, including cell line development, process optimisation, GMP manufacturing, and analytical development services. It has a strong global presence, rapid turnaround times, and extensive capabilities in cell and gene therapies. Samsung Biologics A relatively new player compared to others, Samsung Biologics offers a full-service CDMO for biologics, with process, development, clinical and commercial manufacturing services, as well as drug product services including aseptic fill/finish and lyophilization. Fujifilm Diosynth Biotechnologies Located in the United States and Europe, Fujifilm Diosynth Biotechnologies specialises in the development and manufacturing of biologics, with expertise in process development, analytical development, and GMP manufacturing. Catalent Biologics With a focus on speed and flexibility, Catalent Biologics offers integrated biologics development and manufacturing solutions, including cell line development, process development, fill/finish, packaging, clinical supply services, analytical services, and commercial manufacturing. Boehringer Ingelheim BioXcellence Boehringer Ingelheim BioXcellence has a long history of experience in biopharmaceutical manufacturing. It provides a comprehensive, premium service offering for biologics manufacturing. Millipore Sigma With strong expertise in bioprocessing technologies and a focus on innovation, Millipore Sigma services include cell culture media, filtration, purification systems, analytical testing and validation, and manufacturing services. Cytiva Cytiva has a strong legacy in bioprocessing and an extensive product and technology service offering. This includes cell culture, filtration, and purification solutions as well as automation and digital solutions for biomanufacturing. Sartorius Sartorious is one of the leading providers of single-use bioprocessing technologies and has a strong focus on innovation and process efficiency. It has a comprehensive product portfolio for biologic manufacturing Conclusion Scaling up the production of a biologic requires many considerations and optimization strategies. Choosing the right company to partner with can significantly streamline this process, ensuring the biologic is produced efficiently and meets regulatory standards. Author BioFocus Newsroom Previous Next

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The drug, Wainzua, specifically targets type 2 inflammation-driven asthma, a form associated with severe, persistent symptoms and significant impairment in quality of life. < Back AstraZeneca's Wainzua Recommended for EU Approval as New Therapy for Severe Asthma The drug, Wainzua, specifically targets type 2 inflammation-driven asthma, a form associated with severe, persistent symptoms and significant impairment in quality of life. In a significant development for asthma treatment, AstraZeneca announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its new therapy, Wainzua (inavolisib). The drug, designed to address severe asthma in adults, holds promise for individuals whose condition remains poorly controlled with currently available therapies. The European Commission will consider the CHMP recommendation and is expected to make a final decision within the coming months. Wainzua specifically targets type 2 inflammation-driven asthma, a form associated with severe, persistent symptoms and significant impairment in quality of life. Patients with this type of asthma often rely on high doses of corticosteroids and may still experience frequent exacerbations, raising the need for more effective treatment options. By acting on this specific inflammatory pathway, Wainzua offers a targeted therapeutic approach to reduce exacerbations, lower corticosteroid use, and improve respiratory function. Key Findings and Clinical Impact In Phase III trials, Wainzua demonstrated remarkable results. Patients receiving Wainzua experienced a substantial reduction in exacerbations compared to those on standard care, as well as improved lung function and symptom control. The benefits observed in these studies underscore the potential of Wainzua to help patients regain control of their condition and enhance their overall quality of life. Dr. Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, stated: “This CHMP recommendation underscores our commitment to advancing science and providing innovative solutions for chronic respiratory diseases. Wainzua has the potential to transform the lives of patients living with severe asthma, an area where unmet needs remain high.” Anticipated Approval and Launch Pending approval by the European Commission, Wainzua could be available to patients across the EU by early 2025. AstraZeneca is poised to work closely with healthcare systems across Europe to ensure Wainzua’s availability, with a strong emphasis on affordability and accessibility. AstraZeneca’s success with Wainzua highlights the company's ongoing dedication to developing specialized treatments for chronic respiratory diseases. If approved, Wainzua will join AstraZeneca’s expanding portfolio of respiratory and immunology therapies, marking a significant advancement in the treatment of severe asthma and promising a new wave of relief for patients throughout Europe. Author BioFocus Newsroom Previous Next

Dupixent has received FDA priority review for the treatment of bullous pemphigoid, a rare autoimmune skin disorder. If approved, Dupixent would become the first targeted therapy for BP, offering a safer and more effective treatment option. < Back Sanofi's Dupixent Receives FDA Priority Review for Bullous Pemphigoid Treatment Dupixent has received FDA priority review for the treatment of bullous pemphigoid, a rare autoimmune skin disorder. If approved, Dupixent would become the first targeted therapy for BP, offering a safer and more effective treatment option. Sanofi and Regeneron have announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental biologics license application (sBLA) for Dupixent (dupilumab) as a treatment for adults with bullous pemphigoid (BP). This decision grants priority review status, with an expected FDA verdict by June 20, 2025. If approved, Dupixent would become the first targeted therapy available for BP patients in the United States. Understanding Bullous Pemphigoid Bullous pemphigoid is a rare autoimmune skin disorder predominantly affecting individuals over the age of 60. The condition arises when the immune system erroneously attacks the skin's basement membrane, leading to the formation of large, fluid-filled blisters. These blisters commonly develop on the abdomen, arms, legs, and groin areas, and are often accompanied by intense itching and redness. While the exact cause remains unclear, BP has been associated with certain medications and underlying health conditions. Traditional treatments include corticosteroids and immunosuppressive agents, which can have significant side effects, especially with long-term use. Dupixent's Clinical Advancements The sBLA submission is underpinned by positive results from a pivotal trial involving 106 adults with moderate-to-severe BP. In this study, Dupixent demonstrated significant improvements in sustained disease remission compared to placebo. The therapy works by inhibiting the signaling of interleukin-4 and interleukin-13, key drivers of type 2 inflammation, which is believed to play a central role in BP's pathophysiology. Dr. John Reed, Global Head of Research and Development at Sanofi, stated: "The FDA's priority review of Dupixent for bullous pemphigoid underscores the urgent need for a targeted treatment option for this debilitating disease. We are committed to bringing this innovative therapy to patients as swiftly as possible." Implications for Clinical Practice For healthcare professionals, the potential approval of Dupixent offers a novel therapeutic avenue for managing BP, particularly for patients who are unresponsive to or cannot tolerate existing treatments. The targeted mechanism of Dupixent may provide a more favorable safety profile, reducing the reliance on broad immunosuppressants and their associated risks. As the FDA's decision approaches, clinicians are advised to stay informed about emerging data and prepare for the integration of this therapy into practice, pending approval. Sanofi and Regeneron continue to collaborate closely with regulatory authorities to facilitate access to Dupixent for BP patients in need. Author BioFocus Newsroom Previous Next

The pharma giant will close its cell therapy unit, cutting 250 jobs and ending work on Type 1 diabetes and Parkinson's programs, as new CEO shifts focus to obesity, diabetes, and liver disease treatments. < Back Novo Nordisk Pulls Plug on Cell Therapy in $1.3B Restructuring Push The pharma giant will close its cell therapy unit, cutting 250 jobs and ending work on Type 1 diabetes and Parkinson's programs, as new CEO shifts focus to obesity, diabetes, and liver disease treatments. In a major shift under new CEO Maziar Mike Doustdar, Novo Nordisk has announced the complete closure of its cell therapy operations, a move that will eliminate nearly all 250 positions within the division and mark the end of its long-running efforts to develop regenerative treatments for Type 1 diabetes, Parkinson’s disease, and heart failure. A company spokesperson confirmed that “we have decided to discontinue our cell therapy R&D efforts,” adding that Novo Nordisk is “in the process of identifying partners with the right capabilities and manufacturing capacity to further develop our innovations.” “Out of respect for the employees involved, we will not share additional details about individual sites or areas,” the spokesperson said. The decision, first reported by Danish outlet Børsen , comes as part of Doustdar’s broader restructuring campaign to streamline operations and redirect investment into Novo’s highest-growth areas - particularly obesity and diabetes, where demand for GLP-1 drugs such as Wegovy and Ozempic continues to surge globally. The plan is expected to generate annual savings of roughly $1.3 billion by the end of 2026 through a global headcount reduction of about 9,000 employees, or 11% of the total workforce. “As part of this change, we are assessing all business areas and regions to simplify structures, reduce duplication and sharpen focus,” the spokesperson said. The discontinuation marks a symbolic end to Novo’s decade-long ambitions in cell therapy, once a promising avenue for achieving functional cures for chronic diseases. Novo had invested heavily in stem cell–based programs targeting insulin-producing beta cell replacement for Type 1 diabetes, alongside exploratory work in Parkinson’s disease and chronic heart failure. But recent recalibration appears to prioritise near-term commercial impact over longer-horizon regenerative bets. Less than two weeks ago, Novo terminated a $598 million cell therapy collaboration in cardiovascular disease, signalling that the retreat from the modality was already underway. For observers, the exit underscores the mounting financial and manufacturing challenges that have constrained the scalability of cell therapies beyond oncology. Takeda Pharmaceuticals announced a similar withdrawal from cell therapy R&D just last week, citing similar operational hurdles. Novo’s retrenchment in cell therapy coincides with an aggressive expansion into other high-value therapeutic areas. The company revealed plans to acquire U.S.-based Akero Therapeutics for up to $5.2 billion, gaining control of its FGF21 analogue, a promising liver disease drug currently in phase 3 development. Data from the pivotal program are expected in the first half of 2026. Analysts view the Akero acquisition as a continuation of Novo’s strategy to consolidate its leadership in metabolic and endocrine disorders, leveraging its GLP-1 franchise to diversify into adjacent spaces such as NASH and broader cardiometabolic disease. For pharmaceutical professionals, the move represents a growing industry consensus: capital-intensive modalities like cell therapy may be taking a back seat to more commercially viable biologics and small molecules in the current funding climate. With the company’s weight-loss and diabetes drugs continuing to dominate global demand, and supply chains stretched to meet that demand, Novo's latest restructuring signals a clear focus on efficiency, profitability, and market leadership in metabolic health. Author BioFocus Newsroom Previous Next

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Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) has been approved in Australia for treating early-stage Alzheimer’s disease in patients with confirmed amyloid pathology. < Back Eli Lilly’s Alzheimer’s Drug Kisunla (Donanemab) Receives Marketing Authorization in Australia Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) has been approved in Australia for treating early-stage Alzheimer’s disease in patients with confirmed amyloid pathology. Australia’s Therapeutic Goods Administration (TGA) has approved Kisunla™ (donanemab-azbt), a monoclonal antibody developed by Eli Lilly, for the treatment of early symptomatic Alzheimer’s disease in adults with confirmed amyloid pathology. This marks the first new Alzheimer’s treatment in 25 years that targets the underlying cause of the disease by removing amyloid plaques in the brain. Kisunla is administered intravenously once a month for up to 18 months. Clinical trials have shown that it can slow cognitive and functional decline by approximately one-third compared to placebo in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease. However, the treatment is not suitable for all Alzheimer's patients. Only 10–20% of Australia's estimated 400,000 dementia patients are likely to be eligible, due to strict criteria including early-stage diagnosis, specific genetic markers, and risk assessments for side effects like brain swelling and bleeding. The cost of Kisunla treatment, which includes drug and diagnostic expenses such as MRI scans and PET imaging, may exceed $80,000. Currently, it is not covered by Medicare or the Pharmaceutical Benefits Scheme (PBS). Eli Lilly has applied for PBS listing, with a review by the Pharmaceutical Benefits Advisory Committee scheduled for July. Alzheimer's disease affects around 600,000 Australians, with approximately 75% in the early stages. The disease's economic impact is projected to more than double by 2050, reaching $17 billion . Experts and advocates consider Kisunla's approval an important advance in dementia care, while emphasizing the need for improved diagnostic pathways and government support to ensure affordability and accessibility. Eli Lilly remains committed to advancing treatments for Alzheimer's disease and continues to work with regulatory authorities to expand access to Kisunla in other regions. However, currently, the National Institute for Health and Care Excellence (NICE) has not recommended Kisunla for use on the National Health Service (NHS) due to concerns about its cost-effectiveness. NICE's independent committee concluded that while Kisunla can slow cognitive decline by four to seven months, the benefit does not justify the high cost to the NHS. Author BioFocus Newsroom Previous Next