Latest news with #drugDevelopment
Reuters
2 days ago
- Health
- Reuters
Roche to test if new drug can prevent Alzheimer's disease, Bloomberg News reports
July 27 (Reuters) - Swiss drugmaker Roche Holding (ROG.S), opens new tab plans to test whether an experimental medicine can prevent Alzheimer's disease symptoms in high-risk people, Bloomberg News reported on Sunday. The new late-stage study will target people who are at risk of cognitive decline and aim to slow down the emergence of symptoms or prevent them fully, the report said, citing a statement. The new pre-clinical study is the third largest late-stage trial that the company has announced for its drug trontinemab, which uses an experimental technology called brain shuttle to ferry medicine past the protective blood-brain barrier, according to the report. Rivals like Eli Lilly (LLY.N), opens new tab have been making progress in the complicated field of Alzheimer's recently with Lilly's Alzheimer's drug Kisunla getting recommendation from the European Medicines Agency (EMA) last week. Reuters could not immediately verify the report. Roche did not immediately respond to a request for a comment. Treatments for Alzheimer's approved so far, including Eisai (4523.T), opens new tab and Biogen's (BIIB.O), opens new tab Leqembi, and Eli Lilly's Kisunla, are designed to clear sticky clumps of a protein called amyloid beta in the brain. They also carry hefty price tags and the risk of serious brain swelling and bleeding.
Bloomberg
2 days ago
- Health
- Bloomberg
Roche to Test Whether New Drug Can Prevent Alzheimer's Disease
Roche Holding AG plans to test whether an experimental medicine can prevent Alzheimer's disease symptoms in high-risk people, its latest investment in one of the most failure-prone areas of drugmaking. The new late-stage study will focus on people who are at risk of cognitive decline, Roche said in a statement late Sunday. The goal would be to slow down the emergence of symptoms, or prevent them entirely.
Wall Street Journal
09-07-2025
- Business
- Wall Street Journal
Vie Ventures Launches to Bankroll Autoimmune-Disease Biotechs
Two veteran life-sciences investors have launched Vie Ventures, which plans to fund biotechnology startups targeting autoimmune diseases and connect them with nonprofits that might accelerate their drug development. Vie Co-founders Luke Evnin and Dr. Steven St. Peter previously invested together with MPM Capital, now MPM BioImpact. Both also have experience with nonprofits: Evnin is chairman of the Scleroderma Research Foundation and St. Peter most recently was managing director of the T1D Fund, the venture-philanthropy arm of Breakthrough T1D, which supports Type 1 diabetes research.
Associated Press
04-07-2025
- Health
- Associated Press
R&D Investments Fuel Next-Gen Immunomodulator Development Amid Patent Expiry
DUBLIN--(BUSINESS WIRE)--Jul 4, 2025-- The 'Immunomodulator Therapeutics Market, Global, 2024-2030" report has been added to offering. Revenue estimate for the base year 2024 is $93 billion with a CAGR of 9.0% for the study period 2024-2030. This research service offers a comprehensive analysis of the global immunomodulator therapeutics market, specifically targeting inflammatory disorders in the immunology, gastrointestinal (GI), and dermatology segments. The report defines this market through products designed to modify and regulate pathological immune responses, either by inhibiting or suppressing them. It categorizes the market by modality and key indications, providing a 6-year revenue forecast for global immunomodulator prescription drugs, alongside an analysis of key industry participants. The geographic scope encompasses North America, Europe, Asia-Pacific (APAC), the Middle East and Africa (MEA), and Latin America (LATAM), with regional revenue share estimates presented on a best-effort basis. The report also discusses prevalent and emerging business models, analyzes trends in market access and reimbursement for immunomodulator therapies, and offers competitive assessments and revenue share analyses. It examines the factors driving and restraining growth in this space, offering insights into drug development trends, partnerships, and the investment landscape. The report highlights key companies pioneering disruptive virtual care technologies and adjunctive therapies for effective disease management. Based on clinical needs, technological advancements, business models, and competitive dynamics, the report identifies the growth opportunities emerging from this space for market players and stakeholders to leverage. The base year is 2024, and the forecast period is from 2025 to 2030. Growth Drivers Rising Prevalence of Autoimmune and Inflammatory Diseases Increasing prevalence of diseases like lupus, RA, Crohn's disease, and psoriasis is driving demand for immunomodulators like tumor necrosis factor (TNF) inhibitors (e.g., Humira, Remicade) and JAK inhibitors (e.g., Xeljanz). The rapidly aging global population is more susceptible to chronic autoimmune conditions. It is further bolstering demand for treatments tailored to older adults, such as more tolerable biologics. Biotech Advancements Innovations in biotech platforms and advanced modalities such as CGT, bispecific antibodies, and RNA therapies are enhancing the efficacy and safety profiles of immunomodulators and driving the development of next-gen targeted therapies. Carisma Therapeutics Inc. and Moderna, Inc. have collaborated to use Carisma's proprietary CAR-M technology and Moderna's mRNA/lipid nanoparticles (LNP) platform to develop a macrophage engineering approach for autoimmune diseases. Growing Investment in R&D Increased funding from both public and private sectors is accelerating R&D efforts for discovering new therapies and improving existing ones. The NIH allocates significant funding for research on immunomodulatory therapies, fostering innovation. An increasing number of M&A deals demonstrate a growing focus on immunology by big pharma. Success in Oncology and Expanding Applications The success of immunotherapies in oncology has raised awareness and acceptance of similar approaches in treating autoimmune and inflammatory diseases. For example, Roche's Gazyva/Gazyvaro (obinutuzumab), approved in 100 nations for several lymphoma types, is being investigated in the Phase III REGISTRY trial for lupus nephritis. Growth Restraints Immunomodulator Therapeutics: Growth Restraints, Global, 2025-2030 Stringent Regulatory Processes: Stringent regulatory processes for immunomodulatory treatment approval or the development of novel mechanisms of action, globally, can cause delays in market access and raise development expenses for pharmaceutical companies. Moreover, inadequate reimbursement/insurance coverage globally may deter wide-scale adoption, especially in public health systems or regions with limited healthcare resources. Inadequate coverage of high-cost new drugs would increase the expenses of managing long-term conditions, impacting patient compliance and market growth. Potential Adverse Effects and Safety Concerns: Immunomodulators may have serious adverse effects, such as an elevated risk of infections and autoimmune responses. For example, checkpoint inhibitor use in autoimmune disease is linked to immune-related side effects that need to be carefully managed. Adverse outcomes and safety risks may lead to regulatory actions such as market recalls, limited prescriptions, and reduced patient confidence, challenging market uptake. Patent Expiry: Expiry of blockbuster drug patents is leading to the introduction of biosimilars and generic versions, intensifying market competition, resulting in price erosions, and leading to a loss of sales revenue for branded products. For example, AbbVie's blockbuster Humira, approved for several autoimmune conditions like RA, psoriasis, Crohn's disease, and ankylosing spondylitis, started facing biosimilar competition in 2023. Patient Inconvenience: Biotech advancements have facilitated the development of effective biologic therapies; however, therapy administration requires frequent injections or infusions, making it challenging for patients to adhere to their treatment regimens. It may affect overall patient satisfaction and treatment discontinuation. The Impact of the Top 3 Strategic Imperatives on the Immunomodulator Therapeutics Industry Disruptive Technologies Why: There is an increasing incidence of autoimmune diseases, particularly impacting women. Limitations in existing therapies demand more targeted applications. Analyst Perspective: A new wave of drug classes (JAK1, IL, calcineurin, TNF?, TYK2, PDE4), across small molecules, biologics, and cell and gene therapies, will emerge, offering enhanced efficacy and safety profiles for treating autoimmune and inflammatory conditions. There will be a growing trend towards combination therapies that utilize multiple mechanisms of action to achieve better clinical outcomes. Internal Challenges Why: The industry is moving toward an extended patent cliff, with several revenue-generating blockbuster drugs like Humira and Stelara losing their exclusivity, leading to revenue losses and increased biosimilar competition, creating an urgent need for pipeline growth, and driving increased research and development (R&D). Resource demands for R&D can strain budgets, especially for smaller biotech firms. Analyst Perspective: Companies may increasingly seek strategic partnerships to share costs and risks, fostering innovation through collaborative R&D efforts. Companies that emphasize unique value propositions in these strategic alliances will be better positioned to access markets/fair pricing with drugs like JAK inhibitors and women-specific therapies. Payers will scrutinize clinical costs and patient outcomes to ensure balance and sustainable reimbursement models that reflect indication-specific needs and improve affordability. Transformative Megatrends Why: Healthcare systems are under pressure to contain current and future spending. Healthcare plan sponsors are considering their next moves as governments contemplate the impact of the Inflation Reduction Act (IRA) 2022, and associated price cuts in the United States. Analyst Perspective: Firms will invest in adaptive trial designs for evidence generation to expedite approvals for novel MoA-based targeted therapies, advancing precision medicine going forward. Pharma companies will utilize diagnostic delivery services to improve patient access by partnering with telehealth/AI-enabled symptom monitoring platforms (e.g., Ada Health) and focus on an emerging market-expansion strategy. Focus on predictive convergence of drugs and digital therapeutics will likely personalize medicine and improve experiences and outcomes. Scope of Analysis Ecosystem in the Immunomodulator Therapeutics Sector Growth Opportunity Universe in Immunomodulator Therapeutics Sector Key Competitors For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. View source version on CONTACT: Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL HEALTH SOURCE: Research and Markets Copyright Business Wire 2025. PUB: 07/04/2025 06:43 AM/DISC: 07/04/2025 06:43 AM
News.com.au
16-06-2025
- Business
- News.com.au
Health Check: A pancreatic cancer ‘cure' has been elusive, but Amplia may have cracked the nut
Amplia shares soar almost 50% on news of a 'complete response' in a patient with metastasised pancreatic cancer Syntara and Kazia also report progress with their cancer drug candidates Emvision pockets $5 million of non-dilutive grant funding Has Amplia (ASX:ATX) cured pancreatic cancer, one of the deadliest tumour types? The drug developer reports a 'pathological complete response' in an advanced (metastatic) pancreatic cancer patient – an 'extremely rare' event. A pathological complete response means there are no signs of cancer in tissue examined by a pathologist following surgical removal. The treatment appeared to have reduced the tumour to a size where both the primary tumour in the pancreas and secondary liver tumours could be excised. Amplia's drug candidate AMP-945 (narmafotinib) is a focus kinase (FAK) inhibitor. FAKs are not cuss words but a type of protein overexpressed in pancreatic cancers. Dubbed Accent, Amplia's trial uses narmafotinib in combination with standard chemotherapy gemcitabine. The company is carrying out the phase 1b/2a trial at seven local sites and five in South Korea. The first stanza (1b) already has assessed dosing safety and tolerability The company notes about 5% of patients with non-metastatic pancreatic cancer achieve a pathological compete response. The bar for cancers that have spread is much higher. 'This is wonderful news for the patient and the clinical team involved,' Amplia CEO Dr Chris Burns says. 'We firmly believe this outcome further demonstrates the promising activity narmafotinib, on top of standard-of-care, is showing in treating advanced pancreatic cancer.' While one swallow doesn't make a summer, investors pushed Amplia shares as much as 47% higher before profit takers moved in. Syntara's blood cancer program looks the goods Amplia chief Chris Burns co-developed the myelofibrosis (blood cancer) drug Ojjaara, one of the few home-grown remedies to be approved by the US Food and Drud Administration (FDA). Can Syntara (ASX:SNT) follow suit? The company reports further data from its phase II trial, evaluating its drug candidate SNT-5505 in combo with the standard-of-care drug ruxolitinib. The patients had been treated with ruxolitinib for at least three years, so had enhanced symptoms such as enlarged spleen size and blood counts 'indicative of high disease burden.' The results showed eight of eleven evaluable patients (73%) achieved a reduction of more than 50% at 24 weeks. This was measured by a standard gauge called TSS50. The patients achieved a median improvement of 39%. Four out of nine patients (44%) had a spleen volume reduction of 25% at week 24 or beyond. The ongoing trial enrolled 16 patients with intermediate or high-risk myelofibrosis, for 52 weeks of treatment. However, five dropped out by the 24-week mark, a 'withdrawal rate consistent with that seen in other myelofibrsis studies of patients with similar disease severity." Eight patients reaching 38 weeks showed an average 56% reduction in symptoms. Of these, Five patients reaching 52 weeks showed a 63% decline. The company plans to release the final study results after the September quarter, when the remaining three patients have completed their treatment. Syntara intends to meet with the FDA in the September quarter to discuss the design of a pivotal phase 2c/3 study. The company announced the results on Friday and aired them at the weekend's European Hematology Association conference in Milan. Kazia's cancer news from the Nasdaq Further afield, the Nasdaq listed and formerly ASX-domiciled Kazia last week said its immunotherapy candidate paxalisib showed 'anti-tumour activity in advanced breast cancer'. In collaboration with the Queensland Institute of Medical Research (QIMR) Berghofer, Kazia is carrying out a 24-patient, phase Ib trial in combo with the standard-of-care pembrolizumab (Keytruda). The Sydney-based Kazia licensed the tech from the QIMR. The company said the data provided 'strong scientific and translational rationale for continued development of paxalisib as part of immunotherapy-based regimens.' The dual-listed Kazia delisted from the ASX last November, to reduce costs. The experience of ASX biotechs joining the Nasdaq has been patchy, to put it mildly. But Kazia shares last week more than doubled on the news. The pain of Mayne stays mainly on display Mayne Pharma (ASX:MYX) will forge ahead with a planned shareholder meeting to approve its takeover scheme of arrangement, despite receiving a second 'dear John' letter from suitor Cosette. Mayne says the correspondence – almost certainly not written on rose-scented parchment – affirms that Cosette intends to terminate the scheme implementation deed (SID) on the grounds of alleged breaches. It maintains Cosette has 'no lawful basis' to terminate the SID. So, as it stands Mayne shareholders will file into Melbourne's Intercontinental Hotel on Wednesday to vote on an offer that a reluctant suitor has no intention of executing. With no whiff of rapprochement, this one is headed for the courts. Emvision wins $5 million government grant There's no better funding than the non-dilutive variety, as EMvision Medical Devices (ASX:EMV) attests. The feds have awarded Emvision a $5 million federal government grant, to further the development of its First Responder portable brain scanner. The funds are by way of an Australian Government Industry Growth Program (IGP) Commercialisation and Growth Grant. First Responder distinguishes between bleed and clot strokes at the scene and is designed to be used by ambulances and by paramedics. The device should shorten diagnosis time – a crucial element in the patient getting the right treatment. 'First Responder … is a genuine world first product with potential to transform the landscape of pre-hospital stroke and traumatic brain injury care,' Emvision chief Scott Kirkland says. '… quite simply, if we can help save time, we can help save lives and reduce disability.' As of the end of March, Emvision had $12.5 million of cash and expected $800,000 of funding from the Australian Stroke Alliance this financial year. Heramed in maternity monitoring collab Still on non-dilutive funding, foetal monitoring device developer HeraMED (ASX:HMD) has partnered with RMIT University (RMIT) and the Digital Health Cooperative Research Centre in a research partnership. The $1.245 million project will delve into better ways to deliver maternity care for culturally and linguistically diverse women. As is the way in the modern world, the project involves refining AI-based predictive health models and tools. This is based on monitoring and collecting data on 200 pregnant women. 'The initiative will use a combination of clinical, biometric, lifestyle and genetic data, with a focus on diversity, inclusion, and clinical applicability," Heramed says. Heramed is contributing $250,000 over the 18-month project and the other parties are contributing the rest via grant funding. 'With 51% of Australians having at least one parent born overseas, the need for culturally informed healthcare is critical and relevant,' says Heramed CEO Anoushka Gungadin.
