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Biogen completes $1.15bn HI-Bio acquisition to expand immunology presence

As Eli Lilly’s Kisunla (donanemab) enters the Alzheimer’s treatment space, its leading competitor Biogen is undergoing therapy diversification after completing its $1.15bn acquisition of Human Immunology Biosciences (HI-Bio). The deal, which was agreed upon in May this year and includes $650m in milestone payments, sees Biogen bolster its pipeline with US-based HI-Bio’s anti-CD38 monoclonal antibody candidate felzartamab. Biogen’s head of development Priya Singhal said the company is “very excited” about the addition of felzartamab to its rosters in a 2 July press release, adding that Biogen will advance the candidate to Phase III now the transaction is complete. Felzartamab has already demonstrated positive Phase II data in a range of immune-mediated diseases, including IgA nephropathy (IgAN), antibody-mediated rejection (AMR), and primary membranous nephropathy (PMN). The Phase III development plans are for all three diseases, according to Biogen. Felzartamab was originally developed by MorphoSys as a possible competitor to Johnson & ...
- Source: drugdu
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- July 5, 2024
【EXPERT Q&A】Where can I download the approved online sales registration certificate for medical devices?

Drugdu.com expert’s response: After the approval of the online sales registration for medical devices, you can obtain and download the registration certificate through the following methods: 1.Online Platform or System: If you submitted the online sales registration application for medical devices through a specific online platform or system, there will usually be a corresponding function or option in the user interface of that platform or system for you to download the registration certificate. Log in to the online platform or system where you submitted the application and locate the relevant page or module for online sales registration of medical devices.On that page or module, you should be able to find the option to download the registration certificate. Click on the option and follow the system prompts to download it. 2.Government or Regulatory Agency Website: Visit the website of the government or regulatory agency in your country or region, as they ...
- Source: drugdu
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- July 5, 2024
Advanced Blood Test Helps Improve Cancer Treatments

Early detection of cancer significantly increases the likelihood of successful treatment across various cancer types. In addition to personalized evaluation of therapy benefits and risks, continuous monitoring of treatment success is vital. Traditionally, oncologists rely on imaging technology and invasive procedures such as tissue biopsies, punctures, and endoscopic measures to monitor patients. Now, researchers have further developed an advanced method, a type of liquid biopsy that utilizes blood samples rather than direct tissue sampling for detecting various types of cancer. The technique, developed by researchers at the University of Zurich (UZH, Zurich, Switzerland) and the University Hospital Zurich (USZ, Zurich, Switzerland), involves sequencing and analyzing DNA fragments that circulate in the blood of patients to identify changes specific to particular cancers. The research team examined alterations in the number and length distribution of the DNA fragments, enabling them to distinguish between biologically less and more aggressive metastatic cancers even earlier ...
- Source: drugdu
- 119
- July 4, 2024
Novel AI-Based Analysis Method Uncovers New Insight into ALS Progression

Amyotrophic Lateral Sclerosis (ALS) is a fatal condition where motor neurons, which are crucial for controlling movement, progressively die. Currently, there is no cure for ALS, and patients typically live between 2 and 5 years after diagnosis. Now, in a new study published in Science Advances, researchers have shown how to leverage artificial intelligence (AI) to gain deeper insights into ALS progression. The study, led by researchers from the School of Psychology and Neuroscience at the University of St Andrews (Scotland, UK), in collaboration with the Department of Neuroscience, University of Copenhagen (Copenhagen, Denmark), found that certain neural circuits that control movement are compromised early in the disease, while others deteriorate later as the disease progresses. The techniques used in the study allow for the simultaneous analysis of multiple cell types within the spinal cord, enhanced by an innovative AI-driven analytical method. This enabled the identification of specific networks of ...
- Source: drugdu
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- July 4, 2024
FDA Approves Lilly’s Kisunla for the Treatment of Early Symptomatic Alzheimer’s Disease

By Don Tracy, Associate Editor Kisnula is the first amyloid plaque-targeting therapy that allows for stopping treatment upon plaque removal, company says. The FDA has approved Eli Lilly’s Kisunla (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion) to treat adults with early symptomatic Alzheimer’s disease, including mild cognitive impairment and mild dementia with confirmed amyloid pathology. According to the company, Kisunla the first amyloid plaque-targeting therapy that allows for stopping treatment upon plaque removal, potentially reducing costs and infusion frequency. Approval was based on results from the Phase III TRAILBLAZER-ALZ 2 study.1 “Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options. We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis,” said Anne White, EVP, president, Lilly Neuroscience, Eli ...
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- July 4, 2024
Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi

Eli Lilly’s Kisunla is now FDA approved for treating patients in the early stages of Alzheimer’s disease. In addition to slowing cognitive decline and disease progression, clinical trial results showed that amyloid beta plaques were reduced to the point where some patients could stop taking the infused therapy. By Frank VinluanEli Lilly Alzheimer’s disease drug has received its long-awaited FDA approval, bringing patients a treatment that works similarly to an Eisai medication for the neurodegenerative disorder but with dosing advantages that patients might prefer. The Tuesday regulatory decision comes less than a month after an FDA advisory committee voted unanimously that the benefits of the Lilly drug in slowing cognitive decline outweigh its safety risks. The approval covers the treatment of Alzheimer’s patients with mild cognitive impairment or mild dementia, the same population that was evaluated in clinical trials. Known in development as donanemab, Lilly will market its new Alzheimer’s ...
- Source: drugdu
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- July 4, 2024
Female cancer survivors at low risk of developing obstetric complications

According to WHO, around 15% of pregnant women will develop an obstetric complication Researchers from the Universities of Birmingham, Bristol and Edinburgh have revealed that the majority of women who have survived cancer are at low risk of developing obstetric complications. The study published in the Lancet Oncology was funded by Children with Cancer UK, the Brain Tumour Charity and the Academy of Medical Sciences. Currently the most prevalent cancer in the UK, breast cancer affects around 55,000 women every year. According to the World Health Organization, around 15% of all pregnant women will develop a potentially life-threatening obstetric complication, including pyrexia and sepsis intrapartum haemorrhage, in pregnancy and childbirth and some will require a major obstetrical intervention to survive. After analysing data from almost 100,000 female survivors of cancer who had been diagnosed between the ages of 15 and 39 years between 1971 and 2006, approximately 21,437 births had ...
- Source: drugdu
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- July 4, 2024
Researchers find whole genome sequencing improves care for paediatric cancer

Affecting around 3,755 young people in the UK every year, leukaemia is the most commonly diagnosed cancer in children Researchers from the Wellcome Sanger Institute, Cambridge University Hospitals NHS Trust, Great Ormond Street Hospital and the University of Cambridge have revealed that whole genome sequencing (WGS) can improve the clinical care of children with cancer. Published in Nature Medicine, the study showed that cutting-edge genomic testing could improve the management of care in real-time while providing more benefits compared to all other current tests combined. Every year, around 3,755 young people are diagnosed with cancer in the UK, with some of the most prevalent childhood cancers including lymphoma, muscle or bone cancers, neuroblastoma and leukaemia, which is the most commonly diagnosed cancer in children. WGS is a single test that provides a complete readout of the tumour’s entire genetic code while identifying every single cancer-causing mutation. Researchers, for the first ...
- Source: drugdu
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- July 4, 2024
Henlius Receives Approval in Japan for Phase 3 MRCT of Anti-PD-1 mAb Serplulimab Combo on First-Line mCRC

Shanghai, China, July 2, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the clinical trial notification (CTN) for phase 3 international multicenter clinical study (ASTRUM-015) of Henlius’ self-developed anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) in combination with bevacizumab and chemotherapy in patients with metastatic colorectal cancer (mCRC) has been permitted by Japan’s Pharmaceuticals and Medical Devices Agency. The study has previously completed dosing of the first subject in China, and the regulatory registration and clinical development is advancing efficiently in more countries and regions around the world. Colorectal cancer (CRC) is one of the most common malignant cancers globally. Over 1.9 million newly diagnosed cases and more than 900,000 deaths were estimated in 2022, and the incidence rates were highest in Europe and Oceania [1]. It is estimated that, by 2040, the burden of CRC will increase to 3.2 million new cases per year (an increase of 63%) and ...
- Source: drugdu
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- July 4, 2024
Hengrui Pharmaceuticals Bupivacaine Liposome Injection Approved for Marketing in the United States

Today, Hengrui Pharmaceuticals Bupivacaine Liposome Injection was successfully approved for listing in the United States. This product is the first generic drug of this species approved for marketing in the world, and its listing in the U.S. is an important milestone in the international development of the company’s high-end preparations. Bupivacaine liposome injection was first approved in the United States in 2011, and the original product is currently sold only in the United States and Europe, and has not been imported domestically. Because of its high technical barriers, no generic product has been successfully listed for more than 10 years. Hengrui Pharmaceuticals Bupivacaine Liposome Injection has been approved to be listed in China at the end of 2022, which is the exclusive global first generic of Hengrui Pharmaceuticals’ Class 3 new drug, deemed to have passed the consistency evaluation, and is also the first ultra-long-acting local anesthesia drug in China, ...
- Source: drugdu
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- July 4, 2024

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