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Yi Li Shu® Approved in the European Union, Becoming the First Innovative Biological Drug Approved in China, the U.S. and Europe

On March 22nd, Yi Li Shu® (Efbemalenograstim Alfa Injection), an innovative biopharmaceutical product developed by EVIVE and exclusively commercialized in China by Chiatai Tianqing, received the “COMMISSION IMPLEMENTATION DECISION” from the European Commission approving its marketing and sales in the European Union. The decision is based on the positive review opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Thus, Efbemalenograstim Alfa Injection has become the first innovative biopharmaceutical in China that has been approved for marketing in China, the United States and the European Union, as well as the first innovative drug approved by a Chinese pharmaceutical company in the European Union in the year 2024. Previously, Chiatai Tianqing has signed a commercialization cooperation agreement with EVIVE to obtain all intellectual property rights and exclusive commercialization rights of Yi Li Shu® in China. Efbemalenograstim Alfa Injection is the only drug among ...
- Source: drugdu
- 179
- March 26, 2024
Innovate UK awards ten projects over £6m to develop new clinical tools for dementia

Dementia is estimated to affect 850,000 people in the UK and costs the nation around £23bn a year Innovate UK has awarded ten new projects over £6m in funding to identify, develop and commercialise biomarker clinical tools and technologies for dementia and neurodegeneration. Through Innovate UK’s Small Business Research Initiative, the competition will aid in enhancing clinical trials and precision therapies for patients living with dementia. Estimated to affect 850,000 people in the UK, dementia is a general term for the impaired ability to remember, think or make decisions, which is economically responsible to cost £23bn a year. Alzheimer’s disease, the most common form of dementia, affects one in 14 people over the age of 65 and one in six people over the age of 80. In alignment with the Dame Barbara Windsor Dementia Mission, a government-led effort to develop new precision dementia therapies and solutions in the UK, the ...
- Source: drugdu
- 133
- March 26, 2024
Four international teams awarded £4.7m to investigate heart and circulatory diseases

These types of conditions are responsible for 25% of all UK deaths and affect 7.6 million people nationally The British Heart Foundation (BHF), the Dutch Heart Foundation and the German Centre for Cardiovascular Research have awarded four international research teams £4.7m for research in heart and circulatory diseases. Over four years, researchers from the UK, Germany and the Netherlands will drive breakthroughs in the detection, diagnosis and treatment of these conditions. Responsible for 25% of all deaths in the UK, heart and circulatory diseases affect around 7.6 million people nationally. Researchers from the University of Bristol, Maastricht University Medical Center, the University of Birmingham, Charité-Universitätsmedizin Berlin, Amsterdam University Medical Center (Amsterdam UMC), the University of Cambridge, Universiteit Leiden, King’s College London (KCL) and University Medical Center Goettingen (UMC Goettingen) have been selected to be funded through the International Cardiovascular Research Partnership Awards. The projects will investigate different areas, including the ...
- Source: drugdu
- 105
- March 26, 2024
FDA Fast Tracks ImmVira’s Oncolytic Herpes Simplex Virus Therapy for Head and Neck Squamous Cell Cancer

Davy James MVR-T3011 IT is in development to treat patients with recurrent or metastatic head and neck squamous cell cancer whose disease progressed following platinum-based chemotherapy and at least one prior line of a PD-1/PD-L1 therapy. ImmVira’s oncolytic herpes simplex virus (oHSV) therapy MVR-T3011 IT for intratumoral injection has been granted Fast Track designation by the FDA to treat patients with recurrent or metastatic head and neck squamous cell cancer (HNSCC) whose disease progressed following platinum-based chemotherapy and at least one prior line of an anti–programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy.1 The novel oHSV treatment is a genetically engineered virus developed to produce replication potency in tumor cells as well as highly restricted replication in normal cells. The ability of MVR-T3011 to boost the immune response within the tumor microenvironment is increased by adding a PD-1 antibody and IL-12 into the construct, according to ImmVira. “Attaining ...
- Source: drugdu
- 83
- March 25, 2024
Precision Medicine Startup Mirador Unveils $400M for R&D of New I&I Drugs

Mirador Therapeutics applies machine learning to human data to discover new immunology and inflammation drugs. The startup’s management includes several from the executive team of Prometheus Biosciences, an immunology biotech bought by Merck last year. By FRANK VINLUAN Nearly a year ago, Merck struck a $10.8 billion deal to acquire Prometheus Biosciences, a clinical-stage company whose technology platform analyzed genetics and biology data to discover new drugs. The executive who led Prometheus to that buyout is now back with a new immunology startup supported by $400 million. Mirador Therapeutics launched Thursday, aiming to take the precision medicine approaches that have led to advances in cancer drugs and apply them to the research of new therapies for immunology and inflammation. It’s a similar strategy to the one taken by Prometheus under the helm of Mark McKenna, now the CEO of San Diego-based Mirador. There’s a plethora of immunology drugs on the ...
- Source: drugdu
- 116
- March 25, 2024
Biomechanical model simulates breast tumor growth

Scientists from Universidad Carlos III de Madrid (UC3M) and Johns Hopkins University (JHU), in the USA, have analyzed the growth of breast tumors from a biomechanical perspective and have created a computational model that simulates the invasion process of cancer cells, depending on the characteristics of the surrounding tissue and cell junctions, among other parameters. This type of model will help predict the evolution of a tumor in patients from its mechanical properties (stiffness, density, etc.) of the surrounding microenvironment, which can be determined through a biopsy or imaging techniques. The growth process of a solid tumor involves its expansion through the surrounding tissue, usually composed of a fibrillar matrix (for example, collagen). Its expansion depends on many factors such as the total number of tumor cells, their volume and stiffness, their access to nutrients, and the mechanical properties of the tissue in which they are developing. Supported by experimental ...
- Source: drugdu
- 105
- March 25, 2024
Capital Rx, Prime Therapeutics Form Strategic Alliance

Pharmacy solutions and pharmacy benefit managers perform several functions, including administrative tasks, handling benefit processing claims and negotiating with the supply chain. However, the problem is that many of them are performing these tasks on outdated technology. “All of those things, to do them well, require a foundation of technology capabilities to enable our people to operate at the top of their license. … The majority of the industry is using 30 to 40-year-old technology to do all of this work,” said Mostafa Kamal, president and CEO of pharmacy benefit manager Prime Therapeutics, in an interview. That’s why Prime Therapeutics has formed a strategic alliance with Capital Rx, which is also a PBM, the companies announced last week. Through the alliance, Prime Therapeutics will be the only PBM — aside from Capital Rx — to use Capital Rx’s JUDI platform. JUDI is a pharmacy benefits administration platform that puts all ...
- Source: drugdu
- 121
- March 25, 2024
AstraZeneca Joins Radiopharma Deals Spree With $2B Fusion Acquisition

AstraZeneca’s Fusion Pharmaceuticals acquisition is the latest in a wave of M&A activity that includes recent deals by Eli Lilly and Bristol Myers Squibb. The lead Fusion program is in mid-stage clinical development for treating advanced prostate cancer. By FRANK VINLUAN AstraZeneca is following in the footsteps of some of its big pharmaceutical company peers, plunking down $2 billion to acquire its radiopharmaceuticals partner Fusion Pharmaceuticals. More than adding a pipeline of targeted radiation therapies, AstraZeneca gains the crucial supply chain and manufacturing infrastructure to support them. The sum is an upfront payment. According to the deal terms announced Tuesday, AstraZeneca will pay $21 cash for each Fusion share, representing a 97% premium to Fusion’s closing stock price on Monday. Shareholders of the radiopharmaceutical company could get even more. The deal includes a contingent value right that will pay an additional $3 per share upon achievement of a regulatory milestone. ...
- Source: drugdu
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- March 23, 2024
Groundbreaking pTau217 Blood Test as Accurate as Brain Imaging or CSF Testing in Diagnosing Alzheimer’s

Alzheimer’s disease (AD) is a neurodegenerative condition that causes the brain to deteriorate over time, marked by the buildup of certain harmful proteins that eventually lead to a decline in brain function and cell death. These changes can happen long before any symptoms show up. Scientists have found certain proteins in the cerebrospinal fluid that are good indicators of AD. One of the most promising markers for early and more precise detection of AD in the blood is phosphorylated tau at position 217 (pTau217). It’s seen as a game-changer for diagnosing AD sooner, categorizing patients for research studies, and improving how patients are cared for and treated. Now, an innovative and novel blood test can be used in the screening, diagnosis, and monitoring of AD based on the circulating level of this promising biomarker pTau217. ALZpath Dx (Carlsbad, CA, USA) has developed a robust and scalable plasma-based ultra-sensitive assay, branded ...
- Source: drugdu
- 151
- March 23, 2024
AI Predicts Cancer Spreading To Brain from Lung Biopsy Images

Lung cancer is the leading cause of cancer-related deaths globally, with non-small cell lung cancers making up the majority of cases, which are often linked to smoking. When detected early, these cancers are usually confined to the lung, making surgery the preferred initial treatment. However, about 30% of these early-stage patients see their cancer advance to more critical areas, like the lymph nodes and organs, frequently affecting the brain first. This progression necessitates additional treatments such as chemotherapy, targeted drugs, radiation, or immunotherapy. Unfortunately, despite 70% of patients not developing brain metastasis, doctors have lacked the means to predict whose cancer will progress and often opt for aggressive treatments as a precautionary measure. Now, a new study offers hope in improving the approach to treating early-stage lung cancer by achieving the correct balance between proactive intervention and cautious monitoring. In the study, scientists at Washington University School of Medicine in ...
- Source: drugdu
- 103
- March 23, 2024

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