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FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease

Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many side effects. FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease. By FRANK VINLUANDuchenne muscular dystrophy has several approved drugs, including a gene therapy that provides children who have the rare, inherited muscle-wasting disease the option of a one-time treatment. But each of these therapies only treats certain defined patient groups. While corticosteroids can reach more Duchenne patients, they introduce many side effects. The FDA just approved the first nonsteroidal Duchenne drug. The late Thursday approval of Italfarmaco drug givinostat covers patients age 6 and older and spans all genetic variants that drive the inherited disease. The twice-daily oral suspension will be marketed under the brand name Duvyzat. In an email, Italfarmaco said Duvyzat’s price has not yet been set. The Milan, Italy-based ...
- Source: drugdu
- 207
- March 26, 2024
Evive Biotech’s Ryzneuta (Efbemalenograstim alfa Injection) approved in the EU

Recently, the innovative biologic drug Efbemalenograstim alfa Injection (Chinese trade name “Ryzneuta”), independently developed by Evive Biotech and for which Chia Tai Tianqing has exclusive commercialization rights in China, received the “COMMISSION IMPLEMENTING DECISION” issued by the European Commission, approved for sale in the EU. The decision is based on a positive review by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). So far, Efbemalenograstim alfa Injection has become the first domestic innovative biological drug that has been approved for marketing in China, the United States and the European Union. It has also become the first innovative drug approved by the European Union by a Chinese pharmaceutical company in 2024. Previously, Chia Tai Tianqing had signed a commercial cooperation agreement with Evive Biotech and obtained all intellectual property rights and exclusive commercialization rights of Yilisu® in China. Efbemalenograstim alfa Injection is currently the only G-CSF ...
- Source: drugdu
- 178
- March 26, 2024
New antibiotic to fight infections caused by multidrug-resistant bacteria

EMA has recommended granting a marketing authorisation in the European Union (EU) for Emblaveo (aztreonam-avibactam), indicated for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of bacteria (aerobic Gram-negative) where treatment options are limited. Infections due to Gram-negative bacteria that are resistant to many currently available antibiotics are a serious public health problem since patients have limited or sometimes no treatment options. Infections due to multidrug-resistant bacteria are estimated to cause 35,000 deaths in the EU every year. Emblaveo is a fixed-dose combination of two active substances, aztreonam and avibactam. Aztreonam is already authorised for use in the EU on its own and avibactam is authorised for use in combination with another antibiotic (ceftazidime). Aztreonam is an antibiotic that belongs to the group ‘beta-lactams’. It works by attaching to proteins on the surface of the bacteria. This prevents the bacteria from ...
- Source: drugdu
- 120
- March 26, 2024
The Results of Phase II Clinical Study of KN046 Plus Chemotherapy as First-line Treatment for Metastatic NSCLC were Published in Cell Reports Medicine

SUZHOU, China, March 22, 2024 /PRNewswire/ — Alphamab Oncology (stock code: 9966.HK) announced that the phase II clinical research results of anti- PD-L1/CTLA-4 bispecific antibody KN046 plus chemotherapy as first-line treatment for metastatic non-small cell lung cancer (NSCLC) were published online in the renowned journal Cell Reports Medicine (IF: 14.3). Professor Li Zhang from Sun Yat-Sen University Cancer Center is the corresponding author of this paper, and Professor Yuanyuan Zhao is the first author. Lung cancer is one of the most common cancers in the world, and it is the malignant tumor with the highest morbidity and mortality in China. According to the latest national cancer statistics released by the National Cancer Center, there are 1.06 million new cases of lung cancer, with a total death toll of 0.73 million in year 2022, far exceeding other tumor types. NSCLC accounts for about 80% – 90% of all lung cancers, and ...
- Source: drugdu
- 146
- March 26, 2024
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
- 188
- 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
- 163
- 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
- 124
- 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
- 94
- 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
- 125
- 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
- 112
- March 25, 2024

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