Search Results for “EC” – Page 42 – media

Minhai Biotech Signs Strategic Cooperation Memorandum with Daxing District Government and AstraZeneca

On March 25th, Daxing District Government, AstraZeneca, Minhai Biological and other companies signed a strategic cooperation memorandum in Daxing, Beijing, to jointly explore the mode of cooperation in the field of vaccines, and help China’s vaccine innovation products to cooperate and develop at home and abroad. Daxing District’s life and health industry ecosystem has been continuously improved, creating a favorable business environment that attracts foreign investment and strengthens the confidence of global outstanding enterprises in long-term development in Beijing. The strategic cooperation between AstraZeneca and Minhai Biotechnology will further expand the circle of friends and influence of Daxing District’s world-class vaccine industry cluster, and will become a substantive measure for Daxing District to implement the “Action Plan for Attracting and Utilizing Foreign Investments with Greater Efforts by Solidly Pushing Forward the Opening Up of the Country to the Outside World at a High Level”. This time in Beijing Daxing to ...
- Source: drugdu
- 132
- March 30, 2024
【EXPERT Q&A】What is the content of the MDR technical document that EU CE needs to submit for medical device registration?

Drugdu.com expert’s response: The MDR technical documentation required for medical device registration in the European Union typically includes the following components: 1.General Information: Basic product information, manufacturer details, product classification, and product description. 2.Design and Manufacturing Information: Details about the product’s design process, manufacturing process, material selection, assembly process, etc. 3.Performance and Functionality: Expected use of the product, performance indicators, technical specifications, functional descriptions, etc. 4.Risk Analysis: Analysis and assessment of potential risks associated with the product, including descriptions of control measures and risk management plans. 5.Clinical Evaluation: Clinical trial data and assessment results for the product, including trial design, results, safety, and efficacy data. 6.Summary of Technical Documentation: Comprehensive summary and explanation of the above content to ensure the integrity and consistency of the documentation. Additionally, depending on the specific characteristics and classification of the product, other relevant information and documents may be required to ensure compliance with the ...
- Source: drugdu
- 105
- March 30, 2024
Simple Skin Biopsy Test Detects Parkinson’s and Related Neurodegenerative Diseases

Parkinson’s disease and a group of related neurodegenerative disorders known as synucleinopathies impact millions globally. These conditions, including Parkinson’s disease (PD), dementia with Lewy bodies (DLB), multiple system atrophy (MSA), and pure autonomic failure (PAF), are progressive neurodegenerative diseases that, despite having some similar symptoms like tremors and cognitive issues, vary in their outcomes and do not benefit from identical treatments. A common feature among them is the accumulation of an abnormal protein in nerve fibers within the skin, known as phosphorylated α-synuclein (P-SYN). Now, neurologists have developed a simple skin biopsy test that can detect this abnormal form of alpha-synuclein with high positivity rates in individuals with such disorders. In the study, neurologists at Beth Israel Deaconess Medical Center (BIDMC, Boston, MA, USA) enrolled 428 people, ages 40-99 years who were either diagnosed with one of the synucleinopathies based on clinical evaluations confirmed by specialists or were healthy volunteers ...
- Source: drugdu
- 124
- March 29, 2024
Ruike Biologicals and Rongsheng Biologicals Sign Strategic Cooperation Agreement on New Adjuvant Vaccine Project

On March 25th, Jiangsu Ruike Biotechnology Co., Ltd (hereinafter referred to as “Ruike Biotechnology”, stock code: 02179.HK) and Shanghai Rongsheng Biopharmaceutical Co. (hereinafter referred to as “Rongsheng Biopharmaceuticals”) in Shanghai. At the meeting, both parties signed a strategic cooperation agreement on the new adjuvant vaccine project and discussed the details of the project. Adjuvant is an important component in the development of vaccines, and new adjuvants have become the key to the success of innovative vaccine research and development. According to the terms of the agreement, the two parties will jointly carry out the development of new adjuvant vaccines, with Ruike Biologicals providing new adjuvants independently developed based on the new adjuvant technology platform, and Rongsheng Biologicals providing viral antigens independently designed by Rongsheng Biologicals. The project will improve the immunogenicity of existing Rongsheng Bio’s vaccines under development by empowering them with novel adjuvants for the purpose of optimizing immunization ...
- Source: drugdu
- 108
- March 29, 2024
Beijing Municipal Party Secretary Yin Li Met with Novartis Global CEO Wansheim

On the afternoon of March 25, Yin Li, Secretary of the Municipal Party Committee of Beijing, met with Novartis Global CEO Wansheim, Pfizer Chairman and CEO Eberle, and Danaher Global President and CEO Bjørnen. Yin Li introduced the economic and social development of Beijing and the health condition of its residents. He said that the Beijing Municipal Government attaches great importance to residents’ health, vigorously develops health care, gives full play to the advantages of rich scientific and technological talent resources, and continuously improves the level of medical services for the people in the city. Beijing’s pharmaceutical and health industry has a good foundation and a perfect system. In recent years, it has laid out its biopharmaceutical industry in key areas such as cellular genes, nucleic acid drugs, new antibodies, etc., and has formed international leading source innovative varieties in the fields of antibody drugs and immunotherapy drugs. Beijing’s science ...
- Source: drugdu
- 111
- March 29, 2024
Fluid Biomarker Test Detects Neurodegenerative Diseases Before Symptoms Appear

Amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease) and frontotemporal dementia (FTD) are two progressively neurodegenerative conditions that damage essential nerve cells. ALS compromises nerve cells in the brain and spinal cord, leading to movement impairment, while FTD damages brain areas responsible for personality, behavior, and language. Studies indicate that in ALS or FTD patients, TAR DNA-binding protein 43 (TDP-43) malfunctions. This disruption prevents the correct splicing of ribonucleic acid (RNA), essential for generating proteins necessary for nerve growth and function. Instead, RNA strands become riddled with erroneous code sequences, known as “cryptic exons,” which are linked to an elevated risk of developing ALS and FTD. The timing of this anomaly in the disease progression of ALS and FTD was previously unknown. Now, researchers from Johns Hopkins Medicine (Baltimore, MD, USA) have developed a method for identifying a specific protein, hepatoma-derived growth factor-like 2 [HDGFL2], linked to TDP-43 ...
- Source: drugdu
- 85
- March 28, 2024
EU recommendations for 2024/2025 seasonal flu vaccine composition

EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024. Every year, EMA issues EU recommendations for the composition of seasonal influenza vaccines on the basis of observations by the World Health Organization (WHO) which are informed by regular monitoring activities on the prevalence and characteristics of different influenza viruses worldwide. Based on this data EMA’s Emergency Task Force (ETF) has issued a statement recommending a transition from quadrivalent to trivalent vaccines that do not include the B/Yamagata component. Currently, most authorised influenza vaccines are quadrivalent, which means that they are formulated to protect against the four main strains of influenza responsible for seasonal flu, A(H1N1)pdm09 and A(H3N2), B/Victoria and B/Yamagata. However, the B/Yamagata strain of the influenza B virus has not been detected in circulation since March 2020. This is thought to be due ...
- Source: drugdu
- 119
- March 28, 2024
Another Chiatai Tianqing’s contrast agent, iopromide injection, was approved for marketing

Recently, Chiatai Tianqing received the Certificate of Drug Registration approved and issued by the State Drug Administration (NMPA), in which the company’s product Iopromide Injection in the field of medical imaging was approved to be listed and deemed to have passed the consistency evaluation as the second domestic one. Iopromide injection is a diagnostic drug, which can be used for intravascular and intracorporeal imaging, and is currently widely used in clinical applications and has great potential. Iopromide is a tri-iodinated non-ionic water-soluble X-ray contrast agent with high iodine content and good contrast effect, which is used for computed tomography (CT) enhancement, arteriography and venography, arterial/venous digital subtraction angiography (DSA), cardiovascular angiography, venous urography, endoscopic retrograde cholangiopancreatography (ERCP), arthrocentesis, and other body cavity examinations. Iopromide has the advantages of stable nature, easy to use, lower toxic side effects than ionic iodine contrast agent, good systemic tolerance, etc., and has become a ...
- Source: drugdu
- 130
- March 28, 2024
BIO-THERA’s Phase II Clinical Trial Application for BAT8006 (ADC- FRα) for Injection Approved by US FDA

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”, today announced that its Phase II clinical trial application (IND) for BAT8006 (ADC- FRα) for injection has been approved by the U.S. Federal Drug Administration (FDA). The Company today announced that it has recently received approval from the U.S. Food and Drug Administration (FDA) for a Phase II clinical trial (IND) of its investigational drug, BAT8006 for injection, to evaluate its efficacy and safety in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. Previously, BAT8006 has initiated a Phase I dose-escalation and dose-expansion study in China with phase I data. BAT8006 is an antibody drug coupling (ADC) developed by BIO-THERA targeting folate receptor alpha (FRα), which is intended to be developed for the treatment of solid tumors.FRα is a folate-binding protein located ...
- Source: drugdu
- 125
- March 28, 2024
Hengrui’s Thiotepa for Injection for Pre-treatment of Hematopoietic Stem Cell Transplantation Approved for Marketing

Recently, Hengrui Pharmaceuticals has received the Certificate of Drug Registration issued by the State Drug Administration, which approves Thiotepa for Injection (Trademark: Ruihang®, two specifications of 15mg and 100mg) to be listed in Class 3 of the Chemical Drugs, with the indication of “This product is suitable for the pre-treatment of allo-HSCT for children with β-thalassemia major (<18 years of age)”. The indication of the product is “This product is suitable for allogeneic hematopoietic stem cell transplantation (allo-HSCT) pretreatment for children (<18 years old) with beta-thalassemia major”. Thiotepa for injection is the first generic product in China and has been approved for sale in the United States and Europe. Thiotepa is the first Thiotepa product approved for transplantation preconditioning in China. Beta-thalassemia (β-thalassemia for short) is a common hemolytic disease in clinic, and there are about 300,000 patients with severe and intermediate β-thalassemia in China at this stage.1 Currently, the ...
- Source: drugdu
- 88
- March 27, 2024

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