The Singapore manufacturing site will be AstraZeneca’s first facility capable of handling all steps of antibody drug conjugate production. AstraZeneca aims to open the facility in 2029.Antibody drug conjugates have fast become a big piece of AstraZeneca’s revenue growth. The drugmaker is taking steps to ensure it has the production capacity to meet market demand for these cancer drugs, revealing plans for a $1.5 billion manufacturing site in Singapore to support its global supply of ADC medicines. Construction of the ADC manufacturing facility will receive support from the Singapore Economic Development Board, AstraZeneca said Monday. The company expects to begin design and construction of the facility by the end of this year. Construction of a new drug manufacturing site and receiving the regulatory approvals for commercial production can take several years. AstraZeneca aims to open its new site for ADC production in 2029. An ADC is a cancer therapy made ...
The 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) is set to take place from June 26 to June 29 in Munich, Germany. Henlius will share the latest clinical data of phase 2 study (HLX22-GC-201) of its novel anti-HER2 monoclonal antibody (mAb), HLX22, combined with HANQUYOU (trastuzumab, HLX02, trade name: HERCESSI™️ in U.S. and Zercepac® in Europe) and chemotherapy for the first-line treatment of HER2-positive gastric/gastroesophageal junction (G/GEJ) cancer with Professor Jin Li of Shanghai East Hospital, School of Medicine, Tongji University as the leading principal investigator of this study. The results from HLX22-GC-201 were first released at the 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI) in January 2024, which showed that adding HLX22 to HLX02 (trastuzumab) and chemotherapy prolonged progression-free survival and enhanced antitumour response in patients with HER2-positive G/GEJ cancer in the first-line setting, with a manageable safety profile. The data released at 2024 ESMO GI are as follows: ...
Recently, the team of Chiatai Tianqing and WuXi AppTec disclosed for the first time in Bioorganic & Medicinal Chemistry Letters the molecular design thinking of the novel CDK2/4/6 inhibitor – TQB3616 (Culmerciclib) and R&D history. Small molecule CDK4/6 inhibitors (Palbociclib, Ribociclib, and Abemaciclib) have been successively approved for the treatment of metastatic breast cancer, of which Abemaciclib has shown fewer adverse effects in the clinic attributed to its superior inhibitory activity on CDK4 kinase than on CDK6. Therefore, the research team worked to discover pyrimidine-indazole molecules that are biased to inhibit CDK4 kinase and have some inhibitory activity against CDK2 and CDK6, and TQB3616 was the preferred molecule among such small molecules obtained by SAR screening. It was found that comparing Palbociclib and Abemaciclib, TQB3616 demonstrated different degrees of inhibitory effects on CDK2, CDK4, and CDK6 kinases, and a higher inhibitory capacity for CDK4 kinase [1]. The inhibition of tumor ...
The network will support the development, evaluation and adoption of innovative health and care technology The National Institute for Health and Care Research (NIHR) has awarded an NIHR HealthTech Research Centre (HRC) Network £5m to provide national coordination and leadership for NIHR HRCs to advance health innovations. Hosted by Sheffield Teaching Hospitals NHS Foundation Trust from 1 September 2024, the network will support the development, evaluation and adoption of innovative health and care technology. In November 2023, the NIHR announced £42m in funding to support 14 new NIHR HRCs to work with businesses to support the development of medical devices, diagnostics and digital technologies to allow people to better monitor their health, make earlier diagnoses and improve the management of conditions such as cancer, dementia, cardiovascular and respiratory disease. The HRCs are located in leading NHS organisations across England, including Guy’s and St Thomas’ and King’s College London’s HRC for ...
The funding aims to reduce health inequalities in these groups and save more lives The Community Grants Programme led by NHS Blood and Transplant (NHSBT) has dedicated £600,000 to address the shortage of organ and blood donors from black, Asian and mixed ethnic backgrounds. The funding builds on the ongoing commitment by the government and the NHS to address health inequalities for individuals who need life-saving transplants or regular blood transfusions. The Community Grants Programme funds projects led by community, faith or belief organisations to provide greater awareness and support for donations, particularly among black and Asian communities. Furthermore, the scheme aims to inform and recruit more donors of black heritage to treat people with sickle cell disease, the fastest growing blood disorder in the UK, which is more prevalent in people of this heritage. The NHSBT is seeking applications to engage diverse communities across England and Wales and is ...
Organiser:Informa Time:18- 20 June 2024 address:Messepiazza 1, 70629 Stuttgart, Stuttgart Germany Exhibition hall: Messe Stuttgart Product range: Precision instruments: Specialized medical alloys, microprocessors, computer numerical control (CNC), ultrasound and laser technology, surgical equipment, interventional cardiac devices and medical accessories for surgical technology Medical plastics technology: medical classification of plastic raw materials, outsourcing and processing of medical consumables, packaging and drug delivery Automation equipment technology: automatic production process about automatic setting, assembly process and robot motion control Pharmaceutical packaging: Packaging solutions from filling processes to packaging materials and from disposable product manufacturers to outsourcers About MedtecLIVE: The German medical equipment and medical technology exhibition MedtecLIVE, the second largest exhibition in Europe’s medical technology field, is held once a year, covering the entire supply chain, and more than 400 medical suppliers from the global medical technology field present innovative products, solutions and services for distributors and equipment manufacturers. Discuss the most important ...
Drugdu.com expert’s response: To obtain a Class III Medical Device Operating License, you would need to follow a specific process and meet certain requirements. Here is a general outline of the steps in English: 1.Prepare Application Materials: Gather all necessary documents, including the “Application Form for Medical Device Operating License” (signed by the legal representative or stamped with the company seal), proof of identity, education, and appointment documents for the legal representative. Also, provide copies of the “Pre-Approval Notice for Enterprise Name” or “Business License” issued by the Administration for Industry and Commerce. Additionally, submit proof of property or lease agreements with the lessor’s property certificate, as well as layout plans of the business premises and warehouse. 2.Submit Application Materials: Submit the prepared application materials to the local Food and Drug Administration or Market Regulatory Department. 3.Review and Onsite Inspection: The local Food and Drug Administration or Market Regulatory Department ...
Stroke is the primary cause of disability globally and ranks as the second leading cause of death. However, timely early intervention can prevent severe outcomes. Most strokes are ischemic, resulting from a blockage that disrupts blood flow to the brain. Large vessel occlusion (LVO) strokes, a severe form of ischemic stroke, occur when a major artery in the brain is obstructed. The brain cells begin to die within minutes due to the deprivation of oxygen and nutrients. LVO strokes are critical emergencies that necessitate rapid treatment with mechanical thrombectomy, a procedure that removes the obstruction. Now, a new test combines blood-based biomarkers with a clinical score to accurately identify patients suffering from LVO strokes. Mechanical thrombectomy has revolutionized stroke treatment, potentially restoring individuals to full health as though they never experienced a stroke. The sooner this procedure is applied, the better the outcomes for patients. This groundbreaking technology, developed by ...
Precision in diagnosing and categorizing tumors is essential for delivering effective treatment to patients. Currently, the gold standard for identifying various types of brain tumors involves DNA methylation-based profiling. DNA methylation functions as a regulatory mechanism to control gene activity, essentially turning genes on or off. However, the time required for such testing can be a significant hindrance, often taking several weeks—a delay that can be critical when patients need prompt decisions regarding their treatment. Additionally, these tests are not widely available in most hospitals around the world. Now, a new artificial intelligence (AI) tool has been developed to classify brain tumors more quickly and accurately. Researchers at The Australian National University (ANU, Canberra, Australia) have created DEPLOY. This new method predicts DNA methylation patterns to classify brain tumors into 10 major subtypes. DEPLOY utilizes histopathology images, which are microscopic images of patient tissue samples. The model was trained and ...
Don Tracy, Associate Editor Investment from the Alzheimer’s Drug Discovery Foundation (ADDF) aims to support the development of Coya 302, a therapeutic candidate for the treatment of frontotemporal dementia (FTD). Coya Therapeutics announced that it has received a $5 million strategic investment from the Alzheimer’s Drug Discovery Foundation (ADDF). According to the company, the investment consisted of 603,136 shares of stock at $8.29 per share. Coya intends to use the funding for supporting the development of Coya 302, its lead therapeutic candidate, mainly in an upcoming Phase II trial targeting frontotemporal dementia (FTD). Reportedly, the investment was made through a private placement under Section 4(a)(2) of the Securities Act of 1933 and Regulation D, aiming to file a registration statement with the SEC for resale of the securities.1 “We are grateful that a world-renowned organization like the ADDF has chosen to support our corporate mission as well as the clinical ...
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