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Groundbreaking CRISPR Screen Technology Rapidly Determines Disease Mechanism from Tissues

Thanks to over a decade of advancements in human genetics, scientists have compiled extensive lists of genetic variations linked to a wide array of human diseases. However, understanding how a gene contributes to disease is quite different from knowing how to treat the disease. Each risk gene can affect multiple cell types, and pinpointing how these cell types—and even individual cells—influence a gene and its role in disease progression is crucial for developing effective treatments. Now, a new CRISPR screen method allows for the rapid analysis of brain cell types associated with key developmental genes, providing insights into the genetic and cellular mechanisms underlying various neurological disorders at an unprecedented level. Developed at Scripps Research (La Jolla, CA, USA), the new technique, called in vivo Perturb-seq, utilizes CRISPR-Cas9 technology combined with single-cell transcriptomic analysis as a readout to measure the effects of genomic alterations on individual cells. By employing CRISPR-Cas9, ...
- Source: drugdu
- 95
- May 23, 2024
FDA Approves Biocon Biologics’ Yesafili, an Eylea Biosimilar, for the Treatment of Multiple Ophthalmic Conditions

Don Tracy, Associate Editor Approval of Yesafili represents Biocon’s entrance into the US ophthalmology market, following previous approvals in Europe and the UK. Biocon Biologics announced that it has received FDA approval for Yesafili (aflibercept-jbvf), a biosimilar to Eylea (aflibercept). According to the company, Yesafili is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of several ophthalmic conditions such as neovascular age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV). Prior to being approved by the FDA, Yesafili was cleared in the United Kingdom back in November, while European approval came in September. Additionally, it is expected to launch in Canada by July 1, 2025.1 “The FDA approval of Yesafili (aflibercept) as the first interchangeable biological product to Eylea is a significant milestone for Biocon Biologics marking our entry into ophthalmology, a new therapeutic ...
- Source: drugdu
- 93
- May 23, 2024
AstraZeneca Plans $1.5B Manufacturing Site for Global Production of ADC Cancer Drugs

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 ...
- Source: drugdu
- 91
- May 23, 2024
Henlius to Release Latest Clinical Data of HLX22 at 2024 ESMO GI

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: ...
- Source: drugdu
- 97
- May 23, 2024
First Publication of Chiatai Tianqing’s Novel CDK2/4/6 Inhibitor TQB3616 (Cumoxil) Development and Design Strategy

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 ...
- Source: drugdu
- 93
- May 23, 2024
NIHR awards HealthTech Research Centre Network £5m to advance health innovations

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 ...
- Source: drugdu
- 77
- May 23, 2024
NHS addresses shortage of ethnic organ and blood donors with £600,000 funding

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 ...
- Source: drugdu
- 103
- May 23, 2024
MedtecLIVE 2024

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 ...
- Source: drugdu
- 225
- May 23, 2024
【EXPERT Q&A】How to apply for a medical device class III business license?

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 ...
- Source: drugdu
- 152
- May 22, 2024
Game-Changing Blood Test for Stroke Detection Could Bring Life-Saving Care to Patients

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 ...
- Source: drugdu
- 89
- May 22, 2024

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