Search Results for “EU” – Page 10 – media

FDA Grants Accelerated Approval to Adaptimmune Therapeutics’ Tecelra for Adults with Synovial Sarcoma Who Have Undergone Prior Chemotherapy

By Don Tracy, Associate Editor Regulatory action marks the first engineered cell therapy approved for a solid tumor cancer in the United States.The FDA has granted accelerated approval to Adaptimmune Therapeutics’ Tecelra (afamitresgene autoleucel), an engineered cell therapy that targets resectable or metastatic synovial sarcoma in adults who have undergone prior chemotherapy and are HLA-A*02 positive with MAGE-A4 antigen expression. The treatment, which was approved based on results from the SPEARHEAD-1 trial, marks the first engineered cell therapy for a solid tumor cancer to be approved in the United States, according to the company.1 “The approval of Tecelra is a momentous step in Adaptimmune’s journey to redefine the way cancer is treated and the culmination of a decade of groundbreaking R&D. I want to thank the patients, caregivers, investigators, and clinical teams as well as everyone at Adaptimmune and our partners who made possible this watershed moment for cell therapy ...
- Source: drugdu
- 97
- August 6, 2024
Porton Advanced and Geneseed Biotech Enter into Strategic Collaboration to Focus on Advancing circRNA Innovative Therapeutics

SUZHOU, China, July 30, 2024 /PRNewswire/ — On July 29, 2024, Porton Advanced Solutions (“Porton Advanced”) announced that it had reached a strategic cooperation with Guangzhou Geneseed Biotech Co., Ltd (“Geneseed Biotech”). Both sides will combine their respective strengths in the field of gene therapy to jointly provide better drug development services. Leveraging Porton Advanced’s end-to-end cell and gene therapy CDMO service platform and resource advantages, combined with Geneseed Biotech’s comprehensive core patented technologies in circRNA drug concept validation and process development, the two companies will jointly propel technological innovation and clinical translation, thereby accelerating the implementation of innovative circRNA therapies. Proton Advanced is committed to providing end-to-end CDMO services for cell and gene therapy, and has extensive experience in nucleic acid therapy process development and GMP production, covering various types including mRNA, saRNA, circRNA, and more. Porton Advanced can provide comprehensive CMC services from preclinical to clinical production. Geneseed ...
- Source: drugdu
- 117
- August 6, 2024
WuXi Biologics’ Four Manufacturing Facilities and Biosafety Testing Center Certified Again by European Medicines Agency for Ten Biologics

WUXI and SUZHOU, China, Aug. 1, 2024 /PRNewswire/ — WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that four manufacturing facilities and Suzhou Biosafety Testing Center in China have received Good Manufacturing Practice (GMP) certificates from the European Medicines Agency (EMA), demonstrating the company’s commitment to meeting rigorous international industry quality standards across its global network. Following comprehensive inspections of the company’s facilities– specifically MFG1, MFG2, MFG5, and DP1 in Wuxi– EMA GMP certificates were issued for commercial and New Drug Application (NDA)-ready manufacturing and services for eight biologics, an endorsement to the company’s capabilities in providing such services for global clients. All of these facilities were previously approved by the EMA and other major regulatory authorities for the development of multiple biologic therapeutics. Furthermore, the company’s Suzhou Biosafety Testing Center was once again certified by the EMA to provide services ...
- Source: drugdu
- 78
- August 6, 2024
HDR UK and DPUK granted £2m for new motor neurone disease research initiative

The rapidly progressive neurological condition affects around 5,000 people in the UK Health Data Research UK (HDR UK) and Dementias Platforms UK (DPUK) have received £2m in funding to launch a new initiative to accelerate motor neurone disease research. Supported by the UK Dementia Research Institute, the MND Research Data Catalyst is funded by the Department of Health and Social Care and delivered through the National Institute of Health and Care Research (NIHR). Currently affecting around 5,000 people in the UK, MND is a fatal, rapidly progressing neurological condition caused by the accumulation of proteins in the brain that clump together to gradually stop cells from working. Supported by the UK government in partnership with charities and organisations including the NIHR, UK Research and Innovation, MND Association, My Name’5 Doddie Foundation, MND Scotland and LifeArc, along with the MND research community, the new initiative aims to accelerate the discovery of ...
- Source: drugdu
- 94
- August 3, 2024
FDA Grants Priority Review to Novartis’ Scemblix for Newly Diagnosed Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase

By Don Tracy, Associate Editor Results from the ASC4FIRST study lead to FDA priority review designation of Scemblix in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Blood cell red 3d background vein flow platelet wave cancer medicine artery abstract. Red cell hemoglobin blood donate anemia isolated plasma leukemia donor vascular system anatomy hemophilia vessels. Image Credit: Adobe Stock Images/Five Million StocksThe FDA has granted priority to review to Novartis’ Scemblix (asciminib) for newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase (Ph+ CML-CP). According to the company, the designation was based on promising results from the Phase III ASC4FIRST trial, in which Scemblix showed superior major molecular response (MMR) rates compared to current standard-of-care (SoC) tyrosine kinase inhibitors (TKIs), such as imatinib, nilotinib, dasatinib, and bosutinib.1 “We welcome the FDA’s decision to grant Priority Review and Breakthrough Therapy designations to ...
- Source: drugdu
- 71
- August 2, 2024
Fosun PharmaceuPharmacopeia as an Official Control Product

On July 23, 2024, Guilin Nanopharm received a letter from the United States Pharmacopeial Convention (hereinafter referred to as USP) “Donation Recognition Program Team”, which mentioned that the artesunate control product donated by Guilin Nanopharm has been listed as an official control product by USP. Artesunate is the original anti-malarial drug developed by Guilin Pharmaceuticals for the secondary research and development of artemisinin. It solved the problem of water solubility of artemisinin and obtained the certificate of Class I New Drug No. X-01 issued by the Ministry of Health of China in 1987. The control of Artesunate was calibrated by Guilin Southern Pharmaceuticals and USP official laboratories respectively, and the content determination results were identical, both were 99.8%. The data of infrared, mass spectrometry, nuclear magnetic resonance (NMR), related substances, moisture and other assays showed complete match. The inclusion of this control as an official control by USP ...
- Source: drugdu
- 83
- August 1, 2024
Avzivi® (BAT1706) receives marketing approval from European Commission

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is dedicated to the development of a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology, and other major diseases that threaten human life or health. The Company recently received notification from the European Commission that Avzivi (BAT1706), a biosimilar developed by BIO-THERA with reference to Avastin® (bevacizumab), Intravenous Solution, has been granted marketing authorization by the European Commission for the treatment of metastatic colorectal, metastatic breast, non-small-cell lung, renal-cell, epithelial ovarian, fallopian tube or primary peritoneal, and cervical cancer. The decision was based on a positive review opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). In September 2021, BIO-THERA signed a commercialization and license ...
- Source: drugdu
- 81
- August 1, 2024
KCL study finds cell ageing could reveal early signs of neurodegenerative disease

Researchers from King’s College London (KCL), along with other collaborators, have found that ageing cells could reveal early signs of neurodegenerative diseases, including Alzheimer’s disease or amyotrophic lateral sclerosis. Published in Aging Cell, the findings could provide a wider picture of a target area for drugs and could improve treatments for these types of conditions. Affecting more than one million people in the UK, neurodegenerative conditions, such as multiple sclerosis and Parkinson’s disease, occur when cells of the central nervous system stop working or die. Using fluorescence to measure the viscosity of neuronal cytoplasm, the fluid enclosed by the cell membrane of the neuron, in mice, researchers found that the viscosity of the cytoplasm in the neuron (soma) increased as the mice aged. However, it did not increase in the cytoplasm of the axon, a tail-like structure that transmits electrical and chemical signals to other cells. Researchers suggested that the ...
- Source: drugdu
- 61
- July 30, 2024
EMA backs Wegovy cardiovascular label update as Novo seeks EU coverage

The European Medicines Agency (EMA) has offered a positive opinion to Novo Nordisk, which should pave the way for the company to update the label for its blockbuster weight loss drug Wegovy (semaglutide 2.4mg). The new label will reflect the therapy’s positive effects on cardiovascular health, potentially improving its chances for reimbursement in Europe. Under the new label, healthcare providers will be able to prescribe Wegovy to patients to reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with established cardiovascular disease. If approved, this will be available for patients who are overweight or obese (initial BMI ≥27kg/m²) without having diabetes. The EMA’s Committee for Medicinal Products for Human Use (CHMP) supported the label update based on data from the Phase III SELECT (NCT03574597) study. The trial demonstrated that Wegovy decreased the incidence of MACE, in a statistically significant ...
- Source: drugdu
- 93
- July 29, 2024
ANKE Bio received clinical approval for another therapeutic mRNA vaccine

ANKE Bio (Group) Co., Ltd. and Hefei Alfana Biotechnology Co., Ltd. jointly developed a Class 1 new drug that received clinical approval from the Drug Administration (Drug Clinical Trial Approval Notification: 2024LP01608), with an indication for the treatment of cervical intraepithelial neoplasia. It is reported that this is the first therapeutic mRNA vaccine approved for clinical use in cervical intraepithelial neoplasia in China. Pre-cancerous lesions and their eventual malignant changes caused by viral infections are a serious threat to people’s lives and health. Globally, approximately 600 million people are infected with human papillomavirus (HPV), in addition to approximately 250 million people infected with hepatitis B virus (HBV), and 71 million people infected with hepatitis C virus (HCV). People infected with each of these viruses face a potential cancer risk. For example, approximately 30 million women are diagnosed each year with cervical intraepithelial neoplasia (CIN), an important precursor to cervical cancer. ...
- Source: drugdu
- 82
- July 25, 2024

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