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Study finds 3D-printed blood vessels could improve heart bypass outcomes

Coronary heart disease is the most common form of heart and circulatory disease Researchers from the University of Edinburgh, in collaboration with Heriot-Watt University, have revealed that artificial blood vessels printed using novel 3D printing technology could transform the treatment of cardiovascular diseases (CVD). The findings published in Advanced Materials Technologies demonstrate that artificial blood vessels could improve outcomes for heart bypass patients. CVD affects around seven million people in the UK and is a significant cause of disability and death. Heart bypass surgery is a procedure used to treat coronary heart disease, the most common form of heart and circulatory disease that affects around 2.3 million people in the UK. It occurs when coronary arteries become narrowed by a build-up of fatty material within their walls. Researchers led by the University of Edinburgh’s School of Engineering used a rotating spindle integrated into a 3D printer to print tubular grafts made from ...
- Source: https://pharmatimes.com/news/study-finds-3d-printed-blood-vessels-could-improve-heart-bypass-outcomes/
- 119
- August 1, 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
- 95
- 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
- 88
- August 1, 2024
Pfizer Hemophilia Gene Therapy Meets Phase 3 Goals, But Its Success Matters More to Sangamo

Pfizer’s hemophilia A gene therapy reduced annualized bleeding rates in a Phase 3 clinical trial, setting the stage for discussions with regulators. However, the market for such one-time treatments is uncertain, as uptake of commercialized hemophilia gene therapies remains slow. By Frank Vinluan A Pfizer gene therapy for hemophilia A reduced bleeding rates in patients with the inherited blood disorder, meeting goals of its Phase 3 study. The preliminary results announced Wednesday are measures taken at 15 months in a study that will follow patients for up to five years, meaning the one-time treatment’s durability remains an open question. The pharmaceutical giant now plans to meet with regulators to discuss next steps for the therapy. In hemophilia A, insufficient levels of a clotting protein called factor VIII make patients susceptible to frequent bleeding events. Treatment includes regular infusions of this clotting protein to prevent these events. The Pfizer gene therapy, giroctocogene fitelparvovec, delivers ...
- Source: https://medcitynews.com/author/fvinluan/
- 118
- July 27, 2024
Sage and Biogen Halt Phase II Study After Novel Drug Shows No Significant Improvement in Treating Essential Tremor

Image Credit: Adobe Stock Images/Creative Cat Studio Data from the Phase II KINETIC 2 study, which evaluated SAGE-324 (BIIB124) as a treatment for essential tremor (ET), show the drug did not achieve the trial’s primary objectives. According to Sage Therapeutics and Biogen, the study aimed to determine the dose-response relationship of SAGE-324 by assessing changes from baseline to day 91 in the TETRAS Performance Subscale Item 4 total score, measuring upper limb tremor severity. Results found that SAGE-324 offered no statistically significant improvement across different doses compared to placebo. As a result, both companies have decided to halt the ongoing open-label safety study and cease further clinical development of SAGE-324 for ET.1 “There has been little innovation in the pharmacological treatment of essential tremor over the past 50 years, and people living with this debilitating condition have a pressing need for new treatment options. We are disappointed that the results ...
- Source: https://www.pharmexec.com/authors/don-tracy-associate-editor
- 146
- July 27, 2024
New Drug Marketing Application for BBM-H901 Injection, a Gene Therapy Product for Hemophilia B, Accepted by the National Drug Administration

Takeda China and Conviction Pharmaceuticals Group (hereinafter referred to as Conviction Pharmaceuticals) announced today that the National Drug Administration (NDA) has formally accepted the New Drug Application (NDA) for BBM-H901 Injection for the treatment of adult patients with Hemophilia B. BBM-H901 Injection is a recombinant adeno-associated virus (AAV) gene therapy product that was independently developed and manufactured by Conviction Pharmaceuticals, and the commercialization of this product will be undertaken by Takeda China in the future. Takeda China is responsible for the commercialization of the product in Mainland China, Hong Kong, China and Macau, China. This milestone development means that the product is expected to bring new treatment options for hemophilia B patients in China. Zhang Lei, the lead investigator of the registered clinical study of BBM-H901 injection and a professor at the Hospital for Hematological Diseases of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical ...
- Source: drugdu
- 118
- July 26, 2024
AstraZeneca grows oncology portfolio with Pinetree’s EGFR degrader

AstraZeneca has signed a licensing agreement with Pinetree Therapeutics for a preclinical epidermal growth factor receptor (EGFR) degrader candidate, potentially worth more than $545m. AstraZeneca will pay $45m upfront for global developmental and commercialisation rights for the pan-EGFR degrader, and Pinetree will also be in line to receive up to $500m in milestone-based payments along with tiered royalties on sales. “[The] pan-EGFR degrader was developed from AbReptor, our proprietary multispecific antibody platform and has demonstrated promising preclinical anti-tumour activity in drug-resistant and tyrosine kinase inhibitor (TKI)-resistant tumours, as well as enhanced activity when used in combination with current EGFR inhibitors,” said Dr Hojuhn Song, founder and CEO of Pinetree. Targeted protein degraders, often called molecular glues, have been a growing area of interest in recent years. Most of these therapies are developed in oncology. According to GlobalData’s drug database, over 200 therapies in development have been classified as molecular glue ...
- Source: drugdu
- 98
- July 26, 2024
BioAtla receives FDA fast track designation for ozuriftamab vedotin

BioAtla has received a fast track designation from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) ozuriftamab vedotin (BA3021) to treat a certain type of head and neck cancer. Ozuriftamab vedotin is a conditionally and reversibly active ADC targeted against ROR2, a receptor tyrosine kinase present in many solid tumours. ROR2 is a non-canonical wnt5A signalling receptor, the overexpression of which is associated with poor prognosis and resistance to standard therapies. This fast track designation concerns the use of ozuriftamab vedotin in treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) for whom the disease has progressed despite platinum-based chemotherapy and anti-PD-1/PD-L1 antibody treatment. The ADC is the subject of an ongoing multi-centre, open label Phase II trial (NCT05271604) investigating the therapy’s efficacy and safety for this indication. Though a full readout is still pending, interim data from ...
- Source: drugdu
- 94
- July 26, 2024
New study suggests CAR-T therapy monitoring time could be slashed

The US Food and Drug Administration (FDA)-mandated monitoring time for CAR-T therapy patients could be halved, according to a new study. Chimeric antigen receptor (CAR)-T therapy involves modifying a patient’s T cells to recognise and attack cancer cells. There are three approved therapies to treat diffuse large B-cell non-Hodgkin lymphoma (DLBCL), notably Gilead’s Yescarta (axicabtagene ciloleucel) and Novartis’s Kymriah (tisagenlecleucel), which were approved by the FDA in 2017; and Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), which won approval in 2021. Safety concerns surrounding CAR-T cell therapies related to cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), led to strict FDA-mandated monitoring requirements when the therapies were first approved in 2017. To allow for the safe use of these therapies, the FDA established a risk evaluation and mitigation strategy (REMS) programme, which covered these monitoring requirements. Under the REMS programme, patients need to stay near the treatment centre ...
- Source: drugdu
- 93
- July 26, 2024
AI Model Identifies Breast Tumor Stages Likely To Progress to Invasive Cancer

Ductal carcinoma in situ (DCIS) is a non-invasive type of tumor that can sometimes progress to a more lethal form of breast cancer and represents about 25% of all breast cancer cases. Between 30% and 50% of DCIS patients may develop an invasive stage of cancer, yet identifying which tumors will progress is still a challenge due to unknown biomarkers. Current diagnostic practices include multiplexed staining or single-cell RNA sequencing to determine DCIS stages in tissue samples, but these methods are costly and not widely used. This has led to potential overtreatment of patients with DCIS. Now, a new artificial intelligence (AI) model can distinguish different stages of DCIS from inexpensive and readily available breast tissue images. The model developed by an interdisciplinary team of researchers from MIT (Cambridge, MA, USA) and ETH Zurich (Zurich, Switzerland) was trained and tested using one of the largest datasets of its kind ...
- Source: https://www.labmedica.com/pathology/articles/294801919/ai-model-identifies-breast-tumor-stages-likely-to-progress-to-invasive-cancer.html
- 86
- July 26, 2024

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