Search Results for “Clinical Trial” – Page 52 – media

Q&A with Amy Ripston

By Mike Hollan Ripston discusses the Biospecimen Management Consortium and how its working to develop best practices for driving sample excellence. Slope recently announced the launching of the Biospecimen Management Consortium (BMC), and new group focused on ensuring sample excellence in clinical trials. The group’s executive director, Amy Ripston, spoke with Pharmaceutical Executive about the group, it’s goals, and the importance of this work in the modern world. Pharmaceutical Executive: What are the goals of the BMC? Amy Ripston: The Biospecimen Management Consortium (BMC) was formed to elevate industry-wide excellence in sample management, raise the bar for data integrity and quality, and enable the future of complex clinical research. To accomplish this, the BMC will drive a variety of initiatives aimed at developing best practices and industry standards, streamlining biospecimen lifecycle operations and data management, and influencing regulatory policy. These initiatives will take a critical look at existing processes including, ...
- Source: drugdu
- 93
- July 20, 2024
FDA launches new rare disease innovation hub

Anew rare disease innovation hub set up by the US Food and Drug Administration (FDA) aims to expedite the development and approval of orphan drugs. Rare disease clinical trials can be tricky to navigate, especially for conditions with very few patients. Moreover, even after clinical success, some therapies for rare diseases have been dropped by companies due to the high development costs. The FDA’s hub will act as a central point of connection and engagement with the rare disease community, aiding the navigation of FDA-related concerns. It will enhance inter-centre collaboration on scientific, clinical, and policy issues in rare disease product development, said the agency. It also aims to advance novel endpoints, biomarkers, trial designs, real-world evidence, and statistical methods. The hub will be co-led by Dr. Patrizia Cavazzoni, director at the Center for Drug Evaluation and Research (CDER), and Dr. Peter Marks, director at the Center for Biologics Evaluation ...
- Source: drugdu
- 88
- July 20, 2024
FDA Grants Fast Track Designation to Abdera Therapeutics’ Treatment for Extensive-Stage Small Cell Lung Cancer

By Don Tracy, Associate Editor The novel therapy, ABD-147, uses advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, a protein found on neuroendocrine tumors. The FDA has granted Fast Track Designation to Abdera Therapeutics’ ABD-147, a next-generation precision radiopharmaceutical therapy designed for patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed following platinum-based chemotherapy. According to the company, ABD-147 implements advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, which is a protein commonly found on neuroendocrine tumors but rarely expressed on the surface of normal cells or tissues.1 “Aggressive neuroendocrine cancers such as SCLC carry a poor prognosis and new treatment options are urgently needed,” said Lori Lyons-Williams, president, CEO, Abdera Therapeutics, in a press release. “These cancers have the most aggressive clinical course of any type of pulmonary tumor and often rapidly metastasize to other parts of the body. We are ...
- Source: drugdu
- 99
- July 19, 2024
KCL leads first guidelines on immune monitoring for hard-to-treat blood cancer

Myelodysplastic syndromes are a group of blood cancers that currently affect more than 7,000 people in the UK King’s College London (KCL) has led the publication of first-in-their-kind guidelines that aim to standardise how clinicians measure the immune response of patients living with a hard-to-treat form of blood cancer. The new guidelines will help identify which patients could respond to certain types of therapies, as well as better categorise patients based on whether their immune response is autoimmune or autoinflammatory to determine the choice of therapy and clinical outcome. Affecting more than 7,000 people in the UK, myelodysplastic syndromes (MDS) are a group of blood cancers in which immature blood cells in the bone marrow do not mature or become healthy blood cells, causing them to die in the bone marrow or just after entering the bloodstream. Risks associated with MDS can include an increased likelihood of infections, anaemia, bleeding ...
- Source: drugdu
- 79
- July 19, 2024
Study finds Parkinson’s disease SLT more effective than one used in NHS

The progressive neurodegenerative condition affects around 153,000 people in the UK Researchers from the Universities of Nottingham and Birmingham have revealed that a new form of speech therapy was more effective than the speech and language therapy (SLT) currently used in the NHS for Parkinson’s disease (PD). Published in the British Medical Journal, the PD-COMM trial has been evaluating the effectiveness and cost-effectiveness of two forms of SLT for people living with the neurological disease who have self-reported problems with voice or speech. Affecting around 153,000 people in the UK, PD is a neurodegenerative condition in which parts of the brain become progressively damaged, causing problems such as shaking and stiffness. Due to changes in the brain in people with PD, movements in the muscles to generate speech become smaller and less forceful than before, leading to speech and communication problems. Carried out across the UK by NHS Speech and ...
- Source: drugdu
- 74
- July 19, 2024
【EXPERT Q&A】What are the potential areas for improvement in the accuracy of medical equipment?

Drugdu.com expert’s response: The potential for improvement in the accuracy of medical equipment primarily manifests in the following aspects: I.Technological Advancement and Innovation 1.Genetic Testing and Analysis: By leveraging advanced genomic technologies, patient genetic information can be analyzed with greater precision, providing data support for the customization of personalized medical devices. This precise data analysis facilitates the devices’ better adaptation to individual patient differences. 2.Personalized Drug Delivery Systems: Developing delivery systems capable of precisely adjusting drug dosage and release rates based on patients’ genetic profiles and physiological states ensures the drugs’ effectiveness and safety within the body. 3.3D Printing Technology: Utilizing 3D printing to create patient-specific surgical models and prosthetics enhances surgical precision and personalization. For instance, printing prosthetics that perfectly match patients’ anatomical structures reduces surgical risks and improves recovery outcomes. 4.Real-time Physiological Monitoring: Developing medical devices capable of continuously and accurately monitoring patients’ physiological states, such as wearable ...
- Source: drugdu
- 87
- July 19, 2024
Nature Medicine publishes latest results of combination chemotherapy with Benmelstobart and anlotinib, with a median OS of 19.32 months in SCLC

On July 11, encouraging news came from the ETER701 study completed by 72 centers nationwide led by Professor Cheng Ying of Jilin Cancer Hospital. The academic paper Benmelstobart, anlotinib and chemotherapy in extensive-stage small-cell lung cancer: a randomized phase 3 trial was published online in the international authoritative medical journal Nature ETER701 was a study of Chiatai Tianqing’s Benmelstobart and anlotinib in combination with chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer. The study showed that the median progression-free survival (mPFS) and median overall survival (mOS) of patients included in the current study were the highest in the history of the registry study, and that the combination chemotherapy regimen of Benmelstobart and amlotinib is expected to provide a survival benefit for patients with extensive-stage small cell lung cancer (ES-SCLC). This is another authoritative recognition of Benmelstobart in combination with amlotinib and chemotherapy in the field of extensive-stage small ...
- Source: drugdu
- 80
- July 18, 2024
Positive Data in Pancreatic Cancer Pave Way for Pivotal Test of Revolution Medicines Drug

Revolution Medicines drug RMC-6236 increased progression-free survival in patients with advanced cases of pancreatic ductal adenocarcinoma. With these results, the biotech is preparing for a Phase 3 clinical trial in this indication, the most common type of pancreatic cancer. By Frank Vinluan Pancreatic cancer remains one of the toughest cancers to treat, but Revolution Medicines has data from an early-stage study showing its experimental treatment helped patients live longer without their disease worsening. With these encouraging results, Revolution said Monday it is preparing to proceed to a pivotal clinical trial enrolling patients with advanced cases of the most common type of pancreatic cancer. Revolution develops therapies that target the RAS family of proteins, validated but elusive targets for cancer drug research. Mutations to these proteins lead to the uncontrolled cell growth that happens in a variety of cancers. The most advanced program from Redwood City, California-based Revolution is RMC-6236. This small molecule is ...
- Source: https://medcitynews.com/author/fvinluan/
- 73
- July 17, 2024
FDA Says ‘No’ to Novo Nordisk’s Once-Weekly Insulin

The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news. By Frank VinluanNovo Nordisk’s bid to bring diabetes patients a less burdensome dosing regimen has encountered a setback. The FDA turned down the company’s application for icodec, a slow-acting insulin the company designed for once-weekly dosing as an alternative to daily insulin injections. According to Novo Nordisk, the FDA’s complete response letter raised questions about icodec’s manufacturing process as well as the use of the product in patients with type 1 diabetes. In May, an FDA advisory committee concluded that the available data were not sufficient to show that icodec’s benefits outweigh its risks in type 1 diabetes. Some committee members expressed concerns about icodec’s ...
- Source: drugdu
- 94
- July 16, 2024
Publication in Journal of Translational Medicine Highlighting Henlius’ Dual HER2 Blockade Therapy Mechanism of Action

Recently, Journal of Translational Medicine, a prestigious medical journal, published a research article describing mechanism of action (MOA) of Henlius’ innovative anti-HER2 monoclonal antibody (mAb), HLX22, in dual HER2 blockade therapy. The research analysed the structure foundation and mechanisms of action associated with HLX22, further validating its potential in combination with trastuzumab in the first-line treatment of HER2-positive gastric/gastroesophageal junction (G/GEJ) cancer to benefit more patients worldwide. Trastuzumab, the first HER2-targeted cancer therapy, was introduced in clinical practice and revolutionised the treatment of HER2-positive breast cancer and gastric cancer. Trastuzumab in combination with pertuzumab and docetaxel has also verified their synergistic effect in the treatment of HER2-positive metastatic breast cancer, and the combination regimen is now the standard of care in this indication. However, a phase 3 trial that assessed the efficacy of pertuzumab versus placebo in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic gastric or G/GEJ cancer ...
- Source: drugdu
- 80
- July 15, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.