Search Results for “EC” – Page 250 – media

The Impact of Micropayments in Clinical Trials

Micropayments provide an additional incentive for patients to complete required tests, procedures, and diary entries, ensuring that sites, sponsors, and CROs are able to collect the required data needed to complete a clinical trial on time and on budget. By Tanya Kogan on May 10, 2024 Clinical trials today require more patient involvement than ever before. Yet longer, more frequent site visits or participation that requires extensive travel can impact a patient’s willingness to participate in and remain in a clinical trial over the long term. As a result, patient recruitment and retention can be a challenge for sites and pharmaceutical companies, especially when the target patient population is small or geographically dispersed. Sadly, the average dropout rate across clinical trials is 30 percent. With the increasing need for consistent and accurate patient data, sponsors and sites are investing in electronic patient-reported outcomes (ePRO) and electronic clinical outcomes assessment (eCOA) ...
- Source: drugdu
- 100
- May 13, 2024
FDA posts final guidance on remanufacturing medical devices

Dive Brief The Food and Drug Administration published final guidance on the remanufacturing of medical devices on Thursday. Acting on feedback from groups including Advamed, the FDA has changed the title of the text and added a section on the regulatory requirements for remanufacturers. The new section, which applies to original equipment manufacturers and service providers, is intended to help entities that are less familiar with the medical device regulatory requirements. Dive Insight The FDA published draft guidance in 2021 to clarify the distinction between device remanufacturing and servicing. Many reusable medical devices are serviced. Previously, it was unclear when servicing became so extensive that it qualified as remanufacturing. The draft defined remanufacturing as an act done to a finished device that significantly changes the performance, safety or intended use, including renovating, repackaging or restoring products. After assessing feedback on the draft, the FDA has retained its definition of remanufacturing ...
- Source: drugdu
- 101
- May 13, 2024
Novel Biomarkers to Improve Diagnosis of Renal Cell Carcinoma Subtypes

Renal cell carcinomas (RCCs) are notably diverse, encompassing over 20 distinct subtypes and generally categorized into clear cell and non-clear cell types; around 20% of all RCCs fall into the non-clear cell RCCs (non-ccRCC) category, with many subtypes being exceedingly rare and not extensively studied. Despite their varied molecular characteristics, non-ccRCCs are commonly treated with therapies designed for the more prevalent clear cell type, which impacts the effectiveness of the treatments. The differential diagnosis of non-ccRCC tumors poses significant challenges due to the overlapping morphological characteristics and the current biomarkers’ lack of specificity. A study has now uncovered new biomarkers in RCCs that could enhance the accuracy of diagnoses and potentially improve treatment strategies. This research utilized an integrative approach to examine comprehensive proteogenomic data from both cc and non-cc RCCs, advancing previous genomic-focused studies and deepening the understanding of the mechanisms driving renal cell carcinomas. These discoveries provide a ...
- Source: drugdu
- 89
- May 13, 2024
Oregon and Lantern collaborate to develop drug candidate for various cancer indications

Anticancer drugs will be responsible for 90% of nearly 612,000 predicted US cancer deaths in 2024 Oregon Therapeutics and Lantern Pharma have entered into a strategic artificial intelligence (AI)-driven collaboration to optimise the development of a protein disulfide isomerase (PDI) inhibitor drug candidate for a variety of novel and targeted cancer indications. XCE853 is being developed by Oregon in various indications, including drug-resistant ovarian and pancreatic cancer, certain haematological cancers and several paediatric cancers, including central nervous system cancers. Nearly 612,000 deaths are predicted to occur in the US in 2024 due to cancer and resistance to anticancer drugs will be responsible for 90% of those deaths. Under the terms of the agreement, Lantern will receive equal intellectual property (IP) co-ownership and drug development rights in newly discovered biomarkers, novel indications, and pharmacological use strategies for XCE853, while Oregon is entitled to financial benefits resulting from the licensing of the ...
- Source: drugdu
- 99
- May 13, 2024
Chiesi and Gossamer collaborate to develop drug to treat respiratory diseases

Chiesi Group and Gossamer Bio have announced a global collaboration and license agreement to develop and commercialise seralutinib to treat respiratory diseases. Chiesi will support Gossamer’s ongoing work for seralutinib in pulmonary arterial hypertension (PAH), as well as its development in pulmonary hypertension associated with interstitial lung disease (PH-ILD). Predicted to affect up to 50,000 people in the US, PAH is a rare, progressive condition that causes high blood pressure in the lungs’ arteries. It is estimated that PH-ILD affects up to 100,000 patients in the US. Seralutinib is an inhaled inhibitor designed to be delivered via a dry powder inhaler for the potential treatment of pulmonary hypertension. As part of the deal, Chiesi will pay Gossamer $160m as a development reimbursement and the biopharmaceutical company will also be eligible to receive up to $146m in regulatory milestones and $180m in sales milestones. Under the terms of the agreement, Gossamer ...
- Source: drugdu
- 78
- May 13, 2024
【EXPERT Q&A】What does FDACFR21 in the United States refer to?

Drugdu.com expert’s response: The U.S. FDACFR21 regulations refer to Title 21 of the Code of Federal Regulations (CFR), which encompasses regulations established under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This set of regulations, overseen by the U.S. Food and Drug Administration (FDA), governs various aspects of the production, distribution, labeling, advertising, and safety of food, drugs, medical devices, cosmetics, and other related products. CFR Title 21 includes provisions covering: 1.Drug Quality and Manufacturing Practices: Regulations concerning quality control, processes, equipment, raw materials, packaging, and other aspects of drug manufacturing. 2.Food Labeling and Ingredients: Requirements for information on food labels, ingredient lists, nutrition labeling, etc., ensuring consumers receive accurate information. 3.Medical Device Registration and Reporting: Mandates for medical device manufacturers to register and report, as well as comply with relevant quality management system requirements. 4.Cosmetic Safety and Labeling: Standards for cosmetic safety, ingredient restrictions, and labeling requirements to ...
- Source: drugdu
- 150
- May 13, 2024
Francis Crick Institute and Broken String Biosciences partner for ALS research

The Francis Crick Institute and Broken String Biosciences have announced a new collaboration to advance research in amyotrophic lateral sclerosis (ALS). The partnership aims to advance the understanding of genomic instability in the development of the neurodegenerative disease. Affecting an estimated 5,000 people in the UK, ALS is a rare and fatal neurological disorder that causes the brain and spinal cord nerve cells to progressively degenerate. The disorder gradually causes a loss of the ability to control voluntary movements and basic bodily functions. As part of the collaboration, the research project aims to develop novel applications for Broken String’s proprietary DNA break-mapping platform, INDUCE-seq, to leverage the technology to investigate the impact of genomic instability in the development of ALS. INDUCE-seq is a scalable platform technology that reveals the breaks induced by any nuclease-based genome editing system with high precision. It was created to address an unmet need for accurate ...
- Source: drugdu
- 78
- May 10, 2024
NHS to roll out fibre optic laser therapy to prevent seizures in epileptic patients

The chronic brain disease that causes seizures currently affects around 600,000 people living in the UK The NHS has announced that it will be rolling out a new laser beam therapy this June to help prevent seizures in patients living with epilepsy. The new fibre optic laser therapy called laser interstitial thermal therapy (LITT) works to target the part of the brain that causes seizures without the need for invasive surgery. Affecting around 600,000 people in the UK, epilepsy is a chronic brain disease that causes seizures, which lead to involuntary movement. Around one in three people living with the condition are unable to control their seizures using anti-seizure drugs and may need invasive neurosurgery to remove the epilepsy-causing part of the brain. Being offered at King’s College Hospital NHS Foundation Trust and the Walton Centre in Liverpool, the treatment involves drilling a small hole to allow a 1.5mm-wide probe ...
- Source: drugdu
- 70
- May 10, 2024
Otsuka Launches New Company to Commercialize Rejoyn, the First Digital Therapeutic for Depression

Otsuka Pharmaceutical is launching a subsidiary that will commercialize its digital therapeutic Rejoyn — as well as other digital therapeutics and connected health products down the line. Last month, Rejoyn became the first FDA-cleared digital therapeutic for patients with depression.Last month, an app named Rejoyn became the first FDA-cleared prescription digital therapeutic for patients with major depressive disorder. The app, which changes users’ behavior through various lessons and exercises, was developed by Otsuka Pharmaceutical and Click Therapeutics. On Monday, Otsuka announced that it is launching a new data and technology-focused subsidiary that will commercialize Rejoyn — as well as other digital therapeutics and connected health products down the line. The new company — named Otsuka Precision Health — is a subsidiary of Otsuka America, which is a subsidiary of Tokyo-based Otsuka Pharmaceutical. Rejoyn is a six-week program intended to be used alongside antidepressants. The app leverages clinically validated cognitive emotional ...
- Source: drugdu
- 110
- May 10, 2024
Integrated Solution Ushers New Era of Automated Tuberculosis Testing

Tuberculosis (TB) is responsible for 1.3 million deaths every year, positioning it as one of the top killers globally due to a single infectious agent. In 2022, around 10.6 million people were diagnosed with TB, and it’s estimated that as many as one-quarter of the global population may be infected with Mycobacterium tuberculosis (MTB). Effective TB control requires healthcare providers to address not only those with active TB but also the vast, often unnoticed reservoir of individuals with latent TB infection (LTBI). Screening for latent TB involves identifying and testing people at risk of contracting TB or those who might progress from latent to active TB. Now, a unique blood-based interferon-gamma release assay (IGRA) paired with an automated liquid handling platform enables accurate TB testing and streamlined lab workflows without compromising on clinical performance. Revvity, Inc. (Waltham, MA, USA) has introduced the T-SPOT.TB test for use on the Auto-Pure 2400 ...
- Source: drugdu
- 114
- May 10, 2024

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