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【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
- 157
- May 13, 2024
Chiatai Tianqing Completes Enrollment of First Subject in Phase III Clinical Trial of New Class 1 Drug Garsorasib (D-1553)

Chiatai Tianqing is conducting the “Randomized, controlled, double-blind, dual-simulation, multicenter Phase III clinical study to evaluate D1553 versus docetaxel for the treatment of locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation-positive lung cancer that has failed previous standard therapy (D1553-III-01)” nationwide. Recently, the project has completed the enrollment and successful dosing of the first subject. Garsorasib is a novel targeted KRAS G12C mutation inhibitor, registered under the classification of chemical drug class 1, is the first self-developed KRAS G12C inhibitor in China that has entered the clinical trial stage, and is included in the breakthrough therapeutic varieties by the CDE. on December 29, 2023, the National Drug Administration (NMPA) has accepted Garsorasib’s New Drug Marketing Application for the treatment of locally advanced or metastatic non-small cell lung cancer with disease progression or intolerable disease after prior first-line systemic therapy and with the presence of a KRAS ...
- Source: drugdu
- 81
- May 10, 2024
Introduced GLP-1 product Simeglutide Injection

Recently, Tong Hua Dong Bao Pharmaceutical Company Limited (“Tong Hua Dong Bao” or the “Company”) signed a Commercialization License and MAH Cooperation Agreement (“Commercialization License and MAH Cooperation Agreement”) on the GLP-1 product simelglutide injection (“Simelglutide Injection”) with Beijing Quality Peptide Bio-pharmaceutical Technology Co. (hereinafter referred to as “QPBio”) entered into the Commercialization License and MAH Cooperation Agreement (hereinafter referred to as the “Agreement”) in relation to the GLP-1 product, Simeglutide Injection. Pursuant to the Agreement, the Company will obtain the exclusive commercialization rights and interests in Mainland China for ZT001 Simeglutide Injection (indication: blood glucose control in adults with type 2 diabetes mellitus) (the “Collaboration Product”), which is a clinical product under development by Plasmapeptide Biologics, as well as the right to co-develop the overseas market. The Cooperative Product has completed the Phase I clinical trial for the indication of type 2 diabetes mellitus in Mainland China and has ...
- Source: drugdu
- 114
- May 10, 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
- 80
- 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
- 72
- May 10, 2024
Securing Audience Measurement in Pharma Marketing

Ray Kingman The industry must find a way to balance consumer privacy and a return on investment in pharma marketing. Promoting advances in pharmaceuticals is full of challenges. From recruiting clinical trial participants, to engaging patients with their permission at the point of care, to creating brand lift and awareness, the marketing landscape for pharma presents both logistical and regulatory obstacles when it comes to constructing and executing a successful marketing program. Identity, and how it is managed, presents special challenges for audience targeting and especially measurement of campaign performance in an evolving identity resolution environment. Across our multi-channel, multi-platform and multi-media landscape the signals that avail us for targeting and measurement are often impeded by the requirement to block or exercise restraint when it comes to sensitive data and patient privacy rights. Building privacy-compliant audiences for pharma campaigns takes special care, but identifying audience engagement that measures campaign outcomes ...
- Source: drugdu
- 87
- 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
- 111
- 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
- 117
- May 10, 2024
Advanced Blood Test to Spot Alzheimer’s Before Progression to Dementia

Alzheimer’s disease is well known for its slow development over many years, which typically leads to treatment interventions only after the disease has advanced to stages where it may be nearly impossible to slow down its progression. The results of a groundbreaking study, recently published in the journal Nature Communications, have offered new hope for not only earlier diagnosis but also for potentially slowing the course of Alzheimer’s disease. A team of researchers from Aarhus University (Aarhus, Denmark) has identified a specific receptor found on immune cells that can bind and neutralize harmful “beta proteins”, which are closely linked with the development of Alzheimer’s disease. The study underscores the significant role that the peripheral immune system may play in defending the body against Alzheimer’s by preventing the build-up of these harmful proteins in the brain. This discovery paves the way for detecting the disease-related changes much earlier than current methodologies ...
- Source: drugdu
- 116
- May 10, 2024
Outset Medical gets FDA nod for dialysis accessory months after halting sales

Dive Brief Outset Medical received 510(k) clearance for TabloCart with prefiltration, an accessory that filters sediment and minerals out of water before it enters the company’s dialysis machines. Outset stopped distributing the accessory last year after receiving a warning letter in July 2023 from the Food and Drug Administration stating that it needed 510(k) clearance. BTIG analyst Marie Thibault wrote in a research note that the clearance is a “big win” for Outset, adding that she expects the company to now be able to work through a customer backlog. Dive Insight San Jose, California-based Outset is competing in the market for dialysis equipment. Its Tablo hemodialysis system can be used in acute or chronic care facilities and was cleared for home use in 2020. The company also makes an accessory for the system, called TabloCart, which includes wheels, storage drawers, and water prefiltration to remove sediment and minerals from supply ...
- Source: drugdu
- 81
- May 9, 2024

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