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The clinical Phase III study results of the BIO-THERA Tocilizumab biosimilar, TOFIDENCE™, have been published in The Lancet Rheumatology.

The clinical Phase III study results of the BIO-THERA Tocilizumab biosimilar, TOFIDENCE™ (BAT1806/BIIB800), have been published in the prestigious international rheumatology journal, The Lancet Rheumatology (impact factor IF = 25.4). This research, derived from a global multicenter, randomized, double-blind, active-controlled Phase III clinical study (ClinicalTrials.gov, NCT03830203; EudraCT, 2018-002202-31), reveals outcomes from the initial treatment phase (TP1). The study, conducted in 54 centers across five countries (China, Ukraine, Poland, Georgia, Bulgaria), included a 24-week initial treatment phase (TP1) followed by a subsequent 24-week secondary treatment phase (TP2). A total of 621 patients with moderate to severe rheumatoid arthritis, unresponsive to methotrexate, were enrolled. During the trial, participants received investigational drug therapy with an initial dose of 8mg/kg, administered intravenously every four weeks, either BAT1806/BIIB800 or the reference Tocilizumab. The study consisted of two treatment stages (TP1 and TP2), with 50% of the control group transitioning to BAT1806/BIIB800 treatment in TP2 until ...
- Source: drugdu
- 115
- December 22, 2023
InxMed Enters License Agreement with Escugen to Develop Next-Generation ADCs

Nanjing, China– InxMed, a clinical-stage biotechnology company dedicates on developing innovative therapies against drug resistance, and Escugen, a clinical-stage antibody–drug conjugate (ADC) company, today announced that InxMed licensed EZWi-Fit® linker-payload platform from Escugen for the development of the next generation tumor-associated antigens (TAAs) targeting ADCs. The license agreement provides InxMed with right to use EZWi-Fit® platform on the several novel ADC candidate molecules. InxMed will have the right for development, manufacturing, and commercialization of these ADC candidate molecules. InxMed is developing next generation TAAs targeting ADCs with significant improvement of efficacy and therapeutic window. Meanwhile, the company is developing solutions to boost ADC’s efficacy including enhancing ADC penetration via FAK inhibitor and developing stroma targeting ADC to create synergy. InxMed is positioned to invent next generation ADCs, with the attributes to be more tumor selective and potent, and broad combination potential. The novel antibodies discovered by InxMed to be equipped ...
- Source: drugdu
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- December 22, 2023
China updates guidelines for vaccination practices

BEIJING — China has released new vaccination guidelines to enhance standardized immunization management, according to the National Disease Control and Prevention Administration. The updated guidelines, a revision of the 2016 version, mandate standardized requirements for vaccination practices, including vaccine-use management, the monitoring and handling of suspected adverse reactions, as well as vaccination-rate surveillance. According to the guidelines, disease control agencies and vaccination centers should implement a routine vaccine inspection system. This involves monthly checks on factors such as vaccine quantity, source, packaging, storage temperature and expiration date, with records maintained. In China, vaccines are categorized into immunization plan vaccines, mandated by government regulations, and non-immunization plan vaccines, which residents voluntarily choose, excluding those specified in the official immunization plan. http://english.nmpa.gov.cn/2023-12/18/c_948768.htm
- Source: drugdu
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- December 22, 2023
【EXPERT Q&A】What documents are needed and what is the specific process for exporting medical equipment?

Drugdu.com expert’s response: Exporting medical equipment requires a thorough understanding of the regulatory requirements of both the exporting and importing countries, and involves several steps and essential documents: 1.Regulatory Compliance Compliance with Exporting Country Regulations: Ensure the medical equipment meets the regulatory standards of the country of origin. Compliance with Importing Country Regulations: Understand and comply with the medical device regulations of the destination country, which may include certifications like CE Marking (for Europe) or FDA approval (for the United States). 2.Essential Documents Export License: Depending on the type of equipment and the destination, an export license may be required. Commercial Invoice: Details the transaction between the exporter and importer. Packing List: Describes the contents and packaging details of the shipment. Bill of Lading or Airway Bill: Used for the shipment of goods. Certificate of Origin: States where the equipment was manufactured. Product Certifications: Documents like CE Certificate or FDA ...
- Source: drugdu
- 174
- December 22, 2023
FDA drafts guidance outlining real-world evidence for medical device submissions

Dive Brief The Food and Drug Administration posted a draft guidance on Monday clarifying how it evaluates real-world data in its decisions to clear or approve medical devices. The draft is an update to a final guidance in 2017 and includes more detail on how the agency assesses the relevance and reliability of real-world data, study design elements and recommendations on documentation for FDA review. An omnibus spending bill passed at the end of 2022 required the FDA to issue a draft guidance on the use of real-world data in premarket submissions. Two years after the public health emergency ended, the law also requires the FDA to specify how many requests for clearance or approval it has received and how many of those applications were approved or denied when real-world evidence was submitted. Dive Insight The 21st Century Cures Act, signed into law in 2016, created a framework for the ...
- Source: drugdu
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- December 21, 2023
Cutting-Edge Lab Automation System Supports High-Volume Needs and Provides Faster Results

A new, innovative automation solution for clinical labs featuring smart technology can boost lab performance and flexibility, reduce turnaround time, and eliminate 80% of manual steps, thereby increasing reliability and minimizing errors to provide quicker lab results Abbott’s (Lake Forest, IL, USA) GLP systems Track is a cutting-edge technology and scalable automation solution that helps laboratories meet high-volume demand and maximize productivity. This system introduces innovative features that boost safety, productivity, and capacity to meet increasing laboratory demands. The flexibility of the GLP systems Track is a standout feature, offering laboratories the ability to tailor the system’s configuration to their specific requirements. A key innovation in this system is the CAR, a smart, self-propelled single sample carrier, which allows samples to move independently, not attached to rigid, fixed mechanized track systems. This innovation minimizes mechanical breakdowns that could halt operations, ensuring continuous functionality and adaptability to the lab’s evolving needs. ...
- Source: drugdu
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- December 21, 2023
Gene Therapy and a New Medicine Delivery Approach Signal Progress for Cystic Fibrosis Patients

It’s time to build the infrastructure needed to scale up inhaled gene therapies targeting cystic fibrosis, and to bolster investment that supports several key program components. By JOAN LAU Thanks to simultaneous achievements in gene therapy and medicine delivery platforms, new solutions to intractable problems are bringing us to a real watershed moment in the treatment of respiratory disease. This synchronicity of science and tech advancements is no accident; along with colleagues in my own and other organizations, I have been working for the past several years on the medical and technological leaps that together signal hope for respiratory-disease patients with unmet need. This is especially true for those with cystic fibrosis (CF), for whom the standard of care is in urgent need of update. And now that we have the science and the technology in place, we must push to scale-up efforts; patients are waiting. Right now, CF patients ...
- Source: drugdu
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- December 21, 2023
Chiesi Rare Skin Disease Drug Acquired in Billion Dollar Deal Wins FDA Approval

Chiesi Group’s Filsuvez is the second drug to win FDA approval for epidermolysis bullosa and the first for junctional EB, a more severe form of the rare skin disease. The birch tree bark-derived drug is from Chiesi’s $1.25 billion Amryt Pharma acquisition. By FRANK VINLUAN The rare inherited disorder epidermolysis bullosa, or EB, leads to skin so fragile that it tears like tissue paper. The resulting wounds and blisters are slow to heal and prone to infection. On Tuesday, the FDA approved a Chiesi Group drug developed to promote faster wound healing in EB patients. Privately held Chiesi will market its new drug as Filsuvez, the same brand name for the product in Europe, where it won its first regulatory approval last year. The FDA decision for this topical gel covers the treatment of patients age six months and older. EB stems from a mutation to the gene that codes ...
- Source: drugdu
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- December 21, 2023
Phase III Clinical Study of New Generation sleep medication Daridorexant Dosed the First Patient in China

On December 17, 2023, the Chinese Phase III clinical study of Daridorexant Hydrochloride Tablets （Daridorexant）, dosed the first patient at the xx hospital. Daridorexant is a novel sleep medication collaborated between Simcere Pharmaceutical Group Limited (Simcere; 2096.HK) and Idorsia Pharmaceutials Ltd. (Idorsia), for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning. This study is led by Professor Yuping Wang at Xuanwu Hospital of Capital Medical University and conducted in 33 centers across China. It is a local pivotal registry study of Daridorexant in China. Insomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of daytime functioning. This impact on sleep quantity or quality should be present for at least three nights per week, lasts for at least three months, and occurs despite an adequate opportunity to ...
- Source: drugdu
- 105
- December 21, 2023
reminder on known risk of gambling disorder

The MHRA has reminded healthcare professionals prescribing aripiprazole to be alert to the known risk of patients developing addictive gambling, following a rise in the number of reports received in 2023 Aripiprazole is an important medicine for the treatment of schizophrenia and bipolar disorder. Patients are advised to tell their doctor if they or their family and friends notice they are having unusual urges or cravings that they cannot resist, including behaviours such as addictive gambling, excessive eating or spending, or an abnormally high sex drive. Patients should continue taking aripiprazole as advised. Stopping aripiprazole without medical advice can be harmful. In the last 14 years, the MHRA’s Yellow Card scheme received 69 reports of gambling or gambling disorder where aripiprazole was suspected to be the cause. Thirty-two of these reports were received between 1 January and 31 August this year. In March 2023, the MHRA asked gambling clinics to ...
- Source: drugdu
- 85
- December 21, 2023

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