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【EXPERT Q&A】What is a medical device traceability system?

Drugdu.com expert’s response: The medical device traceability system is a full-process traceability management platform system that connects all aspects of medical device production materials, processing, and consumers, making the entire chain visible and transparent. The system consists of raw material and processing plant traceability management, production traceability management system, logistics distribution scanning system, sales market medical device traceability system, and consumer query system. Its main functions include the collection and tracking of production raw material information, medical device life cycle management, pre-event prevention, in-process control, and post-event traceability. Through this system, enterprises can improve the quality of medical devices, facilitate tracking management, and also provide consumers with a channel for query and traceability.
- Source: drugdu
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- June 18, 2024
Philips launches stent system to restore blood flow in blocked veins

Dive Brief Philips has launched its Duo Venous Stent System in the U.S. to treat patients with blockages in their veins, the company said Wednesday. The implant, which won approval in December, is designed to address the root cause of chronic deep venous disease and comes in two forms for use in different types of veins. Philips acquired the device in its 2022 takeover of Vesper Medical. The company paid 227 million euros upfront for Vesper to expand its image guided therapy business. Dive Insight The Duo Venous Stent System is a portfolio of self-expanding stents mounted on disposable delivery devices. Vesper designed the stents to increase the diameter of obstructed veins. Restoring blood flow could improve quality of life by alleviating symptoms of venous disease, which include pain, swelling and discoloration of skin. Philips tracked improvements on observational quality-of-life endpoints in a trial of the device. Using data from ...
- Source: drugdu
- 126
- June 17, 2024
New insights into physical activity adoption for rheumatic patients

An HPR abstract sessions at the 2024 EULAR congress looked specifically at harnessing the benefits of exercise in rheumatic and musculoskeletal diseases (RMD) – and the challenges to their practical implementation. Mohamed Saadi presented a systematic review examining barriers and facilitators affecting adherence to EULAR’s physical activity recommendations. Across 68 selected articles, 29 different themes were identified – 9 of which were social, 16 environmental, and 4 systemic. The five most frequently found themes were having supportive family and friends, a supportive health professional, followed by costs, and access or proximity to adapted and supervised programs. Importantly, there may be country-level differences in these three key factors. Social considerations include the level of support available, as well as whether people feel social pressure or body shaming, and if they have social physical activity built into their everyday lives – such as walking a dog or playing with children. Systemic differences ...
- Source: drugdu
- 149
- June 17, 2024
Barinthus Bio slashes headcount by 25% and refocuses pipeline

Much like the mythological navigator from which it takes its name, Barinthus Biotherapeutics is steering a new course of pipeline prioritisation and restructuring by shelving its prostate cancer candidate and a major workforce reduction. The UK-based T cell specialist – formerly known as Vaccitech – said it will prioritise its pipeline to focus on two of its immunotherapy candidates, VTP-300 and VTP-1000, in chronic hepatitis B and coeliac disease indications respectively. Shares in the Nasdaq-listed Barinthus opened 4.7% lower when the market opened on 13 June following the company announcement on 12 June. Barinthus’ market cap is $73m. As part of the pipeline shuffle, the biopharma said that it expects to undergo a restructuring which will include reducing its employee number by around a quarter. The company currently has a headcount of around 130 employees, according to GlobalData. Barinthus also plans to extend its cash runway into Q2 of 2026, ...
- Source: drugdu
- 95
- June 17, 2024
Flagship Pioneering and ProFound link for obesity therapies

Flagship Pioneering and ProFound Therapeutics have entered a partnership to develop new therapeutics for the treatment of obesity. The collaboration marks the first initiative executed under Flagship’s Pioneering Medicines deal with Pfizer announced in July 2023. Pioneering Medicines is the in-house drug discovery and development unit of Flagship and will spearhead the partnership’s efforts with Pfizer. ProFound’s ProFoundry Platform will be deployed with Pioneering Medicines’ capabilities in drug development to discover new proteins and assess their therapeutic potential to treat obesity. ProFound Therapeutics CEO and Flagship Pioneering CEO-partner John Lepore stated: “We are thrilled to be part of the Flagship and Pfizer partnership and to collaborate with Pioneering Medicines to discover and validate novel proteins that have the potential to lead to innovative, first-in-class medicines for patients with obesity. “Through our ProFoundry Platform, we have discovered and validated an extensive library of novel proteins that unlock a new universe of ...
- Source: drugdu
- 127
- June 17, 2024
WuXi Biologics Named to MSCI ESG Leaders Indexes for Second Consecutive Year

Shanghai, June 14, 2024, WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced it has been named to the 2024 MSCI ESG Leaders Indexes. This marks the second consecutive year the company has been included in the indexes for its outstanding sustainability performance. MSCI, a leading investment research firm, provides stock indexes and portfolio performance analytics to institutional investors. Its ESG Leaders Indexes are designed to represent the performance of companies with high ESG ratings relative to their sector peers. The index suite utilizes MSCI’s award-winning ESG Research and ESG Ratings to identify companies that have demonstrated an ability to manage their ESG risks and opportunities and are therefore eligible for inclusion. In 2023, WuXi Biologics received an AAA rating from MSCI for outstanding performance in Key Issues of Climate Change, Corporate Governance, Talent Development, and Product Safety & Quality, on its rating ...
- Source: drugdu
- 118
- June 17, 2024
AbbVie and Future Gen Biopharm Announce License Agreement to Co-Develop Next Generation Inflammatory Bowel Disease Therapies

On June 13, 2010, AbbVie and Future Gen Biopharm announced the signing of a license agreement to co-develop FG-M701, a next-generation TL1A antibody in preclinical development for the treatment of inflammatory bowel disease (IBD). FG-M701 is a fully human monoclonal antibody targeting TL1A, a clinically validated target for inflammatory bowel disease. Uniquely engineered to have potentially best-in-class functional properties compared to first-generation TL1A antibodies, FG-M701 is designed to provide improved efficacy and reduced dosing frequency in the treatment of inflammatory bowel disease. Dr. Jonathon Sedgwick, Senior Vice President and Global Head of Discovery Research at AbbVie, said that the prevalence of inflammatory bowel disease continues to rise, and many people with ulcerative colitis and Crohn’s disease do not respond to current therapies. AbbVie’s mission is to raise the standard of care by pursuing transformative therapies to help more patients with autoimmune diseases achieve remission. We look forward to working with ...
- Source: drugdu
- 114
- June 17, 2024
Sridhar Babu inaugurates Innovera’s new site in New Jersey

Minister Sridhar Babu inaugurated Innovera Pharma’s latest site in New Jersey, USA, during his recent visit. The new facility is expected to expand Innovera Pharma’s research, development, and production capabilities. The roots of this collaboration were established during a key meeting at the World Economic Forum (WEF) in Davos, Switzerland wherein Telangana CM Revanth Reddy and Sridhar Babu led a delegation earlier this year. These discussions paved the way for the company to invest in Telangana. Solidifying this partnership, within 30 days of the announcement, a ceremony was held on February 22, 2024, in Suryapet, Telangana. This event marked the commencement of a project aimed at enhancing local manufacturing capabilities and infrastructure. The partnership highlights how regional governments can support enterprises in scaling their operations globally. By fostering such alliances, this active partnership not only strengthens Innovera’s global presence but also reinforces Telangana’s strides to develop the pharmaceutical and biotechnology ...
- Source: drugdu
- 126
- June 15, 2024
Pfizer investigational gene therapy for DMD fails in Phase 3 study

Pfizer announced that CIFFREO, a Phase 3 global, multicentre, randomised, double-blind, placebo-controlled study evaluating the investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD) did not meet its primary endpoint of improvement in motor function among boys 4 to 7 years of age treated with the gene therapy compared to placebo. The primary endpoint in the final analysis was assessed by change in the North Star Ambulatory Assessment (NSAA) a year after treatment. Key secondary endpoints, including 10-metre run/walk velocity and time to rise from floor velocity, also did not show a significant difference between participants treated with fordadistrogene movaparvovec and placebo. The overall safety profile of fordadistrogene movaparvovec in the CIFFREO trial was manageable, with mostly mild to moderate adverse events, and treatment-related serious adverse events generally responding to clinical management. Pfizer will continue to closely monitor all participants enrolled in the study and ...
- Source: drugdu
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- June 15, 2024
drugdu

The amyotrophic lateral sclerosis (ALS) market across the 8MM (8MM: the US, France, Germany, Italy, Spain, the UK, Japan, and Canada) is projected to grow at a compound annual growth rate (CAGR) of 15 per cent from $317 million in 2019 to $1.28 billion in 2029, forecasts drugdu. The key opinion leaders (KOLs) interviewed by drugdu identified the greatest unmet needs within the ALS space. These entail earlier diagnosis, disease-modifying therapies (DMTs), identification of biomarkers, and efficacious first-line treatment options. However, the consensus amongst them is that the need to diagnose ALS early and the development of DMTs is imperative for any change to take place within the treatment space. Momna Ali, Healthcare Analyst at drugdu, comments, “Due to the variety in the presentation of ALS development and symptoms, there have been historical difficulties in diagnosing patients in a timely manner. Pharmaceutical companies have an opportunity to educate physicians both ...
- Source: drugdu
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- June 15, 2024

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