media – Page 43 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】The Critical Necessity of Usability Engineering Reports for Medical Devices

Drugdu.com expert’s response: The usability engineering report for medical devices holds immense significance as it serves as a pivotal element in ensuring product safety, efficacy, compliance, and market competitiveness. The following analysis unfolds across four key dimensions: regulatory requirements, product risk control, user experience optimization, and enhancement of market competitiveness. I. Regulatory Mandates: The “Passport” to Compliance International Regulatory Framework FDA (United States): Mandates that medical device design adheres to the “human-computer interaction safety principle.” 21 CFR Part 820 explicitly stipulates the necessity of usability testing to validate design rationality, with non-compliance potentially leading to product recalls or market access hindrances. EU MDR (European Union): Incorporates “usability engineering” into the General Safety and Performance Requirements (GSPR), requiring manufacturers to furnish documentation on user interface design, risk analysis, and user testing as essential materials for CE certification. ISO 14971: This international risk management standard explicitly mandates the inclusion of “use errors” ...
- Source: drugdu
- 80
- September 5, 2025
Daily probiotic reduces pouchitis risk after colon removal surgery but may not be cost-effective

A new UCLA Health study found that taking an 8-strain probiotic daily may reduce the risk of pouchitis, a common inflammatory condition that occurs after colon removal surgery for ulcerative colitis, but the treatment may not be worth the cost depending on a patient’s likelihood of flare-ups. The study, published in the journal Gastro Hep Advances, is the first to evaluate the cost-effectiveness of the probiotic treatment, which was shown in previous studies to be effective at preventing the initial onset of and the reoccurrence of pouchitis. The UCLA study affirmed that the probiotic formulation was effective at preventing pouchitis compared to patients taking no probiotics but found that the cost to third-party payers may outweigh those benefits in most cases unless the cost of the probiotic formulation is lowered. Our findings highlight that while probiotic treatments can reduce the risk of this complication, their high costs limit their overall ...
- Source: drugdu
- 101
- September 4, 2025
Wegovy Linked To Lower Heart Risks Than Similar Drugs, Study Shows

WEDNESDAY, Sept. 3, 2025 (HealthDay News) — The weight-loss drug Wegovy may lower the risk of heart attack, stroke or death more than similar medications, according to new research from its maker, Novo Nordisk. In a study of more than 21,000 patients with obesity and heart disease but no diabetes, those taking Wegovy — which contains the active ingredient semaglutide — saw a 57% greater reduction in heart-related risks compared to people taking tirzepatide, the ingredient in Eli Lilly’s weight-loss drugs Mounjaro and Zepbound. The findings were presented at a medical conference and have not yet been peer-reviewed or published. As such, they should be regarded as preliminary. “This data confirms that semaglutide stands apart as the only available GLP-1-based medication with proven cardiovascular benefits for people living with obesity and cardiovascular disease, without diabetes,” Ludovic Helfgott, Novo Nordisk’s head of product and portfolio strategy, said in a news release. ...
- Source: drugdu
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- September 4, 2025
OPM plans to acquire 100% of Pengli Biopharmaceuticals and lowers its private placement to 362 million yuan.

An announcement was issued on September 4, stating that the company plans to purchase 100% of the equity of Pengli Biotechnology (Shanghai) Co., Ltd. (hereinafter referred to as “Pengli Biotechnology” or “the target company”) through the issuance of shares and payment of cash, and to issue shares to no more than 35 specific investors to raise matching funds. The company previously received an audit inquiry letter from the Shanghai Stock Exchange and has completed its response to the relevant questions. The company’s independent financial advisor, accounting firm, law firm, and appraisal agency have reviewed the relevant matters in the audit inquiry letter and issued clear opinions. They have also revised the relevant documents and materials previously released by the company. The company has reviewed and self-examined the entire text of the “Restructuring Report” (revised draft), and has made minor additions to the text, which have no impact on the transaction ...
- Source: drugdu
- 122
- September 4, 2025
Fukang Pharmaceuticals files for Hong Kong IPO

Recently, Fukang Pharmaceutical officially submitted an application for listing on the main board of the Hong Kong Stock Exchange, marking a key step towards the capital market. Founded in 2015, Fukang Pharmaceuticals is a clinical-stage, global, and China-based company dedicated to developing innovative medicines for oncology, viral diseases, and aging-related diseases. Fukang’s core team primarily hails from leading domestic and international pharmaceutical companies such as Novartis and Huahai Pharmaceuticals, and the company collaborates with renowned research institutes both domestically and internationally, including the Shanghai Institute of Materia Medica, Chinese Academy of Sciences. According to its prospectus, Fukang Pharmaceutical has established a diversified product portfolio consisting of one commercialized product, two core products, two key products, and 12 other drug candidates under development. Of these 16 drug candidates, five are in Phase I/II clinical development, seven are in preclinical development, and four are generic drug candidates. Its pipeline focuses primarily on ...
- Source: drugdu
- 125
- September 4, 2025
Sales of herpes zoster vaccines suffered a setback, with Beike Bio turning from profit to loss in the first half of this year.

Beike BioRecently, the company disclosed its 2025 semi-annual report. During the reporting period, the company achieved revenue of only RMB 285 million, a year-on-year decline of 53.93%; the net profit attributable to the parent company was RMB -73.5734 million, a sharp year-on-year decline of 153.47%. The main reason affecting the performance was that the sales of herpes zoster vaccine fell short of expectations. Since 2024, Beike Bio’s performance has declined sharply, and in the first half of this year, it turned from profit to loss. With the sales of core products falling short of expectations, the nasal spray flu vaccineThe live attenuated vaccine (liquid preparation) was approved for marketing in the first half of this year. With the advancement of the commercialization of the new product, can it boost Beike Bio’s performance in the second half of the year? Core product sales suffered setbacks Beike Bio’s revenue mainly depends on ...
- Source: drugdu
- 322
- September 4, 2025
Zhonghui Bio’s quadrivalent influenza virus subunit vaccine marketing application approved

On September 3, Zhonghui Bio announced that the National Medical Products Administration has approved the company’s quadrivalent influenza vaccine　　for people aged 6-35 months.The new drug application for the influenza virus subunit vaccine was filed. The announcement shows that this vaccine has become the first and only full-dose quadrivalent influenza virus subunit vaccine approved for marketing in China. https://finance.eastmoney.com/a/202509033503778045.html
- Source: drugdu
- 214
- September 4, 2025
The Central and Western China Medical Equipment Exhibition (CWMEE)

Organiser: Anhui Medical-Engineering Collaborative Innovation Society, Anhui Health Service Industry Association Time：March 20-22, 2026 address：No. 3899 Jinxiu Avenue, Hefei City Exhibition hall：Hefei Binhu International Convention and Exhibition Center Product range: Medical Imaging Equipment: 5G+ intelligent imaging products AI-assisted diagnostics Radiology equipment Magnetic resonance imaging (MRI) devices Nuclear medicine equipment Ultrasound imaging devices Molecular imaging Medical optical equipment Interventional products, etc. In Vitro Diagnostic Equipment and Reagents: Clinical diagnostic equipment Diagnostic reagents Point-of-care testing (POCT) Biochemical analyzers Immunological analyzers Bacterial analyzers Urine analyzers Blood analyzers Hemodialysis machines Genetic testing, molecular testing, viral testing Blood transfusion equipment and various test reagents Medical Electronic Equipment: Cardiac, cerebral, and electromyographic diagnostic devices Functional examination equipment Pathological diagnostic equipment Endoscopic examination equipment Respiratory function and gas analysis devices Monitoring instruments Laser equipment Emergency equipment Anesthesia and analgesia equipment, etc. Operating Room and Emergency Equipment: Surgical robots Integrated operating rooms Digital hybrid operating rooms 5G+ ...
- Source: drugdu
- 232
- September 4, 2025
【EXPERT Q&A】What is the outlook for medical CDMO?

Drugdu.com expert’s response: The medical Contract Development and Manufacturing Organization (CDMO) industry boasts a broad prospect and is now at a critical juncture of transitioning from “scale expansion” to “value creation”. Technological innovation, green production, and global layout will be the keys for enterprises to break through. The specific analysis is as follows: I. Demand Side: Expansion of Global Pharmaceutical R&D Pipelines and Growth Driven by Emerging Therapies Continuous Growth of Global R&D Pipelines In 2025, the number of global pharmaceutical R&D pipelines will surpass 25,800, representing a year-on-year increase of 4.6%, with biologics accounting for over 60%. This trend directly drives the recovery of CDMO demand, particularly for small-molecule CDMOs (which are returning to growth after shaking off the high base effect of COVID-19 orders) and peptide CDMOs (which have become one of the fastest-growing sectors due to the explosion of the GLP-1-based antidiabetic drug market). Emerging Therapies Reshaping ...
- Source: drugdu
- 192
- September 3, 2025
Revascularization strategy fails to show noninferiority in STEMI patients

Noninferiority was not demonstrated between immediate and staged complete revascularisation in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease undergoing percutaneous coronary intervention (PCI), according to late-breaking research presented in a Hot Line session today at ESC Congress 20251. Multivessel coronary artery disease – when at least two coronary arteries are blocked – affects almost half of patients who have STEMI, a type of heart attack. ESC Guidelines recommend complete revascularisation with PCI in patients with STEMI and multivessel disease, involving treating the blocked artery that caused the heart attack (culprit lesion) plus other affected vessels (non-culprit lesions).2 Explaining the aim of the OPTION-STEMI trial, its Principal Investigator, Professor Youngkeun Ahn from Chonnam National University Hospital, Gwangju, South Korea, stated, “We compared immediate complete revascularisation with PCI for the culprit and non-culprit lesions during the same procedure with staged complete revascularisation, where PCI for non-culprit lesions took place ...
- Source: drugdu
- 124
- September 2, 2025

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