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【EXPERT Q&A】How can the safety of subjects be guaranteed in drug clinical trials?

Drugdu.com expert’s response: Drug clinical trials are a critical step in evaluating the safety and efficacy of new drugs, with ensuring the safety of trial participants being the foremost principle. To safeguard participant safety, drug clinical trials have established a comprehensive safety assurance system through stringent regulatory oversight, scientifically rigorous design, thorough risk assessment and management, multi-layered protective measures, and continuous ethical review and supervision. The following elaborates on these aspects in detail: 1. Stringent Regulatory and Ethical Requirements Adherence to International Norms: Drug clinical trials must comply with internationally recognized ethical guidelines, such as the Declaration of Helsinki and the Belmont Report, which emphasize principles such as participant protection, informed consent, and risk minimization. Compliance with Domestic Regulations: In China, drug clinical trials must adhere to relevant laws and regulations, including the Good Clinical Practice (GCP) guidelines and the Drug Administration Law. These regulations impose explicit requirements on all ...
- Source: drugdu
- 49
- February 13, 2026
The first patient in the Phase IB/II trial of Verizon’s triple-negative breast cancer was successfully treated.

On February 10, Veolizhibo (09887) announced that the company is pleased to announce that Veolizhibo (PD-L1/4-1BB bispecific antibody opatidisulfimab, LBL-024) has been successfully administered to the first patient in the Phase IB/II trial of recurrent or metastatic triple-negative breast cancer. This trial, led by Professor Yin Yongmei of Jiangsu Provincial People’s Hospital, aims to evaluate the efficacy and safety of opatitumumab alone or in combination with albumin-bound paclitaxel. Verlisin is a bispecific antibody that simultaneously targets PD-L1 and 4-1BB, possessing broad-spectrum cancer treatment potential. In two clinical trials in China, this drug demonstrated promising efficacy and safety in patients with advanced extrapulmonary neuroendocrine carcinoma, whether used as monotherapy or in combination with chemotherapy. In addition, the company received approval from the National Medical Products Administration to conduct a single-arm registration clinical trial in April 2024, obtained Breakthrough Therapy Designation for the treatment of late-line advanced extrapulmonary neuroendocrine carcinoma in October ...
- Source: drugdu
- 60
- February 12, 2026
Watson Bio’s live attenuated varicella vaccine clinical trial approved

Beijing Business Daily , February 10th – Watson BiotechnologyThe company announced that its varicella attenuated live vaccine, jointly developed and applied for clinical trials by the company and its subsidiaries Yunnan Vaccine Laboratory Co., Ltd., Beijing Watson Innovation Biotechnology Co., Ltd., and Yuxi Watson Biotechnology Co., Ltd., recently received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, agreeing to conduct clinical trials for the prevention of varicella. The announcement indicates that the vaccine is a live attenuated vaccine produced by inoculating human diploid cells with an attenuated strain of varicella-zoster virus and then freeze-drying it. After vaccination, it stimulates the body to produce immunity against the varicella-zoster virus, thus preventing chickenpox. Currently, six companies in China have received marketing authorization for their live attenuated varicella vaccines. https://finance.eastmoney.com/a/202602103646820558.html
- Source: drugdu
- 53
- February 12, 2026
The first subject has been dosed in the Phase II clinical trial of its innovative small nucleic acid drug EDP167.

On February 9, Yiteng Jiahe (06998) issued an announcement, announcing that its innovative small nucleic acid drug…The first subject was successfully dosed in the Phase II clinical trial of EDP167. This trial is aimed at adult patients with homozygous familial hypercholesterolemia (HoFH) and aims to evaluate the efficacy and safety of EDP167 in HoFH patients. The primary endpoint is the change in low-density lipoprotein cholesterol (LDL-C) levels from baseline 24 weeks after the first dose. The evaluation of the primary endpoint is expected to be completed in the fourth quarter of 2026. EDP167 is an innovative siRNA therapy specifically designed to treat dyslipidemia. Its mechanism of action is independent of the LDL receptor pathway, overcoming the limitations of traditional lipid-lowering drugs. Prior to initiating a Phase II clinical trial for HoFH patients, the company completed a Phase I clinical study in healthy individuals and those with mild dyslipidemia. Results showed ...
- Source: drugdu
- 50
- February 12, 2026
Novo Nordisk’s oral weight-loss drug advertisement has been flagged by the FDA for allegedly misleading advertising.

According to the U.S. Food and Drug Administration (FDA), Danish pharmaceutical company Novo Nordisk…For oral weight loss drugsA television advertisement was found to contain “false or misleading” claims. Novo Nordisk is the manufacturer of semaglutide, a drug that is also produced by Eli Lilly.Tirzepatide is a GLP-1 weight loss drug . In January of this year, the oral version of semaglutide was approved for marketing in the United States, becoming the world’s first oral GLP-1 inhibitor for the treatment of obesity. Novo Nordisk stated last week that more than 170,000 patients in the United States are currently using the drug. However, in a letter to Novo Nordisk on February 5, the FDA stated that Novo Nordisk’s advertising for the drug constituted “misbranding,” and therefore its dissemination of the information violated federal law. In its letter, the FDA stated that Novo Nordisk’s advertising was misleading, suggesting that its oral medication was ...
- Source: drugdu
- 51
- February 12, 2026
Visipine®, the first and only oral S1P receptor modulator for ulcerative colitis in my country, has been approved, ushering in a new era of “deep healing”.

On February 6, 2026, the National Medical Products Administration (NMPA) of China officially approved Velisipity® (arginine eltromod tablets) for marketing, for the treatment of adult patients with moderate to severe active ulcerative colitis (UC) who have an inadequate response, loss of response, or intolerance to conventional therapies or biologics. This drug fills a significant gap in the treatment of moderate to severe ulcerative colitis and provides a new option for innovative oral treatments targeting deep mucosal healing. As a new generation of highly selective S1P receptor modulators, Visiprine® is taken orally once daily, enabling rapid onset of action and potent deep mucosal healing, while also possessing good safety profiles. It has the potential to be the best-in-disease and provides a new first-line treatment option for adult patients with ulcerative colitis. The incidence of UC is rising and showing a trend towards affecting younger people. Mucosal healing has a low clinical ...
- Source: drugdu
- 52
- February 12, 2026
Multi-dimensional Breakthroughs in Policy, Rules, and Pricing

As the final year of the 14th Five-Year Plan, 2025’s successful completion of its goals and tasks not only lays a solid foundation for a good start to the 15th Five-Year Plan period but also demonstrates the significant achievements the country has made in the coordinated development and governance of the three medical systems (medical services, pharmaceuticals, and healthcare). Focusing on the area of centralized drug procurement, the core strategy for 2025 is to lay out plans around several dimensions, including the standardization and improvement of centralized procurement policies and the listing and withdrawal mechanisms, and the comprehensive monitoring and governance of pharmaceutical prices and procurement credit. 01 Centralized Procurement Policy In March 2025, the “Draft Plan for Further Optimizing Centralized Drug Procurement Policies (for Public Comment)” circulated within the healthcare industry and caused a stir. In May 2025, a second draft of the same plan circulated again. A comparison ...
- Source: drugdu
- 45
- February 12, 2026
Meditex Bangladesh

Organiser：CEMS-Global Time：May 7 – 9, 2026 Address：Agargaon, Sher-E-Bangla Nagar, Dhaka – 1207, Bangladesh Exhibition hall： Bangabandhu International Conference Center Product range: Hospital medical equipment, apparatus, disposable consumables, surgical equipment and accessories, surgical equipment, physiotherapy equipment, orthopedic equipment, plastic surgery equipment, prosthetic materials, restorative materials, medical and healthcare apparatus, electronic medical equipment, medical technology, testing and diagnostic equipment, therapeutic equipment, dental equipment and supplies, laboratory equipment, professional medical uniforms, first-aid equipment, hospital supplies, hospital furniture, communication equipment, control and automation systems, medical service providers and related services, technologies, and equipment, pharmaceuticals, prescription drugs, herbal preparations, nutritional health products such as supplementary minerals and vitamins, and dietary nutritional products, etc. About Meditex Bangladesh ： The Dhaka Medical Equipment Exhibition in Bangladesh is the highest-caliber exhibition for medical equipment and supplies in the country. Numerous exhibitors showcase a wide variety of medical devices, enabling them to conduct business or stay informed about the latest ...
- Source: drugdu
- 49
- February 12, 2026
【EXPERT Q&A】What important regulations and requirements should be mastered for the medical device equivalence certificate of the EU MDRCE?

Drugdu.com expert’s response: Under the framework of the EU Medical Device Regulation (MDR), the demonstration of equivalence for medical devices is a crucial step in assessing the similarity between a new product and a marketed product in terms of technical, biological, and clinical characteristics. This directly determines whether the new product can enter the EU market in compliance with regulations. Below are the key provisions and requirements that need to be mastered for demonstrating equivalence: I. Technical Characteristics Requirements Similar Usage Conditions: The device under evaluation and the presumed equivalent device must be used under similar conditions, meaning there should be no significant clinical differences in their safety and clinical performance. This implies that in real-world medical scenarios, both devices should exhibit similar levels of patient protection and stability in treatment outcomes. Similar Software Algorithms: For medical devices incorporating software algorithms, the functional principles, clinical performance, and intended purposes of ...
- Source: drugdu
- 47
- February 11, 2026
The first subject has been dosed in the Phase I clinical trial of Yuandong Bio’s EP-0210 monoclonal antibody injection.

On the evening of February 9, Yuandong Bio issued an announcement stating that its wholly-owned subsidiary, Chengdu Youluo Biotechnology Co., Ltd., is conducting a Phase I clinical trial of its independently developed Class 1 biological drug EP-0210 monoclonal antibody injection for the treatment of inflammatory bowel disease, and recently completed the dosing of the first subject. The announcement shows that EP-0210 monoclonal antibody injection is a humanized IgG1 monoclonal antibody drug that targets human tumor necrosis factor-like ligand 1A (TL1A). Its proposed indication is inflammatory bowel disease. Its mechanism of action is to bind to human TL1A efficiently and block the TL1A-mediated pro-inflammatory signaling pathway, thereby playing a role in the treatment of inflammatory bowel disease. Yuandong Bio stated that TL1A antibody drug development is one of the most promising emerging targets in the field of inflammatory bowel disease research, and currently there are no drugs targeting the same target ...
- Source: drugdu
- 63
- February 10, 2026

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