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【EXPERT Q&A】What are the requirements for clinical evaluation of medical devices under the EU MDR ?

Drugdu.com expert’s response: The EU Medical Device Regulation (MDR) aims to ensure the safety and efficacy of medical devices through its requirements for clinical evaluation. The specific requirements are as follows: I. Clinical Evaluation Plan Purpose and Scope: The clinical evaluation plan should clearly outline the objectives, scope, methods, and timeline of the evaluation, taking into account the intended use, risks, and expected clinical outcomes of the medical device. Clinical Data Collection and Analysis: It should describe how clinical data related to the medical device will be collected, analyzed, and evaluated, including the selection of patient populations, data collection methods and time points, and statistical methods for data analysis. Design and Management of Clinical Trials: If clinical trials are required, the plan should detail the design and management of the trials, including participant selection criteria, trial arrangements, duration, supervision, and management. Reporting of Clinical Evaluation Results: It should specify how ...
- Source: drugdu
- 146
- October 6, 2025
Dongcheng Pharmaceutical’s subsidiary’s new prostate cancer drug approved for clinical trials

Dongcheng Pharmaceutical recently announced that its controlling subsidiary, Lannacheng, has received approval from the National Medical Products Administration (NMPA) for the clinical trial of 225Ac-LNC1011 injection, authorizing it to conduct clinical trials for prostate cancer. This drug, an alpha-particle radioactive in vivo therapeutic targeting prostate-specific membrane antigen (PSMA), is intended for the treatment of patients with advanced prostate cancer who are PSMA-positive. Currently, no similar product is marketed outside of China , and no sales data is available. The project has invested approximately 14.53 million yuan in R&D. In completed animal and human trials, 225Ac-LNC1011 injection has demonstrated therapeutic potential for prostate cancer. However, the drug development cycle, clinical trial approval, and production are long and involve many steps. Investors need to be aware of the risk of drug development failure.
- Source: https://www.stcn.com/article/detail/3353547.html
- 143
- October 5, 2025
Rectal bleeding increases the odds of colorectal cancer diagnosis by 8.5 times

Adults under 50 undergoing colonoscopy were found to have a dramatically higher risk of having colorectal cancer when the procedure was done for rectal bleeding. Researchers found that rectal bleeding increased the odds of a colorectal cancer diagnosis by 8.5 times, underscoring the need to take the symptom seriously even in the absence of a family history in a population who may not otherwise meet screening age criteria. The research will be presented at the American College of Surgeons (ACS) Clinical Congress 2025 in Chicago, October 4-7. The retrospective study analyzed 443 patients under 50 who underwent a colonoscopy at the University of Louisville Health System between 2021 and 2023. Of them, 195 (44%) were diagnosed with early-onset colorectal cancer, while 248 (56%) had normal results. “Many of the early-onset colorectal cancers that I see have no family history. This research lends support to the question of ...
- Source: drugdu
- 136
- October 5, 2025
FDA Announces New Domestic Generic Drug Fast-Track Review Program

FDA announced a new pilot program designed to provide faster reviews for domestically tested and manufactured generic drugs. The program is part of a larger initiative to promote and reward domestic investments by pharmaceutical companies. The abbreviated new drug applications (ANDAs) are meant to strengthen the domestic pharmaceutical supply chain while also helping to get less expensive drugs to market sooner. In a press release, director of FDA’s Center for Drug Evaluation and Research Dr. George Tidmarsh, MD, PhD, said, “Ensuring that Americans have access to high-quality, safe and effective generic medicines is critical to public health. Overreliance on foreign drug manufacturing and testing creates risks both to national security and patient access, and undermines investments in U.S. research, manufacturing and production. It also slows down reviews and costs taxpayers more money, as these foreign research and testing sites must be inspected by FDA, and foreign inspections take ...
- Source: drugdu
- 156
- October 5, 2025
World’s first vaccine trial against elephant endotheliotropic herpesvirus proves safe and effective

The world’s first vaccine trial against elephant endotheliotropic herpesvirus (EEHV) – a leading cause of death in young Asian elephants – is safe and triggers a strong virus-fighting immune response, according to an international team led by the University of Surrey, in collaboration with Chester Zoo and the Animal and Plant Health Agency. Published in Nature Communications, the proof‑of‑concept study involved adult elephants at Chester Zoo. No side effects were seen, and the vaccine successfully activated a key part of the immune system that helps fight viruses. The results suggest the vaccine could prevent deadly EEHV disease in calves – the group most at risk – and support conservation breeding programmes worldwide. Professor Falko Steinbach, senior author of the study and Professor of Veterinary Immunology at the University of Surrey, said: “This is a landmark moment in our work to develop safe and efficacious vaccines. For the first time, we have ...
- Source: Medical News
- 147
- October 4, 2025
FDA Signs Off on New Version of Abortion Pill Mifepristone

A new low-cost version of the abortion pill mifepristone just received federal approval and it’s already stirring political controversy. The U.S. Food and Drug Administration (FDA) recently granted approval to Evita Solutions for its generic version of mifepristone, a medication used to end early pregnancies up to 10 weeks. The original version of mifepristone has been available in the U.S. for 25 years and is commonly prescribed alongside another medication, misoprostol, to complete a medication abortion. Evita “believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care,” the company said. While the approval process for generic drugs is usually routine, this decision quickly caused backlash from anti-abortion groups, The Associated Press reported. Students for Life Action called the approval “a stain on the Trump presidency and another sign that the deep state at the FDA must go.” Meanwhile, Republican ...
- Source: Healthday
- 157
- October 4, 2025
Kangtai Biological and AstraZeneca terminate cooperation on adenovirus vector COVID-19 vaccine

On September 30, Kangtai Biological(300601) issued an announcement that the company signed a license termination agreement with AstraZeneca UK Limited (AstraZeneca) to terminate the cooperation in the research and development, production and commercialization of ChAdOx1 adenovirus vector new crown vaccine. The termination of the cooperation on the licensed product and the signing of the termination agreement are prudent decisions made by the company after comprehensive assessment of factors such as the prevalent strains of the new coronavirus vaccine and the significant changes in the market environment, as well as its own resource allocation. The company mentioned that in the future it will concentrate its superior resources to focus on the research and development and industrialization of multi-component and multivalent vaccines, adult vaccines, innovative vaccines, and therapeutic vaccines, continue to deepen its roots in the vaccine field, and enhance its core competitiveness. By mid-2025, CanSino Biologics achieved revenue of 1.392 billion yuan and net ...
- Source: drugdu
- 142
- October 3, 2025
CanSino accelerates global deployment of dual vaccines

The reporter recently learned from CanSinoIt is learned that on September 29, CanSino’s independently developed 13-valent pneumococcal polysaccharide conjugate vaccine PCV13i and Asia’s first quadrivalent meningococcal polysaccharide conjugate vaccine MCV4 were shipped to the domestic and overseas markets respectively. CanSino Biologics’ independently developed 13-valent pneumococcal polysaccharide conjugate vaccine, Upexin®, was officially approved by the National Medical Products Administration in June of this year. It is China’s first pneumococcal polysaccharide conjugate vaccine to utilize a dual vector consisting of an avirulent mutant of diphtheria toxin (CRM197) and tetanus toxoid (TT). This vaccine provides enhanced protection against the four serotypes (19F, 19A, 7F, and 3) that carry the heaviest burden of pneumococcal disease in children in China. It is reported that by 2026, Upexin® will expand its reach into the domestic market, with overseas expansion also in the works. When Youpexin® was shipped domestically, Asia’s first ACYW135 group meningococcal polysaccharide conjugate vaccine (CRM197 vector) Manhaixin® also ...
- Source: drugdu
- 148
- October 3, 2025
Lencaneluzumab biosimilar approved for clinical trials for the treatment of Alzheimer’s disease

Sinopharm announced that its subsidiary, Jushi Biopharmaceuticals Co., Ltd., of CSPC Pharmaceutical Group, has received the “Notice of Approval for Clinical Trial of Lencanelumab Injection” from the National Medical Products Administration (NMPA). Clinical trials of the drug will commence soon. Lencanelumab Injection is a recombinant anti-human amyloid-β monoclonal antibody and a biosimilar to Leyibao, indicated for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer’s disease. The product approved for clinical trials by Sinopharm is the first biosimilar to lencanelumab injection to obtain clinical approval in China . Currently, there are only a handful of new Alzheimer’s disease drugs on the market, such as Lencaneluzumab and Donezetimumab, all developed by multinational pharmaceutical companies and relatively expensive. The clinical approval of domestically produced biosimilars suggests the potential for improved patient accessibility and reduced financial burdens in the future. Source: https://cj.sina.cn/articles/view/5953189932/162d6782c06703893e?froms=ggmp
- Source: drugdu
- 79
- October 3, 2025
New molecular sensor for taste-based detection of influenza

Flu season is fast approaching in the northern hemisphere. And a taste-based influenza test could someday have you swapping nasal swabs for chewing gum. A new molecular sensor has been designed to release a thyme flavor when it encounters the influenza virus. Researchers reporting in ACS Central Science say that they plan to incorporate this type of low-tech sensor into gum or lozenges to increase at-home screenings and potentially prevent pre-symptomatic transmission of the disease. Staying home is critical to preventing the spread of infectious diseases like influenza; however, people with the flu are contagious before they develop symptoms. Current flu diagnostics like nasal swab-based PCR tests are accurate, but they are slow and expensive. At-home lateral flow tests, akin to those used to test for COVID-19, are convenient and generally low-cost, but don’t catch pre-symptomatic infections. As written in their published study, Lorenz Meinel and colleagues address these flu ...
- Source: drugdu
- 77
- October 3, 2025

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