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【EXPERT Q&A】What processes do medical devices need to go through before they can be produced?

Drugdu.com expert’s response: Key Processes for Medical Devices from R&D to Production Medical devices must undergo several critical processes, including infrastructure establishment, quality management system (QMS) development, product design and development, registration testing, clinical evaluation, product registration application, on-site QMS verification, production license application, and market launch. The specifics are as follows: Infrastructure Establishment Business Registration: Determine the business scope based on corporate development plans and product positioning, then complete registration under the current registered capital subscription system and the “three-in-one” registration system (merging business licenses, organization code certificates, and tax registration certificates). Hardware Preparation: Construct facilities compliant with the Medical Device Production Quality Management Standardsaccording to the category and process requirements of the intended medical devices. If the product requires a sterile environment, a qualified cleanroom must be built. Additionally, acquire production equipment and inspection instruments necessary for manufacturing and testing. If a company faces challenges in hardware investment or ...
- Source: drugdu
- 159
- October 13, 2025
Sanofi achieves a major victory in Phase II clinical trials, challenging its dominance as the “number one nuclear medicine company”!

Sanofi announced that its targeted alpha nuclide therapy AlphaMedix achieved all primary efficacy endpoints in the Phase II clinical trial ALPHAMEDIX-02, demonstrating significant clinically meaningful efficacy in patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This achievement not only further confirms the potential of targeted α therapy to provide precise treatment for GEP-NETs, but also marks Sanofi’s challenge to Novartis, the “No. 1 nuclear medicine company.” 01 New Force Alpha Nuclide AlphaMedix is a targeted alpha therapy based on lead-212. It consists of a peptide complex that binds to somatostatin receptors and is coupled to a radionuclide. It serves as an in vivo generator of alpha particles. Due to their high energy and short range, alpha particles can precisely kill cancer cells while minimizing damage to surrounding healthy tissue, presenting potential therapeutic advantages. AlphaMedix wasn’t developed independently by Sanofi, but rather a key move in rapidly expanding its nuclear medicine portfolio ...
- Source: drugdu
- 127
- October 11, 2025
Paclitaxel for Injection Obtains Marketing Authorization in Multiple Countries

　　Shanghai Securities News China SecuritiesNetxun Huiyu Pharmaceutical announced on the evening of the 9th that its subsidiary Seacross Pharma (Europe) Ltd. recently received marketing authorization for the company’s product paclitaxel for injection (albumin-bound) approved and issued by the Netherlands Medicines Evaluation Committee, the Irish Health Products Regulatory Authority, the Finnish Medicines Agency, and the Swedish Medicines Agency. 　　Paclitaxel (albumin-bound) for injection is primarily indicated as monotherapy for the treatment of adult patients with metastatic breast cancer whose disease has not improved after first-line treatment of metastatic disease and for whom standard anthracycline-containing regimens are not appropriate; in combination with gemcitabine, it is indicated for the first treatment of adult patients with metastatic pancreatic adenocarcinoma; and in combination with carboplatin, it is indicated for the initial treatment of adult patients with non-small cell lung cancer who are not suitable for potentially curative surgery or radiotherapy. 　　Huiyu Pharmaceuticals stated that following its ...
- Source: drugdu
- 99
- October 11, 2025
Sinovac’s quadrivalent influenza vaccine has been approved to cover people aged 6 months and above

　　Shanghai Securities News China SecuritiesNet News (Reporter Zhang Xue) The reporter learned from Sinovac Holdings on October 10 that recently, Beijing Sinovac BiotechQuadrivalent influenza virusThe National Medical Products Administration (NMPA) has approved an expanded age range for the Sinovac quadrivalent influenza vaccine, expanding its coverage to include individuals aged 6-35 months, in addition to those aged 3 years and above. With this expanded age range, the Sinovac quadrivalent influenza vaccine now covers all ages 6 months and older and is currently in use in nearly 20 countries and regions worldwide. 　　Infants and young children aged 6-35 months are at high risk for influenza- related complications. Flu vaccination is the most effective and economical way to prevent influenza and reduce the risk of complications. Furthermore, families are a key venue for influenza transmission. Studies have shown that 26% of influenza infections can be attributed to transmission within the family, and the ...
- Source: drugdu
- 144
- October 11, 2025
No more chemotherapy after gastric cancer surgery? Henlius’s successful clinical trial of Hans-like therapy is the world’s first

　　This newspaper (Reporter Jin Wanxia) reported on October 9 that Shanghai Fuhong Hanlin Biotech Co., Ltd. (hereinafter referred to as ” Fuhong Hanlin “) announced that the company’s Phase III clinical study of its self-developed innovative PD-1 inhibitor Hanseluzumab (slulizumab) combined with chemotherapy for neoadjuvant/monoadjuvant treatment of gastric cancer has met the pre-set superiority criteria and the treatment regimen has a good safety profile. This is the world’s first treatment regimen for gastric cancer in the perioperative (preoperative/postoperative) period to replace postoperative adjuvant chemotherapy with a single immunotherapy agent, achieving a major breakthrough in this field. 　　In light of these data, Henlius intends to advance its marketing authorization application for this indication. Dr. Zhu Jun, Executive Director and CEO of Henlius, stated, “Gastrointestinal cancer is a core area of focus for Henlius. We will actively promote the translation of our research findings to benefit patients as soon as possible, and ...
- Source: drugdu
- 91
- October 11, 2025
Multimodal nanocarriers offer targeted solutions for tumor treatment

Cancer remains a leading cause of global morbidity and mortality. Traditional therapies like chemotherapy and radiotherapy are often limited by their lack of specificity, leading to systemic toxicity and the emergence of drug resistance. Nanoparticles, with dimensions ranging from 1 to 100 nm, offer a sophisticated solution. Their unique physicochemical properties allow them to navigate biological barriers and can be engineered for active targeting (e.g., using ligands for overexpressed cancer cell receptors) or passive targeting (exploiting the Enhanced Permeability and Retention effect of tumor vasculature). The cellular uptake of these nanocarriers is a critical process, primarily occurring through various endocytic pathways such as clathrin-mediated, caveolin-mediated, and macropinocytosis, followed by crucial intracellular steps like endosomal or lysosomal escape to ensure the therapeutic cargo reaches its target intact. Nanocarriers in drug-delivery systems for cancer treatment A diverse arsenal of nanocarriers has been developed, each with distinct advantages and limitations. Liposomes, spherical phospholipid ...
- Source: drugdu
- 78
- October 11, 2025
Drug Combo Effective Against Advanced Prostate Cancer

By Dennis Thompson HealthDay ReporterFRIDAY, Oct. 10, 2025 (HealthDay News) — A new drug combo is offering hope for men with advanced prostate cancer. Adding the targeted cancer drug niraparib to hormone therapy reduced the risk of prostate tumor growth and slowed symptom advance, according to findings published Oct. 7 in the journal Nature Medicine. The combination was even more effective among men with genetic mutations driving their prostate cancer, researchers noted. “Although current standard treatments are very effective for the majority of patients with advanced prostate cancer, a small but very significant proportion of patients have limited benefit,” said lead researcher Dr. Gerhardt Attard, chair of medical oncology with the University College London Cancer Institute. “By combining with niraparib we can delay the cancer returning and hopefully significantly prolonging life expectancy,” he said in a news release. Niraparib is a “maintenance” drug approved to keep certain types of cancer ...
- Source: drugdu
- 75
- October 11, 2025
Scientists have developed a nano vaccine to prevent animal cancer, which can effectively inhibit the spread of cancer cells

According to a new research published in the journal Cell Reporting Medicine on the 10th, the team of the University of Massachusetts Amherst in the United States has developed a nano vaccine to prevent animal cancer, which has shown significant effects in preventing mouse melanoma, pancreatic cancer and triple negative breast cancer. Among the mice vaccinated with this vaccine, up to 88% remained tumor free (the specific proportion varies depending on the type of cancer), and the vaccine effectively inhibited the spread of cancer cells, even completely preventing metastasis in some cases. This platform technology has broad applicability and can be used for the prevention and treatment of various types of cancer, and is expected to be used in high-risk cancer populations in the future. Previous team research has demonstrated that this nanoparticle based drug design can shrink and eliminate tumors in mice. This study further confirms that the ...
- Source: drugdu
- 72
- October 11, 2025
“Efficient research and development+cost advantage” recognized, innovative drugs surging overseas trend

Recently, Nuocheng Jianhua and global biopharmaceutical company Zenas jointly announced a global authorization cooperation agreement, with a potential total transaction amount of over 2 billion US dollars, adding another heavyweight footnote to China’s innovative drugs going global. Since 2025, the trend of innovative drugs going global has continued to heat up. Previously, leading pharmaceutical companies such as Hengrui Pharmaceutical and Xinda Biotechnology have successively achieved international breakthroughs in technology and market through overseas authorization. Analysts believe that the continuous increase in the amount and quantity of foreign authorizations for innovative drugs in China is an inevitable trend after the research and development capabilities in this field are globally recognized. In the past few years, the product data of domestic innovative pharmaceutical companies has continuously verified their clinical value, from early individual enterprise breakthroughs to collective global cooperation today. Essentially, it is the global market’s recognition of Chinese pharmaceutical companies’ “efficient ...
- Source: drugdu
- 143
- October 11, 2025
FDA Approves Jascayd for Idiopathic Pulmonary Fibrosis Treatment

FDA announced its approval of Boehringer Ingelheim’s Jascayd (nerandomilast) tablets for the treatment of idiopathic pulmonary fibrosis (IPF). Jascayd’s approval makes it the first approved new therapy treatment for IPF in over 10 years, and with IPF being a rare, serious, and progressive disease with no cure and limited treatments, the approval marks a significant step in supporting those suffering from the disease. FDA’s approval of Jascayd was a data backed decision FDA based its approval on results collected from two Phase III trials, Fibroneer-IPF and Fibroneer-ILD.1 Jascayd’s efficiency was evaluated in both randomized, double-blind, placebo-controlled trials of adults with IPF.1 The primary endpoint was the absolute change from baseline in Forced Vital Capacity, which is the maximum amount of air a person can forcefully exhale after taking the deepest possible breath.1 Results indicated that Participants administered with Jascayd had significantly reduced FVC decline when compared to participants treated with ...
- Source: drugdu
- 91
- October 10, 2025

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