media – Page 28 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】Is it mandatory to have a stability test protocol and report for stress testing during the pharmaceutical R&D process?

Drugdu.com expert’s response Yes, stability test protocols and reports are mandatory for stress testing in the pharmaceutical R&D process. The reasons are as follows: I. Regulatory Requirements Consistency in International and Domestic Regulations: Whether it is China’s NMPA, the U.S. FDA, or the international ICH guidelines, all explicitly mandate that stress testing must be conducted for active pharmaceutical ingredients (APIs), accompanied by comprehensive stability test protocols and reports. These documents are essential prerequisites for drug marketing authorization, and their absence will directly result in application rejection. Essential Materials for Marketing Authorization: Stability test protocols and reports constitute core documentation for drug registration submissions. Regulatory authorities review these files to assess the quality controllability and safety of pharmaceutical products. II. Logical Imperatives in R&D Guiding Subsequent R&D Stages: Stability test protocols meticulously document critical information such as test methods, conditions, and sampling points, providing a foundation for subsequent accelerated and long-term ...
- Source: drugdu
- 149
- October 24, 2025
Simem 2026

Organiser：Algerian Ministry of Health, Algerian Healthcare Reform and Development Commission Time：April 8th -11th, 2025 Address：Les Genets, Chemin de Wilaya, Route 75, Oran, Algeria Exhibition hall：Centre des Conventions d’Oran Product range: Medical Equipment: Medical technology equipment, laboratory instruments and equipment, medical electronic equipment, medical diagnostic equipment, ophthalmic equipment and protective products, surgical instruments, emergency response equipment, hospital, dental, and medical facilities, dental service equipment, disposable medical products for hospitals and households, hospital and dental medical data processing systems, orthodontic and reconstructive equipment. Pharmaceuticals: Foreign prescription drugs, herbal preparations, nutritional health supplements such as minerals and vitamins, dietary nutrition products, homeopathic preparations, dermatological preparations, maternal and child healthcare products and infant food, personal hygiene products, incontinence products, medical consumables, etc. About Simem 2026： The Algerian International Medical Equipment Exhibition (SIMEM) is the most renowned medical equipment exhibition in Algeria. It is the only specialized exhibition for medical devices, pharmaceuticals, and dentistry in ...
- Source: drugdu
- 218
- October 23, 2025
【EXPERT Q&A】What are the requirements for applying to operate Class II medical devices?

Drugdu.com expert’s response: The application for a Class II medical device operating license must meet key requirements across four dimensions: enterprise qualifications, personnel allocation, facility conditions, and quality management systems. I. Enterprise Legal Qualifications Legal Person Status The applicant must possess valid legal person status, and the enterprise must be registered with the industrial and commercial authorities and hold a valid business license. Registered Capital and Scale The registered capital shall generally be no less than RMB 1 million (specific amounts may vary by regional policies and should comply with local requirements). The enterprise scale must align with its business scope to ensure capacity for fulfilling corresponding responsibilities. Registered Address and Premises The registered address must be an independent business venue with a floor area of no less than 80 square meters, separate from the residential address. The operating premises must comply with national laws and regulations, providing adequate space for storing medical ...
- Source: drugdu
- 158
- October 22, 2025
CPhI Japan 2026

Organiser: Informa Markets Time: April 21 – 23, 2026 Address: Tokyo Big Sight International Exhibition Center, 3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall: Tokyo Big Sight International Exhibition Center Product range: Active Pharmaceutical Ingredients (APIs): Vitamins, Hormones, Sulfonamides, Antipyretics and Analgesics, Tetracyclines, Amino Acids and Derivatives, Chloramphenicols, Gastrointestinal Medications, Other Antiinfectives, Penicillins, Aminoglycosides, Lincomycins, Cardiovascular Medications, Antiparasitic Drugs, Cephalosporins, Macrolides, Respiratory Medications, Central Nervous System Medications, Other Pharmaceutical Raw Materials Excipients & Dosage Forms: Excipients, Glidants, Enteric Coatings, Antioxidants, Sweeteners, Penetration Enhancers, Preservatives, Disintegrants, Coating Materials, Surfactants, Opacifiers, Flavors, Filter Aids, Stabilizers, Lubricants, Plasticizers, Solvents, Taste Masking Agents, Colorants, Clarifiers, pH Adjusters, Others Natural Extracts: Plant Extracts, Animal Extracts, Traditional Chinese Medicine Ingredients, Functional Food Ingredients, Health Supplement Ingredients, Nutritional Health Ingredients, Supplements, Dietary Fibers, Cosmetic Ingredients Biological Products & Reagents: Antibodies, Nucleic Acid/Protein Synthesis, Vectors & Constructs, Cellular Biology Assays, Animal/Plant Proteins/Antigens/Peptides, Nucleic Acid Analysis, Libraries & Constructs, Biochemistry, Standards/Controls, Protein Detection, Nucleic Acid Testing, Cloning ...
- Source: drugdu
- 200
- October 20, 2025
【EXPERT Q&A】What are the functions and roles of a ventilator?

Drugdu.com expert’s response: A ventilator is a medical device capable of replacing, controlling, or modifying a patient’s spontaneous breathing movements, providing mechanical ventilation support. Its core function is to maintain effective gas exchange, ensuring oxygen supply and carbon dioxide removal while reducing the workload on respiratory muscles. Below are the key functions and roles of ventilators: I. Core Functions Ventilation Support Replacing Spontaneous Breathing: When respiratory failure occurs due to disease, trauma, or anesthesia, ventilators can fully or partially replace pulmonary ventilation to ensure gas exchange. Adjusting Respiratory Parameters: By setting parameters such as tidal volume (air volume per breath), respiratory rate, and inspiratory-to-expiratory ratio, ventilators precisely control ventilation volume to avoid hyperventilation or hypoventilation. Oxygenation Support Increasing Blood Oxygen Levels: By delivering high concentrations of oxygen (adjustable FiO₂), ventilators correct hypoxemia (e.g., in pneumonia, ARDS, or cardiogenic pulmonary edema). Positive Pressure Ventilation: Utilizing airway positive pressure (e.g., CPAP, BiPAP ...
- Source: drugdu
- 168
- October 20, 2025
Sugemalimab receives positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use

On the morning of October 17, CStone Pharmaceuticals announced on the Hong Kong Stock Exchange that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion, recommending the approval of sugemalimab monotherapy for the treatment of adult patients with unresectable stage III non-small cell lung cancer (NSCLC) whose tumor cells express PD-L1 ≥1%, have no epidermal growth factor receptor (EGFR)-sensitive mutations or ALK or ROS1 genomic alterations, and have not progressed after platinum-containing chemoradiotherapy (CRT). https://finance.eastmoney.com/a/202510173536614458.html
- Source: drugdu
- 92
- October 18, 2025
Buchang Pharmaceutical’s subsidiary partners with WuXi AppTec to expand preclinical drug research with a contract exceeding 10 million yuan

On October 16, Buchang Pharmaceutical(603858) announced that its controlling subsidiary Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. and Suzhou WuXi AppTecNew Drug Development Co., Ltd. signed a “Technical Service Contract” with Luzhou Buchang Pharmaceutical Co., Ltd. The total contract amount is RMB 10.8 million, including 6% tax. Luzhou Buchang will pay the relevant fees in installments as agreed in the contract. The collaboration aims to entrust WuXi AppTec to conduct pharmacokinetic and toxicology testing projects, which is expected to help expand the company’s drug research and development capabilities and scope, and save clinical trial time and costs. As of December 31, 2024, Luzhou Buchang’s total assets were 2.223 billion yuan, total liabilities were 2 billion yuan, and net assets were 223 million yuan. In 2024, it achieved operating income of 47,100 yuan and a net profit of -16.24 million yuan. By June 30, 2025, total assets will rise to 2.34 billion ...
- Source: drugdu
- 83
- October 18, 2025
MRX-5 has completed Phase I clinical trials in healthy subjects in Australia

The latest investor relations activity record released by MicuRx Pharmaceutical on October 15 shows that the company participated in the analyst meetings of Huashang Fund and Jianxin Pension on October 13, and exchanged views with all parties on the research and development prospects and progress of the company’s products. Regarding the clinical application prospects of MRX-4 after it is launched on the market, the company stated that MRX-4 is a water-soluble prodrug of contezolizumab tablets, which is converted into contezolizumab in the body to exert therapeutic effects. The injectable dosage form has greatly expanded the usage scenarios. According to the “Guiding Principles for the Clinical Application of Antimicrobial Drugs” issued by the National Health Commission in 2015, intravenous administration can quickly reach high drug concentrations. For patients with severe infections and rapid disease progression who require emergency treatment, intravenous administration should be the first choice for clinical use of antibiotics. ...
- Source: drugdu
- 98
- October 18, 2025
Why Might GLP-1 Drugs Reduce Alcohol Cravings? New Experiment Suggests An Answer

By Dennis Thompson HealthDay ReporterTHURSDAY, Oct. 16, 2025 (HealthDay News) — Weight-loss drugs like Ozempic and Zepbound appear to reduce alcohol cravings, but doctors have been at a loss to explain why – until now. Glucagon-like peptide-1 (GLP-1) drugs appear to slow the speed at which alcohol enters the bloodstream, which also diminishes its effects on a person’s brain, according to pilot study results published Oct. 15 in the journal Scientific Reports. Essentially, people don’t feel the effects of alcohol as intensely if they’re taking a GLP-1 med, researchers said. “People who drink know there’s a difference between nursing a glass of wine and downing a shot of whiskey,” researcher Alex DiFeliceantonio said in a news release. She’s interim co-director of the Roanoke, Virginia-based Fralin Biomedical Research Institute at VTC’s Center for Health Behaviors Research. Both drinks contain the same amount of alcohol, but the shot brings a rapid increase ...
- Source: drugdu
- 92
- October 17, 2025
Biopharma Funding Rounds Advance Clinical Development of Novel Therapy and Treatment Solutions

The momentum of funding in biopharmaceutical continues, as organizations focus on advancing R&D for respective leading therapy and treatment candidates undergoing clinical testing. Companies such as Veradermics Inc., Peptilogics, and BridGene Biosciences all recently announced the completion of major funding rounds, helping to advance clinical testing. Veradermic Incorporated Veradermics announced the completion of an oversubscribed $150 million Series C financing round.1 The funding is expected to support the registrational development and planned New Drug Application submission for Veradermics’ lead investigational product, VDPHL01, which holds potential to be the first and only extended-release oral minoxidil treatment designed specifically for hair regrowth in women and men.1 According to a press release from Veradermic, the collected capital will be invested in advancing and completing the ongoing Phase III trials for its lead candidate. SR One led the financing round and received a mixed participation from both new and current investors, including the following. ...
- Source: drugdu
- 81
- October 17, 2025

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