media – Page 17 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】What standards need to be followed for clinical performance studies under the EU IVDR regulation?

Drugdu.com expert’s response: Under the EU’s In Vitro Diagnostic Regulation (IVDR), clinical performance studies must adhere to the following core standards to ensure the scientific validity, reliability, and compliance of the study results: I. Regulatory Framework and Core Requirements 1. IVDR Regulation (Regulation (EU) 2017/746) Clinical performance studies must comply with the requirements outlined in Articles 57-77 and Annex XIV of the IVDR, covering aspects such as study design, ethical review, subject protection, and data management. It is necessary to demonstrate the scientific validity, analytical performance, and clinical performance of in vitro diagnostic reagents (IVDs), ensuring their association with specific clinical conditions or physiological states. 2. ISO 20916:2024 Standard Core Role: As a harmonized standard under the IVDR, ISO 20916 provides a comprehensive framework for the planning, design, implementation, documentation, and reporting of clinical performance studies. Key Content: Presumption of Conformity: Compliance with the normative clauses of ISO 20916 is ...
- Source: drugdu
- 106
- April 10, 2026
Hologic Acquired for $18.3 Billion, New CEO Joins from Baxter

Hologic, a leader in breast health, in vitro diagnostics, gynecological surgery, and bone health, announced the completion of its go private acquisition led jointly by private equity giants Blackstone and TPG. At the same time, a key management transition was finalized: the company formally appointed José (Joe) E. Almeida, a veteran leader in the medical technology industry, as Chief Executive Officer, effective immediately upon announcement. This management change took place efficiently and in quick succession. Just one day earlier, on April 6, Hologic disclosed that Steve MacMillan, its long serving CEO, would retire upon completion of the privatization transaction. In a single day, this century old healthcare giant completed both its capital restructuring and leadership transition, officially entering a new phase of development. The high profile privatization deal was first agreed in October 2025, when Hologic reached a definitive acquisition agreement with funds managed by Blackstone and TPG. The transaction ...
- Source: drugdu
- 113
- April 9, 2026
China’s First CO₂ Contrast Injection Device Approved; Amed Medical Closes Over RMB 200M Series D Financing

Artery Network has exclusively learned that Amed Medical Devices (Beijing) Co., Ltd. (“Améd Medical” or “Amed”) has recently completed a Series D financing round of over RMB 200 million. The round was led by Zhesheng Collaborative Life Health Fund, with participation from Henan Key Intellectual Property Fund, Global Hedge Fund Management Co., Ltd., and other institutions. Following this financing, Améd Medical’s post-investment valuation exceeds RMB 1.5 billion. According to the company, the proceeds will mainly be used for the R&D and global registration of its core series of 3D-printed biodegradable vascular stents, as well as market promotion of its newly launched China-first CO₂ contrast injection device. Rising Demand for Vascular Interventions and the “Implant-Free Intervention” Trend Drive Rapid Growth of Biodegradable Stents and Interventional Auxiliary Devices Driven by population aging and other factors, the number of patients with cardiovascular diseases has grown rapidly. In China alone, the 2024 Report on ...
- Source: drugdu
- 101
- April 9, 2026
Haogrei Secures Tens of Millions of Yuan in Strategic Financing; Domestic Liquid Metal Bearing X ray Tubes Deployed in Multiple Class III A Hospitals

Recently, Haogrei Technology, an innovator focusing on core components for high end medical imaging, announced the completion of tens of millions of yuan in strategic financing. The round was jointly invested by Anhui Tongchuang Small and Medium sized Sci Tech Transformation Fund Partnership (L.P.), Shenzhen Tongchuang Angel Phase II Private Equity Venture Capital Fund Partnership (L.P.), Huzhou Nanhui Xunying Venture Capital Partnership (L.P.), and Huzhou Nanxun Xunying Venture Capital Partnership (L.P.). The proceeds will be used for large scale mass production and capacity expansion of core products, R&D investment in next generation technology platforms, recruitment of key talents, and construction of global marketing channels. Previously, Haogrei Technology had secured support from multiple leading institutions including Tongchuang Weiye, Yuanming Capital, and Su Venture Capital, with cumulative financing reaching nearly 100 million yuan. This fully demonstrates capital market confidence in its technical strength and the prospects of domestic substitution for core components ...
- Source: drugdu
- 105
- April 9, 2026
PHARMPACK

Organiser：Reed Sinopharm Exhibitions Time：May 13 – May 15, 2026 Address：No. 333 Songze Avenue, Xujing Town, Qingpu District, Shanghai Exhibition hall：National Exhibition and Convention Center (Shanghai) Product range: Pharmaceutical glass Bottle caps and stoppers Aluminum foil, aluminum-plastic packaging, and aluminum products Packaging printing Capsules and gelatin Pharmaceutical plastic bottles Plastic trays Pharmaceutical PVC rigid sheets Pharmaceutical polyethylene bags Pharmaceutical composite films Pharmaceutical flexible tubes Packaging drums for bulk pharmaceutical chemicals Desiccants Cleanroom garments and materials Aerosol packaging Packaging materials for injectables Other packaging materials About PHARMPACK： As a significant pharmaceutical packaging event in Asia, renowned for its large scale, comprehensive range of products, and gathering of leading overseas enterprises, the Shanghai International Pharmaceutical Packaging Exhibition adopts the theme of “Smart Packaging, Innovation-Driven.” It introduces a series of themed activities, such as the “Innovative Product Display Zone for Pharmaceutical Packaging and Drug Delivery Systems.” The exhibition attracts outstanding pharmaceutical packaging ...
- Source: drugdu
- 116
- April 9, 2026
With revenue surging 7.6 times, another innovative pharmaceutical company delivers outstanding results.

Recently, Wangshan Wangshui released its first financial report since its listing on the Hong Kong Stock Exchange. In 2025, the company’s annual revenue reached RMB 102 million, a year-on-year increase of 762.9% , and the gross profit margin soared from 29.5% to 79.0%. The explosive growth in revenue was mainly due to the rapid increase in sales volume after the launch of the new ED drug and the revenue from licensing new indications for VV116. However, Wangshan Wangshui’s losses widened further to 360 million yuan in 2025, mainly due to share-based payment expenses and listing-related costs. Excluding these one-off factors, the company’s core business’s ability to generate cash is strengthening . 01 The commercialization of the new ED drug got off to a flying start. In 2025, the biggest highlight of Wangshan Wangshui will be the successful NMPA approval of the Class 1 new drug Onveda (seminafil hydrochloride tablets, R&D ...
- Source: drugdu
- 101
- April 8, 2026
$53.7 billion! Lilly’s new betting direction

When Eli Lilly acquired Centessa Pharmaceuticals for $7.8 billion (approximately RMB 53.7 billion), the market saw not only a high-premium deal, but also a strategic positioning for the future of neuroscience. While pharmaceutical giants are betting heavily on popular areas such as weight loss and oncology, why is Eli Lilly going against the grain and investing heavily in “wake-up” drugs? 01 Acquisition at a 41% premium In mergers and acquisitions in the biopharmaceutical industry, the premium often directly reflects the acquirer’s judgment on the value of the target asset. Eli Lilly’s 40.5% premium and the transaction structure of $6.3 billion down payment + $1.5 billion CVR are by no means blindly following the trend, but are based on a deep recognition of Centessa’s core asset – the OX2R agonist combination. From the transaction structure perspective, Eli Lilly’s payment method reflects both its affirmation of Centessa’s existing assets and its avoidance ...
- Source: drugdu
- 100
- April 8, 2026
[Another Achievement] Hengdao Pharmaceuticals’ Peramivir Sodium Chloride Injection Approved for Marketing

Innovation and progress, perseverance and a commitment to excellence – another achievement! Recently, our company’s Class 4 chemical drug, Peramivir Sodium Chloride Injection, received a Drug Registration Certificate issued by the National Medical Products Administration. This is considered equivalent to passing the consistency evaluation of generic drug quality and efficacy, further authoritative recognition of our R&D capabilities. Details are as follows: Basic information about drugs Generic name of the drug: Peramivir Sodium Chloride Injection English name: Peramivir and Sodium Chloride Injection Dosage form: Injection Specifications: 100ml: Peramivir (calculated as C 15 H 28 N 4 O 4 ) 0.15g and Sodium Chloride 0.9g Registration Category: Class 4 Chemical Drugs Listing Authorization Holder: Nanjing Hengdao Pharmaceutical Technology Co., Ltd. Drug Approval Number: National Drug Approval Number H20263763 Indications: Used for influenza A or B. For the treatment of influenza A and B (peramivir is effective in treating influenza A and B, ...
- Source: drugdu
- 90
- April 8, 2026
Good news! Chang Le Pharmaceutical’s Bumetanide Injection has received approval for its Supplemental Drug Application

Recently, Chang Le Pharmaceutical, a subsidiary of Lianhuan Pharmaceutical, received the “Approval Notice for Supplementary Drug Application” issued by the National Medical Products Administration. Bumetanide injection was successfully approved, marking a new stage in the company’s production and supply capacity and quality management level in the field of diuretics, and injecting strong momentum into the company’s high-quality development. Bumetanide injection is a commonly used, potent diuretic in clinical practice, widely applied in the treatment of edematous diseases, hypertension, prevention of acute renal failure, and hyperkalemia, demonstrating significant clinical value. This approval includes a new 1ml:0.5mg product specification, along with simultaneous changes to the manufacturing process, production volume, and packaging materials and containers. Since the project’s inception, Chang Le Pharmaceutical has assembled a professional R&D and production team, conducting systematic pharmaceutical research over several months. Adhering strictly to national drug development principles, the team has carried out comprehensive and in-depth experimental ...
- Source: drugdu
- 87
- April 8, 2026
New Drug Launch | Gan & Lee Pharmaceuticals’ Sitagliptin Metformin Tablets (II) Approved

Beijing, China, April 7, 2026 – Gan & Lee Pharmaceuticals Inc. (hereinafter referred to as “Gan & Lee Pharmaceuticals”, stock code: 603087.SH) announced that its wholly-owned subsidiary, Gan & Lee Pharmaceuticals Shandong Co., Ltd., recently received a drug registration certificate for sitagliptin metformin tablets (II) issued by the National Medical Products Administration (hereinafter referred to as “NMPA”) (Acceptance No.: CYHS2403373, Certificate No.: 2026S00914, Drug Approval No.: H20263765). Sitagliptin and metformin tablets (II) are a combination oral hypoglycemic agent. Each tablet contains 50 mg of sitagliptin phosphate (calculated as sitagliptin) and 850 mg of metformin hydrochloride. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that stimulates insulin release in a glucose-dependent manner and reduces glucagon levels by increasing the level of active incretin. Metformin inhibits hepatic gluconeogenesis, reduces glucose absorption in the small intestine, and improves peripheral tissue sensitivity to insulin by increasing glucose uptake and utilization. This product, in combination with ...
- Source: drugdu
- 90
- April 8, 2026

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