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【EXPERT Q&A】What are the registration and regulatory requirements that IVD test reagents for Chikungunya virus need to comply with?

Drugdu.com expert’s response: The registration and regulatory requirements for IVD test reagents for Chikungunya virus vary across different countries and regions. Below are the specific requirements for some major countries and regions: European Union Regulatory Compliance: Must comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746). Product Classification: According to the classification rules of the IVDR, IVD test reagents for Chikungunya virus are typically classified as Class C or Class D, depending on their intended use and risk level. Review and Certification: For Class C or Class D products, review and certification by a Notified Body are required. Quality Management System: Companies must establish a quality management system that complies with the ISO 13485 standard and ensure that the product meets relevant basic requirements. Submission of Technical Documentation: Technical documentation, including product performance evaluation reports, clinical evidence, labels, and instructions, must be submitted. CE Marking and ...
- Source: drugdu
- 199
- August 22, 2025
Investigation raises concerns over tooth stem cell banking claims

Parents are spending thousands of pounds to bank stem cells from their children’s milk teeth – but the recipient companies’ claims about their future medical value are unproven and potentially misleading, reveals an investigation by The BMJ, published today. The companies’ claims include that stem cells banked from teeth are already being used in treatments for autism and diabetes. They also highlight current research using stem cells in multiple sclerosis, Parkinson’s disease, and heart attacks. Tooth stem cell banking involves parents sending their children’s lost milk teeth to a laboratory where the dental pulp stem cells are harvested and stored. The service costs around £1900 (€2189; $2573) with an additional annual storage fee of £95, explains freelance journalist Emma Wilkinson. The three companies in the UK offering tooth stem cell banking – Future Health Biobank, BioEden and Stem Protect – all operate through one laboratory. Future Health Biobank says on ...
- Source: drugdu
- 116
- August 21, 2025
Seniors Neglecting Steps To Protect Heart Health, Study Says

By Dennis Thompson HealthDay ReporterWEDNESDAY, Aug. 20, 2025 (HealthDay News) — Seniors with known heart-related problems aren’t doing a very good job taking steps to protect their health, a new study says. Older folks with high blood pressure, stroke survivors and heart failure patients in the United States all have been neglecting Life’s Essential 8 — a checklist of lifestyle factors that can protect heart health, researchers found. “On average, participants with one cardiovascular disease had a Life’s Essential 8 score 9 points lower than those without cardiovascular disease,” lead researcher James Walker, a medical student at Northwestern University in Chicago, said in a news release. Life’s Essential 8 recommends that people eat healthy, exercise, avoid smoking, sleep better, lose excess weight, and manage their cholesterol, blood sugar and blood pressure levels, according to the American Heart Association. For this study, researchers analyzed a sample of more than 3,000 adults ...
- Source: drugdu
- 99
- August 21, 2025
Pfizer’s $5.4 billion gamble fails

Recently, Pfizer announced that its key sickle cell disease drug inclacumab failed to reach the primary endpoint in the phase III THRIVE-131 study. This news casts a shadow over Pfizer’s layout in this field. The Phase III THRIVE-131 study was designed to evaluate the effect of inclacumab in reducing vaso-occlusive crises. The results of the study showed that there was no significant difference in the incidence of vascular occlusive crisis between the inclacumab group and the placebo group, and inclacumab failed to achieve a statistically significant effect. Sickle cell disease (SCD) is a hereditary blood disorder in which red blood cells are sickle-shaped due to abnormalities in hemoglobin molecules, affecting blood flow and oxygen delivery. Patients often have symptoms such as pain and anemia, and may face many difficulties in life due to sudden illness, which brings a heavy burden to patients and families. Looking back at Pfizer’s layout of ...
- Source: drugdu
- 80
- August 21, 2025
InnoCare Pharma’s new anticancer drug Mesutoclax completes first patient dosing in clinical trial

InnoCare Pharma announced on August 21 that the first patient was dosed in the registrational clinical trial of the company’s independently developed novel BCL2 inhibitor Mesutoclax (ICP-248) for the treatment of mantle cell lymphoma (MCL) previously treated with BTK inhibitors. Mesutoclax is a novel, oral, highly selective BCL2 inhibitor. BCL2 is a key regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development and progression of various hematological malignancies. Mesutoclax selectively inhibits BCL2, restoring the programmed cell death mechanism in tumor cells, thereby exerting its anti-tumor efficacy. This unique mechanism of action holds great potential for the treatment of MCL, chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other indications. InnoCare Pharma is currently advancing clinical trials for these indications globally. This registrational clinical trial is designed to evaluate the safety and efficacy of mesutoclax in patients with MCL ...
- Source: drugdu
- 85
- August 21, 2025
Novartis’ innovative drug Noradrena approved for IgA nephropathy in China

On August 20, Novartis Group announced that its innovative product, Noradrena® (atrasentan hydrochloride tablets), has received approval from the National Medical Products Administration (NMPA) for the reduction of proteinuria in adult patients with primary immunoglobulin A nephropathy (IgA nephropathy) at risk of rapid disease progression. Noradrena is reportedly the first non-immunological therapy approved in China for the treatment of IgA nephropathy and the first and currently only highly selective endothelin A (ETA) receptor antagonist for this indication. https://finance.eastmoney.com/a/202508203489375117.html
- Source: drugdu
- 121
- August 21, 2025
Sino Biopharmaceutical’s subsidiary’s innovative drug LM-302 has been included in the Breakthrough Therapy Program

On August 19, Sino Biopharmaceutical (01177) issued an announcement, announcing that its wholly-owned subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd., independently developed an innovative drug.LM-302 (CLDN18.2ADC) has been included in the Breakthrough Therapy Designation program by the Center for Drug Evaluation of the China National Medical Products Administration for the first-line treatment of CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma in combination with a PD-1 monoclonal antibody. LM-302 is a potential first-in-class antibody-drug conjugate targeting CLDN18.2. Clinical studies have demonstrated an objective response rate (ORR) of 65.9% and a disease control rate (DCR) of 85.4% in 41 evaluable patients. For 32 patients with CLDN18.2 ≥ 25%, the ORR was 71.9% and the DCR was 96.9%. This drug is currently undergoing a Phase III clinical trial in China. Its inclusion in the Breakthrough Therapy program is expected to accelerate its market launch, providing an innovative treatment option for ...
- Source: drugdu
- 95
- August 21, 2025
Interphex

Organiser: American Pharmacists Association Time：April 21 – April 23, 2026 address：655 West 34th Street, New York, NY 10001-1188, USA Exhibition hall：Javits Convention Center, NYC Product range: Active Pharmaceutical Ingredients (APIs): Western medicine raw materials such as vitamins, hormones, cephalosporins, macrolides, and central nervous system drugs Excipients and Dosage Forms: Excipients, fluids, enteric coatings, antioxidants, sweeteners, permeation enhancers, preservatives, disintegrants, clarifying agents, pH regulators, etc. Natural Extracts: Plant extracts, animal extracts, dietary fibers, and cosmetic raw materials About Interphex： The Interphex in New York, USA, is a globally leading pharmaceutical and biotechnology event that integrates industry innovation with expert-led conferences. Since its inception in 1979, it has been the most trusted life sciences exhibition in North America, spanning both the chemical pharmaceutical and biopharmaceutical sectors. Exhibitors have the opportunity to meet decision-making buyers from top global pharmaceutical companies through this event.
- Source: drugdu
- 223
- August 21, 2025
After the impact of centralized procurement, this old pharmaceutical company gambled heavily on research and development

When the heavy hammer of national centralized procurement hit the core products, Fudan Zhangjiang’s revenue and net profit were both under pressure. Recently, Fudan Zhangjiang released its 2025 semi-annual report: achieving revenue of 390 million yuan, a year-on-year decrease of 4.42%; The net profit attributable to the parent was 5.7151 million yuan, a year-on-year decrease of 91.89%. However, the company still maintains high R&D investment, focusing on the two major technical fields of photodynamic drugs and ADC, and preparing chips for future comebacks. The financial report shows that Fudan Zhangjiang invested a total of 178 million yuan in R&D in the first half of 2025, a year-on-year increase of 14.58%, accounting for 45.63% of revenue, a year-on-year increase of 7.57 percentage points. Impact of centralized procurement: 35% price reduction of main products According to public information, Shanghai Fudan Zhangjiang was founded in Zhangjiang High-tech Park, Pudong, Shanghai in November 1996. ...
- Source: drugdu
- 112
- August 20, 2025
Zhifei Biological has turned from profit to loss, and the transformation and breakthrough of domestic vaccines have become a trend

The once leading player in the vaccine industry is now facing unprecedented challenges. On August 18th, the semi-annual report released by Chongqing Zhifei Biological Products Co., LTD., a leading domestic vaccine enterprise, showed that the company’s revenue was 4.919 billion yuan, a year-on-year plunge of 73.06%. Net profit plummeted sharply from a profit of 2.234 billion yuan in the same period of the previous year to a loss of 597 million yuan. From the perspective of specific products, in the first half of 2025, the batch release volume of Chongqing Zhifei Biological’s nine-valent HPV vaccine dropped by 76.8% year-on-year, from 18.2717 million doses to 4.2388 million doses. The batch release volume of the quadrivalent HPV vaccine has dropped from 466,000 doses in the same period last year to zero. The revenue from its agency of Merck’s products dropped from 17.59 billion yuan in the same period last year to 4.37 ...
- Source: drugdu
- 198
- August 20, 2025

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