media – Page 25 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

the first of its kind to achieve the primary endpoint of mid-term analysis in nasopharyngeal carcinoma stage III clinical trials with iza bene

On the evening of July 2nd, Baili Tianheng announced that its independently developed EGFR × HER3 dual antibody ADC (iza bene), which is a first in class, new concept, and the only one to enter the Phase III clinical stage, has reached the primary endpoint in the Phase III clinical trial of nasopharyngeal carcinoma (study protocol number: BL-B01D1-303). The indication is for recurrent or metastatic nasopharyngeal carcinoma that has been previously treated with PD-1/PD-L1 monoclonal antibodies and has failed at least two lines of chemotherapy (at least one line containing platinum). The announcement shows that Iza bren is conducting over 40 clinical trials targeting multiple types of tumors in China and the United States. As of now, Iza bren has 5 indications included in the breakthrough treatment list by the Drug Evaluation Center of the National Medical Products Administration. Baili Tianheng presented Phase I research data on Iza bren treatment ...
- Source: drugdu
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- July 4, 2025
Gout treatment welcomes new choices! Changchun High tech’s first domestically approved injection of Fuxinqibai monoclonal antibody for market launch

On the evening of July 2nd, Changchun High tech announced that its subsidiary Jinsai Pharmaceutical, which is controlled by the company, has obtained approval from the National Medical Products Administration for the injection of Fuxinqibai monoclonal antibody (formerly known as Jinna monoclonal antibody for injection). This drug is the first domestically approved IL-1 inhibitor for the treatment of acute attacks of gouty arthritis, and its precise and long-lasting anti-inflammatory advantages will bring new treatment options for gout patients. It is reported that Fuxinqibai monoclonal antibody for injection is a new type of fully human anti-IL-1 β monoclonal antibody drug developed by the company. It belongs to the first class of therapeutic biological products and can specifically bind to human IL-1 β, block the production of inflammatory mediators induced by IL-1 β. It is suitable for acute attacks of gouty arthritis in adults who are contraindicated, intolerant or lack efficacy of ...
- Source: drugdu
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- July 4, 2025
this is the path to carbon neutrality

Is it possible to achieve carbon – dioxide – free operation of pharmaceutical warehouses? The answer is yes. United Therapeutics, a biopharmaceutical company, has built a Good Manufacturing Practice (GMP) – compliant warehouse in North Carolina, southern United States, which is worthy of being called a milestone project. Next, let’s take a closer look at the details. Generally, GMP – compliant pharmaceutical warehouses are not energy – efficient buildings. The temperature – control system needs to run continuously, the air humidity needs to be kept stable, and the whole system also needs to go through strict verification. The power consumption of the air – conditioning system is huge, and when a cryogenic area needs to be set up for sensitive active ingredients, the energy consumption is doubled. All in all, these conditions are not ideal for designing a net – zero energy – consumption building. Nevertheless, it is indeed feasible. ...
- Source: drugdu
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- July 4, 2025
Dizal (Jiangsu) Pharmaceutical Co., Ltd. Voluntary Disclosure of Announcement Regarding Accelerated Marketing Approval of Suvoderm® by the U.S. FDA

Dizal (Jiangsu) Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”) has officially received approval from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of its independently developed Sulvoteran® (English trade name: ZEGFROVY®, generic name: Sulvotinib Tablets). It is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (Exon20ins) as detected by an FDA-approved testing kit, whose disease has progressed during or after platinum-containing chemotherapy. Sulvoteran® was approved for marketing through the Priority Review process, becoming the world’s first and currently the only domestically innovative drug approved in the U.S. for EGFR Exon20ins NSCLC. It has achieved significant innovations in molecular design at the source, breaking through intractable targets, and is China’s first globally first-in-class innovative drug independently developed and approved in the U.S. I. Information Related to the Drug ...
- Source: drugdu
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- July 4, 2025
Rare, Recurrent, and Still a Challenge

Despite the rising incidence of rheumatoid arthritis (RA), extra-articular manifestations have become rare in the era of modern treat-to-target therapy. However, they still present clinical challenges — particularly in the case of rheumatoid nodules. In addition to the need to rule out serious differential diagnoses and address potential complications, especially those involving the lungs, these recurrent inflammatory granulomas can affect daily life not only cosmetically but also functionally. Christopher Edwards, MD, professor of rheumatology at University Hospital Southampton in Southampton, England, discussed the clinical relevance and management of rheumatoid nodules during the 2025 Annual Meeting of the European Alliance of Associations for Rheumatology. When Edwards began his career in rheumatology, the presence of rheumatoid nodules was considered a key diagnostic criterion for RA. If not found on the hands, clinicians often examined the elbows and Achilles tendons, which are also common sites. Histologically, rheumatoid nodules are granulomatous inflammatory lesions that ...
- Source: drugdu
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- July 4, 2025
FDA Vaccine Official Restricted COVID Vaccine Approvals Against the Advice of Agency Staff

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two COVID-19 vaccinesWASHINGTON (AP) — The government’s top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval of two COVID-19 vaccines, disregarding recommendations from government scientists, according to federal documents released Wednesday. The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots from vaccine makers Novavax and Moderna. Both vaccines were approved by the FDA in May after months of analysis by rank-and-file FDA reviewers. But internal correspondence show Prasad disagreed with staffers who planned to approve the shots for everyone 12 and older, similar to previous COVID vaccines. The scientists had concluded the benefit from the vaccines and the risk of COVID-19 outweighed the risk of possible side effects, which are ...
- Source: drugdu
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- July 4, 2025
【EXPERT Q&A】Why do we need CE certification?

Drugdu.com expert’s response: The CE certification serves as a “passport” for products to enter the European market, with its core purpose being to ensure that products comply with the EU’s fundamental requirements for safety, health, and environmental protection, while also facilitating the free flow of goods within the EU internal market. The following are the main reasons and specific values for enterprises to pursue CE certification: I. Legal Compliance: Avoiding Market Access Barriers EU Mandatory Requirement: The CE mark is a mandatory certification symbol for product safety, health, and environmental protection in the EU. According to EU regulations (such as the Low Voltage Directive, Electromagnetic Compatibility Directive, and Machinery Directive), products without the CE mark are prohibited from being sold in the EU market. Avoiding Legal Risks: Products that fail to pass CE certification may face customs seizure, mandatory recalls, hefty fines, or even criminal penalties. For example, electronic and ...
- Source: drugdu
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- July 4, 2025
The marine economy is facing significant policy benefits, and the industrial chain is expected to continue to benefit; Two departments propose 16 measures to support the high-quality development of innovative drugs – “Investment Early Participation”

（1） Important Market News 1. The three major stock indexes in the United States closed with mixed gains and losses, with the Nasdaq falling 0.82%, the Dow Jones Industrial Average rising 0.91%, and the S&P 500 index falling 0.11%; Tesla fell over 5%, Netflix fell over 3%, Nvidia fell over 2%, Microsoft fell over 1%, and Apple rose over 1%. Chinese concept stocks fluctuated, with the Nasdaq China Golden Dragon Index up 0.2%, Huya Live up nearly 13%, NIO and Xiaopeng Motors up over 2%, Tiger Securities down over 2%, and Futu Holdings down over 1%. 2. According to CCTV News, on July 1st local time, when asked whether the uncertainty caused by the current tariff system of the US government had led to the Fed delaying interest rate cuts, Fed Powell gave a positive answer, adding that due to the impact of tariffs, almost all forecasts for US ...
- Source: drugdu
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- July 3, 2025
Earwax Secretions May Help Detect Parkinson’s Disease

Odors from earwax may help distinguish individuals with Parkinson’s disease (PD) from those without the condition, a new study suggests. Researchers found that four volatile organic compounds (VOCs) in ear canal secretions significantly differed between participants with and without PD. The compounds — ethylbenzene, 4-ethyltoluene, pentanal, and 2-pentadecyl-1,3-dioxolane — may represent potential biomarkers. An artificial intelligence olfactory (AIO)-based screening model used in the study identified those with PD with 94% accuracy. “The accuracy of the model really surprised us,” study investigator Hao Dong, Research Center for Frontier Fundamental Studies, Zhejiang Lab, Hangzhou, China, MD, told Medscape Medical News. However, the study was a “small-scale, single-center experiment,” he noted in a press release. “The next step is to conduct further research at different stages of the disease, in multiple research centers, and among multiple ethnic groups in order to determine whether this method has greater practical application value,” Dong said. The ...
- Source: drugdu
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- July 3, 2025
IBS Rates Nearly Doubled During the Pandemic

By Dennis Thompson HealthDay ReporterMONDAY, July 1, 2025 (HealthDay News) — The COVID-19 pandemic took a toll on Americans’ guts, researchers report. Gut disorders like irritable bowel syndrome (IBS) increased significantly during the COVID-19 pandemic, a new study says. Rates of IBS nearly doubled among U.S. adults, rising from around 6% in May 2020 to about 11% in May 2022, results show. Other gut health problems like constipation also increased, researchers report in the journal Neurogastroenterology & Motility. “Rates of digestive issues such as irritable bowel syndrome and chronic idiopathic constipation rose significantly,” lead researcher Dr. Christopher Almario, a gastroenterologist at Cedars-Sinai Medical Center in Los Angeles, said in a news release. “These findings underscore the significant toll the pandemic has taken on digestive health,” Almario added. Conditions like IBS and chronic constipation are driven by complex interactions between the gut and the nervous system, researchers said in background notes. ...
- Source: drugdu
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- July 3, 2025

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