media – Page 154 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Popular weight loss drugs have benefits and risks

In an observational study published in the latest issue of Nature Medicine, scientists analyzed the health effects of using glucagon-like peptide 1 receptor agonists (GLP-1RAs), concluding that 42 health risks decreased and 19 health risks increased. GLP-1RAs have become popular in the past few years because of their claims of weight loss. People are also studying the broader efficacy of GLP-1RAs, including the treatment of diseases such as Alzheimer’s disease, osteoarthritis and sleep apnea. However, some adverse events such as suicidal tendencies and gastrointestinal problems have also been reported. Therefore, it is necessary to further study the health benefits and risks of GLP-1RAs. A team from Washington University in St. Louis analyzed data from the U.S. Department of Veterans Affairs and studied the relationship between the use of GLP-1RAs and 175 health outcomes in 215,970 diabetic patients. Compared with a control group using non-GLP-1RA anti-hyperglycemic drugs, participants using GLP-1RA had ...
- Source: drugdu
- 309
- February 5, 2025
2025 will be a year of overseas expansion | Make a wish in spring

In mid-January 2025, WuXi Biologics announced that the company will add 151 projects in 2024, bringing the total number of projects to 817; the company expects that 24 PPQ (process performance confirmation) projects will be advanced in 2025, and the Irish production facility is expected to achieve profitability as planned in 2025. The above announcement actually conveys two very important messages. In 2024, the number of new projects of WuXi Biologics reached a new high. At the same time, the company’s “pioneer” Irish base in the international layout of that year ushered in a major breakthrough. But behind this announcement, as WuXi Biologics CEO Chen Zhisheng commented, it was a year of “roller coaster” for WuXi Biologics. In the ten years from 2014 to 2023, WuXi Biologics’ revenue compound annual growth rate exceeded 50%, which means that the company achieved a growth rate that was three times higher than the ...
- Source: drugdu
- 484
- February 5, 2025
Tianyu shares Avatrombopag maleate API passed CDE review

On January 27, Tianyu shares (300702) issued an announcement that the company’s Avatrombopag maleate API recently passed the review of the National Drug Administration Drug Review Center (CDE). The API belongs to Class 4 chemical drugs, with a registration number of Y20230000333, and the review result and the preparation are jointly reviewed as A. The company submitted a registration application for Avatrombopag maleate API to CDE in June 2023 and was accepted. Although the API has passed the CDE review, it still needs to obtain the “compliance” result of the GMP compliance inspection of the Zhejiang Provincial Drug Administration before it can be marketed in China. At present, there are 14 manufacturers in China that have passed the CDE technical review. The company is preparing to apply for a GMP compliance inspection. There is still uncertainty about the time of listing and sales. Investors are reminded to make prudent decisions ...
- Source: drugdu
- 269
- February 5, 2025
From being crowded to being deserted, why has the business of consistency evaluation of generic drugs “cooled down”?

Recently, discussions about generic drugs and original research drugs have been heated, and the appearance of identical data in consistency evaluation has become the first “oolong” in the pharmaceutical industry in 2025. However, in the public opinion field, the voices of pharmaceutical companies and CRO (pharmaceutical research and development outsourcing) companies are almost inaudible. Even a CRO company told the reporter of “Daily Economic News” that “there has been no generic drug (consistency) test in the past five or six years.” This was hard to imagine eight years ago. In March 2016, the “Opinions of the General Office of the State Council on Conducting Consistency Evaluation of Generic Drug Quality and Efficacy” kicked off the domestic consistency evaluation of generic drugs. Pharmaceutical companies are willing to spend millions of yuan on consistency evaluation, and CRO companies are also very busy. The business of consistency evaluation of generic drugs by CRO ...
- Source: drugdu
- 289
- February 5, 2025
PD-(L)1 “rolls” into the second half and new drugs are launched. What is Kelun Botai selling?

On January 20, Kelun Pharmaceutical (SZ002422, stock price 28.13 yuan, market value 45.05 billion yuan) announced that its subsidiary Kelun Botai’s anti-PD-L1 tagolizumab (trade name: Kotel) was approved for combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). This is the second indication approved for tagolizumab. At the end of December 2024, the China National Medical Products Administration (NMPA) has approved tagolizumab monotherapy for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma who have failed 2 or more lines of chemotherapy for listing in China. It is worth noting that both among the 20 PD-(L)1 drugs that have been launched in China and in the indication of nasopharyngeal carcinoma, tagolizumab is “late to the party”. As a PD-L1 introduced from Kangfang Bio in 2014, why did Kelun Biotech still launch it to the market despite being “late to the ...
- Source: drugdu
- 279
- February 5, 2025
Editing errors caused

In response to the duplication of data on consistency evaluation of some generic drugs reported by the media, on January 24, 2025, the Data Management Office of the Drug Evaluation Center of the National Medical Products Administration issued a “Correction Statement” stating that it was caused by editing errors and has been corrected. Earlier, according to the First Financial News, there was news online recently that the similarity of multiple bioavailability data of the consistency evaluation of generic drugs by the National Medical Products Administration has aroused concern. The reporter checked the website of the Drug Evaluation Center of the National Medical Products Administration and found that there were indeed two generic drugs with exactly the same bioequivalence data when searching for “Rosuvastatin Calcium Tablets” and “Trimetazidine Hydrochloride Tablets”. The “Correction Note” stated that recently, the center received reports from relevant media and companies that there were duplicate data on ...
- Source: drugdu
- 302
- February 5, 2025
Core product sales are gratifying, and innovative drug companies are gradually entering the harvest period

Benefiting from the gradual recovery of industry prosperity, the continuous development of overseas markets, and the implementation of favorable pharmaceutical policies, A-share biopharmaceutical companies will continue to write innovative transcripts in 2024 in the process of resilient development. Choice data shows that as of January 25, more than 200 A-share biopharmaceutical companies have released their 2024 performance forecasts. From the lower limit of the forecast net profit growth, a total of 108 companies are expected to make profits, of which 18 companies expect their net profits to double (excluding loss-making and loss-reducing). In addition, 18 companies including Baili Tianheng, Hisun Pharmaceutical, Sinovac Pharmaceuticals, and Sinocell are expected to turn losses into profits, and 29 companies including Changshan Pharmaceuticals and Novozymes have also achieved year-on-year loss reduction. Sales volume drives performance growth Specifically, among the pharmaceutical companies that have released performance forecasts, 40 are expected to achieve year-on-year growth in net ...
- Source: drugdu
- 329
- February 5, 2025
【EXPERT Q&A】What are the requirements of EU medical device CE audit for quality management system document control?

Drugdu.com expert’s response: The CE certification requirements for medical devices in the European Union (EU) are quite stringent in terms of quality management system (QMS) document control. Below is an overview of the specific requirements: I. Content and Requirements of QMS Documents Completeness: The QMS documents should include policies, procedures, guidelines, forms, records, etc., comprehensively covering all aspects of the quality management system. These documents need to detail and prove that the product complies with EU regulations and standards, including but not limited to product design descriptions, performance test reports, risk assessment reports, biocompatibility assessment reports, electromagnetic compatibility test reports, etc. Accuracy: The information in technical documents must be accurate and capable of truthfully reflecting the technical characteristics and safety performance of the product. Traceability: The QMS documents should ensure the traceability of product quality, including raw material sources, production processes, quality control, and other links. Continuous Improvement: The QMS ...
- Source: drugdu
- 337
- February 5, 2025
Tianyu Pharmaceutical’s Avatrombopag Maleate Bulk Drug Substance Passes CDE Review

On January 27, it was reported that Tianyu Pharmaceutical (300702) announced that its avatrombopag maleate bulk drug substance has recently passed the review of the Center for Drug Evaluation (CDE) of the National Medical Products Administration. This bulk drug substance belongs to chemical drug category 4, with the registration number Y20230000333, and the review result, jointly evaluated with the preparation, is A. The company submitted the registration application for avatrombopag maleate bulk drug substance to CDE in June 2023 and was accepted. Although this bulk drug substance has passed the CDE review, it still needs to obtain a “meeting requirements” result from the GMP compliance inspection by the Zhejiang Provincial Medical Products Administration before it can be launched and sold in China. Currently, 14 manufacturers in China have passed the CDE technical review. The company is preparing to apply for the GMP compliance inspection, and the time for market launch ...
- Source: drugdu
- 208
- February 4, 2025
Livzon Group’s Recombinant Human Follicle – Stimulating Hormone Accepted by the Drug Administration

On January 26, it was reported that Livzon Group (000513/01513) announced that the application for domestic drug production registration of the recombinant human follicle – stimulating hormone injection developed by its holding subsidiary, Zhuhai Livzon Mab Biotech Co., Ltd., has been accepted by the National Medical Products Administration. The specification of the accepted drug is 33μg (450IU)/0.75mL, and the registration category is 3.3 for therapeutic biological products. According to the announcement, the cumulative R & D cost of the recombinant human follicle – stimulating hormone injection has reached 104 million yuan. The announcement mentioned that the indications of the recombinant human follicle – stimulating hormone injection include anovulatory women, superovulation in assisted reproductive technology, and patients with severe luteinizing hormone and follicle – stimulating hormone deficiencies. The market demand for the drug has been continuously increasing due to the annual rise in the domestic infertility rate. In 2023, the domestic ...
- Source: drugdu
- 256
- February 4, 2025

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