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【EXPERT Q&A】What requirements does the FDA have for the unique identification (UDI) of medical combination products?

Drugdu.com expert’s response: I. Which combination products does the FDA regulate? First, clarify the scope The FDA’s UDI rules primarily target medical device components, but combination products (such as drug – device combinations or device – drug co – packaged products) need to be treated differently based on their types. In simple terms: If the device is the main function in a combination product (for example, a drug – eluting stent, where the core is the stent): It must be labeled with a UDI, and the drug’s NDC code cannot be used as a substitute. If the drug is the main function (for example, a prefilled syringe, where the core is the drug inside): If it has already been labeled with an NDC code, the device part does not need to be additionally labeled with a UDI (but if the device components are sold separately, they still need to be ...
- Source: drugdu
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- November 5, 2025
to invest $3 billion in the Netherlands to build a new manufacturing facility and expand its oral drug production capacity.

November 3rd, ReiThe company announced plans to acquire Caterpillar in the Netherlands.Vic is investing $3 billion to build a new manufacturing facility to expand its oral drug production capacity and improve its global supply chain. Eli Lilly stated that the facility will be responsible for producing its first oral small-molecule GLP-1 receptor agonist, orforglipron. The company plans to submit applications for the drug’s use in obesity treatment to regulatory agencies worldwide by the end of this year. Eli Lilly also stated that the investment plan will create 500 high-paying jobs in South Holland, targeting highly skilled engineers, scientists, operations specialists, and laboratory technicians. In addition, approximately 1,500 new jobs are expected during construction. The project is scheduled to begin next year, with final implementation depending on the completion of government permits and local approvals. https://finance.eastmoney.com/a/202511033553774014.html
- Source: drugdu
- 112
- November 4, 2025
Pfizer files antitrust lawsuit to block Novo Nordisk’s acquisition of Metsera.

American pharmaceutical company PfizerFor Metsera and Novo NordiskA lawsuit has been filed against the two weight-loss drug companies .The latest merger agreement reached with the property developer violates U.S. federal antitrust laws. This is Pfizer ‘s second lawsuit in four days, aimed at preserving its acquisition agreement that was unexpectedly disrupted by Novo Nordisk . According to a complaint filed by Pfizer in the U.S. District Court for the District of Delaware on Monday, Pfizer alleges that Novo Nordisk, the maker of Ozempic , is planning a proposed acquisition of U.S. biopharmaceutical company Metsera, which would further solidify its leadership in the field of obesity treatments by killing a smaller competitor. The background to this event is that in September of this year, Pfizer announced that it had agreed to acquire Metera for $47.50 per share in cash, corresponding to an enterprise value of approximately $4.9 billion. If certain research and development targets are met, Pfizer will pay an additional $22.50 ...
- Source: drugdu
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- November 4, 2025
Livzon Pharmaceutical’s innovative quadrivalent recombinant protein influenza vaccine completes Phase I clinical trial with first cohort vaccination

Shanghai Securities News China Securities(Reporter Zhang Xue) On October 30, Livzon Pharmaceutical Group announced that its developed quadrivalent recombinant protein…influenzaThe LZSN2401 vaccine recently completed vaccination of the first cohort of subjects in its Phase I clinical trial, and subsequent cohort enrollment has successfully commenced. This vaccine is the world’s first adjuvanted quadrivalent recombinant protein influenza vaccine, and its development deeply integrated artificial intelligence.The technology, along with a significant breakthrough in adjuvant systems, promises to provide better protection for influenza prevention and control, especially for the elderly. According to the company, in the development of LZSN2401, Livzon Pharmaceutical applied artificial intelligence technology systems to process development and analysis method optimization, which greatly improved R&D efficiency and product quality, fully demonstrating the company’s strategic direction of using artificial intelligence to promote R&D efficiency in recent years. Qualcomm utilizes AI algorithms to analyze key process parameters.Through quantitative simulation and intelligent screening, the team optimized a process route that would have taken more than six months under the traditional model ...
- Source: drugdu
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- November 4, 2025
A recent study published in the international academic journal *Vaccines* shows that Sinovac’s varicella vaccine has a better safety profile than the control vaccine.

Reporters have learned that the internationally renowned academic journal *Vaccines* recently published a research paper entitled “Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Healthy Children Aged 12 to 15 Months.” This study is the first to use Beijing Sinovac Biotech…Sinovac Biotech’s (hereinafter referred to as “Sinovac”) varicella live attenuated vaccine was compared head-to-head with another control vaccine that has passed WHO prequalification. The results showed that Sinovac’s varicella live attenuated vaccine met the non-inferiority standard for immunogenicity and had better safety than the control vaccine. This study was a randomized, double-blind, positive-control, non-inferiority phase III clinical trial conducted at San Juan de Dios Hospital in the Philippines. A total of 484 healthy children aged 12 to 15 months were enrolled and randomly assigned to receive either one dose of Sinovac varicella attenuated live vaccine (239 cases) or control vaccine (245 cases). The primary evaluation factor was the varicella-zoster ...
- Source: drugdu
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- November 4, 2025
BIO-Europe Autumn

Organiser：EBD Group Inc. Time：November 3 – November 5, 2025 Address：Messeplatz 1, Postfach 277, A-1021 Wien, Vienna, Austria Exhibition hall：MESSE WIEN Exhibition Congress Centre Product range: Animal and plant pharmaceuticals, gene/cell therapy, bioinformatics, genomics/genetics, medical devices, nanotechnology, clinical research and laboratory services, platform technologies, chemistry, stem cell research, drug delivery, technology transfer, and pharmaceutical R&D. About BIO-Europe Autumn： The BIO-Europe Autumn in Austria is Europe’s most professional exhibition focusing on biotechnology, pharmaceuticals, and nutraceuticals. Held in different cities each autumn, the BIO conference brings together thousands of leaders from the biotechnology industry across multiple countries. The event aims to make every connection meaningful and targeted, fostering activities dedicated to achieving breakthroughs in biotechnology. The exhibitors at BIO-Europe Autumn in Austria span a wide range of sectors, including analytical services, the bioinformatics industry, cloud computing, software and hardware development, clinical research reporting/clinical data management, imaging software, and information technology. These ...
- Source: drugdu
- 134
- November 4, 2025
CAR-T therapy, a “sky-high priced cancer treatment,” may see a breakthrough in commercial insurance pricing negotiations this year.

At approximately 3 PM today, during the on-site negotiations for the 2025 National Reimbursement Drug List and the discussion on innovative drugs covered by commercial insurance…At the price negotiation meeting, representatives from HeYuan Biotech, unable to hide their joy after concluding price negotiations, told reporters from Cailian Press, “We’ve reached an agreement,” but the final result will still be subject to the final announcement by the National Healthcare Security Administration. This means that CAR-T drugs, including HeYuan Biotech’s Nakiorenzai injection, are expected to achieve a breakthrough in this year’s price negotiations for innovative drugs covered by commercial insurance. HeYuan Biotech’s Nakiorenzai injection was approved for marketing in 2023, and five CAR-T drugs, represented by Nakiorenzai, have all passed the preliminary review for the innovative drug list covered by commercial insurance this year. Due to its high price, CAR-T therapy has failed to enter the “threshold” of national medical insurance negotiations for the past four years. ...
- Source: drugdu
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- November 3, 2025
Hanyu Pharmaceuticals returned to profitability in the first three quarters, with overseas markets becoming the engine of growth.

Recently, Shenzhen Hanyu Pharmaceutical Co., Ltd.According to the third-quarter report of 2025 disclosed by Hanyu Pharmaceutical Co., Ltd. (hereinafter referred to as ” Hanyu Pharmaceutical “, 300199.SZ), the company suffered a net loss of 74.1171 million yuan in the quarter, a year-on-year decrease of 203.18%. However, the net profit for the first three quarters showed a significant increase, turning a profit compared to the same period last year. At the same time, the company’s cash flow continued to improve. According to the Economic Information Daily, Hanyu Pharmaceutical has suffered losses for three consecutive years, but its performance has continued to grow this year. It is currently accelerating its layout of peptide drugs, and overseas markets have become its growth engine. Net profit turned around year-on-year in the first three quarters Founded in April 2003, Hanyu Pharmaceutical is a national high-tech enterprise specializing in the research, development, production, and sales of ...
- Source: drugdu
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- November 3, 2025
Strategic Cooperation Agreement Reached with Shengsi Biotechnology; Subsidiary Granted Exclusive Distribution Rights for FRSW117 Product in Greater China

China Securities Intelligent Finance: Betta Pharmaceuticals(300558) announced on the evening of November 2 that, in order to further expand its new drug innovation technology platform and enrich its product pipeline layout, the company has reached a strategic cooperation with Jiangsu Shengsi Biopharmaceutical Co., Ltd. and Hangzhou Shengsi Biopharmaceutical Co., Ltd. (the latter two are collectively referred to as “Shengsi Biopharmaceutical”). Betta Pharmaceuticals will support Shengsi Biopharmaceutical in R&D, clinical trials, production, registration and sales promotion, and promote the R&D and commercialization of related products. On the same day, the company’s wholly-owned subsidiary, Zhejiang Beta Pharmaceutical Sales Co., Ltd., signed a “Commercial Cooperation Agreement” with Hangzhou Shengsi Biotechnology, and was granted the exclusive distribution rights for FRSW117 products in the Greater China region. According to the announcement, the target product FRSW117 is a therapeutic biological product.Class 1, intended for routine prophylaxis, on-demand treatment, and perioperative bleeding management in patients with hemophilia A, with prophylactic treatment ...
- Source: drugdu
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- November 3, 2025
Reached a project cooperation agreement with Neurocrine

On November 3, Yaojie Ankang announced on the Hong Kong Stock Exchange that Neurocrine Biosciences, Inc. ( NASDAQ: 00000)NBIX (“Neurocrine”) has entered into a patent transfer and research collaboration agreement with the Company for the payment of royalties in order to develop NLRP3 inhibitors for the treatment of a variety of diseases. Under the agreement, Neurocrine is granted exclusive rights outside Greater China to develop, manufacture, and commercialize its NLRP3 inhibitors from the Genecast NLRP3 drug platform, while the Company retains the rights to develop, manufacture, and commercialize NLRP3 inhibitors within Greater China. The Company will be entitled to an upfront payment under the agreement, and may receive further milestone payments related to R&D and sales milestones as Neurocrine’s development and commercialization progress. The total potential value of the agreement is US$881.5 million. The agreement further covers research collaboration between the parties to further develop NLRP3-related technologies. Source: https://finance.eastmoney.com/a/202511033552850633.html
- Source: drugdu
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- November 3, 2025

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