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The result exceeded expectations, but AstraZeneca’s “life-saving drug” was still rejected by the FDA

Recently, AstraZeneca announced that the FDA rejected the full approval of its drug Andexxa. It is worth mentioning that the drug was applied for listing in China in December last year. In 2018, Andexxa was approved by the FDA for accelerated listing in the United States, and the following year it won conditional approval from the European Union for the treatment of acute bleeding complications caused by apixaban and rivaroxaban. It is the first and only treatment method that can specifically reverse the activity of FXa inhibitors and achieve hemostasis. It can be said to be a “life-saving drug” in clinical practice. In 2021, AstraZeneca acquired the rare disease giant Alexion for US$39 billion, and Andexxa became a drug under AstraZeneca. Last year, Andexxa contributed US$182 million in sales to AstraZeneca, a year-on-year increase of 23%. In its reply letter, the FDA pointed out that the rejection was because the ...
- Source: drugdu
- 40
- December 24, 2024
TIHE

Organiser：ITE Group Plc (UK) Time：April 15 – 17, 2025 Address：5, Furkat str., Shaykhontour district, Tashkent Exhibition hall：Navruz Palace Product range: Pharmaceuticals, herbal preparations, nutritional supplements including minerals and vitamins, dietary nutrition products, homeopathic preparations, dermatological preparations, maternal and child healthcare products and infant formula, personal hygiene products, incontinence products, medical consumables, pharmaceutical manufacturing and equipment, medical devices, laboratory equipment and instruments, medical electronic equipment, surgical instruments, ophthalmic equipment and protective products, emergency and first-aid equipment, hospital, dental, and medical facilities About TIHE： The Tashkent International Healthcare Exhibition (TIHE) is a renowned professional medical exhibition in Central Asia. It has significantly promoted the development of the medical and pharmaceutical industries in Uzbekistan and Central Asia, establishing the region as one of the markets with the greatest development potential. TIHE is held concurrently with the Uzbekistan Dental Exhibition. Since its inception, it has received strong support from the Ministry of ...
- Source: drugdu
- 39
- December 24, 2024
Merck’s long-acting RSV antibody therapy submitted for marketing application

Reducing RSV-related hospitalization rates by more than 80%, FDA accepts Merck’s long-acting antibody therapy marketing application Merck (MSD) announced today that the U.S. FDA has accepted the company’s biologics license application (BLA) for the investigational preventive long-acting monoclonal antibody clesrovimab (MK-1654), which is designed to protect infants from RSV disease during their first respiratory syncytial virus (RSV) season. The FDA is scheduled to complete the review by June 10, 2025. Clesrovimab is an extended half-life monoclonal antibody under investigation for the prevention of RSV disease as a passive immunization method. The application is based on the results of the pivotal Phase 2b/3 clinical trial CLEVER, a randomized, placebo-controlled trial evaluating the effect of a single dose of clesrovimab in healthy premature and full-term infants; and interim results of the ongoing Phase 3 clinical trial SMART, which evaluates the safety and efficacy of clesrovimab compared with palivizumab in high-risk infants and ...
- Source: drugdu
- 49
- December 23, 2024
After buying four years of performance, Kangchen Pharmaceuticals finally suffered a goodwill explosion

On the evening of December 16, Kangchen Pharmaceuticals issued an announcement. First, it will make an impairment provision for the goodwill formed by the acquisition of Tailing International’s equity; second, the “Annual Production of 500kg Anti-tumor API Production Base Construction Project” (hereinafter referred to as the “API Project”) is expected to be extended to December 2026. At the opening of December 17, Kangchen Pharmaceuticals’ stock price fell by more than 2%. As of the close, Kangchen Pharmaceuticals reported 25.9 yuan/share, down 3.61%, and the current market value is 4.144 billion yuan. In fact, Kangchen Pharmaceuticals has acquired Tailing International’s equity for four years. In April 2020, Kangchen Pharmaceuticals acquired 100% of Tailing International’s equity by paying 900 million yuan in cash, thereby obtaining the “Migaix” business. After acquiring Tailing International, Kangchen Pharmaceuticals has conducted impairment tests on the goodwill formed every year. As of now, the company has not made ...
- Source: drugdu
- 44
- December 23, 2024
The first wholly foreign-owned tertiary general hospital was established in Tianjin

According to Xinhua News Agency, Tianjin (reporters Zhang Jianxin and Bai Jiali), on December 16, Tianjin issued the first wholly foreign-owned tertiary general hospital medical institution practice license, and Perennial General Hospital (Tianjin Perennial Hospital) became the first wholly foreign-owned tertiary general hospital in my country. At the end of November this year, the National Health Commission, the Ministry of Commerce, the State Administration of Traditional Chinese Medicine, and the National Center for Disease Control and Prevention announced the “Pilot Work Plan for Expanding the Opening of Wholly Foreign-Owned Hospitals”. Previously, relevant departments have proposed to allow the establishment of wholly foreign-owned hospitals in Beijing, Tianjin, Shanghai and other places (except for traditional Chinese medicine, excluding mergers and acquisitions of public hospitals). Tianjin Perennial Hospital was invested and built by Singapore Perennial Group with a total investment of approximately RMB 1 billion and 500 beds. It not only has special ...
- Source: drugdu
- 42
- December 23, 2024
Legendary liver disease drug falls from the altar

Ocaliva (obeticholic acid), which started as a blockbuster liver disease therapy and attracted much attention for its great potential in MASH treatment, will further fade away at the end of 2024. Not only did the “bad” news come one after another, but it also came from the two regulatory agencies covering the European and American markets, the FDA and the EMA. However, looking back at the development history of obeticholic acid, it is actually not smooth. Since it was approved for the treatment of primary cholangitis (PBC) in 2016, Intercept has tried twice to expand the drug to MASH, but both attempts failed. This made Intercept completely abandon the MASH project and lay off one-third of its employees. Later, Intercept was acquired by the Italian pharmaceutical company Alfasigma, but the change of destination did not improve the fate of obeticholic acid. And with the first PPAR agonist Elafibranor approved by ...
- Source: drugdu
- 41
- December 23, 2024
【EXPERT Q&A】What is the development process of a qualified medical device?

Drugdu.com expert’s response: The development process of a qualified medical device typically includes the following key steps: Ⅰ. Preliminary Preparations Business Registration: Register the company and clarify the business scope to prepare for future product production ranges and avoid subsequent changes. Team Formation: Establish a professional and efficient R&D team, including talents in mechanical engineering, electrical engineering, software engineering, etc., to ensure the technical feasibility of the product. Ⅱ. Product Development and Design Product Requirement Determination: Conduct market research, clinical application scenario analysis, doctor visits, etc., by the product manager to clarify the product’s functional requirements, performance requirements, and user expectations. System Requirement Determination: Convert product requirements into engineering technical indicators, complete the division of system functional architecture and constituent components, and output related requirements for regulations and standards, risk and safety, usability, serviceability, and manufacturability. R&D and Design: Based on system requirements, carry out structural design, sampling verification, and ...
- Source: drugdu
- 44
- December 23, 2024
Yingtai Medical acquires Weiqiang Medical

Yingtai Medical (01501. HK) recently announced that the company has signed a letter of intent to acquire its target company Hangzhou Weiqiang Medical Technology Co., Ltd. and its affiliated group companies on December 18, 2024. According to the terms of the agreement, Yingtai Medical plans to acquire at least 51% of the controlling stake in Weiqiang Medical through capital increase, share expansion, and acquisition of shares from some shareholders. This transaction also stipulates that Yingtai Medical will inject no less than RMB 200 million in new funds into Weiqiang Medical after the acquisition is completed, and must pay a prepayment of RMB 30 million after the agreement takes effect. Weiqiang Medical has attracted much attention for its outstanding product development and clinical integration capabilities. In its product line, it includes Professor Guo Wei’s WeFlow Branch split type thoracic aortic stent graft from 301 Hospital, and Professor Fu Weiguo’s Fabulous stent ...
- Source: drugdu
- 52
- December 21, 2024
4 innovative medical devices approved for market launch

Recently, the National Medical Products Administration approved the registration applications for four innovative products: Changsha Huiwei Intelligent Medical Technology Co., Ltd. (hereinafter referred to as “Changsha Huiwei Intelligent”)’s “Intestinal Polyp Electronic Lower Digestive Endoscopy Image Assisted Detection Software”, Shanghai Minimally Invasive Melody Medical Technology Co., Ltd. (hereinafter referred to as “Minimally Invasive Melody”)’s “Spinning Intervention Therapy Device” and “Disposable Coronary Spinning Grinding Catheter”, and Hunan Aptech Medical Equipment Co., Ltd. (hereinafter referred to as “Aptech Medical”)’s “Disposable Magnetoelectric Positioning Pressure Monitoring Pulse Electric Field Ablation Catheter”.  Changsha Huiwei Intelligence, another heavyweight product approved Changsha Huiwei Intelligent was established in 2020 and is a wholly-owned subsidiary of Suzhou Huiwei Intelligent Medical Technology Co., Ltd. (hereinafter referred to as “Huiwei Intelligent”). Huiwei Intelligent was established in June 2019, specializing in the research and development, production, and sales of intelligent medical products. Driven by independent core technologies in the fields of “artificial ...
- Source: drugdu
- 50
- December 21, 2024
Once a month, potential “best-in-class” lipid-lowering drugs apply for listing

Today, LIB Therapeutics announced that it has submitted a biologics license application (BLA) to the U.S. FDA, seeking approval for its third-generation PCSK9 inhibitor lerodalcibep to lower low-density lipoprotein cholesterol (LDL-C) to treat patients with atherosclerotic cardiovascular disease (ASCVD), as well as patients with very high or high ASCVD risk and primary hyperlipidemia (including heterozygous and homozygous familial hypercholesterolemia, HeFH/HoFH). At the same time, LIB Therapeutics is preparing to submit a marketing application (MAA) to the European Medicines Agency (EMA), which is expected to be completed in mid-2025. Cardiovascular disease (CVD) affects hundreds of millions of people worldwide, and the number of related deaths exceeds the sum of cancer, chronic lung disease and diabetes. It is estimated that by addressing the factors that cause or aggravate CVD, about 80% of premature deaths caused by CVD can be prevented. ASCVD accounts for approximately 85% of all cardiovascular deaths. ASCVD is caused ...
- Source: drugdu
- 49
- December 21, 2024

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