Merck and Pfizer have announced a second accelerated approval in the US for Bavencio in less than two months, in this instance for certain patients with metastatic urothelial carcinoma.
Breakthrough treatment varieties refer to innovative drugs or improved new drugs used to prevent and treat diseases that seriously endanger life or seriously affect quality of life, and for which there are no effective prevention and treatment methods or sufficient evidence to show significant clinical advantages compared to existing treatment methods. After obtaining this recognition, it can accelerate the review process, accelerate the drug development process, and solve the unmet clinical needs of patients. In the past October, the CDE official website plans to include 5 breakthrough therapy varieties, including 1 therapeutic vaccine, 3 ADC drugs, and 1 monoclonal antibody drug. The following are introductions to 5 innovative drugs for reference only. 1. TVAX-008: Hepatitis B On October 14th, Nanjing Yuanda Weixin Biopharmaceutical Co., Ltd. TVAX-008 applied to be included in the breakthrough treatment category, suitable for the treatment of chronic hepatitis B virus (HBV) infection. TVAX-008 is a therapeutic ...
Recently, the National Medical Products Administration announced the approval of the registration applications for two innovative products, Yabonixi Medical Technology (Suzhou) Co., Ltd.’s “knee joint prosthesis system” and Shanghai Xinwei Medical Technology Co., Ltd.’s “intracranial aneurysm embolization assisted stent”. Yabonixi Medical offers freedom of movement in all aspects Yabonixi Medical is a wholly-owned subsidiary of Jiaoying Medical Equipment (Shanghai) Co., Ltd., dedicated to the research, development, production, and sales of high-end orthopedic medical equipment, minimally invasive surgical medical equipment, and more. Yabonixi Medical was founded by Dr. Yao Jianqing, a leading figure in the international orthopedic field. It is reported that Yao Jianqing is an experienced veteran in the field of medical devices, with 36 years of rich experience in medical device and tissue engineering research and industrialization. He has served as the Global R&D Senior Director and Asia Pacific R&D Senior Director of ZimmerBiomet, a joint company. Yao Jianqing ...
Drugdu.com expert’s response: Non-conformities in the quality management system for medical devices refer to situations where an activity or its outcome in the quality management system activities related to medical device production, sales, and after-sales service fails to meet established requirements or standards. These requirements or standards typically originate from relevant regulations, standards, contracts, and internal quality management system documents of the enterprise. Non-conformities can manifest in various forms, including but not limited to non-conformities related to documents, products, processes, personnel, environments, records, and data. Specifically, non-conformities in the quality management system for medical devices may involve the following aspects: Document Non-conformity: Quality management system documents do not comply with applicable laws, regulations, standards, or contracts. For instance, there may be no documented corrective action control procedure established, no clear review of nonconformities (including customer complaints), no determination of the causes of nonconformities, no evaluation of measures needed to ensure ...
Recently, the Q3 financial reports of MNCs have been released one after another, and some are happy and some are sad. When a number of MNCs began to lower their full-year EPS, Amgen’s Q3 financial report earnings gave a high score answer sheet. Among them, Amgen’s total revenue in the third quarter increased by 23%, and its GAAP net earnings per share (EPS) increased by 62% year-on-year, from US$3.22 to US$5.22. What is more imaginative is that with the data catalysis of the new macromolecular weight loss drug AMG133, this macromolecular antibody that goes against the grain and antagonizes GIPR may become Amgen’s next gold mine. According to Amgen’s Q3 2024 financial report, the most significant year-on-year growth is LUMAKRAS (AMG510) – a targeted drug for KRASG12C mutation-positive lung cancer. The sales ceiling of this gene mutation in European and American countries will be much higher than that in Asian ...
Recently, Beijing Tong Ren Tang issued an announcement on foreign investment, stating that its holding subsidiary Beijing Tong Ren Tang Commercial intends to sign a “Share Transfer Agreement” with Honghui Technology, Daopei Hongde, Honghui Pharmaceutical, Wang Desheng and Wang Aixiao, and intends to pay about 105 million yuan to acquire Honghui Technology’s 51% stake in Honghui Pharmaceutical. As a pharmaceutical and medical device operating company, Honghui Pharmaceutical was established in 1994 and is mainly engaged in pharmaceutical research and development, pharmaceutical production and sales, and medical device operations. The performance in the first half of 2024 showed that Honghui Pharmaceutical achieved revenue of 844 million yuan and net profit of 25.5713 million yuan (unaudited). In 2023, Honghui Pharmaceutical achieved a net profit of 228 million yuan (unaudited). At present, Honghui Pharmaceutical is still a long way from catching up with last year’s full-year net profit. Tong Ren Tang is a ...
On October 30, Xi’an Xintong Pharmaceutical Research Co., Ltd. held a press conference in the Silk Road Innovation and Smart Valley of Xi’an High-tech Zone to announce the approval of “Xinshi Mu,” a first-class innovative drug targeting hepatitis B. It is the commercial name approved for the drug Preadfovir mesylate tablets, which is indicated for the treatment of chronic hepatitis B in adults. The drug utilizes the HepDirect liver-targeted delivery system to concentrate the active ingredients in the target organ, enhancing efficacy and reducing toxicity. This makes it the world’s first approved liver-targeted innovative drug for hepatitis B. Zhang Denge, chairman of Xintong Pharmaceutical, stated that “Xinshi Mu” is part of the national major new drug creation projects during the 12th and 13th Five-Year Plans, with research beginning in 2011, and it took 13 years to gain approval for market release. Wang Liping, the Drug Safety Director of the Shaanxi ...
The development of therapies for Alzheimer’s disease has always caused many developers to feel exhausted, and now AbbVie has also increased its investment in neurodegenerative diseases. AbbVie has agreed to spend $1.4 billion to acquire Aliada Therapeutics, whose main acquisition asset is Aliada’s authorized Alzheimer’s disease candidate drug ALIA-1758 from Johnson&Johnson. Its mechanism of action is still an anti beta amyloid protein (3pE-A β) antibody, but the unique feature of ALIA-1758 is that it can cross the blood-brain barrier, greatly improving the brain’s absorption rate. Aliada started a phase 1 trial among healthy volunteers in May, but AbbVie believes the timing is ripe for acquisition. Previously, AbbVie made the decision to abandon its internal Alzheimer’s disease asset ABBV-916. This anti beta amyloid antibody has no significant difference in safety and efficacy compared to the already marketed monoclonal antibody therapy for Alzheimer’s disease. Therefore, AbbVie decided to terminate the development ...
Organiser:Pharmaceutical Research and Manufacturers of America (PhRMA) Time: April 1st – 3rd, 2025 Address:655 West 34th Street, New York, NY 10001-1188, USA Exhibition hall:Javits Convention Center, NYC Product range: Active Pharmaceutical Ingredients (APIs): Vitamins, hormones, cephalosporins, macrolides, central nervous system drugs, and other western medicine raw materials Excipients & Dosage Forms: Excipients, fluids, enteric coatings, antioxidants, sweeteners, osmotic agents, preservatives, disintegrants, clarifiers, pH adjusters, etc. Natural Extracts: Plant extracts, animal extracts, dietary fibers, cosmetic ingredients About Interphex: Interphex, the Biopharmaceutical Manufacturing & Technology Exhibition in New York, USA, is a leading event in the pharmaceutical and biotechnology industries, merging industry innovations with expert-led conferences. Since its inception in 1979, it has been the most trusted life science exhibition across both chemical and biopharmaceutical sectors in North America. Exhibitors have the opportunity to meet with decision-makers from top pharmaceutical companies worldwide through this exhibition.
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