Recently, Hu Zhihong, Wang Manli, Luo Minhua and Zeng Wenbo from the Wuhan Institute of Virology, Chinese Academy of Sciences, jointly published a research paper entitled “Efficient Strategy for Synthesizing Vector Free and Oncolytic Herpes Simplex Type 1 Viruses” on the international academic journal ACS Synthetic Biology. This research carried out the construction and optimization of an artificial synthesis platform based on type I herpes simplex virus type F, and used this platform to transform oncolytic viruses. Type I herpes simplex virus (HSV-1) has important application prospects as an oncolytic virus in cancer treatment. In this study, the research team developed a new method for efficient synthesis and rescue of HSV-1 virus. Unlike traditional methods of synthesizing complete genomes containing vector sequences in vitro and transfecting them into mammalian cells to rescue viruses, the research team synthesized HSV-1 genome fragments containing homologous arms through transformation related homologous recombination (TAR) in ...
The approval of HYMPAVZI is based on the results of a phase III trial study, which showed that compared with factor based prophylaxis and on-demand treatment, the drug can significantly reduce bleeding rates in eligible hemophilia A and hemophilia B patients without inhibitors. HYMPAVZI is the first weekly subcutaneous injection regimen provided in the United States for eligible hemophilia B patients. At the same time, it is also the first regular treatment provided to eligible hemophilia A and hemophilia B patients through pre filled injection pens or syringes. Recently, Pfizer’s innovative drug HYMPAVZI ™ Mataximab hncq has been approved by the US Food and Drug Administration (FDA) for the regular treatment of hemophilia A (congenital factor VIII deficiency) or hemophilia B (congenital factor IX deficiency) patients over 12 years old without coagulation factor inhibitors, in order to reduce bleeding episodes. HYMPAVZI is the first and only approved anti tissue factor ...
While the industry is still waiting to see whether the “zombie” approvals will really be eliminated, the new regulations of the National Medical Products Administration have provided a policy basis for the elimination of “zombie” approvals-On October 12, 2024, the National Medical Products Administration issued a notice on the application procedures and application materials requirements for re-registration of domestically produced drugs (No. 38 of 2024), which will be implemented from January 1, 2025. According to the new regulations on re-registration, three types of approvals will face the risk of delisting. The first type of risky products: “zombie” approvals, especially those with missing production scope and production address The “zombie” approvals mentioned above are very likely to be delisted: The “Application Procedures for Re-registration of Domestically Produced Drugs” clearly requires “strengthening the management of drugs that have not been produced on a commercial scale during the period from the approval of ...
On October 11, Yunnan Baiyao issued the “Announcement on the Appointment of Senior Management Personnel”, appointing Li Shengli as its senior vice president. Li Shengli has held important positions in many pharmaceutical companies, including general manager, president, CEO, and chairman of Jiangsu Wanbang Pharmaceutical Marketing Biochemical Oncology Division, co-president, president, and chairman of Jiangsu Fosun Pharmaceutical Sales Co., Ltd., assistant to the president, vice president, senior vice president, executive president, and chief development officer of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. The joining of Li Shengli once again verified the change in Yunnan Baiyao’s talent training model, from internal talent training to the “internal training + external introduction” dual-channel talent model, to create a high-quality talent team that meets its future development needs. Pharmaceutical companies have established their own talent training and selection system, and the company and employees understand each other, have high loyalty, and there is almost no ...
Recently, Ascentage Pharmaceuticals’ APG-2449 has obtained CDE approval and will conduct two registered Phase III clinical studies for the treatment of non-small cell lung cancer. APG-2449 is a small molecule FAK inhibitor independently developed by Ascentage Pharmaceuticals with oral activity. It is a third-generation ALK/ROS1 TKI and the first FAK inhibitor in China to be approved by CDE for clinical trials. This may mean that the node for domestic drugs to disrupt the ALK target pattern is getting closer and closer, and it also indicates that the next blockbuster product of China’s innovative drugs is on the way. The saying “He who gets lung cancer gets the world” is widely circulated in the field of tumors. Lung cancer is the leading cause of morbidity and mortality of malignant tumors in China. The large number of lung cancer patients has always been a must-fight place for pharmaceutical companies. This is also ...
Original Time Biopharmaceutical Editor October 14, 2024 09:20 Shanghai The weight loss drug concept stock Zealand has suffered another setback, as its new drug Dasiglucagon, which was launched to treat congenital hyperinsulinemia (CHI) in children, has once again been rejected by the FDA. Last December, Dasiglucagon was rejected by the FDA for the first time due to the discovery of defects in a third-party contract manufacturing factory. Zealand pointed out that the main reason for Dasiglucagon’s second rejection was that the FDA failed to complete the re inspection of third-party production factories, resulting in the approval process being put on hold. The FDA did not raise any concerns about the effectiveness or safety of Dasiglucagon. Dasiglucagon is a glucagon receptor (GCGR) agonist that acts to release stored glycogen from the liver into the bloodstream. Hypoglycemia is one of the most common acute complications of diabetes, and patients who have the ...
It is reported that the total investment of the production line is about 60 million yuan, and it is equipped with four fully automatic precision fermentation production lines. These production lines are all equipped with advanced automated separation and purification systems, which can monitor various key parameters in the production process in real time, ensuring comprehensive, efficient, and precise control of product quality. The successful delivery of this project not only demonstrates Sanxi Group’s profound technical accumulation in the field of synthetic biological equipment manufacturing, but also demonstrates its efficient project management and delivery capabilities. In recent years, with the continuous development of technologies such as gene editing and artificial intelligence, synthetic biology has sparked a new wave of research. Scientists have high hopes for this cutting-edge science, hoping to use this technology to improve human health, address food crises, alleviate global warming and other common problems faced by humanity. ...
The 2024 Nobel Prize in Physiology or Medicine has finally been announced, and surprisingly, the previously highly requested GLP-1 target and alphafold system have not been awarded, and the award-winning fields are similar to last year, which are pioneers in the field of RNA. Last year it was mRNA, this year it is microRNA. On October 7 at 5:30 p.m., the Sweden Carolinska Institutet announced that the 2024 Nobel Prize in Physiology or Medicine was awarded to Victor Ambros and Gary Ruvkun · · for their “discovery of microRNAs and their role in post-transcriptional gene regulation.” It is reported that the two are professors at the University of Massachusetts Medical School and Harvard Medical School, respectively. As we all know, the winner of the Nobel Prize needs to go through a long time from making relevant achievements to winning the Nobel Prize: the Nobel Prize needs time to test its ...
Zantac was originally a popular heartburn drug. From being popular all over the world to being withdrawn from the market due to carcinogenic risks, the years-long litigation disputes can be regarded as a slow and bumpy roller coaster for patients and manufacturers. This storm can be traced back to June 2019. At that time, Valisure discovered and informed the FDA during routine batch testing that the active ingredient ranitidine in Zantac would degrade under certain conditions and produce N-nitrosodimethylamine (NDMA), a Class 2A carcinogen. In September of the same year, Valisure formally submitted a citizen petition to the FDA, requesting the recall of all products containing ranitidine. Since then, Zantac has been deeply involved in the carcinogenic storm. The FDA further found that the higher the storage temperature or the longer the storage time of Zantac, the higher the risk of exceeding the standard of NDMA, which was originally very ...
More than 20 years ago, research on rare diseases and the treatment of rare diseases were very rare in the medical community. The small market size of rare diseases and the huge difficulty in research and development have made pharmaceutical companies shy away from this field. In the past 25 years, BioMarin has launched eight rare disease drugs with strong R&D capabilities. Arguably, this record is unmatched by few companies in the biotech industry. However, with the failure of the commercialization of its highly-anticipated hemophilia A gene therapy, Roctavian, a strategic review began. Since the beginning of this year, BioMarin has been in turmoil. Over the past nine months, there have been layoffs, executive restructuring, spending cuts, and research projects on hold. With the reshuffle of the business structure and the arrival of new competition, it remains to be seen when BioMarin will be able to get out of this ...
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