On September 26, Medtronic’s official website announced the launch of a new ECMO system called VitalFlow™. This is a configurable single-system ECMO solution built on simplicity and performance. According to the official website, the VitalFlow system has a large, intuitive touch screen that centrally displays real-time performance data, provides configurability, and uses the proven Medtronic Nautilus™ ECMO oxygenator design to achieve long-term stable performance. Medtronic said that the VitalFlow™ ECMO system bridges the gap between bedside care and in-hospital transportation, providing clinicians with an easier and smarter ECMO experience. Dr. Karim Bandali, president of the cardiac surgery business within the Medtronic cardiovascular product portfolio, believes that the VitalFlow system is simple and easy to use, allowing users with different comfort levels to serve patients confidently and efficiently. It can be easily moved between different departments of the hospital and has durable and reliable performance. In March 2024, Medtronic completed ...
In recent years, China’s blood gas analyzer market has shown a strong development trend, especially in critical illness, emergency and surgical scenarios, and the scale has expanded dramatically. At present, the market size of blood gas analysis in China is about 2.7 billion yuan, and the industry growth rate is about 20%. From the perspective of market share, imported brands have the first-mover advantage in R&D and market, according to the data reported by the China Research Institute of Puhua Industry Research Institute, about 80% of the current market share of the domestic blood gas analyzer market is still occupied by imported brands, mainly for Radiometer, Wolfen, Abbott, etc., and domestic brands are mainly represented by the head brand of blood gas. According to the statistics of the bidding network, in the first half of 2024, the scale and demand for blood gas equipment procurement across the country ...
RNA targeted drugs are a completely new category of drugs that are completely different from small molecule drugs and antibody drugs. On the one hand, they can target mRNA, ncRNA, and other intracellular proteins through gene silencing to inhibit their expression and achieve the goal of treating diseases; On the other hand, new generation vaccines and protein replacement therapies can also be developed based on mRNA. RNA targeted drugs are undoubtedly a strategic frontier in biopharmaceutical innovation, with broad potential application scenarios in the future. The production process technology of mRNA industrialization is particularly important for the widespread application and industrialization of mRNA. Based on this, this article will focus on the optimization strategies for the production process of RNA targeted drugs. Stability chemical modification enhances drug safety and efficacy For RNA targeted drugs, chemical modification (excluding tissue targeting ligands) mainly has two basic functions: firstly, chemical modification can significantly ...
In September, several domestic companies focused on the field of cell and gene therapy (CGT) announced progress in financing. This article will share basic information about its 7 companies based on publicly available materials. Xingsairui has successfully completed tens of millions of yuan in angel round financing On September 14th, Hangzhou Xingsai Ruizhen Biotechnology Co., Ltd. (hereinafter referred to as “Xingsai Ruizhen”) announced the completion of tens of millions of yuan in angel round financing and officially launched the angel+round financing plan! This round of financing is jointly invested by Fosun Pharma’s Rehabilitation Capital New Drug Innovation Fund and Chuangrui Investment Jiaxing Chuangyan Fund. This round of financing will be used for the continuous promotion of core pipelines and platforms, as well as the construction of the company’s team and research and development laboratories. Xingsai Ruizhen was founded in July 2022 and incubated by the New Drug Innovation ...
Since the discovery of cyclin-dependent kinases (CDKs), scientists have been trying to target them to disrupt cancer cell division and proliferation. Breast cancer in particular relies on this process to grow. Because of this, the first-generation CDK inhibitors targeting CDK4 and CDK6 have been very successful. In February 2015, palbociclib, the first CDK4/6 inhibitor developed by Pfizer, was approved for marketing in the United States for the treatment of locally advanced or metastatic breast cancer of HR/HER2-. There are many breast cancer patients, and in 2020, there were more than 2.3 million new breast cancer patients in the world, making it the world’s largest cancer type. Based on the large patient size, the sales scale of palbociclib is also considerable. In 2016, the sales of palbociclib in the first full year of marketing reached 2.135 billion US dollars, becoming a well-deserved blockbuster drug. Since then, CDK4/6 inhibitors of Eli ...
On September 25, Humanwell Pharmaceutical announced that it had received a “Notification Letter on the Company’s Application for Reorganization” from Wuhan Contemporary Technology Industry Group Co., Ltd. (hereinafter referred to as “Modern Technology”), the controlling shareholder of the company, the day before, and Wuhan Credit Risk Management Financing Guarantee Co., Ltd. and Tianjin Shengcao Law Firm had applied to the Intermediate People’s Court of Wuhan City, Hubei Province for the reorganization of Modern Technology. At present, Humanwell Pharma has not received the documents of the Wuhan Intermediate People’s Court on the acceptance of the above-mentioned application for reorganization, and it is not yet known whether the court will accept it and whether Modern Technology will enter the reorganization procedure in the future. In this regard, many investors took the lead in voting in favor, believing that the replacement of the major shareholder of Modern Technology will be more conducive to ...
On September 29, Shi Pharma Group signed an exclusive licensing agreement with Jiangsu Conri Pharma on the development and commercialization of JSKN003 in mainland China. JSKN003 is a HER2-targeting bispecific antibody-drug conjugate (ADC) with dual HER2 targeting, giving it stronger internalization induction and bystander killing effects, making it highly active against HER2-expressing tumors. Currently, JSKN003 is undergoing Phase I clinical trials in Australia and Phase I/II and Phase III clinical trials in China. Next, Jinmant Bio (a wholly-owned subsidiary of Chiatai Tianqing Pharmaceutical Group) will be granted exclusive license and sublicensing rights for the development, sales, promised sales, and commercialization of the product. They will bear all clinical development costs and become the sole marketing authorization holder for JSKN003 in Mainland China for that field. According to the agreement, Corning Jerry has the right to receive a total of up to 3.08 billion RMB in upfront and milestone payments, including ...
Mammalian sleep includes rapid eye movement sleep (REMS) and non rapid eye movement sleep (NREM). REMS is also known as paradoxical sleep. The characteristic of NREM is the high amplitude slow wave oscillation of the electroencephalogram, which reflects the synchronous transition of cortical neurons between depolarization rising state and hyperpolarization falling state. In contrast, REM is characterized by an increase in the average firing rate of cortical neurons, rapid oscillations and theta waves in the electroencephalogram, and loss of skeletal muscle activity (muscle tone imbalance). The brainstem’s brainstem is a key structure regulating REMS. Research on cats has shown that the perifocal coeruleus (LC) – α is a crucial region within the pontine tegmentum for inducing REM. Subsequent analysis showed that the subthalatoral nucleus (SLD) of rodents is homologous to LC – α in cats [6,7]. In SLD, inhibiting glutamatergic neurotransmission can reduce REMS levels and alleviate muscle tone ...
The analysis of pathogenic genetic variations has always been an important challenge in the field of human genetics. Single nucleotide mutations in genes related to Mendelian genetic diseases should be the easiest type of mutation to study in human genetics. However, for many disease genes, the clinical importance of at least half of single nucleotide mutations has not been determined, seriously affecting the diagnostic efficiency of genetic diseases, especially rare genetic diseases. Deep mutational screening (DMS) refers to a research method that generates large-scale gene variations through saturation mutagenesis and then studies genetic variations in cell lines through high-throughput methods. This method can greatly accelerate the diagnosis of genetic diseases and deepen our understanding of the clinical importance of single nucleotide mutations. However, the cost and complexity of current deep mutation screening methods hinder their widespread application in clinical research. On September 25, 2024, Monkol Lek’s team from Yale ...
Drugdu.com expert’s response: FDA medical device consensus standards play a pivotal role in the medical device industry. Ⅰ. The Role of FDA Medical Device Consensus Standards Ensuring Safety and Effectiveness: These standards assist manufacturers in ensuring that their medical devices meet safety and effectiveness requirements during design, manufacturing, and usage, thereby safeguarding the health of patients and users. Streamlining Regulatory Processes: Manufacturers can leverage these consensus standards to fulfill FDA regulatory requirements, reducing the need for redundant testing and evaluations, which accelerates pre-market approval timelines. Enhancing Transparency: Consensus standards provide clear benchmarks for medical device performance and safety, contributing to increased industry transparency and fostering fair competition. Facilitating International Harmonization: Many FDA-recognized medical device consensus standards are international, simplifying international trade and market access, thereby promoting coordinated development of the global medical device market. Ⅱ. Definition of FDA Medical Device Consensus Standards FDA medical device consensus standards refer to a ...
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