Search Results for “FDA” – Page 89 – media

How to select T cell targeted antibodies in the strategy of antibody conjugated LNP (Ab LNP) for mRNA CAR-T therapy

Biological Products Circle September 3, 2024 09:20 Hubei The following article is from the Engineering Bacteria Planet, written by the author Yaojun, who has doubled in numberCurrently, the FDA has approved multiple chimeric antigen receptor (CAR) – T-cell therapies for cancer immunotherapy. However, the production technology based on viral vectors and in vitro cell culture has led to high production costs and potential long-term side effects. With the development of mRNA and lipid nanoparticle (LNP) technology, the idea of in vivo delivery of CARs based on LNP, a non viral vector, is expected to be realized. The primary challenge faced by mRNA LNP mediated CAR-T therapy due to its liver tropism is how to achieve mRNA T cell targeting The use of antibody modified LNP (also known as antibody conjugated LNP, Ab LNP) is an effective solution. So, what are the markers on the surface of T cells and how ...
- Source: drugdu
- 81
- September 4, 2024
【EXPERT Q&A】Where to check pharmacovigilance data?

Drugdu.com expert’s response: Regarding the inquiry of pharmacovigilance data, you can access the following specific agencies: Ⅰ. National Medical Products Administration (NMPA) and Its Subsidiaries 1. NMPA Official Website: Each year, the NMPA releases the “Annual Report on National Adverse Drug Reaction Monitoring,” which informs the public of the annual status of adverse drug reaction monitoring in China. These reports and related pharmacovigilance information can be found on the NMPA’s official website (nmpa.gov.cn). 2. National Center for Adverse Drug Reaction Monitoring (NCADR): The NCADR regularly compiles and publishes domestic pharmacovigilance information, as well as international pharmacovigilance alerts. This information can also be accessed on the NMPA’s official website or the NCADR’s official website (cdr-adr.org.cn). Ⅱ. Local Governments and Agencies Some local governments or drug regulatory agencies may have established their own pharmacovigilance databases or information platforms. For instance, Shandong Province has the “Medication ‘Alert’ Platform,” which utilizes information technology to provide ...
- Source: drugdu
- 77
- September 4, 2024
Down payment of 150 million! Non small cell lung cancer pipeline BD+1

On August 30, 2024, Shanghai Iris Pharmaceutical Technology Co., Ltd. (Iris) (688578. SH) signed a strategic cooperation agreement with Carcos Pharmaceutical (1167. HK). Iris obtained the exclusive license to research, develop, produce, register and commercialize the KRAS G12C inhibitor Golarese and SHP2 inhibitor JAB-3312 in China (including Chinese Mainland, Hong Kong, Macao and Taiwan). According to the terms of the agreement, Elys will pay 150 million yuan in head of state payments, up to 700 million yuan in development and sales milestone payments, and double-digit sales commissions to Gakos for this authorization, including value-added tax. Established in 2004, Elise is an innovative pharmaceutical company dedicated to providing unmet clinical needs for patients worldwide. It was listed on the Shanghai Stock Exchange’s Science and Technology Innovation Board in 2020. Since its establishment, the company has adhered to independent innovation and established a complete new drug research and development system, covering various ...
- Source: drugdu
- 115
- September 3, 2024
BeiGene’s “BTK Double Swords” Unleashed

When it comes to BeiGene’s BTK, you will think of zanubrutinib without thinking, but BeiGene’s BTK inhibitors are not limited to zanubrutinib. BGB-16673, which is under development in the pipeline, is another potential “sharp sword”. Recently, BeiGene’s BTK PROTAC molecule BGB-16673 was granted fast track qualification by the FDA for CLL/SLL patients who have undergone at least two lines of treatment, including BTK inhibitors and Bcl-2 inhibitors. Since the first BTK inhibitor ibrutinib was approved for marketing in 2013, 6 BTK inhibitors have been approved for marketing worldwide. Although many BTK inhibitors have been approved for marketing and these drugs have demonstrated excellent efficacy, they still have certain limitations, namely the problem of drug resistance. PROTAC (protein degradation) has been a very hot research and development track in recent years. Compared with small molecule inhibitors, PROTAC degraders have many advantages: they expand the druggable targets and can target target proteins ...
- Source: drugdu
- 73
- September 3, 2024
Tumor drugs without OS are also hanging in China

Before this, furiquintinib was regarded as another effective treatment option for gastric cancer patients. After all, gastric cancer is the fifth most common cancer in the world, and my country is a country with a high incidence of gastric cancer, with a large number of patients. With the continuous development of precision medicine, PD-1 combined with chemotherapy has become a new standard for first-line treatment of advanced gastric cancer. However, both in China and around the world, there is still a lack of treatment options available for second-line and above patients. Global pharmaceutical companies have deployed a large number of research in this field to promote clinical trials including PD-1, ADC, and VEGFR inhibitors. Among them, VEGFR inhibitors play a vital role in inhibiting tumor angiogenesis, and studies have shown that gastric cancer tissues often express high levels of VEGF, which is associated with more advanced disease and poor prognosis. ...
- Source: drugdu
- 73
- September 3, 2024
Fulbright Medicalwithdraws its application for issuance and listing

On August 23rd, the IPO review status of Jiangsu Fulbright Medical Equipment Co., Ltd. (referred to as Fulbright Medical) on the Science and Technology Innovation Board of the Shanghai Stock Exchange changed to “terminated”. Due to the withdrawal of the issuance and listing application by Fulbright Medical and its sponsor, in accordance with Article 63 of the Shanghai Stock Exchange’s Stock Issuance and Listing Review Rules, the Shanghai Stock Exchange has terminated its issuance and listing review. The Shanghai Stock Exchange issued an inquiry letter on July 23, 2023 regarding the review of the application documents for the initial public offering and listing of Jiangsu Fulbright Medical Equipment Co., Ltd. on the Science and Technology Innovation Board, requiring Fulbright Medical to respond to multiple questions regarding its main products, market, volume based procurement, core technology, and more. On January 17, 2024, Fulbright Medical updated its response to the first round ...
- Source: drugdu
- 67
- August 31, 2024
Chongqing’s first Class 1 innovative biological drug is launched

On August 27, Chongqing’s first Class 1 biological innovative drug, Celici monoclonal antibody injection, was approved for marketing, achieving a “zero” breakthrough in Chongqing’s biological product innovative drug track. According to Zhixiang Jintai’s official microblog, Celici monoclonal antibody injection is its first product approved for marketing and the first fully human IL-17A target drug in China. Indications for the birth of the “king of medicine” Moderate to severe plaque psoriasis as an indication is regarded as the “Gold Coast” in the field of autoimmune indications. The former “king of medicine” Humira was born from it. Due to the complexity of the psoriasis pathway itself, there are also many antigens that can be targeted in the pathway. The more typical one is the previous generation of “king of medicine” Humira. Adalimumab is a monoclonal antibody targeting TNF-α. This target has a wide range of adaptability for autoimmune diseases. Its indications range ...
- Source: drugdu
- 67
- August 31, 2024
Treatment of small cell lung cancer enters a period of accelerated breakthroughs

In the field of tumors, any breakthrough is not easy. Although humans have discovered cancer for a long time, chemotherapy has long been the core treatment method. Of course, after countless failures and dashed hopes, once there is a breakthrough, the progress is often unexpected. For example, after decades of silence, the treatment of small cell carcinoma seems to have ushered in a period of accelerated breakthroughs. On August 15, AstraZeneca announced that its drug durvalumab has been accepted by the FDA for the indication of limited small cell lung cancer (LS-SCLC). If approved for marketing, this will be the first immunotherapy in 40 years to show survival benefits in this field, representing an important breakthrough. For limited-stage SCLC, the current first-line treatment is still chemoradiotherapy, especially the treatment of cisplatin combined with etoposide, which occupies an absolute dominant position in treatment. Amgen has also made progress in the field ...
- Source: drugdu
- 91
- August 31, 2024
Siemens Healthineers plans to acquire Novartis’ diagnostic business for €200 million

Recently, according to the Financial Times, Siemens Healthineers plans to acquire the diagnostic business of Advanced Accelerator Applications (AAA), a subsidiary of Novartis, for 200 million euros (approximately 1.593 billion yuan). AAA specializes in producing radioactive nuclide drugs, also known as nuclear drugs, for molecular imaging equipment PET (positron emission tomography). The transaction is expected to be completed in the fourth quarter. Expand business territory AAA was spun off from the European Organization for Nuclear Research (CERN) in 2002 and is an innovative radiopharmaceutical company focused on targeted radioligand therapy, precise radioligand imaging, and molecular imaging product development. Its main focus is on the development, production, and commercial application of Molecular Nuclear Medicine (MNM) products. On October 30, 2017, Novartis acquired the company for $3.9 billion to strengthen its radiopharmaceutical business capabilities, making AAA a subsidiary of Novartis. After years of development, AAA has built a pipeline covering various diagnostic ...
- Source: drugdu
- 87
- August 30, 2024
SynaptixBio awarded £2m BioMedical Catalyst grant from Innovate UK

Oxford-based SynaptixBio has been awarded a £2m BioMedical Catalyst grant from Innovate UK to support first-in-human clinical trials of its therapeutic targeting H-ABC, the most severe form of TUBB4A leukodystrophy. In November 2023, SynaptixBio received an earlier grant from Innovate UK to expand its search for rare disease therapies. The company was given a second Orphan Drug Designation from the US FDA in February this year for a therapy targeting Isolated Hypomyelination – a less severe form of TUBB4A leukodystrophy. In the UK, a rare disease is defined as a condition that affects fewer than one in 2,000 in the population and SynaptixBio is the only company licensed to commercialise a treatment for this rare, deadly and currently incurable disease. Currently, there is no cure for TUBB4A-related leukodystrophies, a group of rare neurodegenerative caused by mutations in the TUBB4A gene. The diseases result in disruption to the signals between nerve ...
- Source: drugdu
- 65
- August 28, 2024

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