Search Results for “immune” – Page 18 – media

【EXPERT Q&A】What are the advantages and disadvantages of antibody drugs versus RNA drugs?

Drugdu.com expert’s response: Antibody drugs and RNA drugs are two distinct categories of biotechnology medications, each possessing unique strengths and weaknesses. Below is a detailed analysis of their respective advantages and disadvantages: Ⅰ. Advantages of Antibody Drugs High Specificity: Antibody drugs can specifically recognize and bind to target antigens, typically proteins on cell surfaces, providing a high degree of selectivity that minimizes damage to normal cells. Long-lasting Effect: Antibody drugs typically have longer half-lives, enabling extended duration of action within the body, reducing the frequency of dosing and enhancing patient convenience. Low Immunogenicity: Fully humanized antibody drugs exhibit lower immunogenicity, mitigating the risk of immune reactions and improving drug tolerability and safety. High Success Rate: In clinical studies, antibody drugs demonstrate significantly higher success rates compared to traditional small-molecule chemical drugs. In the US, approximately 25%-30% of large-molecule drugs (including antibody drugs) entering clinical trials are ultimately approved for market, ...
- Source: drugdu
- 76
- September 2, 2024
The Nation’s First Stem Cell Drug Production License Issued Cell Therapy Track to Meet the Development Opportunities

Beijing Drug Administration held a half-year working meeting, at which the work of issuing the country’s first stem cell “drug production license” was particularly recognized. According to the search results of “Administrative License Information” on the website of Beijing Drug Administration, Platinum Bio-Excellence Biotechnology (Beijing) Co., Ltd. is the first company to obtain the national stem cell drug production license. The issuance of the Drug Manufacturing License is of epoch-making significance as it is the first drug manufacturing license specifically for stem cell drugs in China. The issuance of the Drug Manufacturing License signifies that the relevant enterprise has obtained the legal qualification and ability to manufacture stem cell drugs. In recent years, with the introduction of policies such as the “14th Five-Year Plan” for the development of bio-economy, China has clearly put forward the development of new technologies such as stem cell therapy, strengthening the synergy between industry, academia, ...
- Source: drugdu
- 72
- September 2, 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
- 74
- August 31, 2024
Celltrion’s SteQeyma receives EC approval for chronic inflammatory diseases

The European Commission (EC) has approved Celltrion‘s SteQeyma (CT-P43), a biosimilar to Stelara (ustekinumab), for treating various chronic inflammatory conditions. This approval, which encompasses gastroenterology, dermatology, and rheumatology indications, follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June this year. SteQeyma, previously known as CT-P43, acts as an antagonist to human IL-12 and IL-23, addressing multiple immune-mediated diseases. It is available in subcutaneous and intravenous formulations, with the subcutaneous injection offered in 45mg/0.5ml or 90mg/1ml strengths in a single-dose, prefilled syringe. The intravenous infusion is available as a 130mg/26ml (5mg/ml) solution in a single-dose vial. Stelara, the reference product for SteQeyma, is a biologic therapy targeting interleukin (IL)-12 and IL-23 cytokines, crucial in inflammatory and immune responses. The EC’s decision is grounded on comprehensive evidence, including a Phase III trial in adults with moderate to severe plaque ...
- Source: drugdu
- 118
- August 28, 2024
FDA declines to approve Regeneron’s linvoseltamab amid manufacturing issues

The US Food and Drug Administration (FDA) has declined to approve Regeneron Pharmaceuticals’ multiple myeloma candidate linvoseltamab following an issue at a third-party manufacturing site. The complete response letter (CRL) was expected by Regeneron and disclosed in its Q2 results. The approval hold-up relates to findings from an FDA inspection of a third-party fill/finish manufacturing facility, which refers to the stage of processing that involves packaging drug products for storage and distribution. Regeneron stated that the issue was found when the agency was visiting the manufacturer as part of another company’s candidate application, and has since been resolved. An FDA re-inspection is now planned for the coming months, as per a 20 August press release. Regeneron submitted the biologics licence application (BLA) for linvoseltamab under priority review in February this year. The European Medicines Agency (EMA) is still reviewing the therapy in the same indication, and the application to the ...
- Source: drugdu
- 89
- August 23, 2024
Adcendo and Multitude ink ADC deal potentially worth $1bn

The antibody drug conjugate (ADC) dealmaking trend has seen yet another example as Adcendo has signed a licencing agreement potentially worth over $1bn with China-based Multitude for its tissue factor-targeting ADC candidate. The Danish company will acquire the global rights for the development and commercialisation rights for ADCE-T02, except in the Greater China region, including mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan. The companies were light on financial details noting that upfront and milestone payments will “total over $1bn”. The deal also has the option for “single digit to low double digit” tiered royalties. “We are highly impressed by the deep science behind Multitude Therapeutics’ linker/payload platforms and are delighted about our licensing agreement on ADCE-T02, which perfectly complements our existing unique first-in-class ADC pipeline and allows Adcendo to become a clinical-stage biotech company in Q4 2024,” said Adcendo CEO, Michael Pehl. “The highly ...
- Source: drugdu
- 79
- August 22, 2024
First-Of-Its-Kind AI-Enabled Smart Microscopy Platform to Accelerate Traditional Pathology Workflows

Pathology and tissue analysis are areas poised for transformative advancements. Drug developers and clinicians currently depend on long-established methods for crucial tasks such as diagnosing diseases, quantifying biomarkers, and predicting therapeutic responses. While there have been attempts to innovate by digitizing specimens and adding multiple markers to a single slide, there are still limitations, including the analysis of less than 1% of tissue samples and the inability to depict complex tissue architectures and cellular interactions that are only visible in three dimensions. 3D imaging technology captures significantly more data than traditional slide-based methods by digitizing whole biopsy specimens rather than just thin slices.Artificial intelligence (AI) and machine learning algorithms play a crucial role in quantifying relevant biomarkers and identifying areas for more detailed pathologist examination. Now, a pioneering 3D spatial biology platform can digitize entire tissue specimens quickly and non-destructively while providing AI-enabled quantitative analysis. This technology enhances the precision ...
- Source: drugdu
- 97
- August 21, 2024
New research reveals AI bowel cancer test can help patients avoid chemotherapy

A study led by researchers at the University of Leeds has revealed that a new artificial intelligence (AI) test to determine the risk of recurring bowel cancers could help patients avoid chemotherapy. The findings published in the Journal of Clinical Oncology Production could help doctors when deciding whether a patient needs chemotherapy following bowel cancer surgery. Found anywhere in the large bowel, bowel cancer is one of the most common cancers in the world, with 1.9 million cases diagnosed in 2020. In the UK alone, bowel cancer is the fourth most common cancer, affecting over 250,000 people. Researchers aimed to establish whether the number of CD3 cells within tumours could be used to predict the risk of a tumour coming back after surgery. In previous studies, bowel and rectal tumours with higher numbers of CD3 immune cells, which attack the cancer and help the body tackle the disease, have been ...
- Source: drugdu
- 64
- August 21, 2024
Researchers map interactions of 144 active substances to identify drug benefits

Researchers from the Technical University of Munich (TUM) have successfully mapped the interactions of over 100 active substances with around 8,000 proteins to help identify previously unknown benefits of existing drugs. Published in Nature Biotechnology, researchers yielded more than one million dose-responsive curves, which demonstrated the mechanism behind the effects of active substances over the course of treatment. Precision medicine is designed to optimise efficiency or therapeutic benefit for particular groups of patients using genetic or molecular profiling to provide patients with the most individualised treatment possible. To do this, a precise understanding of what is happening at the cellular level is required. Researchers treated cells with various doses of 144 active substances, most of which are already being used in cancer treatment or are in the clinical approval stage. Once extracted, the team analysed proteins using mass spectrometry before studying the cell reactions using the data. In cancer, depending ...
- Source: drugdu
- 75
- August 21, 2024
AstraZeneca wins approval for Imfinzi in NSCLC perioperative setting

AstraZeneca’s Imfinzi (durvalumab) plus chemotherapy has secured US Food and Drug Administration (FDA) approval for non-small cell lung cancer (NSCLC) in the perioperative setting, just weeks after the agency called for an overhaul of perioperative lung cancer trials. This approval is for patients with resectable early-stage (IIA-IIIB) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated in the perioperative setting – a term that refers to the time before, during, and after surgery. In a 25 July meeting, the FDA’s Oncologic Drugs Advisory Committee (ODAC) raised concerns about the design of trials done in this setting. The Imfinzi approval is based on positive data from the Phase III AEGEAN study (NCT03800134), which showed that the perioperative use of the treatment reduced the risk of cancer returning, progressing, or causing death by 32% compared to using chemotherapy alone. ...
- Source: drugdu
- 76
- August 20, 2024

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