Search Results for “antibody” – Page 16 – media

Focusing on complement, standardized diagnosis and treatment of rare diseases usher in a new chapter

So far, the 2024 medical insurance catalog adjustment has announced the drugs and related information that have passed the formal review. From the draft for comments, rare disease drugs are still one of the focuses of the medical insurance catalog adjustment. Rare diseases are also called “orphan diseases”. Most of them are congenital diseases, chronic diseases, and may be life-threatening. Although the incidence of rare diseases is low, there are many types of diseases and the number of patients cannot be underestimated. At present, there are more than 7,000 confirmed rare diseases in the world, and there are about 20 million rare disease patients in China1. For a long time, the clinical phenotypes of rare diseases and common diseases overlap greatly, and early diagnosis is difficult, so the misdiagnosis and missed diagnosis rates are high. According to statistics from the National Organization for Rare Diseases in the United States, among ...
- Source: drugdu
- 55
- September 3, 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
- 72
- 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
- 113
- August 31, 2024
Acelyrin’s izokibep for hidradenitis suppurativa reveals positive results

Acelyrin has shared positive results from a late-stage study of its IL-17A inhibitor izokibep in hidradenitis suppurativa (HS), but has said it will not be moving forward with the asset in this indication. Estimated to affect about 1% of the population in most studied countries, HS is a chronic inflammatory skin condition that causes painful nodules and abscesses. In the phase 3 trial, izokibep demonstrated statistically significant responses across multiple efficacy endpoints at week 12, with 33% of patients being treated with izokibep 160mg weekly achieving at least a 75% reduction in total abscess and inflammatory nodule count (HiSCR75) compared to 21% of those receiving placebo. Results also showed that 25% and 22% of izokibep-treated patients achieved HiSCR90 and HiSCR100, respectively, compared to 9% and 8% in the placebo cohort. The announcement comes shortly after the drug demonstrated promising results in a phase 2b/3 study for psoriatic arthritis (PsA), a ...
- Source: drugdu
- 66
- August 30, 2024
【EXPERT Q&A】What are Radioactive Drug Conjugates (RDCs)?

Drugdu.com expert’s response: Radioactive Drug Conjugates (RDCs) represent a novel class of therapeutic agents that combine the strengths of precise targeting and potent killing capabilities. By linking radioactive nuclides to ligands (such as antibodies, peptides, small molecules, etc.) through linkers and chelators, RDCs achieve precise localization and effective eradication of target cells. Below, I will elaborate on RDCs from four aspects: definition and structure, advantages and applications, classification, as well as challenges and prospects. I. Definition and Structure Definition: RDCs are drug formulations that integrate radioactive nuclides with targeting molecules (ligands) through linker arms (connectors), aimed at delivering precise strikes against tumor or other disease targets. Structure: RDC drugs consist primarily of targeting ligands, linker arms, chelators, and nuclide conjugates. The targeting ligands recognize and bind to specific target cells or tissues; linker arms connect the targeting ligands to the radioactive nuclides; chelators stabilize the radioactive nuclides, preventing their premature ...
- Source: drugdu
- 69
- August 30, 2024
MHRA approves Astellas’ Vyloy combination for gastric cancer

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Astellas Pharma’s Vyloy (zolbetuximab) as part of a first-line combination treatment for a subset of gastric cancer patients. The monoclonal antibody has been authorised for use alongside chemotherapy to treat adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are claudin 18.2 positive. In the UK, adenocarcinomas, which develop from cells in the innermost lining of the stomach, account for most cases of gastric cancer, with around 6,600 people diagnosed every year. Most cases go undetected until an advanced stage, as the disease rarely causes early symptoms and tends to develop slowly over a number of years. Vyloy is now the only licensed treatment to target the claudin 18.2 protein, which is expressed in gastric, oesophageal, lung and ovarian tissues, and is administered intravenously every two to three ...
- Source: drugdu
- 59
- August 29, 2024
Eisai’s Leqembi deemed too costly for NHS

Though the UK became the first country in Europe to authorize use of Eisai and Biogen’s early Alzheimer’s disease drug, Leqembi (lecanemab), patients in the UK’s National Health Services (NHS) will not gain access to the drug as the anti-amyloid treatment was deemed too costly. As per the 22 August draft guidance consultation released by the National Institute for Health and Care Excellence (NICE), an independent committee found that the cost effectiveness estimates were “considerably above what NICE considers an acceptable use of NHS resources.” The committee cited a lack of evidence on the long-term effects of treatment with Leqembi and the costs of providing treatment infusions, monitoring side effects, and determining when to terminate treatment as uncertainties. According to the guidance, NICE has requested additional information from Eisai and NHS England to address the uncertainties and will consider the additional information alongside stakeholder comments in a second meeting. In ...
- Source: drugdu
- 69
- August 26, 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
- 85
- August 23, 2024
FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma

Regeneron Pharmaceuticals said the FDA cited no approvability concerns for its multiple myeloma drug, linvoseltamab, other than previously identified issues with a contract manufacturer. While linvoseltamab trails bispecific antibodies currently marketed by Johnson & Johnson and Pfizer, if approved, it could bring patients an earlier treatment option. By Frank Vinluan on August 21, 2024 Regeneron Pharmaceuticals already lags companies that have launched new multiple myeloma drugs, and it will have to wait a little bit longer to join them. The FDA turned down Regeneron’s application for its drug candidate, but not for any issues with the therapy itself. The regulator cited problems with the treatment’s third party manufacturer. The FDA rejection for the drug, linvoseltamab, is not a surprise. Regeneron foreshadowed that decision earlier this month during its conference call to discuss second quarter 2024 financial results, disclosing that that the FDA flagged unresolved findings with the contract manufacturer. Those problems centered on another company’s ...
- Source: drugdu
- 76
- 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
- 76
- August 22, 2024

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