Search Results for “cancer” – Page 92 – media

The first patient has been dosed, and the latest progress of Abbisko Therapeutics’s new generation EGFR Exon20ins inhibitor ABSK112

On February 23, 2024, Abbisko Therapeutics announced that its independently developed new-generation EGFR Exon20ins inhibitor ABSK112 has completed the first patient administration in its Phase I clinical trial for non-small cell lung cancer (NSCLC). Previously, ABSK112 has obtained clinical research licenses from China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA), and is conducting Phase I clinical trials simultaneously in China and the United States. ABSK112 is a new generation of EGFR Exon20ins oral inhibitor with high activity, high selectivity and brain entry properties. Compared with the previous generation of EGFR Exon20ins inhibitors that have been on the market or entered clinical trials, ABSK112 has demonstrated better brain entry properties, high selectivity against wild-type EGFR, and broader Exon20ins mutation coverage in preclinical studies. It has shown excellent in vivo efficacy in multiple mouse tumor models with EGFR Exon20ins mutations. It has the potential to obtain ...
- Source: drugdu
- 92
- February 27, 2024
Simple Blood Test Quickly and Accurately Diagnoses Potentially Life-Threatening Inflammatory Disease

Sarcoidosis, a chronic inflammatory condition characterized by small lumps known as granulomas in the lungs and other organs, remains a medical mystery with its exact cause yet to be understood. Current theories suggest it might be an immune disorder triggered by specific antigens, usually foreign substances that provoke an immune response. Diagnosing sarcoidosis is currently a complex process that typically involves tissue removal and testing, accompanied by additional screenings to exclude other conditions like tuberculosis or lung cancer. Now, researchers have developed a tool that uses a simple blood test to rapidly and inexpensively diagnose sarcoidosis, potentially reducing the need for more invasive diagnostic techniques presently used to detect the disease. In a research project supported by the National Institutes of Health (NIH, Bethesda, MD, USA), researchers at Wayne State University (Detroit, MI, USA) set out to identify antigens and determine which might be linked to sarcoidosis. They collected lung ...
- Source: drugdu
- 186
- February 26, 2024
Hengrui’s CD79b ADC innovative drug SHR-A1912 received FDA fast track qualification

Recently, SHR-A1912, an innovative CD79b antibody-drug-conjugate (ADC) drug for injection independently developed by Hengrui, was granted fast track designation (FTD) by the U.S. Food and Drug Administration (FDA). ), for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) that has received at least two lines of therapy in the past. This will help accelerate the advancement of clinical trials and marketing registration. This is also the company’s second product to obtain fast tracks designation from the US FDA. In January this year, the company announced that its independently developed HER3 ADC innovative drug SHR-A2009 for injection has been granted fast track designation by the FDA for the treatment of third-generation EGFR-positive tumors, EGFR-mutated metastatic non-small cell lung cancer (NSCLC) with disease progression after amino acid kinase inhibitors and platinum-containing chemotherapy. Previously, the clinical trial application of SHR-A1912 for the treatment of B-cell non-Hodgkin lymphoma has been implicitly approved ...
- Source: drugdu
- 131
- February 26, 2024
Zhuohe Pharmaceutical’s “Category 1.1 innovative traditional Chinese medicine” was approved for marketing

On February 21, the National Medical Product Administration approved the marketing application pf the innovative traditional Chinese medicine Category 1.1 drug Jiuwei Cough Oral Liquid applied by Zhuohe Pharmaceutical Group Co., Ltd. (hereinafter referred to as “Zhuohe Pharmaceutical”). According to the NMPA official website, a randomized, double-blind, placebo and active drug parallel controlled multi-center clinical trial has been conducted. The results show that in terms of the main efficacy indicators: cough disappearance rate and cough disappearance time the test group is better than the placebo group and non-inferior to the positive drug group. This medicine is used for relieving lungs and cough, acute tracheobronchitis and cough that belongs to wind-heat syndrome according to traditional Chinese medicine. The launch of this drug provides more treatment option for patients with acute tracheobronchitis cough. Anti-rheumatic, anti-tumor… According to Zhuohe Pharmaceutical’s public information, the company has professional R&D and innovation capabilities in multiple disciplines ...
- Source: drugdu
- 140
- February 26, 2024
Hengrui Pharmaceuticals’s CD79b ADC Innovative Drug SHR-A1912 Receives U.S. FDA Fast Track Eligibility Recognition

Recently, Hengrui Pharmaceuticals’s self-developed CD79b antibody-drug-conjugate (ADC) innovation SHR-A1912 for injection has been granted fast track designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory diffuse large B-cell lymphomas (R/R DLLC) that have received at least 2 lines of therapy in the past. SHR-A1912 was granted fast track designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) that has previously received at least 2 lines of therapy. This is also the 2nd product of the Company to be granted Fast Track status by the FDA. In January this year, the Company announced that its self-developed HER3 ADC innovative drug SHR-A2009 for injection was granted Fast Track status by the FDA for the treatment of metastatic non-small-cell lung cancer (“NSCLC”) with EGFR mutation that has progressed after third-generation EGFR tyrosine kinase inhibitor and ...
- Source: drugdu
- 110
- February 26, 2024
Treadwell Therapeutic’s Novel Acute Myeloid Leukemia Treatment Granted FDA Orphan Drug Designation

Davy James Ocifisertib is a first-in-class, novel PLK4 inhibitor that has demonstrated significant activity as a monotherapy in both solid and liquid tumors. Image credit: Arif Biswas | stock.adobe.com Treadwell Therapeutics’s ocifisertib (CFI-400945) has been granted orphan drug designation by the FDA for the treatment of acute myeloid leukemia (AML).1 The first-in-class, novel PLK4 inhibitor has been found to regulate centriole duplication in patients with AML. “The FDA’s decision to grant orphan drug designation, along with the previous FDA Fast Track designation for ocifisertib, underscores [our] dedication to addressing this patient population with few treatment options. Patients with relapsed and/or refractory AML—in particular TP53-mutated disease—suffer poor overall survival and represents a high unmet clinical need,” said Roger Sidhu, MD, acting CEO of Treadwell Therapeutics, in a press release. The PLK4 enzyme is typically overexpressed in cancer cells and has been associated with adverse survival outcomes. Inhibiting PLK4 has been found ...
- Source: drugdu
- 87
- February 24, 2024
Regeneron’s Linvoseltamab Granted FDA Priority Review for Relapsed/Refractory Multiple Myeloma

Davy James The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024. Image credit: ibreakstock | stock.adobe.com The FDA has granted Priority Review to Regeneron Pharmaceuticals’ biologics license application (BLA) for linvoseltamab to treat adults with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies. The bispecific antibody was developed to bridge B-cell maturation antigen on multiple myeloma cells that have CD3-expressing T cells, which subsequently activates T cells to prompt the elimination of cancer cells. The FDA assigned the BLA with a Prescription Drug User Fee Act of August 22, 2024. An estimated 35,000 US residents will be diagnosed with multiple myeloma on an annual basis. Although research efforts have achieved significant progress in treating multiple myeloma, the disease is not yet curable. Current treatments have been able ...
- Source: drugdu
- 130
- February 23, 2024
Innovent Announces Primary Endpoint Met in the Phase 3 Clinical Trial (RESTORE-1) of IBI311 (Anti-IGF-1R Antibody) in Treating Thyroid Eye Disease and Plans to Submit NDA to the NMPA

ROCKVILLIE, MD. and SUZHOU, China, February 20, 2024— Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the primary endpoint has been achieved in the Phase 3 registrational study (RESTORE-1) of IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody in Chinese subjects with Thyroid Eye Disease (TED). Innovent plans to submit the new drug application (NDA) for IBI311 in the treatment of TED to the Center for Drug Evaluation (CDE) of the National Drug Administration (NMPA). RESTORE-1 (CTR20223393) is a multicenter, randomized, double-masked, placebo-controlled Phase 2/3 clinical trial to evaluate the efficacy and safety of IBI311 in subjects with TED. The Phase 3 results of RESTORE-1 showed that the primary endpoint was successfully met: at Week 24, the proptosis responder rate in the study eye ...
- Source: drugdu
- 174
- February 23, 2024
Kangpu Biopharmaceuticals to Present Preclinical Efficacy Data of KPG-818 in Crohn’s Disease at the 19th Congress of ECCO (IND Application for Phase II in Progress)

HEFEI, China, Feb. 20, 2024 /PRNewswire/ — Kangpu Biopharmaceuticals, a clinical-stage company dedicated to the discovery and development of novel therapeutics for the treatment of cancer, autoimmune diseases, and inflammation, through targeted protein degradation technology, today announced that a poster on preclinical efficacy data of KPG-818 in Crohn’s disease will be presented at the upcoming 19th Congress of European Crohn’s and Colitis Organisation (ECCO), taking place in Stockholm, Sweden, February 21-24, 2024. Poster Title: Therapeutic Effects of KPG-818 in a Trinitrobenzene Sulfonic Acid-Induced Mouse Crohn’s/Ulcerative Colitis Model Abstract Number: EC24-0844 Exhibition Zone: Poster Exhibition, Hall A Presentation Number: P131 Crohn’s disease is a chronic and difficult-to-treat autoimmune disorder. The current available therapeutic options for this condition are very limited, and there remain significant unmet medical needs. In preclinical studies, KPG-818 demonstrated potent therapeutic efficacy in mouse model of Crohn’s disease. KPG-818 significantly improved clinical symptoms, colorectitis, ulcers, and local immune ...
- Source: drugdu
- 112
- February 23, 2024
Wireless Hepatitis B Test Kit Completes Screening and Data Collection in One Step

Hepatitis B, a significant global health concern, is responsible for chronic liver diseases like cirrhosis and liver cancer which is one of the most common cancers worldwide. The challenge with hepatitis B is that most carriers are asymptomatic, remaining unaware of their infection, which can lead to its unintentional spread. Thus, early diagnosis is vital to halt the spread, initiate timely treatment, and reduce the risk of liver complications primarily caused by the hepatitis B virus. However, conventional tests for hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) are complex, requiring specialized skills and large, expensive machine-based assays typically found in major hospitals. To overcome the problem of inadequate access to screening for Hepatitis B, researchers have developed a wireless, point-of-care test for the Hepatitis B Virus that can make diagnosis simpler and faster. Researchers from Chulalongkorn University (Bangkok, Thailand) have developed a testing kit that enables ...
- Source: drugdu
- 92
- February 22, 2024

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