Search Results for “antibody” – Page 25 – media

Urine Test to Revolutionize Lyme Disease Testing

Lyme disease is the most common animal-to-human transmitted disease in the United States, with around 476,000 people diagnosed and treated annually, and its incidence has been increasing. If not addressed promptly and effectively, those affected may experience persistent symptoms known as Post-Treatment Lyme Disease Syndrome, which include issues with concentration and memory, dizziness, fatigue, body aches, depression, and sleep disturbances. Currently, the standard diagnostic approach involves an antibody blood test that detects the immune system’s response to the bacteria responsible for Lyme disease. Now, urine testing could revolutionize Lyme disease detection and diagnosis thanks to its many advantages over existing techniques. Researchers at George Mason University (Fairfax, VA, USA) have developed a urine test for Lyme disease that detects the Borrelia bacteria, which causes Lyme disease. This advancement allows for the confirmation of an infection shortly after a tick bite, leading to timely treatment and helping to avoid the ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294801060/urine-test-to-revolutionize-lyme-disease-testing.html
- 98
- May 4, 2024
Ono Pharmaceutical acquires cancer-focused biopharma Deciphera for $2.4bn

Deciphera Pharmaceuticals is set to be acquired in a $2.4bn buyout, as the biopharma announced that it has commenced a definitive merger agreement with Ono Pharmaceutical. Under the terms of the offered transaction, Ono will make a cash purchase of all outstanding shares of Deciphera’s common stock at $25.60 per share and subsequently merge Deciphera with a wholly-owned subsidiary of Ono upon the deal’s completion. The deal has been unanimously approved by both companies’ boards of directors and is expected to close in Q3 2024. Following the announcement of acquisition, Deciphera’s stock has jumped 71.9%. Waltham, Massachusetts-based Deciphera brings to the table an extensive kinase inhibitor pipeline, kinase drug discovery expertise, and a strong commercial and sales platform in the US and European markets that is meant to advance Ono’s capabilities and presence in the oncology space. Upon the successful completion of the acquisition, Ono will gain access to Deciphera’s ...
- Source: drugdu
- 107
- May 3, 2024
Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B

The FDA has approved Beqvez, a Pfizer gene therapy developed for moderate-to-severe hemophilia B. The one-time treatment carries a $3.5 million price tag, the same as a CSL Behring gene therapy already available for treating the inherited bleeding disorder. By Frank Vinluan Pfizer’s first FDA-approved gene therapy is the second such treatment for the inherited bleeding disorder hemophilia B, introducing some competition to a therapeutic area that now has two of the most expensive medicines in the world. The FDA approval announced Friday covers the treatment of adults with moderate-to-severe hemophilia B. Known in development as fidanacogene elaparvovec, the Pfizer therapy will be marketed under the brand name Beqvez. The company expects this therapy will become available to patients later in the current quarter. Hemophilias stem from genetic mutations that lead to abnormally low levels of clotting proteins. These disorders mainly affect males and make patients susceptible to bleeding events ...
- Source: drugdu
- 73
- May 2, 2024
Gilead writes $2.4B off Trodelvy as CEO underscores ‘time of focused execution’

The flurry of Trodelvy developments accentuates what Gilead CEO Dan O’Day called “a time of focused execution” at the California biotech. (Jim Watson/AFP/Getty Images) After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. Gilead has cut the carrying value of Trodelvy to $3.5 billion in its first-quarter report, from $5.9 billion at the end of 2023, CFO Andrew Dickinson told investors during a call Thursday. The move comes after a January report of a phase 3 trial that the TROP2-directed antibody-drug conjugate failed to significantly extend the lives of patients with previously treated non-small cell lung cancer compared with chemotherapy. The bad news at that time caused a 10% slide in Gilead’s stock price. The write-off reflects a “smaller addressable market that Trodelvy could serve among second-line-plus metastatic non-small cell lung ...
- Source: drugdu
- 128
- April 30, 2024
First Subject Dosed for Phase 1 Clinical Trial of Henlius’ Novel Anti-GARP/TGF-β1 mAb HLX6018

Shanghai, China, April 23, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced the first subject was dosed for a phase 1 clinical trial of HLX6018 (NCT06310746), a novel anti-GARP/TGF-β1 monoclonal antibody (mAb) independently developed by the company. HLX6018 is the first innovative product of Henlius in the treatment field of chronic inflammatory diseases, and it was recently approved by the National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF). Currently, no product targeting GARP/TGF-β1 has been approved for marketing globally. Fibrosis is a pathological process characterised by persistent tissue scars which attributed to excessive deposition of extracellular matrix (ECM). This condition can be induced by a variety of stimuli such as infections, autoimmune reactions, radiation, and tissue injury. Common fibrosis-related diseases include IPF, non-alcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), cirrhosis, chronic kidney disease (CKD), myocardial infarction (MI), etc. Among them, IPF is a chronic, progressive interstitial ...
- Source: drugdu
- 120
- April 25, 2024
GenFleet Therapeutics Announces FDA’s Clinical Trial Approval for GFH925 (KRAS G12C Inhibitor) Monotherapy in Phase III Registrational Study Treating Metastatic Colorectal Cancer

SHANGHAI, April 19, 2024 /PRNewswire/ — GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced US Food and Drug Administration (FDA) has granted the clinical trial approval for GFH925 (KRAS G12C inhibitor) in a multi-center, open-label, randomized and controlled phase III study treating refractory metastatic colorectal cancer (CRC) patients. It is the first phase III trial of KRAS G12C inhibitor monotherapy targeting CRC patients worldwide, with GFH925 being the first G12C inhibitor that received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for previously treated advanced CRC. GFH925 was also granted BTD and New Drug Application acceptance with Priority Review Designation by NMPA for previously treated advanced non-small cell lung cancer（NSCLC）patients with G12C mutation. The trial (GFH925X0301) will enroll refractory metastatic CRC patients harboring KRAS G12C mutation who have progressed or experienced disease recurrence on or after at least two prior ...
- Source: drugdu
- 118
- April 24, 2024
Chemomab touts study confirming CCL24 link to systemic sclerosis severity

Clinical-stage biotech Chemomab Therapeutics has announced the publication of a study highlighting that high serum CCL24 levels are linked to more severe forms of systemic sclerosis (SSc). SSc is a chronic autoimmune disease characterised by excessive collagen production, leading to thickening and hardening of the skin and various internal organs. Affecting the skin, blood vessels, muscles, and internal organs, the condition causes symptoms like joint pain, skin tightening, and organ dysfunction. The study, published in the Arthritis Care and Research journal and conducted at the University of Leeds in the UK, looked at 200 patients with SSc. It found that a quarter of them had high levels of CCL24 in their blood, even though they were receiving standard treatment. Higher CCL24 levels were linked to more severe forms of the condition, including worse skin problems and lung issues. Scientists identified that high CCL24 levels were predictive of lung problems worsening ...
- Source: drugdu
- 73
- April 20, 2024
FDA Approves Stelara Biosimilar Selarsdi to Treat Psoriasis, Psoriatic Arthritis

Davy James Alvotech’s and Teva’s Selarsdi (ustekinumab-aekn), the second FDA-approved biosimilar to Stelara, is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for patients aged 6 years and above with active psoriatic arthritis. Image credit: Maria | stock.adobe.com Alvotech’s and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) has been approved by the FDA as a biosimilar to Stelara (ustekinumab), which represents the second approval for a Stelara biosimilar.1 Selarsdi is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and for patients aged 6 years and above with active psoriatic arthritis. “The approval of Selarsdi—which is our second biosimilar approval this year—underscores Teva’s commitment to expanding the availability, access and uptake of this important treatment option to patients in the US,” Thomas Rainey, ...
- Source: drugdu
- 78
- April 19, 2024
IND Application for the Clinical Trial of Novel Anti-TIGIT Fc Fusion Protein HLX53 in Combination with HANSIZHUANG Plus HANBEITAI for the First-Line Treatment of Locally Advanced or Metastatic Hepatocellular Carcinoma Patients Approved by NMPA

Shanghai, China, April, 17th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for the clinical trial of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first line treatment of locally advanced or metastatic hepatocellular carcinoma, has been approved by the National Medical Products Administration (NMPA). A phase 2 clinical trial will be initiated to evaluate the safety, tolerance and efficacy of the multiple immunotherapy-based treatment combinations in patients with advanced or metastatic hepatocellular carcinoma. Liver cancer is one of the most prevalent malignancy in the world. According to GLOBALCAN 2022, there are about 870,000 new cases diagnosed and 760,000 deaths for the tumour in the globe. Meanwhile, primary liver cancer (PLC) is the fourth most common cause and the second mortality cancer in China, with about 370,000 new cases and 320,000 deaths in ...
- Source: drugdu
- 82
- April 19, 2024
YuanSong Bio-technology Receives Another Clinical Trial Approval, Its Innovative Lysoma Virus Product Receives Implied Clinical Trial Approval from China CDE

On April 12, 2024, Shanghai Yuansong Biotechnology Co., Ltd (“Yuansong Biotechnology”) announced that its self-developed lysosomal virus Class I new drug “Recombinant L-IFN Adenovirus Injection (YSCH-01)” has received implied clinical trial approval from the Center for Drug Evaluation of the State Drug Administration (CDE) and has been approved to conduct Class I clinical trials in China. The Center for Drug Evaluation (CDE) of the State Drug Administration has granted implied consent for clinical trials and approved to conduct Phase I clinical trials in China for the indication of advanced solid tumors. The approval of this IND filing by the CDE in China is another important progress made by YuanSong Biotech in exploring the clinical study of YSCH-01, in addition to the clinical approval by the US FDA in December 2023 for two original IIT programs under development, including capsular delivery for recurrent gliomas and lysosomal viral nebulized delivery for the ...
- Source: drugdu
- 148
- April 16, 2024

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