PharmaFocus Today – Page 119 – media

Hengrui Pharmaceuticals Class 1 New Drug HRS8807 for ER-positive, HER2-negative Breast Cancer Combination Treatment Approved for Clinical Trial

Recently, Hengrui Pharmaceuticals and its subsidiary Shanghai Hengrui Pharmaceuticals Co., Ltd. received a Notice of Approval of Drug Clinical Trial from the State Drug Administration, approving the company to conduct an open, multi-center Phase I clinical study on the safety, tolerability and pharmacokinetics of HRS8807 combined with dalsylate hydroxyethanesulfonate in ER-positive, HER2-negative metastatic or locally advanced breast cancer patients. Breast cancer is the most common malignant tumor worldwide. According to the Global Cancer Epidemiology Report 2024, breast cancer ranks first among female malignant tumors in terms of incidence and mortality, with approximately 2.31 million new cases of breast cancer and 670,000 deaths per year globally, ranking first in terms of incidence and mortality of female malignant tumors. Among all breast cancer patients, about 70% are ER-positive, and the guideline-recommended standard treatment is endocrine drugs combined with CDK4/6 inhibitors. In contrast, the new generation of oral selective estrogen receptor down-regulators (SERDs) ...
- Source: drugdu
- 80
- April 20, 2024
Image-Based AI Shows Promise for Parasite Detection in Digitized Stool Samples

Infections from soil-transmitted helminths (STHs), commonly known as intestinal parasitic worms, are among the most widespread neglected tropical diseases and impose a significant health burden in low- and middle-income countries, particularly among school-aged children. These infections often lead to chronic health issues that can cause disability, social stigma, and for their substantial economic impacts on communities. STHs are notorious role in nutrient loss, which can contribute to neurocognitive impairments, stunted growth and development, and persistent fatigue in affected children. Additionally, these parasites are a major cause of morbidity and complications during pregnancy. The standard diagnostic method for STHs involves manual microscopy, which requires up to 10 minutes per slide and is hindered by a lack of skilled professionals and access to necessary equipment and lab infrastructure in highly affected regions. There is a pressing need for improved diagnostic techniques, particularly for detecting infections of mild intensity, to effectively manage and ...
- Source: drugdu
- 128
- April 19, 2024
Mouth Bacteria Test Could Predict Colon Cancer Progression

Colon cancer, a relatively common but challenging disease to diagnose, requires confirmation through a colonoscopy or surgery. Recently, there has been a worrying increase in colon cancer rates among younger populations, heightening the need to understand more about the disease’s mechanisms and preventive measures. Fusobacterium nucleatum, a bacterium typically linked with dental plaque and gingivitis, is found more frequently in colon cancer tissues than in normal colon tissues, suggesting its involvement in cancer progression and its association with adverse outcomes after treatment. Now, researchers have identified a specific subtype of this bacterium that can migrate to the gut and proliferate within colorectal cancer tumors. The finding could help improve early screening methods for colorectal cancer by paving the way for a test to screen for the presence of this bacterium with a mouth swab or stool sample. In the study, a team of researchers at Fred Hutch Cancer Center (Seattle, ...
- Source: drugdu
- 90
- April 19, 2024
Eli Lilly Shows Obesity Drug Zepbound Can Treat Sleep Apnea Too

Eli Lilly drug tirzepatide, marketed as Zepbound for weight management, has results from two Phase 3 studies showing reductions in the breathing problems caused by obstructive sleep apnea. Lilly is now preparing regulatory submissions to add this indication to the drug’s label. By Frank Vinluan Sleep apnea could be the next new indication for an Eli Lilly drug that’s already a blockbuster seller in metabolic indications. The pharmaceutical giant has preliminary Phase 3 data showing that treatment with the drug reduced the breathing interruptions characteristic of the common sleep disorder. With the positive data in hand, Lilly said it is now planning for regulatory submissions seeking to expand the label of tirzepatide, which is marketed as Mounjaro for type 2 diabetes and as Zepbound for weight management. Those submissions are expected in the middle of this year. Obstructive sleep apnea (OSA) is the collapse or partial collapse of the upper ...
- Source: drugdu
- 115
- April 19, 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
- 77
- April 19, 2024
Study reveals how specific nasal cells protect against COVID-19 in paediatric patients

Researchers from University College London (UCL) and the Wellcome Sanger Institute have revealed how specific nasal cells differ in children and elderly people when protecting against COVID-19. Published in Nature Microbiology, the study used cells donated from healthy participants from Great Ormond Street Hospital, University College London Hospital and the Royal Free Hospital. Researchers focused on the early effects of the SARS-CoV-2 infections using the human nasal epithelial cells (NECs) gathered from children aged up to 11 years, adults aged 30 to 50 years, as well as elderly people aged over 70 years. After using specialised techniques to regrow these cells into the different types usually found in the nose, researchers used single-cell RNA sequencing to identify the genetic networks and functions of thousands of individual cells to identify 24 epithelial cell types. The cell cultures from each age group were then either mock-infected or infected with SARS-CoV-2. After three ...
- Source: drugdu
- 71
- April 19, 2024
ELRIG UK and SRG collaborate to advance life sciences professionals in drug discovery

Both companies will facilitate career progression while advancing the life sciences industry The European Laboratory Research and Innovation Group (ELRIG) UK has announced its partnership with SRG to support life sciences professionals in advancing their careers in drug discovery. Both will help facilitate career progression as well as support the growth of the life sciences industry. As part of the collaboration, ELRIG UK’s community will gain access to career opportunities, while SRG’s specialist talent solutions will be provided to organisations of all sizes to help grow the life sciences sector. More specifically, early career professionals (ECPs) in industry and academia will be able to attend forums and networking events to meet new people and learn the skills needed to help them progress their careers in drug discovery. The volunteer-led community for drug discovery unites academic and biopharma industry experts and thought leaders to share ideas and information through free-to-attend scientific ...
- Source: drugdu
- 76
- 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
ANKE Bio and SHIJIAN BIOLOGICAL enter into ADC platform technology licensing cooperation

Recently, Anhui ANKE Bio Engineering (Group) Co., Ltd (hereinafter referred to as “ANKE Bio”, stock code: 300009) signed a license agreement with Shanghai Shijian Biotechnology Co. (“ANKE Bio”). According to the license agreement, ANKE Bio has formally obtained the license of EZWi-Fit®, the ADC technology platform of SHIJIAN BIOLOGY, to develop ADC products. During the license period, ANKE Bio will be responsible for the preclinical research, clinical development and commercial production and sales of the developed products in Greater China, and will pay equity payments (including down payment and milestone payments) and a sales commission as a percentage of net sales to SHIJIAN BIO. Shijian Bio acquires an overseas interest in the ADC product. Shijian Bio is a clinical-stage ADC new drug discovery and development company with an ADC clinical pipeline and comprehensive new drug discovery and development capabilities, and has established a new-generation ADC technology platform, EZWi-Fit®, with its ...
- Source: drugdu
- 78
- April 19, 2024
Health Advocate Partners with Tava Health to Increase Access to Teletherapy

Mike Hollan Tava’s network of therapists will be added to Health Advocate’s existing network. While the service existed beforehand, the pandemic pushed telehealth into the spotlight. For many patients, it wasn’t just safer to be able to visit a doctor from the comfort of their own home, it was much simpler. This is especially true for patients visiting their regular doctors for recurring conditions. Due to the pre-existing relationship, doctors can often provide the necessary prescriptions based off of a description of symptoms alone. As the pandemic receded, the value of teletherapy remained. Since then, more and more companies are working to expand access to teletherapy services. Health Advocate announced that it has partnered with Tava Health to expand its access to telehealth.1 This partnership will allow members of Health Advocate to access Tava Health’s nationwide network of therapists. These new therapists will be added to Health Advocate’s existing network ...
- Source: drugdu
- 159
- April 18, 2024

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