BIO-THERA Bio-Pharmaceutical Co., Ltd (Stock Code: 688177) has recently received a Notice of Approval of Drug Clinical Trial approved by the State Drug Administration for the Company’s investigational product BAT7205 for injection. BAT7205 is a PD-L1/IL-15 bifunctional antibody fusion protein developed by BIO-THERA and is intended to be developed for the treatment of locally advanced or metastatic solid tumors.IL-15 is a pleiotropic cytokine that is essential for the regulation of many immune functions, particularly the development, proliferation and activation of CD8+ memory T cells and NK cells, and promotes PD-1 inhibitor-naïve CD8 + activation and proliferation of tumor-infiltrating T cells, which is expected to significantly improve the clinical efficacy of PD-1/PD-L1 analogs. BAT7205 consists of recombinant humanized anti-PD-L1 antibody and IL-15/IL-15Rαsushi fusion protein, which can both block the PD-1/PD-L1 immunosuppressive pathway and activate the immune cells through IL-15, thus achieving the synergistic effect of deregulation of immunosuppression and activation of ...
Recently, Henlius’ self-developed and manufactured HANQUYOU (trastuzumab, trade names: Zercepac® in Europe, Tuzucip® and Trastucip® in Australia) has been approved for marketing in Thailand and the Philippines under the trade names of TRAZHER® and Hertumab®, respectively, for the treatment of HER2-positive breast cancer and gastric cancer. Up to now, HANQUYOU has been successfully approved in Southeast Asian countries, including Singapore and Cambodia, and in a total of more than 40 countries and regions. Breast cancer is the most prevalent malignancy in Southeast Asia, with nearly 170,000 new cases of breast cancer in the region in 2022. About 15% to 20% of breast tumours are HER2-positive breast cancers. On the other hand, the reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%. Trastuzumab has long been a cornerstone of therapy for the treatment of HER2-positive breast and gastric cancers, and has been included as a ...
The project will train a newly developed AI system on data collected from participating men and women Researchers from the University of Glasgow’s James Watt School of Engineering are aiming to ensure that artificial intelligence (AI)-based healthcare monitoring systems in the future are free of gender bias, to improve care for both men and women. For 18 months, the project will examine the potential for gender bias in healthcare AI and discover ways to ensure that AI-supported treatment remains equitable. The use of cutting-edge sensors is currently being investigated to track the rhythms of patients’ hearts and lungs without requiring them to wear monitoring devices or be recorded on video cameras. The team aims to address and ensure that its AI component is properly trained and capable of making the correct judgements without bias towards one gender of patients. Supported by £8,200 in funding from the Université Paris Dauphine-PSL’s Women ...
CDH affects one in 5,000 babies born in the UK, impacting the foetus’ development of vital organs Researchers from University College London (UCL) and Great Ormond Street Hospital (GOSH) have developed a new approach to observing human development in late pregnancy to potentially monitor and treat congenital conditions before birth. Published in Nature Medicine, the study used collected stem cells from late pregnancy to create and grow cell models, known as organoids, to retain babies’ biological information. The study of stem cell organoids aims to facilitate the monitoring of foetal development in late pregnancy, model disease progression and test new treatments for diseases including congenital diaphragmatic hernia (CDH). Affecting one in 5,000 babies born in the UK, CDH occurs when there is a hole in the diaphragm, which can lead to the foetus’ bowel, stomach or liver being moved into the chest cavity during pregnancy. Researchers extracted and characterised live ...
Recently, U.S. President Joe Biden officially signed the “Executive Order on Preventing Countries of Concern from Obtaining Extensive Sensitive Personal Data of U.S. Citizens and U.S. Government-Related Data,” calling for measures to be taken to prevent “bad actors” and “countries of concern” from abusing data related to the United States. Various types of data about citizens, including genomic data, biometric data, personal health data, geolocation data, financial data and other types of personally identifiable information. The executive order may pose new challenges to Chinese life sciences companies operating in the United States. The order requires the Departments of Justice, Homeland Security, Health and Human Services, Veterans Affairs and other agencies to take a variety of actions over the next 12 months, including: Ministry of Justice: Regulations will be enacted to govern cross-border transfers of large-scale data related to genomics, biometrics, personal health data, geolocation and the above areas, including a ...
The US Department of Health and Human Services (HHS), as part of the Centers for Medicare and Medicaid Services (CMS), has announced that all ten pharmaceutical manufacturers taking part in the Medicare drug price negotiations have submitted counteroffers. The announcement comes after the HHS sent initial offers on 1 February in an ongoing effort to lower drug prices in the US as part of the Inflation Reduction Act (IRA) and negotiations will continue over the next several months. First selected last August, the ten medicines subject to the first round of Medicare pricing negotiations included therapies for diabetes, heart failure, immunological disorders and cancer, as well as anticoagulants. The medicines selected included Bristol Myers Squibb/Pfizer’s Eliquis (apixaban), Novartis’ Entresto (valsartan/sacubitril), AstraZeneca’s Farxiga (dapagliflozin), AbbVie/Johnson & Johnson’s Imbruvica (ibrutinib), Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin), and Johnson & Johnson’s Stelara (ustekinumab) and Xarelto (rivaroxaban). According to the HHS, collectively, the drugs were ...
Oral cancer comprises about 90% of head and neck cancer (HNC), which ranks as the seventh most common type of malignancy globally. HNC constitutes roughly 5% of all cancer cases worldwide, with approximately 640,000 new cases annually, leading to around 350,000 deaths. Its incidence is particularly increasing in developing countries. These cancers predominantly affect socioeconomically disadvantaged populations and underserved communities. Diagnosing oral cancers and precancerous mouth lesions early and accurately presents significant challenges. Traditional biopsy methods are not only expensive and invasive, causing stress and potential complications for patients, but also unfeasible for repeated screenings of the same lesion. Now, researchers have developed a noninvasive, affordable test for detecting oral cancer, monitoring precancerous lesions, and determining the need for a biopsy. The findings of the study by a team of researchers, led by Case Western Reserve University (Cleveland, OH, USA), are based on a novel scoring system that assesses the ...
Cancer patients can have varying levels of a specific kind of repetitive DNA known as Alu elements in comparison to those without cancer. Despite constituting about 11% of the DNA in humans and other primates, Alu elements have traditionally been considered too complex to be effectively utilized as biomarkers due to their small, repetitive nature. Now, advancements in machine learning can allow for the measurement of these elements through a simple blood draw. Researchers at Johns Hopkins Medicine (Baltimore, MD, USA) leveraged this insight to improve a test designed for early cancer detection. They began their study with a sample size that was ten times larger than what is usually seen in such research. Alu elements are relatively small, each being about 300 base pairs in length within the vast 2 billion-step DNA ladder. Yet, changes in the proportion of Alu elements in blood plasma are consistent, irrespective of the ...
Don Tracy, Associate Editor This marks the first time that a hyaluronic acid dermal filler has received FDA approval for temple hollowing. Allergan Aesthetics, an AbbVie company, announced that the FDA has approved Juvéderm Voluma XC to treat moderate to severe temple hollowing in adults over 21 years of age. According to the company, the medication has the ability to yield results that last up to 13 months with peak treatment, with approximately 80% of test subjects reporting satisfaction with the outcomes. With this regulatory action, Juvéderm Voluma becomes the first hyaluronic acid (HA) dermal filler indicated for moderate to severe temple hollowing to be approved by the FDA.1 “The approval of Juvéderm Voluma XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs,” said Carrie Strom, president, Allergan Aesthetics, SVP, AbbVie, in a press release. “This is the first US FDA approval of ...
Sandoz drugs Jubbonti and Xgeva are approved for use in all indications covered by the Amgen products, Prolia and Xgeva. But no launch date is planned yet, due to ongoing patent litigation between the two companies. By FRANK VINLUAN A blockbuster Amgen antibody that treats bone conditions is set to face its first biosimilar competition. The FDA on Tuesday approved two Sandoz drugs as interchangeable with and approved for all uses of the Amgen products. The Amgen antibody, denosumab, is marketed as Prolia for the treatment of osteoporosis. A different dose of the antibody is marketed as Xgeva for preventing bone problems in multiple myeloma patients as well as those whose solid tumors have metastasized to the bones. Sandoz’s biosimilar for the osteoporosis indication will be marketed under the name Jubbonti. For cancer, the Sandoz product will be called Wyost. The Amgen and Sandoz drugs work by binding to a ...
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