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FDA Fast Tracks Nurix Therapeutics, Inc’s Novel BTK Inhibitor for CLL, SLL

Pharmaceutical Executive Editorial Staff NX-5948 is under evaluation for for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor. The FDA has granted Fast Track Designation to Nurix Therapeutics, Inc’s investigational Bruton’s tyrosine kinase (BTK) inhibitor NX-5948 for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor.1 NX-5948 has previously demonstrated that it is highly potent across a range of tumor cell lines with BTK inhibitor–resistance, which is an important treatment consideration for heavily pretreated patients with CLL and SLL, according to Nurix. “Fast Track designation for NX-5948 is an important recognition of the unmet patient need in CLL, particularly in the growing number of patients whose cancer has progressed ...
- Source: drugdu
- 122
- January 22, 2024
Ultrasensitive Molecular Diagnostic Tools Detect Asymptomatic Malaria

Malaria remains a significant cause of illness and death, particularly in low-income countries, striking hardest among young children and pregnant women. In 2022 alone, the World Health Organization reported 608,000 malaria deaths globally, with a staggering 95% of these occurring in the African region. A key challenge in controlling malaria, especially in endemic areas, is identifying and treating asymptomatic carriers of the disease. In response to this challenge, researchers have developed advanced diagnostic tools capable of detecting even minimal traces of malaria in individuals who carry the parasite but do not exhibit symptoms. A collaborative effort between scientists from the University of Washington (Seattle, WA, USA) and Med Biotech Laboratories (Kampala, Uganda) has led to significant advancements in malaria detection. The researchers observed that malaria parasite densities in the blood can suddenly fall below the detection threshold of traditional tests due to the evolving nature of the malaria pathogens. This ...
- Source: drugdu
- 168
- January 22, 2024
New Algorithm Detects and Identifies Novel Bacterial Organisms

Hospitals frequently encounter unknown germs, and identifying these pathogens is crucial for efficient bacterial infection treatment. Typically, medical laboratory analysis can identify these pathogens, but standard methods sometimes fall short, especially when dealing with unclassified bacterial species or those difficult to cultivate. Since 2014, a dedicated research team has been collecting and analyzing patient samples containing such elusive germs, leading to the discovery of over 30 new bacteria species, some linked to significant clinical infections. The team at the University of Basel (Basel, Switzerland) examined a total of 61 unidentified bacterial pathogens from various patient blood and tissue samples. These pathogens had previously eluded identification by conventional lab techniques like mass spectroscopy or partial bacterial genome sequencing. The researchers then employed a more recent method to sequence the complete genetic material of these bacteria. By comparing the genomes with known strains using an online tool, they identified 35 previously unknown ...
- Source: drugdu
- 138
- January 22, 2024
Comanche raises $75m to develop preeclampsia therapy

US-based Comanche Biopharma has raised $75m in an oversubscribed Series B financing round to develop its small interfering RNA (siRNA) therapy, CBP-4888, as a treatment for preeclampsia. The financiers included Google Ventures, F-Prime Capital, Lilly Asia Ventures, Longview Healthcare Ventures, New Enterprise Associates (NEA), and Atlas Venture. Furthermore, Scott Gottlieb from NEA and David Grayzel from Atlas will join Comanche’s board. Preeclampsia is persistent high blood pressure that develops during the second trimester of pregnancy or up to six weeks following delivery. It can be associated with high levels of proteins in the blood, decreased blood platelets, fluid in the lungs, or seizures. It occurs in 2-9% of pregnancies and the only management is premature delivery. Recent studies have found that excess circulating placental soluble fms-like tyrosine kinase 1 (sFlt1) is present in patients with preeclampsia, and can therefore, contribute to its pathogenesis. A 2023 study found that the administration ...
- Source: drugdu
- 100
- January 22, 2024
AI Governance Alliance calls for stronger global collaboration

As global leaders and industry power players gather in Davos to address the world’s most pressing problems, the World Economic Forum’s (WEF) AI Governance Alliance (AIGA) has called for stronger collaboration to create a framework for advanced AI. In a series of three new reports, AIGA has focused on unlocking the value and creating a framework for generative AI (GenAI) usage. AIGA said a global effort is needed to create equitable access to AI. According to Cathy Li, head of AI, data and metaverse at the WEF: “The AI Governance Alliance is uniquely positioned to play a crucial role in furthering greater access to AI-related resources, thereby contributing to a more equitable and responsible AI ecosystem globally.” “We must collaborate among governments, the private sector and local communities to ensure the future of AI benefits all,” she added. AIGA has called for experts in various sectors to address key areas ...
- Source: drugdu
- 99
- January 22, 2024
Synendos set to study endocannabinoid inhibitor for neuropsychiatric conditions

Swiss company Synendos therapeutics has been given the go-ahead from the European Medicines Agency (EMA) to advance its lead candidate, SYT-510, into a Phase I clinical trial to treat neuropsychiatric disorders. The first-in-class inhibitor targets endocannabinoids—naturally occurring, lipid-based neurotransmitters that help to maintain homeostasis. SYT-510 is said to inhibit endocannabinoid reuptake, which raises the amount of those neurotransmitters available in the synaptic cleft and increases neurotransmission. In the upcoming planned Phase I first-in-human trial, the focus will be on assessing the safety, tolerability and pharmacokinetics in healthy patients receiving increasing single doses of SYT-510. Basel headquartered-Synendos was spun out of the University of Bern in 2019, raising $27.8m in two Series A funding rounds in 2020 and 2021, co-led by Kurma Partners, Sunstone Life Science Ventures, and Ysios Capital. The company secured a two-year Eurostars grant in 2021, a European Union (EU) funding scheme, named the EndoCARE programme, to propel ...
- Source: drugdu
- 88
- January 22, 2024
Announcement of Tonghua Dongbao on the Achievement of Primary Endpoint in Phase IIa Clinical Trial of URAT1 Inhibitor (THDBH130 Tablets)

Tonghua Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd (“Dongbao Zixing”), a wholly-owned subsidiary of Tonghua Dongbao Pharmaceuticals Co., Ltd. (“Tonghua Dongbao”), has completed a pivotal Phase IIa clinical trial and obtained the summary report of the trial. The results of the study showed that the primary endpoints were achieved. The relevant information is announced as follows: I. Basic information of the drug 1、Name: THDBH130 Tablets 2、Indications：Hyperuricemia and gout 3、Dosage form: Tablet 4、Specification：2.5mg、20mg 5、Registration Classification: Chemical 1 6、Applicant: Dongbao Zixing (Hangzhou) Biomedical Co. 7, drug clinical trial approval: State Drug Administration approved the issuance of drug clinical trial approval notice (2021LP02020). The State Drug Administration approved the issuance of a notice of approval for clinical trial of the drug (2021LP02022; 2021LP02023), agreeing to carry out clinical trials. II. R&D Investment As at the date of this announcement, the Company has invested approximately RMB79.39 million in research and development in the Project. III. ...
- Source: drugdu
- 113
- January 22, 2024
Announcement of Hengrui Pharmaceuticals on the Notification of Approval for Clinical Trial of Drugs by Subsidiary Company

Shanghai Shengdi Pharmaceuticals Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceuticals Company Limited (hereinafter referred to as the “Company”), has received the Notice of Approval for Clinical Trial of Adebenosumab Injection approved by the State Drug Administration (hereinafter referred to as the “State Drug Administration”). Ltd. has received the “Notice of Approval for Clinical Trial” from the State Drug Administration (hereinafter referred to as “SDA”) for Adebenosumab Injection, which will be launched in the near future. The relevant information is announced as follows: I. Basic information of the drug Drug Name: Adebelizumab Injection Formulation: Injection Application: Clinical Trial Acceptance No.: CXSL2300746 Conclusion of Approval: According to the Drug Administration Law of the People’s Republic of China and relevant regulations, after examination, the application for clinical trial of Adebelizumab Injection accepted on October 31, 2023 complies with the relevant requirements for drug registration, and approval is granted for the product to ...
- Source: drugdu
- 121
- January 22, 2024
Announcement of Tasly Bioharma on the Notification of Approval of Drug Clinical Trial

Tasly Bioharma (hereinafter referred to as the “Company”) has received a Notice of Approval for Drug Clinical Trial from the State Drug Administration (hereinafter referred to as the “SDA”) for the project of Human Umbilical Cord Mesenchymal Stem Cell Injection (hereinafter referred to as the “B2278 Injection”), agreeing to carry out the project of Coronary Artery Bypass Grafting (Coronary Artery Bypass Grafting). The Company has received a Notice of Approval for Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection (hereinafter referred to as “B2278 Injection”) from the State Drug Administration (hereinafter referred to as the “SDA”), agreeing to carry out a clinical trial on chronic heart failure caused by chronic ischemic cardiomyopathy with indications of Coronary artery bypass graft (“CABG”). The relevant information is announced as follows: I. Basic information of the drug Drug name: human umbilical cord mesenchymal stem cell injection Dosage form: Injection Specification: 5×107 cells/1 ...
- Source: drugdu
- 113
- January 22, 2024
China Biopharm Launches Phase III Clinical Study of Semaglutide Injection

On January 16, China Biopharmaceutical announced that the Group has initiated a Phase III clinical study of Semaglutide Injection in China for the indication of type 2 diabetes mellitus. Semaglutide is a long-acting glucagon-like peptide-1 (GLP-1) analog with 94% sequence homology to human GLP-1, a peptide secreted by small intestinal L-cells, which is known for its ability to increase insulin synthesis and secretion, inhibit appetite, and delay gastric emptying. Semaglutide reduces blood glucose by stimulating insulin secretion and decreasing glucagon secretion. Semaglutide is the first weekly GLP-1 formulation in China with both hypoglycemic and cardiovascular indications, and its effects in lowering blood glucose, reducing body weight, and cardiovascular protection in diabetes have been well proven. Compared with the previous generation of glucose-lowering drugs, Semaglutide’s outstanding advantage is its longer half-life, which allows it to be administered once a week, greatly improving patient compliance. Currently, Semaglutide has become one of the ...
- Source: drugdu
- 91
- January 21, 2024

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