PharmaFocus Today – Page 186 – media

PhaSER Biomedical receives $2.3m drug discovery grant from the Gates Foundation

Every year, tuberculosis, malaria and HIV cause over five million deaths worldwide PhaSER Biomedical has received a grant from the Bill & Melinda Gates Foundation worth $2.3m to accelerate drug discovery and development. PhaSER’s technology, 8HUM, will become a collaborating institution within the Global Health Discovery Collaboratory Programme, funded by the Gates Foundation. As part of the three-year programme, PhaSER will provide 8HUM transgenic mouse models, humanised for key pathways involved in the metabolism and disposition of drugs, to all grantees of the foundation. Collaborating researchers involved in combating diseases including malaria, tuberculosis (TB), HIV, pandemic preparedness and non-hormonal contraception will be provided with access to the drug discovery and development platform. Considered the ‘big three’ infectious diseases, TB, malaria and HIV are responsible for more than five million deaths worldwide every year. Formed in 2022 in collaboration with researchers at the University of Dundee, CXR Biosciences, Taconic Farms and ...
- Source: drugdu
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- February 28, 2024
Researchers develop terahertz biosensor to detect skin cancer for early diagnosis

Results from the study could also be used for other forms of cancer and diseases Researchers from the University of Glasgow and Queen Mary University of London have developed a new biosensor using terahertz (THz) waves that can detect skin cancer with strong sensitivity. Published in the IEEE Transactions on Biomedical Engineering, the study results could pave the way for easier and earlier diagnoses of skin cancer and potentially other cancers and diseases. Affecting one in four men and one in five women at least once in their lifetime in the UK, skin cancer is an abnormal growth of skin cells that involves three major types: basal cell carcinoma (BCC), squamous cell carcinoma and melanoma. Most skin cancer is often detected using traditional methods that involve expensive, time-consuming CT and PET scans, and invasive higher-frequency technology. After exploring the potential of THz metasurfaces, researchers designed the biosensor to detect subtle ...
- Source: drugdu
- 176
- February 28, 2024
BioCity Announces Enrollment Completion of the IgA Nephropathy (IgAN) Cohort in the Randomized, Placebo-controlled Phase II Clinical Trial of the ETA Receptor Antagonist SC0062

WUXI, China, Feb. 25, 2024 /PRNewswire/ — BioCity Biopharma is pleased to announce the completion of enrollment of all 120 participants in the IgA nephropathy (IgAN) cohort in a randomized, double-blind, placebo-controlled Phase 2 clinical study of the novel, oral endothelin A (ETA)-receptor selective antagonist SC0062, currently under development for chronic kidney disease (CKD), including IgAN and diabetic kidney disease (DKD). The enrollment of DKD cohort is ongoing with expected completion by the end of Q2 2024. “We appreciate the dedication of our colleagues and collaborators. The IgAN cohort enrollment was initiated in June 2023, and we enrolled all 120 subjects in less than 9 months. Thanks to the investigators, their teams, patients, and related BioCity colleagues”, Dr. Ivy Wang, co-founder and executive vice president of BioCity, stated. This accomplishment highlights BioCity’s ability to coordinate resources and operate efficiently in clinical trials, and further solidifies its leading position in the ...
- Source: drugdu
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- February 28, 2024
TransThera initiates IND-Enabling studies for TT-02332, a novel, highly potent and CNS-penetrating NLRP3 inhibitor

NANJING, China and GAITHURSBURG, Md., Feb. 26, 2024 /PRNewswire/ — TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced the initiation of IND-enabling studies for TT-02332, a potent, selective and highly CNS-penetrating NLRP3 inflammasome inhibitor. The NLRP3 inflammasome is a pivotal component of the human innate immune system. Aberrant activation of NLRP3 is strongly linked with a variety of inflammatory disorders, including obesity, neurodegenerative diseases, NASH, inflammatory bowel disease (IBD), dermatitis, and atherosclerosis. “Immuno-inflammation is one of TransThera’s key therapeutic areas of interest. Over the past three years, we have achieved breakthroughs with the NLRP3 inhibitor program.” said Jennifer Sheng, Vice President of Biology at TransThera. “Our clinical candidate compound TT-02332 is a highly potent NLRP3 inhibitor that has shown promising efficacy in a number of disease-relevant in vivo animal models. The compound exhibits desirable pharmacokinetic/ pharmacodynamic (PK/PD) properties, suitable for once-daily dosing. TT-02332 demonstrates an ...
- Source: drugdu
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- February 28, 2024
New report urges UK policymakers to take urgent action on declining child health

The report includes five recommendations for the government to address these issues The Academy of Medical Sciences has published a new report that highlights evidence of declining health among children under five years in the UK and has called on policymakers to take urgent action. The new report highlights that children’s health has been overlooked in policy, the health service and research from pre-conception through pregnancy to the first five years of life. Written by several child health experts, the new report, Prioritising Early Childhood to Promote the Nation’s Health, Well-being and Prosperity, warns the UK government of major health issues including infant mortality, obesity and tooth decay and highlights the economic prosperity of children’s health, which is estimated to cost at least £16bn a year. According to the report, which involved perspectives from parents and carers, infant survival rates are worse than in 60% of similar countries and, between ...
- Source: drugdu
- 155
- February 27, 2024
NIHR awards over £20m to eight new global health research projects

The projects will focus on healthcare in LMICs in the event of extreme weather The National Institute for Health and Care Research (NIHR) has awarded over £20m to eight new global health research projects to strengthen health service delivery and resilience in low- and middle-income countries (LMICs), specifically in the context of extreme weather events. Extreme weather events due to climate change, including tropical storms, droughts and floods, are increasingly common and are “a real threat to health across the globe – driving natural disasters… and disrupting people’s access to healthcare in many countries,” said Professor Lucy Chappell, chief executive officer, NIHR. Over the next three to five years, awards ranging between £1m and £3m will be awarded through the NIHR’s Research and Innovation for Global Health Transformation (RIGHT) Programme to fund health research in LMICs. The new projects follow the endorsement of the Declaration of Climate and Health by ...
- Source: drugdu
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- February 27, 2024
Subsidiary of Zhengda Tianqing Passed FDA’s On-site Inspection with “Zero Defect” for Three Consecutive Times

Recently, Lianyungang Runzhong Pharmaceutical, a wholly-owned subsidiary of Zhengda Tianqing Pharmaceutical Group, passed the on-site inspection of the U.S. Food and Drug Administration (FDA) with “zero defects”, which means that the company’s quality management system has once again been recognized by international authoritative drug regulatory agencies. Previously, Runzhong Pharmaceutical has passed the FDA on-site inspection with zero defects twice in 2014 and 2018. FDA is recognized as one of the most authoritative and strict agencies in the world for drug quality supervision.2024 From January 22 to January 26, FDA conducted pre-approval inspections on two antineoplastic products of Runzhong Pharmaceuticals, as well as supervisory inspections on four products commercialized in the U.S. market, namely, aminophosine, fosaprepitant dimeglumine, phosphonate, and fulvestrant. At the final meeting on January 26, the inspector announced on-site that R&Z passed the inspection with zero defects. It is understood that during this on-site inspection, the FDA inspector conducted ...
- Source: drugdu
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- February 27, 2024
Dupixent® Receives Another FDA Priority Review for Chronic Obstructive Pulmonary Disease (COPD) with Type 2 Inflammation

Sanofi today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of Dupixent (dupliximab) for a sixth potential indication as a supplemental biologic. Sanofi announced today that the U.S. Food and Drug Administration (FDA) has granted priority review of the Supplemental Biologics License Application (SBLA) for the sixth potential indication for dabigatran (duplizumab), an add-on maintenance treatment for adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The FDA approval is expected on June 27, 2024. China has also submitted a marketing authorization application and received acceptance from the Center for Drug Evaluation (CDE) of the State Drug Administration (SDA). Data from two Phase III clinical trials (BOREAS and NOTUS) supporting this SBLA and other applications globally evaluated the efficacy and safety of Dupixent in adult patients with uncontrolled chronic obstructive pulmonary disease (COPD) with type 2 inflammation who are smokers or have a history of ...
- Source: drugdu
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- February 27, 2024
February 23, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was approved for use in combination with dexamethasone to treat certain patients with multiple myeloma. The agency determined the following grounds for withdrawal were met: (1) the confirmatory study conducted as a condition of accelerated approval did not confirm Pepaxto’s clinical benefit, and (2) the available evidence demonstrates that Pepaxto is not shown to be safe or effective under its conditions of use. The final decision was issued by the FDA’s Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D., as the Commissioner’s designee. The decision is effective immediately. The FDA plans to publish a Federal Register notice announcing the availability of today’s decision and remove Pepaxto from the Orange Book. It is the FDA’s ...
- Source: drugdu
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- February 27, 2024
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
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- February 27, 2024

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