Search Results for “Clinical Trial” – Page 69 – media

Cancer Biotech Lands $145M for First-in-Class Drug to Block Elusive Tumor Target

FogPharma’s lead program is a peptide that blocks a difficult-to-drug pathway inside of cells. The new financing will go toward an ongoing Phase 1/2 study in advanced solid tumors and support development of pipeline programs for other elusive cancer targets. By FRANK VINLUAN FogPharma has reached early clinical development with a therapeutic candidate that takes a novel approach to treatment of solid tumors. The company now has $145 million to continue the drug’s clinical development and advance more programs in its pipeline. Cambridge, Massachusetts-based FogPharma discovers and develops peptides capable of entering cells to address targets that drive disease. Such targets haven’t been drugged before due to the difficulty of getting a drug to act within a cell. FogPharma says its peptide drugs, which it calls Helicon therapeutics, can get inside a cell to modulate protein-protein interactions as well as protein-DNA interactions. FogPharma’s lead program is FOG-001, a Helicon therapeutic ...
- Source: drugdu
- 201
- March 5, 2024
Jacobio Pharma Receives IND Approval for P53 Y220C Activator JAB-30300 in the U.S.

BEIJING, SHANGHAI and BOSTON, March 1, 2024 /PRNewswire/ — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C activator) from the FDA of the U.S. Jacobio plans to initiate a Phase I/IIa advanced solid tumors clinical trial in the U.S., to evaluate safety and efficacy of JAB-30300. Jacobio also plans to submit IND in China, and will conduct clinical studies once receives the IND approval. P53 is the single most frequently altered gene in human cancers, with mutations being present in approximately 50% of all invasive tumors. JAB-30300 is an orally bioavailable small molecule activator for the treatment of patients with solid tumors harboring P53 Y220C mutation. Studies shows that, JAB-30300 has shown very high binding affinity to P53 Y220C mutant proteins. Tumor regression was achieved in multiple cancer models covering various ...
- Source: drugdu
- 149
- March 5, 2024
Pfizer’s Bivalent Respiratory Syncytial Virus Vaccine Shows Promising Efficacy Across Two Seasons

Davy James Abrysvo was found to produce durable efficacy against respiratory syncytial virus across two seasons in adults 60 years of age and older. Top-line data from the ongoing, pivotal Phase III RENOIR clinical trial (NCT05035212) demonstrated that Pfizer’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine Abrysvo produces durable efficacy against respiratory syncytial virus (RSV) across two seasons in adults 60 years of age and older. Efficacy against RSV-associated lower respiratory tract disease (LRTD), defined as three or more symptoms, was 88.9% after the first season, whereas efficacy was 77.8% after the second season.1 “We are encouraged by the level of protection that we observed after two full RSV seasons for Abrysvo,” Annaliesa Anderson, PhD, Pfizer senior vice president and chief scientific officer, Vaccine Research and Development, said in a press release. “This new data indicate that broad and durable protection against both types of RSV that cause ...
- Source: drugdu
- 151
- March 4, 2024
New Alzheimer’s Detecting Blood Tests Perform across Broad Range of Races and Ethnicities

Alzheimer’s disease, which traditionally requires costly scans or invasive spinal taps for diagnosis, is now closer to being more easily identified through innovative blood tests. This advancement is particularly crucial with the recent approval of disease-modifying treatments for Alzheimer’s. Now, the results of a study have shown how new Alzheimer’s detecting blood tests perform across a broad range of races and ethnicities for the first time. The Global Alzheimer’s Platform Foundation (GAP, Washington, DC, USA) is releasing the first results from the Bio-Hermes-001 Study. To address diagnostic challenges in Alzheimer’s disease, GAP formed a unique coalition of top biopharma, digital technology firms, nonprofit partners, and 17 clinical research sites from the GAP network (GAP-Net) across the US for the Bio-Hermes study. Conducted with over 1,000 participants from various US communities, the study compared blood and digital biomarker results with brain amyloid PET scans and cerebrospinal fluid assays. The study found ...
- Source: drugdu
- 111
- March 2, 2024
FDA Issues Refusal to File Letter to Theratechnologies for sBLA Seeking Approval of Intramuscular Administration of Trogarzo

Davy James Trogarzo (ibalizumab-uiyk) is currently approved in combination with other antiretroviral therapy for heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen. The FDA has issued a refusal to file letter (RTF) to a supplemental Biologics License Application (sBLA) filed by Theratechnologies Inc. for an intramuscular (IM) method of administration for maintenance dosing of Trogarzo (ibalizumab-uiyk).1 The CD4-directed post-attachment HIV-1 inhibitor is approved in combination with other antiretroviral therapy (ART) for heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current ART regimen.2 The RTF followed a preliminary review of the sBLA by the FDA, which found that the application did not include data the agency required to establish a pharmacokinetic bridge between IM administration and intravenous (IV) administration of Trogarzo. “While we are disappointed to receive this letter from the FDA, we were aware that the approval of this ...
- Source: drugdu
- 109
- March 2, 2024
New digital iTalkBetter app significantly improves speech in stroke patients

Aphasia is a language disorder caused by some form of brain damage, including stroke Researchers from the Neurotherapeutics Group at University College London’s Queen Square Institute of Neurology have developed a new digital app that significantly improves speech in stroke patients. Supported by Wellcome and funded by the National Institute for Health and Care Research (NIHR), the iTalkBetter app provides speech therapy for people living with aphasia, a language disorder. Caused by some form of brain damage, including stroke, severe head injury and brain tumours, aphasia can lead to difficulties with speech or language. The NHS currently provides around 12 hours of speech and language therapy, with further face-to-face therapy available via some charities or privately. However, most aphasia patients are undertreated with therapy. The new app offers practice for over 200 commonly used words, games to maintain engagement and an integrated speech recogniser to analyse speech in real time ...
- Source: drugdu
- 90
- March 2, 2024
【EXPERT Q&A】How to apply for Biologics License Application (BLA)?

Drugdu.com expert’s response: The Biologics License Application (BLA) is a licensing application for biologic products, typically managed and approved by the United States Food and Drug Administration (FDA). BLA submission is required to obtain approval for the sale of biologic products in the U.S. market. The following are the key aspects to consider and the required documents for BLA submission: 1.Clinical Trial Data: Detailed clinical trial data must be provided in the BLA submission, including study design, trial results, safety, and efficacy data. These data should adhere to FDA’s requirements for clinical trial design and reporting. 2.Product Quality Control: Information on product quality control, including manufacturing processes, quality control methods, stability data, etc., needs to be provided. These data ensure that the manufacturing process and quality of the product comply with FDA requirements. 3.Nonclinical Data: Relevant nonclinical data, such as animal model studies, toxicology data, etc., should be provided to assess ...
- Source: drugdu
- 143
- February 29, 2024
UK and Netherlands researchers call for funding to investigate cancer treatments

The white paper outlines three strategic recommendations to support further research Researchers from King’s College London and Erasmus MC in the Netherlands have called for further funding support in a recently published white paper to investigate the use of radioactive cancer-targeted drugs to improve cancer treatments. The white paper, Unlocking the Full Potential of Cancer Treatments Using Targeted Radionuclide Therapy through Netherlands-UK Partnerships, outlined three strategic recommendations to achieve this. Most radioactive drugs are used to specifically deliver a radiation dose to cancer cells to produce a therapeutic effect. They are used to treat the disease areas identified on medical scans but can also specifically target the microscopic tumour deposits, which are involved in the progression of the disease. More specifically, targeted radionuclide therapy, a type of radiation therapy, is effective to treat prostate cancer and some other types of cancer where radionuclide, a radioactive chemical, is linked to cell-targeting ...
- Source: drugdu
- 152
- February 29, 2024
Qyuns Therapeutics passed the IPO hearing on the Main Board of the Hong Kong Stock Exchange

According to the Hong Kong Stock Exchange, on February 26, Jiangsu Qyuns Therapeutics-B passed the IPO hearing on the main board of the Hong Kong Stock Exchange and will be listed soon. It is reported that Qyuns Therapeutics was established in 2015. It is a clinical-stage biotechnology company completely focused on biotherapeutics of autoimmune and allergic diseases, covering four major disease areas: skin, rheumatism, respiratory and digestive tract diseases. According to its official website, based on its complete independent innovation capabilities, Qyuns Therapeutics has formed two core products, QX002N and QX005N, as well as a product pipeline of seven other drug candidates. One variety has been accepted by BLA, one is in clinical phase 3, and four varieties are in clinical phase 2 and 1 respectively. The indications cover silver eyebrow disease, atopic dermatitis, ankylosing spondylitis, systemic lupus erythematosus, It covers four major disease areas including asthma, inflammatory bowel disease, ...
- Source: drugdu
- 95
- February 28, 2024
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
- 132
- February 28, 2024

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