PharmaFocus Today – Page 311 – media

FDA director signals accelerated approval of gene therapy becoming normal! Multiple gene therapies are expected to be launched this year

“If we don’t move toward accelerated approval, many patients will not be able to receive treatment in a timely manner. For many initial approvals of gene therapies, accelerated approval will become the standard process.” Peter Marks said at a seminar held by the Reagan-Udall Foundation in Washington last week . There are currently more than 10,000 rare diseases, but companies often struggle to bring treatments for these diseases to market due to small patient populations and financial constraints. Accelerated approval is a tool that can advance the development of innovative treatments and ensure that companies do not abandon promising treatments. Peter Marks said: “There are many gene therapies for rare diseases that are almost successful. The key question now is, how do we push them to the finish line smoothly?” For gene therapy for rare diseases, a balance between supervision and science is needed. How to supervise gene therapy more ...
- Source: drugdu
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- March 6, 2024
WHO issues guidance to improve access to hearing care in low- and middle-income settings

For World Hearing Day, marked on 3 March, the World Health Organization (WHO) has released new technical guidance on hearing aid service delivery approaches for low- and middle-income settings. This document is designed to provide practical guidance to countries in developing hearing aid services in areas that lack human resources for assessing hearing, as well as fitting and maintaining hearing aids. The guidance, developed with support from the ATScale Global Partnership for Assistive Technology, is based on the principle of task sharing among specialists and trained non-specialists. It includes two approaches, one targeting adults and the other for children 5 years and over, and is accompanied by resources with tips for healthy ear care practices, use of hearing aids and how to support people living with hearing loss. “Over 400 million people with hearing loss could benefit from using hearing devices. However, less than 20% of these needs are fulfilled,” ...
- Source: drugdu
- 266
- March 6, 2024
AbbVie and OSE Immunotherapeutics Announce Collaboration to Develop Novel Monoclonal Antibody for the Treatment of Chronic Inflammatory Diseases

On February 28, 2010, AbbVie and OSE Immunotherapeutics, an immunotherapeutics company, announced a strategic partnership to develop OSE-230, a monoclonal antibody designed to address serious chronic inflammatory diseases, which is currently in preclinical studies. OSE-230 is a first-of-its-kind monoclonal antibody designed to activate the G protein-coupled receptor (GPCR) target ChemR23, which may provide a novel mechanism for relieving chronic inflammation by regulating macrophage and neutrophil function. Dr. Jonathon Sedgwick, Senior Vice President and Global Head of Discovery Research at AbbVie, said: “This collaboration underscores our commitment to expanding our immunology portfolio, with the ultimate goal of raising the standard of care for patients suffering from inflammatory diseases worldwide. We look forward to applying our expertise in immunology drug development to advance the development of OSE-230. Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, said: “We are pleased to partner with AbbVie, a global leader in the development and commercialization of ...
- Source: drugdu
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- March 6, 2024
Henlius Adalimumab Biosimilar Received sNDA Acceptance Notification from the NMPA

Shanghai, China, 29th February 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications (sNDAs) of its adalimumab biosimilar HANDAYUAN for the treatment of polyarticular juvenile idiopathic arthritis，pediatric plaque psoriasis and other indications have been accepted by the National Medical Products Administration (NMPA)，bringing new hope to pediatric patients and their families. As of now, HANDAYUAN has been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. Autoimmune diseases are a group of diseases caused by the body’s immune system attacking its own organs or tissues[1]. It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases[2]. Currently, autoimmune diseases are difficult to cure, and once it occurs, most patients need long-term to lifelong medication. Some autoimmune diseases are particularly dangerous and severely affect the quality of life of patients, posing a threat to their lives and ...
- Source: drugdu
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- March 6, 2024
Poor spatial navigation could predict Alzheimer’s before symptom onset

Around 900,000 people in the UK are affected by the progressive neurodegenerative disease Researchers from University College London (UCL), in collaboration with the University of Cambridge, have revealed that impaired spatial navigation could determine the risk of Alzheimer’s disease (AD) before the onset of symptoms. Published in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, researchers used virtual reality (VR) to test the spatial navigation of 100 asymptomatic adults from the PREVENT-Dementia study. Affecting around 900.000 people in the UK, AD is a neurodegenerative disorder that progressively destroys memory, thinking skills and the ability to carry out simple day-to-day tasks. Researchers recruited adults aged between 43 and 66 years who had a hereditary or physiological risk of AD related to either the APOE-ε4 allele gene, a family history of AD or lifestyle risk factors, including low levels of physical activity, who were around 25 years younger than their estimated ...
- Source: drugdu
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- March 6, 2024
Researchers reveal two different subtypes of prostate cancer using AI

In the UK alone, the aggressive form of cancer affects around 52,000 men every year Researchers from the University of Oxford and the University of Manchester have revealed that prostate cancer is not just a single disease and is made up of two different evotypes – subtypes of the disease. Published in Cell Genomics, the study, funded by Cancer Research UK and Prostate Cancer Research, used artificial intelligence (AI) to reveal a new form of aggressive prostate cancer. Currently the most common cancer affecting men in the UK, prostate cancer is responsible for around 52,000 cases every year. As part of the Pan Prostate Cancer Group; an international consortium set up by the Institute of Cancer Research (ICR) and the University of East Anglia (UEA), researchers applied AI to analyse the genetic data of 159 prostate cancer patient samples across nine countries. Using whole genome sequencing to study changes in ...
- Source: drugdu
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- March 6, 2024
New POC Malaria Test 12 Times Faster Than Currently Available Laboratory-Based Tests

Malaria continues to pose a major global health threat, with approximately 247 million cases and over 600,000 deaths annually, predominantly in sub-Saharan Africa. Particularly alarming is cerebral malaria, a severe form of the disease, which has a high mortality rate, especially among children under five. The existing rapid diagnostic tests (RDTs) for malaria offer a basic positive or negative result, but often fail to detect asymptomatic infections and lack the sensitivity required for early detection of severe cases. More sensitive molecular assays that exist are costly, time-consuming, and need specialized skills and equipment, rendering them unsuitable for widespread application in areas with limited resources. In light of these challenges, researchers have now developed a new test for diagnosing malaria that is both rapid and accurate. This POC rapid malaria test offers a significant improvement over traditional tests and will be especially beneficial for rural areas with limited healthcare facilities. Researchers ...
- Source: drugdu
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- March 5, 2024
New Discoveries of Prostate Cancer Evolution Pave Way for Genetic Test

Prostate cancer ranks as one of the most common cancers affecting men, and while it accounts for a significant number of male cancer fatalities, many men live with it rather than die from it. Understanding when to avoid unnecessary treatments is crucial, as it can prevent side effects like incontinence and impotence. Now, new research has identified two distinct subtypes of prostate cancer, referred to as evotypes. This discovery could lead to major advancements in the diagnosis and treatment of prostate cancer. This discovery was made by an international consortium, called The Pan Prostate Cancer Group, which involved researchers from the University of Oxford (Oxford, UK), who used artificial intelligence (AI) to make new discoveries about the evolution of prostate cancer. Cancer development, like human evolution, can be traced and studied through its evolutionary history. By examining the cancer’s evolutionary tree, valuable insights about the disease can be gained, potentially ...
- Source: drugdu
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- March 5, 2024
CDC’s Advisory Committee Recommends Another Round of Covid-19 Shots for Seniors

Mike Hollan The agency updated its recommendations after a vote by the ACIP advisory committee. The Covid-19 shot isn’t done yet. The CDC is recommending that people over the age of 65 should get another injection of the COVID-19 vaccine. The recommendation comes after the CDC’s Advisory Committee on Immunization Practices (ACIP) voted on the matter, CNN reports.1 The committee voted 11 yes, one no, and one member abstained. According to the new recommendation, anyone over the age of 65 should get the latest version of any of the available COVID vaccines if it has been at least four months since their previous shot. According to CNN, CDC epidemiologist Dr. Ruth Link-Gelles said during a meeting with ACIP advisors, “[The vaccine] doesn’t protect absolutely,” she said. “What the vaccines are doing now is providing an incremental benefit or an extra benefit beyond whatever benefit someone has remaining from their past ...
- Source: drugdu
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- March 5, 2024
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
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- March 5, 2024

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