By Don Tracy, Associate Editor Approval of Spravato would mark the first monotherapy to be available on the market for treatment-resistant depression in the United States.Johnson & Johnson (J&J) has submitted a supplemental New Drug Application (sNDA) to the FDA for the approval of Spravato (esketamine) as the first and only monotherapy for the treatment of treatment-resistant depression (TRD). According to the company, the sDNA is supported by encouraging data from the Phase IV TRD4005 trial, which evaluated the efficacy, safety, and tolerability of Spravato as a monotherapy. “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones,” said Bill Martin, PhD, global therapeutic area head, neuroscience, Johnson & Johnson Innovative Medicine, in a press release. “We’re pleased to build on the more than a ...
Each year, more than 20 million people worldwide suffer from strokes. Large vessel occlusions (LVO) constitute 30% of these cases but are behind 95% of the resulting disabilities and fatalities. The likelihood of recovery improves significantly if a procedure known as ‘thrombectomy’ is performed immediately after the onset of symptoms. However, speeding up this treatment is complicated because it’s difficult to identify LVO strokes outside hospital settings; symptoms can mimic other medical issues. Strokes can also result from blockages in smaller vessels or vessel ruptures, neither of which are suitable for thrombectomy. Ideally, LVO strokes need to be diagnosed quickly and before the patient arrives at the hospital to speed up the initiation of thrombectomy. Currently, there is no sufficiently accurate diagnostic tool for this purpose. Now, a groundbreaking diagnostic test can identify an LVO stroke within 15 minutes, expediting patient transfer to specialized care and saving more than 1 ...
By Don Tracy, Associate Editor JAMA study aims to determine whether financial barriers impact access to mental health services.In the United States, a number of low-income adults struggle to gain access to appropriate mental health care. Despite efforts such as new legislations aimed at extending both private and public insurance through the Affordable Care Act (ACA), financial barriers are still an issue. In a study published in JAMA Psychiatry, researchers aimed to discover whether there was an association between medical debt and delayed or forgone mental health care among adults in the United States. The study included data from the 2022 National Health Interview Survey, which measured responses from 27,651 adults with current or lifetime diagnoses of depression or anxiety. Additionally, Asian, Black, and Hispanic households were oversampled to improve precision of estimates for these groups. To provide accurate results, mental health status was assessed for depression and anxiety, measured ...
By Mike Hollan The tech company’s data platform will be implemented into the genomic research department’s workflow. Genomics research is growing in importance for the pharma industry with each passing year. One issue that researchers face, however, is the significant amount of data that genomics research generates and requires. Not surprisingly, recent advancements in data technology have caught the eye of many in the life sciences industry. Texas A&M Health and BurstIQ announced that they have formed a partnership which will leverage BurstIQ’s LifeGraph management platform to improve genomic data governance. The Texas A&M Health PROVENANCE clinicogenomics registry programs will be the primary benefactors of this partnership. In a press release, Texas A&M’s executive director of clinical, translational, and industry collaborations at the Institute of Biosciences and Technology, Center for Precision and Genomic Medicine Rick Silva, PhD, said, “LifeGraph provides a unique foundation for a modern, data-driven, and scalable approach ...
Candida auris (C. auris) is a rapidly emerging multi drug-resistant fungal pathogen that is commonly found in healthcare environments, where it presents a challenge due to its ability to asymptomatically colonize patients, facilitating its spread within these settings. Known to be a significant risk factor for invasive infections, C. auris is associated with high mortality rates and is resistant to many antifungal medications typically used for treatment. It has been responsible for outbreaks in over 35 countries in the past decade, marking it as a critical antimicrobial resistance threat. Given this, it is crucial to screen for C. auris to enable the timely implementation of contact precautions and infection control measures that can curb its spread within healthcare facilities and prevent potential outbreaks. Traditional testing methods can take days to yield results and often require sending samples to a reference laboratory. Now, a real-time polymerase chain reaction (RT-PCR) assay for ...
By Mike Hollan Ripston discusses the Biospecimen Management Consortium and how its working to develop best practices for driving sample excellence. Slope recently announced the launching of the Biospecimen Management Consortium (BMC), and new group focused on ensuring sample excellence in clinical trials. The group’s executive director, Amy Ripston, spoke with Pharmaceutical Executive about the group, it’s goals, and the importance of this work in the modern world. Pharmaceutical Executive: What are the goals of the BMC? Amy Ripston: The Biospecimen Management Consortium (BMC) was formed to elevate industry-wide excellence in sample management, raise the bar for data integrity and quality, and enable the future of complex clinical research. To accomplish this, the BMC will drive a variety of initiatives aimed at developing best practices and industry standards, streamlining biospecimen lifecycle operations and data management, and influencing regulatory policy. These initiatives will take a critical look at existing processes including, ...
By Don Tracy, Associate Editor Clearance of the NeuroLF Brain PET system marks Positrigo’s first device of its kind to be approved in the United States.The FDA has granted clearance to Positrigo’s NeuroLF brain positron emission tomographic (PET) system, which the company said represents a major advancement in functional brain imaging. The device is designed to diagnose and monitor brain disorders such as Alzheimer disease, brain tumors, epilepsy, and Parkinson disease. As the company’s first brain PET system approved in the United States, Positrigo is currently preparing for global market expansion, with European regulatory approval anticipated later this year.1 “It is not the first device of its kind which receives market clearance in the US, but we believe that our patient-centric and customer-driven design and development efforts over the last couple of years, brought us into the pole position to offer the best imaging solution to address the increased demand ...
Organiser:Reed Exhibitions Time:July 9-11, 2025 address: 3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall:Tokyo Big Sight International Exhibition Center Product range: Biomaterials: Amplification Equipment, DNA Extraction Equipment, Proteome Extraction & Purification, DNA Analysis Equipment, Proteome Analysis Equipment, Nuclear Magnetic Resonance, Automated Workstations, Automatic Dispensers, Cell Analysis Equipment, Incubators, Refrigerators, Nutrient Media, Mixers, Pipettes, Assay Kits, Regenerative Medicine, Drug Development, Biomaterials, Biocontracting, Pharmaceutical Intermediates, Cosmetic Ingredients, Fine Chemicals, Additives, Excipients, Plant Extracts Instrumentation: Analytical Instruments, Laboratory Equipment & Accessories, Chemical Reagents Bioengineering: Bioprocesses, Biochemistry, Biotechnology & Products, Analytical Methods, Nanobiotechnology & Products; Optics & Technologies Bioinformatics & Services: Bioinformatics, Biotechnology Services Medical & Pharmaceutical Applications: Medicine & Pharmaceuticals, Biologics, Biosimilars, & Biobetters Environmental Applications: Environmental Biotechnology, Agricultural Applications, Agricultural Products/Plant Biotechnology, Animal Husbandry Pharmaceutical Excipients: Pharmaceutical Packaging Materials, Pharmaceutical Excipients, Pharmaceutical Adjuvants & Equipment; Excipients (Antimicrobial Preservatives, Antioxidants, Capsules/Encapsulation, Coating Agents, Colors & Dispersions, Drug Delivery Systems, Emulsifiers/Solvents, Flavors & Fragrances, ...
Drugdu.com expert’s response: The potential for improvement in the accuracy of medical equipment primarily manifests in the following aspects: I.Technological Advancement and Innovation 1.Genetic Testing and Analysis: By leveraging advanced genomic technologies, patient genetic information can be analyzed with greater precision, providing data support for the customization of personalized medical devices. This precise data analysis facilitates the devices’ better adaptation to individual patient differences. 2.Personalized Drug Delivery Systems: Developing delivery systems capable of precisely adjusting drug dosage and release rates based on patients’ genetic profiles and physiological states ensures the drugs’ effectiveness and safety within the body. 3.3D Printing Technology: Utilizing 3D printing to create patient-specific surgical models and prosthetics enhances surgical precision and personalization. For instance, printing prosthetics that perfectly match patients’ anatomical structures reduces surgical risks and improves recovery outcomes. 4.Real-time Physiological Monitoring: Developing medical devices capable of continuously and accurately monitoring patients’ physiological states, such as wearable ...
Antimicrobial resistance is becoming a serious global health concern, making many infections increasingly difficult to treat and limiting available treatment options. This escalation in resistance raises the concern of some infections soon becoming untreatable. A major challenge for healthcare providers is quickly distinguishing between organisms that respond to standard first-line drugs and those that are resistant. Traditional testing methods, which involve culturing bacteria, testing them against various antimicrobial agents, and either manual or machine analysis, can take several days. This delay often leads to the administration of ineffective drugs, which can cause more severe health issues and potentially contribute to the development of further drug resistance. Researchers have now demonstrated that artificial intelligence (AI) can significantly cut down the time needed to accurately diagnose drug-resistant infections. They have developed an algorithm capable of correctly identifying drug-resistant bacteria from microscopy images alone. In research published in Nature Communications, the team of ...
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