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Member Defense Network Launches to Prevent Unauthorized Switching in ACA Marketplace

By Mike Hollan The network includes organizations that represent over 45,000 agents and brokers. Industry leaders are taking steps to combat unauthorized plan switching in the Affordable Care Act (ACA) Marketplace. Unauthorized switching occurs when a user’s plan or agent of record is changed without their knowledge or consent. This is a form of fraud and can cause users to face unexpected costs, along with other consequences. Insurers across multiple states have joined together to form a network to prevent users from facing unauthorized switching.1 These insurers include BluCross BlueShield of North Carolina, Group Health Cooperative of South Central Wisconsin, Highmark BlueCross Blue Shield, and others. The network is named the Member Defense Network and it will launch in Florida in July, 2024. According to a press release, the network’s partners represent over 45,000 insurance agents and brokers. The cause of unauthorized switching has been a topic of debate. In ...
- Source: drugdu
- 84
- July 22, 2024
Texas A&M Health Teams With BurstIQ to Improve Genomic Research Data Governance

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 ...
- Source: drugdu
- 74
- July 22, 2024
Rona Therapeutics gains Series A+ funds for siRNA pipeline expansion

Rona Therapeutics has secured $35m in its Series A+ financing round to advance its metabolic small interfering RNA (siRNA) pipeline in clinical settings. The company will also use the investment proceeds to develop next-generation RNA platforms. LongRiver Investments spearheaded the financing round, which saw contributions from Zhaode Investment, Zhongqi Capital, BioTrack Capital and Lilly Asia Ventures. LongRiver Investments will become part of Rona’s board. The company focuses on developing siRNA programmes, with its first product, RN0191, having completed Phase I clinical studies in Australia and China. In December 2023, Rona received clinical trial application clearance from the National Medical Products Administration in China to assess RN0191 injection to treat hypercholesterolemia, mixed hyperlipidemia and atherosclerotic cardiovascular disease, to reduce the risk of cardiovascular events. The asset is set to enter Phase II clinical development for hypercholesterolemia. Rona’s second programme, RN0361, is scheduled to enter clinical trials in the second quarter of ...
- Source: drugdu
- 77
- July 22, 2024
US FDA grants priority review for Pierre Fabre’s EBV+ PTLD

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) and granted priority review for Pierre Fabre Pharmaceuticals’ Tabelecleucel (Tab-cel) to treat Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). Tabelecleucel is being developed as a monotherapy for EBV+ PTLD treatment in adult and paediatric patients aged two years and above who have undergone a minimum of one previous therapy. It is an allogeneic, EBV-specific T-cell immunotherapy and acts on EBV-infected cells. The company’s BLA is supported by the outcomes of 430 subjects who received Tab-cel. For patients who have received solid organ transplants, previous therapy typically includes chemotherapy, except in cases where this is deemed inappropriate. No FDA-approved therapies are currently available for this treatment setting. A decision by the US regulator under the Prescription Drug User Fee Act (PDUFA) is anticipated by 15 January 2025. In November 2023, Pierre Fabre Laboratories obtained marketing rights to ...
- Source: drugdu
- 85
- July 22, 2024
Meitheal gains rights to CONTEPO from Nabriva in North America

Meitheal Pharmaceuticals has expanded its biopharmaceutical portfolio through the acquisition of rights to CONTEPO (fosfomycin for injection) from Nabriva Therapeutics for the North American region. Meitheal gains access to the rights to CONTEPO, including development and regulatory works, intellectual property rights, technology and related know-how. Nabriva will receive payment upon the agreement closing in addition to royalties on net sales of the injection in the US. An intravenous broad-spectrum antibiotic, CONTEPO has shown activity against multi-drug resistant strains causing complicated urinary tract infections (cUTI). Fosfomycin for intravenous administration is already marketed outside the US and has been approved for nine indications, including cUTI and other serious bacterial infections. CONTEPO’s new dosing approach aims to optimise the compound’s pharmacokinetics and pharmacodynamics. It met the primary endpoint in the ZEUS trial enrolling patients with cUTI. Nabriva filed a new drug application with the US Food and Drug Administration (FDA) seeking approval for ...
- Source: drugdu
- 74
- July 22, 2024
EMA accepts Deciphera’s MAA cell tumour treatment for review

The European Medicines Agency (EMA) has accepted for review the marketing authorisation application (MAA) of Ono Pharmaceutical subsidiary Deciphera Pharmaceuticals‘ vimseltinib to treat tenosynovial giant cell tumour (TGCT). Vimseltinib is a colony-stimulating factor 1 receptor (CSF1R). The review will be carried out under the centralised review process of the European regulator for all 27 member states of the European Union (EU), Iceland, Norway and Liechtenstein. The MAA filing is based on the findings of the Phase III MOTION clinical trial assessing the safety and efficacy of vimseltinib in people with TGCT not amenable to surgical procedure without previous anti-CSF1/CSF1R therapy, versus placebo. The study showed a significant objective response rate (ORR) at week 25 – the trial’s primary endpoint – compared to placebo. Secondary endpoints of the study included ORR per tumour volume score, active range of motion, physical function and quality of life assessments. Vimseltinib also showed a manageable ...
- Source: drugdu
- 63
- July 22, 2024
Novel Molecular Test to Help Prevent and Control Multi Drug-Resistant Fungal Pathogen in Healthcare Settings

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 ...
- Source: drugdu
- 85
- July 20, 2024
Automated Benchtop System to Bring Blood Testing To Anyone, Anywhere

Almost all medical decisions are dependent upon laboratory test results, which are essential for disease prevention and the management of chronic illnesses. However, routine blood testing remains limited worldwide. Many adults avoid routine blood tests due to their complexity and the long wait times for results, which can lead to delayed interventions or missed diagnoses, resulting in substantial avoidable costs. Now, a groundbreaking diagnostic platform is set to transform the existing global infrastructure by providing lab-accurate, actionable test results that aid in the early detection and prevention of chronic conditions. Truvian Health (San Diego, CA, USA) has developed an automated benchtop system that allows simple, accurate, and comprehensive routine blood tests to be conducted directly in clinics, doctor’s offices, and pharmacies. Utilizing patented technologies and intelligent integration, Truvian’s compact device offers a convenient and economical alternative to traditional off-site labs, delivering quick, lab-accurate results from just a small blood sample, ...
- Source: drugdu
- 86
- July 20, 2024
Q&A with Amy Ripston

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, ...
- Source: drugdu
- 99
- July 20, 2024
FDA Clears Positrigo’s NeuroLF Brain PET System for the Diagnosis of Multiple Brain Disorders

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 ...
- Source: drugdu
- 84
- July 20, 2024

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