Mushroom gummies being sold to promote brain function may contain the illegal hallucinogen psylocibin and other harmful ingredients not listed on the label, UVA Health experts are warning after five people – including a 3-year-old child – were sickened. A spate of cases seen in UVA Health Medical Center’s emergency department between September and June prompted poison experts with UVA’s Blue Ridge Poison Center to test five different brands of the products sold in Central Virginia gas stations and smoke shops. Of those, three contained psilocybin or psilocin, substances classified as “Schedule I” drugs by the U.S. Food and Drug Administration, meaning they have no medical use and high potential for abuse. Psilocybin and psilocin are illegal at both the federal and state level. All the products tested claimed to contain the Amanita muscaria mushroom, which is legal, or a proprietary mushroom blend. But none disclosed the inclusion of psilocybin ...
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 ...
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 ...
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 ...
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 ...
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, ...
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 ...
Ardelyx has declared that it is filing a lawsuit against the US Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) to keep essential phosphate-lowering therapies separate from the CMS’s renal disease payment bundle, claiming that the action could “limit patient choice”. Ardelyx has teamed up with the American Association of Kidney Patients (AAKP) and the National Minority Quality Forum (NMQF) to sue the government organisations regarding the CMS’s renal disease payment bundle. The End Stage Renal Disease (ESRD) Prospective Payment System (PPS) is a bundled payment scheme for renal dialysis services available for Medicare beneficiaries. The ESRD PPS adjusts treatment costs at the patient and facility level for renal dialysis treatment at an ESRD facility or the patient’s home. This payment includes costs for laboratory services, drugs, supplies, and more, as per CMS’s description. The litigation states that the CMS has “violated ...
Anew rare disease innovation hub set up by the US Food and Drug Administration (FDA) aims to expedite the development and approval of orphan drugs. Rare disease clinical trials can be tricky to navigate, especially for conditions with very few patients. Moreover, even after clinical success, some therapies for rare diseases have been dropped by companies due to the high development costs. The FDA’s hub will act as a central point of connection and engagement with the rare disease community, aiding the navigation of FDA-related concerns. It will enhance inter-centre collaboration on scientific, clinical, and policy issues in rare disease product development, said the agency. It also aims to advance novel endpoints, biomarkers, trial designs, real-world evidence, and statistical methods. The hub will be co-led by Dr. Patrizia Cavazzoni, director at the Center for Drug Evaluation and Research (CDER), and Dr. Peter Marks, director at the Center for Biologics Evaluation ...
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