Mike HollanIt could be time for many Americans to add another vaccine to their list. Pfizer recently announced the results of a study for its RSV vaccine. While the vaccine is already approved for older Americans, the results of the study reportedly show that it is also effective for adults as young as 18. As such, Pfizer is asking FDA to approve the vaccine for adults aged 18 to 59. In a press release, Pfizer stated that Abrysvo met all of its primary endpoints for adults in specified age range who had an increased risk of RSV.1 The study was named MONeT, which is short for RSV Immunization Study in Adults at Higher Risk of Severe Illness. It was conducted to see the efficacy of the vaccine in adults who suffer from certain conditions, such as asthma, diabetes, and chronic obstructive pulmonary disease. These conditions put the patients at a ...
Don Tracy, Associate Editor New methods allow the antiseizure treatment to be crushed and mixed with water for oral suspension or for use through a nasogastric tube. SK Life Science announced that the FDA has approved two new ingestion methods for Xcorpi (cenobamate tablets) CV, an antiseizure medication. As of today, the medication can be crushed and mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube. These new methods of administration were approved as a result of the results of an open-label, randomized, single-center, three-period, six-sequence, crossover study showing biochemical similarity between three administration routes, including the aforementioned methods.1 “The approval addresses the needs of patients living with epilepsy who are currently taking, or who may benefit from starting XCOPRI, but are unable to swallow the tablets whole,” said Louis Ferrari, BS, RPh, MBA, VP, medical affairs, SK Life Science, in ...
Don Tracy, Associate Editor A combination of data from the EMERGENT-4 trial and pooled data from the EMERGENT program showed the promise of KarXT (xanomeline-trospium) in providing symptom improvement for people with schizophrenia. Bristol Myers Squibb announced results from its Phase III EMERGENT-4 trial analyzing the long-term efficacy, safety, and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia, which was showcased at the Annual Congress of the Schizophrenia International Research Society (SIRS). Additionally, the company revealed promising pooled data from EMERGENT-4 and EMERGENT-5 for the long-term safety, tolerability, and metabolic effects of KarXT in schizophrenia over 52 weeks. EMERGENT-4 is a 52-week, open-label extension trial assessing long-term efficacy, safety, and tolerability of KarXT in adults who completed earlier phases of the trial for schizophrenia. Investigators found that over 75% of patients administered KarXT achieved a 30% improvement in symptoms.1 “We are pleased to see a continued and consistent meaningful reduction ...
Shanghai, China & JERSEY CITY, N.J. – April 8, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception from the agreement is China. The randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study (NCT05352516) aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia®) in postmenopausal women with osteoporosis at high risk for fracture. Eligible patients were randomised at a 1:1 ratio to receive subcutaneous injection of 60 mg of HLX14 or reference denosumab (Prolia®) every six months. The primary efficacy endpoint ...
Regular aerobic exercise later in life prevents genomic instability characterized by DNA damage and telomere dysfunction, according to a study from the Department of Internal Medicine at the University of Utah. Researchers will present their work this week at the American Physiology Summit, the flagship annual meeting of the American Physiological Society (APS), in Long Beach, California. Jisok Lim, PhD, said, “These new findings will greatly impact our understanding of the mechanisms on how aerobic exercise improves vascular health at the level of genomic stability.” Late-life exercise used to be thought of as ineffective. However, existing studies indicate aerobic exercise later in life lowers the risk of cardiovascular disease-related mortality. Yet, the specific factors contributing to this effect have not been completely understood. Researchers examined whether regular exercise with aging may prevent DNA damage and telomere dysfunction. Telomeres are protective caps at the end of chromosomes. In this study, exercise ...
A project being led by King’s College London (KCL) has received funding from the Department for Science, Innovation and Technology (DSIT) totalling £100,000 to create a platform to boost artificial intelligence (AI)-assisted healthcare for cancer diagnosis. The PharosAI project will develop a platform for AI researchers and companies to access cancer-related datasets to train AI in healthcare settings. One of 12 teams awarded as part of the DSIT’s Research Venture Catalyst Programme, the project will comprise researchers from KCL, Guy’s and St Thomas’s Trust, Bart’s Cancer Institute and Bart’s Health Trust. The platform will help researchers and companies develop, evaluate and deploy NHS-quality AI for cancer diagnosis, offering AI clinical evaluation, deployment, standards validation services and educational programmes. According to the project proposal, researchers aim to develop a data refinery sourced from over 50,000 patient samples from King’s Health Partners Cancer Biobank and the Breast Cancer Now Tissue Bank to ...
myTomorrows has announced a new partnership with a UK-based charity, brainstrust, to support individuals living with brain cancer. The partnership will help equip patients with knowledge of relevant treatment options, participation in clinical trials and access to pre-approved drugs, while supporting clinicians when recruiting patients to relevant clinical trials. Brain tumours affect around 80,000 people in England, with only 12% of patients surviving beyond five years of their diagnosis. As part of the agreement, the charity will provide its patient network with timely, up-to-date and useful information surrounding credible and accessible clinical trials, along with myTomorrow’s expertise and support. In addition, myTomorrow’s trained patient navigators will play a key role as a single point of contact to help guide patients with brain tumours and their loved ones, as well as healthcare professionals, through medical care and help them make the best decisions during their treatment journey. Using a GDPR-compliant ISO ...
Organiser: Nuremberg Exhibition Co. LTD Time: 4 – 6 June 2024 address:Centro de Exposições Imigrantes Rodovia dos Imigrantes, Km 1,5 São Paulo – SP Exhibition hall: São Paulo Expo Product range: Apis: vitamins, hormones, antipyretic analgesics, digestive system drugs, anti-infective drugs, anti-parasitic drugs, cardiovascular system drugs, intermediates Medical equipment: medical packaging materials, PVC/PVDC composite sheet, PVC hard sheet, PS sheet, packaging anti-counterfeiting technology information, label technology, label filling machine, packaging container molding filling and sealing machine, wrapping machine, paper film packaging machinery, etc Other: large infusion equipment production line, dryer, water treatment equipment, refrigeration compressor, distillation equipment, sterilization equipment, tablet press, coating machine, plastic equipment, crystallization equipment, etc About FCE Pharma: FCE Pharma is the premier pharmaceutical technology exhibition in South America. In addition to bringing together new technologies, trends and technologies for the pharmaceutical industry, products and services, FCE Pharma also offers high-quality content to exchange experiences with professionals, case ...
BY SEAN WHOOLEY The TULSA-PRO system from Profound Medical. [Image from Siemens Healthineers]Profound Medical (Nasdaq:PROF) announced today that it entered into a non-exclusive collaboration with Siemens Healthineers. The two companies aim to lay the groundwork for Profound to begin marketing a complete therapeutics solution. They want to combine the Profound TULSA-PRO system with the Siemens Magnetom Free.Max magnetic resonance (MR) scanner. While this combination falls under the remit of Profound’s own sales force, the company also plan to market TULSA-PRO as a standalone offering. This enables customers to use the technology with the MR hardware of their choice. TULSA-PRO performs the company’s transurethral ultrasound ablation (TULSA) procedure. It employs real-time MR guidance for precision while killing targeted prostate tissue through sound absorption technology. The system enables surgeons to ablate whole- or partial-gland prostate tissue in patients with low- intermediate- or high-risk prostate cancer. It also treats benign prostatic hyperplasia (BPH). ...
CellVoyant – an AI biotechnology spin-out from the University of Bristol – has announced a £7.6 million funding round. Led by Octopus Ventures – with additional participation from Horizons Ventures, Air Street Capital and Verve Ventures – the funding represents the first stage in commercialising CellVoyant’s first of its kind AI and imaging platforms. Meanwhile, the company now aims to enable the rapid development of novel cell therapies. Stem cells unlock a wide range of treatment possibilities that have not historically been available to patients. Indeed, current treatments tend to act on the body’s existing cells, while stem cells have the potential to develop into different cell types in the body – replacing dysfunctional cells or regenerating damaged tissues and organs. CellVoyant’s platform combines advanced AI with live cell imaging to address pain points. The technology can extract spatial and temporal information in real-time from hundreds of millions of cells. ...
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