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PHARMA TECH

FDA Grants Breakthrough Device Designation to JelikaLite

JelikaLite Corp | January 07, 2022

JelikaLite Corp, a medical technology company, announced that the U.S. Food and Drug Administration has granted the Breakthrough Device Designation to its Cognilum System for the reduction of symptoms of moderate to severe autism spectrum disorder in pediatric patients who are 2 to 6 years of age. The FDA’s Breakthrough Device Program recognizes medical devices that meet the criteria and hold the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or condition. Data from a pilot study suggests that Cognilum, a wearable medical device, can significantly improve the symptoms of children living with autism. If approved, it will offer families access to a home-based, easy-to-use, and cost-effective treatment for children with autism not available anywhere else. Autism is a serious developmental disorder that impacts families around the globe. JelikaLite Corp. believes that it can provide relief to patients and families by reducing children's autism symptoms. Children will be able to better integrate into the society and have more fulfilling lives. Their caregivers can lead less stressful lives and both insurance companies and the government will be able to spend less money on effective intervention, special education and lifelong residential care. The Breakthrough Device Designation for Cognilum was based on the results of a double-blind, placebo controlled clinical trial of 30 pediatric patients with moderate to severe autism. The trial showed both safety and efficacy of this technology. By combining non-invasive brain stimulation with near-infrared light, EEG sensors, and AI personalization platform, Cognilum demonstrated improvements in autism symptoms through gains in communication and daily living skills. "We are thrilled that the FDA recognizes that we are developing a novel technology with a potential to change the landscape in the current approach to Autism. For some of the participants in our active condition, the positive change was so dramatic that their parents expressed their desire to continue the treatment even after the study was over. We recognize that Autism is a spectrum, and no two children are alike; our ultimate goal is to develop a personalized approach to every child based on their unique needs and challenges.” Dr. Eugenia Steingold, Chief Science Officer of JelikaLite JelikaLite’s vision is to bring Cognilum into the homes of families raising children with autism around the globe. This device is truly unique as it seeks to offer a personalized treatment for each child with an integrated feedback loop for both caregivers and doctors. About JelikaLite Based in New York, JelikaLite was launched in 2019 to develop Cognilum™, an innovative solution to permanently reduce children's autism symptoms, enabling better integration into society and reducing lifelong costs. Cognilum™ is a data-device integrated system, where a wearable non-invasive therapeutic medical device that provides neurostimulation treatment is combined with an AI personalization platform. JelikaLite has been founded and run by a multidisciplinary team, with experts in autism clinical therapy, transcranial photobiomodulation, commercialization of medical devices, artificial intelligence, product management, and finance.

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PHARMACY MARKET

Rx-360 Launches New auditsPlus®

Rx-360 | June 10, 2021

Rx-360, a global pharmaceutical consortium committed to supply chain integrity and patient safety, is happy to announce the extension of our Audit Program. The release of the new Rx-360 auditsPlus database is the key driver of this growth. This interactive, user-friendly database will not only raise awareness of the Rx-360 Joint Audit Program®. Still, it will also provide Rx-360 program users with new and improved tools to minimize their audit burden. Rx-360's CEO, Jim Fries, stated, "Maintaining quality in pharmaceutical materials is an ever-increasing problem for the pharmaceutical sector. To maintain our commitment to patient safety, this new tool will provide users of our software with better insight into Rx-360 audits. It's another benefit we can provide the industry and our members." Jaye Greene, Rx-360's Head of Audit Operations and Quality, stated, "We are extremely excited to introduce the market to our new auditsPlus platform. The user experience has been greatly improved, and all of the Rx-360 Audit Programs are now easily accessible." About Rx-360 Rx-360, an international pharmaceutical supply chain consortium, was founded in 2009 to support an industry-wide commitment to maintaining patient safety via improved quality and authenticity across the supply chain. The organization's objective is to ensure patient safety by exchanging information and developing processes related to the integrity of the healthcare supply chain and the quality of products used in the supply chain. Rx-360 contains work streams relating to audit and sharing review reports, supply chain security, monitoring and reporting, Asia-focused activities, supplier-focused initiatives, and external relations, communications, and membership to fulfill this mission.

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Vaccine heroes? COVID-19 pitfalls, pricing put pharma on the spot

Fiercepharma | June 16, 2020

Pharma is looking to reset its image with COVID-19 vaccines and treatments, but landmines loom—with pricing likely the biggest. The halo from pharma’s rapid response in research and discovery—and the hope that a vaccine or effective treatments will allow the world to return to some sort of normal—has propelled the industry’s reputation at an all-time high. Forty percent of Americans say their opinion of the pharma industry has turned positive during the COVID-19 pandemic, according to The Harris Poll. However, pricing lurks just beyond the lab. Just this week in media, one well-known pundit posited in a Forbes column that the industry’s reputation hinges on the pricing of Gilead Sciences' treatment remdesivir, while another touted Pfizer CEO Albert Bourla’s promise to not price its vaccine too high in part because “people will not forget if you do that.”

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Spotlight

Do you have a Bachelor's degree in the field of pharmaceutics, chemistry or biotechnology and would you like to expand your knowledge? Find out more about the Master's (MSc) degree programme in Life Sciences