Better HIV, lupus and hep C treatments possible with malaria discovery

Drug Target Review | November 20, 2019

In laboratory models, a research team has showed that strong inflammatory signals caused by malaria infection activate molecules that trigger the production of highly potent antibodies to fight the disease. The same inflammatory signals are seen in human malaria infections, chronic viral infections and autoimmune disorders. This suggests the discovery could be harnessed to develop new vaccines and therapies that are better able to fight infections such as hepatitis C and HIV as well as treat diseases such as lupus. The research was led by PhD student Ms Ann Ly and Dr Diana Hansen from the Walter and Eliza Hall Institute, Australia, with collaborators Dr Yiang Liao and Associate Professor Wei Shi and Professor Axel Kallies from the Doherty Institute. “When we began this study, we expected to see that inflammation was also having a negative effect on B cells. In fact, we found the opposite was true. The inflammatory signals were improving the quality of the antibodies produced, by sending B cells to an elite training ground, where they underwent an exhaustive program to become ‘professional predators’.”

Spotlight

Once it is determined that a clinical trial is necessary, the applicable investigational new drug or medical device regulations will need to be followed. The regulatory requirements for conducting a clinical trial are exactly the same for drugs and devices when it comes to electronic medical records (21 CFR 11), human subject protection (21 CFR 50), financial disclosure (21 CFR 54), and IRB requirements (21 CFR 56). The differences exist in the investigational new drug regulations (21 CFR 312) and the investigational device exemption regulations (21 CFR 812); however, even within 21 CFR 312 and 21 CFR 812, the similarities far outweigh the differences. Some of those differences are described in the tables below.

Spotlight

Once it is determined that a clinical trial is necessary, the applicable investigational new drug or medical device regulations will need to be followed. The regulatory requirements for conducting a clinical trial are exactly the same for drugs and devices when it comes to electronic medical records (21 CFR 11), human subject protection (21 CFR 50), financial disclosure (21 CFR 54), and IRB requirements (21 CFR 56). The differences exist in the investigational new drug regulations (21 CFR 312) and the investigational device exemption regulations (21 CFR 812); however, even within 21 CFR 312 and 21 CFR 812, the similarities far outweigh the differences. Some of those differences are described in the tables below.

Related News

Apricus Health Partners with Medicare Advantage Plan Devoted Health and Full-Service Retail Pharmacy Liton Rx

Apricus Health | November 04, 2020

Apricus Health, an innovative healthcare company delivering high impact, relationship-based care, today announced two new partnerships that provide its members with extraordinary services. Medicare Advantage plan provider Devoted Health and full-service retail pharmacy Liton Rx are now partnering with the Apricus Health Network which is designed by Arizona physicians. "We are committed to helping our members with a range of quality services to improve health outcomes and significantly lower costs for patients and payers," said Dr. Kishlay Anand, CEO and co-founder of Apricus Health. "Our new partnerships with Devoted Health and Liton Rx, further that mission, with both organizations sharing our core value of emphasizing extraordinary customer service."

Read More

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.

Read More

PHARMA TECH

Feds rebuff Pfizer's pleas to speed up supplies of COVID-19 vaccine raw materials

Pfizer | December 21, 2020

Since the time Pfizer was fixed to partake in the U.S. government's Warp Speed exertion to get COVID-19 antibodies to showcase, the organization has made it very clear it didn't have to take any bureaucratic cash to build up the immunization. In any case, did that refusal of R&D subsidizing add to Pfizer's failure to produce more dosages of its mRNA antibody for the U.S. market? Pfizer could give more than the 100 million portions it guaranteed in its unique agreement with the U.S. government in the main portion of one year from now—however just if Trump organization authorities request that providers of crude materials rapidly satisfy the organization's requests. Furthermore, CEO Albert Bourla, Ph.D., is approaching the public authority to utilize the Defense Production Act to do precisely that. The Trump organization hasn't done as such yet on the grounds that they've zeroed in on giving those materials to antibody producers that took government R&D subsidizing, as Moderna, as indicated by anonymous sources who addressed The New York Times. A representative for Pfizer declined to remark, refering to the privacy of conversations with the U.S. government. Yet, Bourla said during a CNBC meet that the organization is in exchanges to sell an extra 100 million dosages of Pfizer's COVID-19 immunization to the U.S. government. "We can give a ton of that in the second from last quarter. The U.S. government needs it in the subsequent quarter," Bourla said in the Monday meet. "We are working cooperatively to attempt to discover an answer and have the option to apportion those 100 million [doses] in the subsequent quarter if conceivable, or a ton of them." Pfizer mentioned almost immediately that the public authority grant it "supported status" with providers of crude materials, however authorities were anxious about the possibility that that would harm contending immunization programs that took government R&D cash, as per the Times report. Among those organizations is Moderna, which is required to win crisis use approval from the FDA for its mRNA immunization this week—and last Friday, inked an arrangement to add 100 million additional portions to its underlying U.S. request.

Read More