FDA oversight of the prescribing of fentanyl products is inadequate, report finds

Healthcare Finance | February 22, 2019

The Food and Drug Administration and manufacturers did not take action when evidence emerged that potentially lethal fentanyl products were being inappropriately prescribed to patients, new research from the John Hopkins Bloomberg School of Public Health shows. The study was based on a review of 4,877 pages of FDA reports and other documents obtained through the Freedom of Information Act from 2012 to 2017. It revealed that, even as evidence emerged that as many as half of patients were taking dangerous medications known as TIRFs that should never have been prescribed to them, the FDA and fentanyl makers did not review prescribing records of even a single physician to consider disqualifying them from the program, which would have prevented them from prescribing the products.

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Digestible sensors? Artificial organs? Medical tricorders? Does any of these already exist, are their development in progress, or do they only appear in our imagination? The world of medical innovations is complex and diverse, full of promising technologies but also hype and marketing.


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FUTURE OF HEALTHCARE

GeneQuantum and AIMEDBIO Collaborate on a First-in-Class Antibody -Drug-Conjugate

GeneQuantum Healthcare | April 19, 2022

GeneQuantum Healthcare Co., Ltd., a company specializing in site-specific bioconjugation for next generation biotherapeutics, has signed an agreement with a Korean biotech company, Aimed Bio Inc., to co-develop a First-in-Class therapeutic antibody drug conjugate (ADC). Aimed Bio, a spin-off company from Samsung Medical Center, is focusing on developing innovative antibody-centric drugs for brain diseases with few treatment options. Additional details were not disclosed. GeneQuantum focuses on next generation Antibody Drug Conjugate development. Taking advantage of the proprietary 'Ligase Dependent Conjugation' technology platform, which allows a site-specific conjugation of cytotoxins or other type of payloads to antibodies, the company has successfully developed a robust pipeline with more than 10 assets, with several at or approaching clinical stage. In addition to expanding the unique technology platform, the company has entered into a number of partnerships with domestic biotech/pharmaceutical companies and international partners. The growing number of partnerships speaks to the power of the GeneQuantum platform technology for not only improving key therapeutic characteristics of existing molecules, but also for creating new classes of molecules, ultimately increasing the number of available treatment options for patients worldwide. GeneQuantum is excited about the significant potential of partnerships with business partners and will continue to expand its deal pipeline in the antibody drug conjugate and protein therapeutic market. The collaborating ADC is a first-in-class asset with highly differentiated antibody against a unique target, a stable linker design and a novel payload with a strong by-stander killing effect. The resulting ADC is expected to treat brain and other cancers with huge unmet needs. "As an innovative antibody+ company, we look for complementary partners to maximize value of our platform technology. Aimed Bio not only has differentiated antibody acting on a unique target but also has deep knowledge and expertise in the field of brain tumor & CNS diseases. This collaboration is based on an excellent match between the two companies to generate a FIC ADC. Through close partnership, we are thrilled to bring revolutionary therapy for those patients without efficient treatment at this moment." Dr. Gang Qin, the Founder & Chairman, CEO of GeneQuantum Dr. Dohyun Nam, the Founder & Chairman, CTO of Aimed Bio and internationally renowned neurosurgeon with 32 years of experience in brain tumor & CNS diseases commented: "Aimed Bio has been successfully expanding its R&D pipeline for the past 2 years, and I am pleased to start this collaboration with GeneQuantum. After evaluating the data, the linker-payload and conjugation technology GeneQuantum provides proved to be very safe and effective. With the best antibody and brain tumor expertise of Aimed Bio, I believe the collaborating ADC will bring a tremendous impact on the field. We look forward to initiating clinical trial as soon as possible." About GeneQuantum Healthcare Co., Ltd. GeneQuantum Healthcare Co., Ltd. is a high-tech biopharmaceutical company dedicated to the development of innovative biotherapeutics. The company is focused on the development of a next generation of bioconjugate therapeutics to meet the unmet medical needs of cancer patients globally. For more information, visit www.genequantum.com. About AIMEDBIO Inc. AIMEDBIO is a spin-off company from Samsung Medical Center established in August 2018. AIMEDBIO aims to provide therapeutic solutions to patients with serious brain diseases, including neuro-oncological and -degenerative diseases, to save patients' lives and improve patients' quality of life. Based on solid global networks with key opinion leaders in the field, an excellent research team with profound achievements, and R&D pipelines with an outstanding drug development platform, AIMEDBIO is an emerging leader for development of innovative therapeutics against diverse brain diseases.

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INSURANCE

Exela Expands PCH Global Solution with Leading Healthcare Insurer

Exela Technologies | January 12, 2022

Exela Technologies, Inc. (“Exela”)today announced that it continues to expand its relationship with a leading health insurance organization that spans almost two decades. This customer continues to accelerate deployment of Exela’s PCH Global platform to speed up their digital transformation and improve both the member and provider experience. The latest expansion is valued at $6.2 million of additional contract value revenue. Exela continues to invest in expanding PCH Global’s capabilities to provide a cloud hosted solution with one of the best edit resolutions for healthcare claims. This extension of deployment marks another milestone in the value proposition of the PCH Global platform to digitally connect members, providers and insurance companies to enable clean claims, payment transparency and digital appeals. PCH Global’s cloud network also offers increased scalability, the highest uptime and best business continuity protections. PCH Global has robust data analytics which are continually improving as Exela processes more and more data. Additionally, PCH Global’s improved data analytics can be accessed via a self-service model. “We are proud of our long standing partnership and privileged to be part of customer’s digital transformation journey. Adoption of our PCH Global platform continues to address healthcare industry’s goal to deliver most efficient, cost effective and best healthcare to the members.” Suresh Yannamani, President of Exela About Exela Technologies Exela Technologies is a business process automation (BPA) leader, leveraging a global footprint and proprietary technology to provide digital transformation solutions enhancing quality, productivity, and end-user experience. With decades of experience operating mission-critical processes, Exela serves a growing roster of more than 4,000 customers throughout 50 countries, including over 60% of the Fortune® 100. Utilizing foundational technologies spanning information management, workflow automation, and integrated communications, Exela’s software and services include multi-industry, departmental solution suites addressing finance and accounting, human capital management, and legal management, as well as industry-specific solutions for banking, healthcare, insurance, and the public sector. Through cloud-enabled platforms, built on a configurable stack of automation modules, and over 17,500 employees operating in 23 countries, Exela rapidly deploys integrated technology and operations as an end-to-end digital journey partner.

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HEALTHTECH SECURITY

Forescout Acquires CyberMDX to Expand Healthcare Cybersecurity Focus

Forescout Technologies | February 02, 2022

Forescout Technologies, the leader in Active Defense for the Enterprise of Things, today announced its acquisition of CyberMDX, a leading healthcare cybersecurity provider delivering visibility and threat prevention for medical devices and clinical networks. The acquisition further strengthens Forescout’s position as the industry leader in out-of-the-box support for the broadest set of connected device types across IT, IoT, OT and IoMT devices. “Forescout is seeing rapid growth in healthcare, a market the company has always focused attention on from a technology and sales perspective. Cybersecurity for IoMT, much like cybersecurity for OT devices, requires specific expertise and technologies. We are pleased to have the CyberMDX team join Forescout as we continue delivering new capabilities on our market-leading platform and grow our R&D center.” Wael Mohamed, Chief Executive Officer of Forescout Forescout is recognized by many of the world’s largest organizations as the leader in device visibility and control, ensuring customers can see all the devices connected to their networks, continuously and in real-time, and then take automated action to mitigate risks. CyberMDX offers a leading solution for visibility and risk management of IoMT devices. Together, Forescout and CyberMDX have a powerful platform that delivers an easy-to-use, scalable and agentless approach to device visibility, classification, threat detection and incident response focused on IoMT devices to better serve healthcare organizations. “CyberMDX enables hospitals to provide quality care by securing and protecting the systems and devices they rely on every day to treat patients and save lives,” said Amir Magner, President and Co-Founder of CyberMDX. “We are thrilled to join the Forescout team where our innovation can continue to make a profound difference to healthcare organizations around the world.” Broad coverage across all device types is essential as larger organizations, such as healthcare, almost always have a wide variety of device types, including IT and a rapidly expanding number of IoT devices, in addition to IoMT and OT devices. In 2018, Forescout acquired Security Matters, a leading providing of solutions for visibility and risk management for OT systems, which are also known as industrial control systems (ICS). Forescout has the largest number of deployments of OT infrastructure protection solutions globally, with major deployments in critical infrastructure sectors such as energy and utilities. Forrester recently recognized Forescout in its inaugural Industrial Control Systems (ICS) Security Solutions Wave, 2021 as the top vendor for market presence for product revenue, total number of customers and deal size. CyberMDX, which was recognized as a Medical Device Security Solution Leader in The Forrester New Wave™: Connected Medical Device Security, Q2 2020, further demonstrates Forescout’s commitment to providing organizations with the most comprehensive solution across all device types. Recently, Forescout announced that its platform discovered 66% more devices than originally expected at the University Health Network (UHN), a group of four hospitals in Toronto, Canada that includes The Toronto General Hospital, which Newsweek ranked in 2021 as the 4thbest hospital in the world. Among many benefits, UHN is leveraging the Forescout platform to “deal with the exponential increase in the number of IoT devices and ever-increasing volume of sophisticated threats, including ransomware,” according to Kashif Parvaiz, Chief Information Security Officer, at UHN. With the addition of CyberMDX’s solution, Forescout customers will be able to gain deeper visibility and risk management of their IoMT and medical devices. Over the past 20 years, Forescout has built unique strength in device intelligence and network fabric technology for device discovery and classification. The company’s Device Cloud database contains over 15 million device fingerprints and ensures Forescout's customers automatically receive highly specific, out-of-the-box device classification capabilities from the Forescout platform for millions of different types of devices. About Forescout Forescout Technologies, Inc. actively defends the Enterprise of Things by identifying, segmenting and enforcing compliance of every connected thing. Fortune 1000 companies trust Forescout as it provides one of the most widely deployed, enterprise-class platforms at scale across IT, IoT, OT and IoMT managed and unmanaged devices. Forescout arms customers with extensive device intelligence, data and policies to allow organizations across every industry to accurately classify risk, detect anomalies and quickly remediate cyberthreats without disruption of critical business assets. Don’t just see it. Secure it.

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DIGITAL HEALTHCARE

Revibe Technologies Announces Clinical Development Updates for its Investigational FokusRx Prescription Digital Therapy for the Treatment of ADHD

Revibe technologies | February 09, 2022

Revibe technologies, a commercial-stage digital therapeutics company, announced today the positive results of their feasibility study examining the efficacy of FokusRx in school aged children with attention deficit hyperactivity disorder (ADHD). FokusRx is an investigational SaMD (Software as a Medical Device) that has the potential to provide a new nonpharmacologic approach to treating attention, focus and hyperactivity deficits associated with ADHD, and other mental health conditions. ADHD is one of the most commonly diagnosed and increasingly prevalent mental health disorders in children and adolescents.Inthe United States, 6.1 million children aged 2-17 years have been diagnosed with ADHD. Approximately 50% of families stop using prescription drug treatments for ADHD within a year.Over 30% of parents refuse pharmacologic treatment for their children with ADHD. In this, single-arm multi-rater feasibility study, parents (n= 38) and teachers (n= 26) rated youth aged 8-12 years with a parent-reported diagnosis of ADHD. Youth were attending in-person classroom learning and not taking medication for their ADHD. The study included a number of outcome measures including the ADHD-RS-5 (Home and School versions), Conners 4 – short version, Weiss Functional Impairment Rating Scale-Parent Form (WFIRS-P), and the Academic Performance Rating Scale (APRS). To be included in the analyses, youth had to have worn the Revibe Connect wearable device to school Monday to Friday for a at least three days per week or a minimum of 15 days total for a period of four weeks. "We are pleased that the feasibility study has proven to be a successful exercise that de-risks our upcoming randomized sham-controlled pivotal trial. The moderate to large effect sizes observed and change scores that exceed standards for minimally important (clinically significant) differences, provide encouraging preliminary evidence supporting the efficacy of our intervention", says Dr.Lindsay Ayearst, Chief Scientific Officer of Revibe. Revibe's Scientific and Medical Advisory Board member, Dr.Margaret Weiss, Director of Clinical Research in Child Psychiatry at Cambridge Health Alliance, stated, "These results are consistent across both symptoms and functioning, and across informants.They would translate into clinically significant change. Most impressive is the demonstration of an effect on academic performance." "The data from the classroom feasibility study suggests FokusRx can effectively and safely improve ADHD symptoms and functioning in school-aged children. It is our intention that FokusRx will provide kids and parents another option to help them succeed and reach their full potential. We are excited to begin designing our pivotal trial planned for the fall." Joseph Koziak, Chief Executive Officer of Revibe About FokusRx FokusRx is an investigational SaMD designed to provide a new nonpharmacologic approach to treating symptoms and impairment associated with ADHD. The FokusRx software is embedded within a dedicated smart watch to act as a digital therapeutic wearable. About Revibe Technologies Revibe Technologies is passionate about leveraging technology to help children and adults with focus and attention problems overcome obstacles in order to succeed in life. Revibe Technologies hopes to be a resource for students, parents, teachers, schools, and clinicians.

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Spotlight

Digestible sensors? Artificial organs? Medical tricorders? Does any of these already exist, are their development in progress, or do they only appear in our imagination? The world of medical innovations is complex and diverse, full of promising technologies but also hype and marketing.

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