FDA approves first medical device ADHD treatment

pharmaphorum | April 23, 2019

US regulators have given the green-light for the first medical device to treat attention deficit hyperactivity disorder (ADHD). NeuroSigma’s prescription-only Monarch external Trigeminal Nerve Stimulation (eTNS) System is the first non-drug treatment for ADHD to be approved by the Food and Drug Administration (FDA) and is indicated for patients aged 7 to 12 who are not taking a prescription ADHD medication. It’s a mobile phone sized device that generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient’s forehead and delivers a low-level electrical stimulation that should feel like a tingling sensation on the skin. Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said: “This new device offers a safe, non-drug option for treatment of ADHD in paediatric patients through the use of mild nerve stimulation, a first of its kind.

Spotlight

ValGenesis e-Logbook eliminates traditional, error-prone, paper-based logbooks for any GMP log type. Say goodbye to illegible handwritten entries, sticky notes, lost logbooks, and cleanroom contamination concerns. Welcome fully compliant, next-generation efficiency.

Spotlight

ValGenesis e-Logbook eliminates traditional, error-prone, paper-based logbooks for any GMP log type. Say goodbye to illegible handwritten entries, sticky notes, lost logbooks, and cleanroom contamination concerns. Welcome fully compliant, next-generation efficiency.

Related News

BUSINESS INSIGHTS, PHARMACY MARKET

OM1 Unveils Patented, AI-powered Platform to Accelerate Personalized Medicine

businesswire | April 17, 2023

OM1, a leading real-world data, outcomes and technology company with a focus on chronic conditions, today launched PhenOM™, its artificial intelligence-powered platform for personalized medicine. Calibrated using OM1’s longitudinal health history datasets, PhenOM uses AI to identify unique digital phenotypes associated with conditions and outcomes and compare patients’ records to them to highlight risks and opportunities. PhenOM powers personalized healthcare insights at scale across the entire healthcare ecosystem, from life science research to point-of-care clinical decision making. PhenOM is an AI that gathers detailed information from large patient datasets – including unstructured clinical notes and disease activity metrics – to isolate unique patterns associated with patients with distinct characteristics. PhenOM synthesizes these patterns into unique digital phenotypes or ‘fingerprints.’ These phenotypes can be studied to inform research and deployed in real-world datasets – inside and outside OM1 – as well as in health systems and through standalone patient-facing web portals. Calibrated using OM1’s differentiated, high-quality data cloud – which is based on billions of data points from more than 300 million patients – PheonOM was built with expert clinician oversight. With an overarching mission to improve individual care and population health, the platform powers five solutions that address pain points across the healthcare system Diagnostic Insights: Finding patients with rare, undiagnosed, or misdiagnosed conditions, including subgroups of interest Treatment Insights: Personalizing treatment recommendations to improve access to care and individualizing treatment selection Risk Insights: Predicting risk of specific negative outcomes, including disease progression, complications, and catastrophic events Utilization Insights: Enabling focus on patients at risk for higher utilization, and utilization growth, over time Clinical Trial Insights: Accelerating trial startup and recruitment by identifying patients most likely to meet qualifications for enrollment, including those potentially overlooked Patient expectations over the last several years have shifted – from the adoption of virtual care and accessibility to the use of advanced technology to improve outcomes – but a persistent gap remains between population-level insights and individual patient experience: personalization. Recognizing this gap, OM1 developed PhenOM to translate patterns in large-scale data into meaningful outputs at the individual level and to better understand patient populations, diagnoses, progression, and treatment response. “Most people have now heard of the promise of AI through GPT-4, but we still have not seen many really mature, real-world clinical applications using advanced language models,” said Dr. Joseph Zabinski, Managing Director of AI & Personalized Medicine at OM1. “PhenOM is groundbreaking technology because it uses AI to translate actionable insights from our highly enriched datasets and phenotyping technology into opportunities for more personalized healthcare. This capability creates a huge potential for impact for all stakeholders, from identifying patients with under-diagnosed conditions to enabling personalized assessments of benefit for particular therapies and accelerating clinical trial enrollment.” About OM1 With specialization in chronic conditions, OM1 is re-imagining real-world data and evidence by developing large electronically connected networks of clinicians and health data in rheumatology, dermatology, gastroenterology, cardiometabolic, respiratory, mental health, central nervous system, and other specialty areas. Leveraging its extensive clinical networks and an unparalleled technology and artificial intelligence (AI) platform, OM1 offers industry leading enriched healthcare datasets, research analytics, data modeling, decision support, and retrospective and prospective clinical studies. With a focus on high-quality data and clinical outcomes, the offerings are used for accelerating research, demonstrating treatment effectiveness, supporting regulatory submissions, monitoring safety, and informing commercialization.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

Ajinomoto Bio-Pharma Services Receives FDA Approval for High Potency Fill Line

prnewswire | April 20, 2023

Ajinomoto Bio-Pharma Services a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce that the United States Food and Drug Administration (FDA) has approved the company's high potency vial line to manufacture a commercial product. "Receiving FDA approval on our HPAPI fill line is an exciting milestone for our company, and couldn't have happened without the hard work, hours of preparation, diligence and support from the Aji Bio-Pharma team across our whole organization. As a leading global CDMO, we are dedicated to providing high-quality drug process development and manufacturing services to biotechnology and pharmaceutical companies worldwide." said Bert Barbosa, President & COO, Ajinomoto Bio Pharma Services, US. Aji Bio-Pharma has six fill finish lines located in San Diego, including a new line that offers a range of configurations, including prefilled syringes, cartridges and vials. The high-speed process is rated to move up to 22,000 syringes per hour through the line, with a batch capacity of over 200 thousand syringes. This multi-purpose fill line has been designed to meet FDA and EMEA commercial compliance. About Ajinomoto Bio-Pharma Services Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India, providing comprehensive development, cGMP API manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities for pre-clinical and pilot programs to commercial quantities, including high potency APIs (HPAPI), continuous flow manufacturing, oligonucleotide synthesis, biocatalysis, Corynex® protein expression technology, antibody drug conjugations (ADC) and more. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our client's needs.

Read More

PHARMACY MARKET

Elixir announces the next wave of innovation for pharmacy benefits technology platform

Businesswire | May 29, 2023

Elixir, a pharmacy benefit management company owned by Rite Aid has announced details of the next release of its Laker Software technology platform. The upcoming enhancements include new automated workflows, a customer service tool and modernization of the user interface. "Already a leader in the industry, Laker Software is going from good to great,” said Jeff Mallad, VP, PBM Technology Sales for Elixir. "Elixir’s technology platform is one of the fastest and most reliable pharmacy claims systems available—and it’s about to become turbo-charged! We’re modernizing the future of pharmacy benefits to support our customers’ business growth, the digital world and cost reduction.” The upgrade will include a range of advanced functionalities that are designed to help customers better manage their pharmacy claims adjudication data and streamline workflows. The new features will allow users to access and share data more efficiently, collaborate more effectively, and improve productivity. For more than 20 years, the Laker Software platform has been a leading technology solution and one of only a few that can manage multiple lines of business including Medicare, Medicaid and Exchange Commercial payers Adjudication and claims processing for 340B pharmacies Prescription savings card programs Workers’ compensation Built on a resilient, scalable architecture, the Laker Software platform is a 100% virtualized environment. The platform processes millions of paid claims per year and is SOC 1 Type 2 certified. It has multiple levels of data security and redundant backup systems. Laker Software provides a full set of robust capabilities, including Claims Processing/Adjudication Call Center Plan Set Up Eligibility Accumulator Accounts Payable/Receivable Prior Authorization Reporting Customers will begin to beta test some of the platform’s newest features shortly, and other enhancements will follow as the next generation of Laker Software evolves. Customers can expect to see improvements in cost reduction due to automation, solutions for improved plan design and channel management, and advanced analytics and statistical analyses. This is in addition to a cloud-based infrastructure and redesigned user interface, allowing for even more flexibility and a better customer experience. "Elixir is committed to investing in innovative solutions to meet the evolving needs of the pharmacy benefits industry,” said Mallad. “In addition to our Laker platform, customers can rely on our full suite of pharmacy benefit services to custom design their ideal solution. We support your business, enable your growth and help you succeed in every segment of the pharmacy lifecycle." About Elixir Elixir, a fully owned subsidiary of Rite Aid Corporation, is a pharmacy services provider that offers pharmacy benefit management services, Medicare-approved prescription drug plans, mail and specialty pharmacy solutions, and prescription discount programs. With the unique ability to optimize the full pharmacy care experience, Elixir is crafting solutions for today’s pharmacy benefits challenges.

Read More