FDA approves first medical device ADHD treatment

pharmaphorum | April 23, 2019

FDA approves first medical device ADHD treatment
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

The research-based pharmaceutical industry makes a major contribution to the prosperity of the world economy. Total spending on medicines is forecast to reach $1.5 trillion by 2021, up 33% from 2016 levels, but down from recent high growth rates in 2014 and 2015, according to a recent analysis by QuintilesIMS, Outlook for Global Medicines Through 2021: Balancing Cost and Value. The global market is highly mature and consolidated. The top-10 pharmaceutical companies in this market had share of around 40% in 2016

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PHARMA TECH

PathAI Announces Strategic Partnership with Roche to Enable Development and Distribution of Digital Pathology Diagnostics

Roche | October 15, 2021

PathAI, a global leader in artificial intelligence (AI)-powered technology for pathology, and Roche, a global pioneer in pharmaceuticals and diagnostics, announced a strategic partnership to develop and distribute PathAI's AI-powered technology through Roche's uPath enterprise software, enabling broad access to digital pathology diagnostics to support clinical research and companion diagnostic (CDx) programs globally. AI-powered pathology has the potential to inform biomarker development, better identify and treat patients, and enable personalized medicine. However, the digital pathology industry is largely fragmented across various software, hardware and algorithm providers, which has prevented effective implementation of AI platforms in labs. The collaboration between PathAI and Roche now provides a comprehensive menu of AI-powered digital pathology solutions in diagnostics. "This collaboration brings together all of the components required to deliver and commercialize a differentiated AI-based digital pathology medical device including assay, scanner, image management system, and image analysis algorithms. We believe this collaboration will unlock the potential for digital pathology in the CDx setting, offering a differentiated service to biopharma sponsors and ultimately new opportunities to improve patient outcomes," - Dr. Andy Beck, CEO of PathAI. The collaboration will initially involve distribution of PathAI-developed research-use-only (RUO) algorithms through NAVIFY Digital Pathology, the cloud version of Roche's uPath enterprise software, focusing on immuno-oncology in multiple cancer types. The collaboration will also support biopharmaceutical partners with an end-to-end solution for CDx development, leveraging Roche's diagnostic assays and pathology lab solutions with new and expanded innovative imaging tools from PathAI, in addition to the AI tools already provided by Roche. About PathAI PathAI is a leading provider of AI-powered research tools and services for pathology. PathAI's platform promises substantial improvements to the accuracy of diagnosis and the efficacy of treatment of diseases like cancer, leveraging modern approaches in machine and deep learning. Based in Boston, PathAI works with leading life sciences companies and researchers to advance precision medicine. To learn more, visit pathai.com. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognized as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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BUSINESS INSIGHTS

Adare Pharma Solutions Acquires Frontida BioPharm to Expand Leading CDMO Offerings

Adare Pharma Solutions | December 02, 2021

Adare Pharma Solutions ("Adare"), a technology-driven contract development and manufacturing organization (CDMO), announced the acquisition of Frontida BioPharm ("Frontida"), a vertically integrated CDMO focused on oral formulations. The acquisition reinforces Adare's commitment to transform drug delivery by providing world class solutions from product development through commercial scale manufacturing and packaging. Adare's portfolio of offerings for its customers will expand to include new capabilities such as high potency compound handling and packaging services. The combination of the two organizations will further establish Adare as a leader in the development and manufacturing of life saving medications in complex dosage forms. "We are devoted to improving the quality of life for patients by solving the most complex formulation challenges for our customers, and we believe this acquisition will bolster our ability to achieve our mission. Frontida and Adare share a commitment to quality and innovation, and we are excited to continue growing together. The combined company will lead in the space of oral formulations, while expanding the services and technical offerings we provide to meet the needs of our customers and their patients." Vivek Sharma, Chief Executive Officer of Adare Dr. Song Li, Frontida's Chairman added, "We are very excited about the opportunities this transaction is expected to provide to both existing and new clients. Our combined resources and capabilities will result in enhanced support and talent to ensure the success of their development and commercialization programs. This transaction is also a testament to the hard work, dedication, and caring culture of the team who has helped Frontida grow, enabling continued investment into the Philadelphia area, which is a respected home for pharmaceutical development and manufacturing. We look forward to continuing our work together to provide innovative, life-enhancing products to the US and global markets." Together, the combined company will offer an expanded suite of solutions for complex oral formulations, such as taste masking, controlled release, high potency formulation manufacturing, and bioavailability enhancement. The addition of Frontida brings Adare's manufacturing footprint to seven sites globally and expands Adare's integrated, end-to-end offering to its partners. The combined organization will be led by Vivek Sharma. Adare is backed by private equity firms Thomas H. Lee Partners and Frazier Healthcare Partners. RBC Capital Markets, LLC acted as exclusive financial advisor to Adare for this transaction. About Adare Adare Pharma Solutions is a leading specialty contract development and manufacturing organization (CDMO) and global provider of advanced pharmaceutical technologies, development services, and manufacturing. The Company utilizes its differentiated pharmaceutical technology and microbiome platforms to develop novel, improved medicines, and therapies for the global market.

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RESEARCH

Pfizer/Biontech Weren't Alone: Moderna Covid-19 Vaccine Data Aimed in Ema Cyberattack

Moderna | December 16, 2020

It would appear that Pfizer and BioNTech's COVID-19 immunization was not the sole objective of a new cyberattack at the European Medicines Agency. Moderna said Monday that reports from its pre-accommodation conversations with EMA about its shot, mRNA-1273, were "unlawfully gotten to" by programmers, refering to a warning from the organization. The assailants didn't get individual data about preliminary members, Moderna said. The organization's EMA accommodation did exclude any information recognizing people in the examination. Now, no extra insights concerning the cyberattack, for example, the size of the penetrate or the character of any suspects—are accessible, and Moderna said it anticipates results from EMA's progressing examination. The disclosure came days after the EMA initially uncovered the cyberattack, and Pfizer and BioNTech's COVID-19 immunization applicant, BNT162b2, was the principal distinguished as an objective. EMA choices on the two immunizations are moving close. Medication commentators at the EMA's Committee for Medicinal Products for Human Use are booked to evaluate BNT162b2 on Dec. 29 and mRNA-1273 on Jan. 12. Moderna was recently focused by programmers looking for its COVID-19 examination, in a cyberattack supposedly upheld by the Chinese government. The U.S. Branch of Justice in July arraigned two Chinese nationals for running a 10-year hacking effort that most as of late rotated to focusing on organizations doing COVID research. Reuters later affirmed Moderna as the antibody producer referenced in the arraignment. China has denied any function in such practices. Other than Moderna and Pfizer/BioNTech, rival COVID immunization designers AstraZeneca, Johnson and Johnson and Novavax apparently have arrived in the line of sight of North Korean programmers. In those hacking endeavors, the assailants regularly conveyed noxious reports or connections by means of email under the appearance of occupation enrollment specialists, partners or different associates of the person in question, as indicated by individuals acquainted with the issue refered to by The Wall Street Journal. Country state programmers from Iran and Russia have likewise been blamed for attempting to take COVID-related data.

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Spotlight

The research-based pharmaceutical industry makes a major contribution to the prosperity of the world economy. Total spending on medicines is forecast to reach $1.5 trillion by 2021, up 33% from 2016 levels, but down from recent high growth rates in 2014 and 2015, according to a recent analysis by QuintilesIMS, Outlook for Global Medicines Through 2021: Balancing Cost and Value. The global market is highly mature and consolidated. The top-10 pharmaceutical companies in this market had share of around 40% in 2016