In this latest K-Cast series, “Advancing Healthcare With Prescription Drug Therapeutics,” Masha Salsabili, PharmD, PhD offers insights on the future of prescription digital therapeutics (PDTs) and how the landscape might evolve for PDTs over the next 5 years. Watch the series here: https://bit.ly/4dR4oLW #ManagedCare #HealthTech
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In this latest K-Cast series, “Advancing Healthcare With Prescription Drug Therapeutics,” experts offer insights on the future of prescription digital therapeutics (PDTs) and how the landscape might evolve for PDTs over the next 5 years. Watch the series here: https://bit.ly/4dR4oLW #ManagedCare #HealthTech Mahsa Salsabili
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In this latest K-Cast series, “Advancing Healthcare With Prescription Drug Therapeutics,” experts discuss gaps in patient care that prescription digital therapeutics can address. Tune in here for insights into #HealthTech and the future of clinical practice: https://bit.ly/3U3ZvGg #ManagedCare Mahsa Salsabili
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Spasticity Pipeline and Clinical Trials Assessment 2023: FDA Approvals, Therapies and Key Companies involved by DelveInsight | Lundbeck, Revance Therapeutics, Ipsen, Saol Therapeutics: (Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Spasticity pipeline constitutes 20 key companies continuously working towards developing 20 Spasticity treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight. The … Continue reading → #Business #HealthMedicine #MarketingSales #PharmaceuticalsBiotech
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Spasticity Pipeline and Clinical Trials Assessment 2023: FDA Approvals, Therapies and Key Companies involved by DelveInsight | Lundbeck, Revance Therapeutics, Ipsen, Saol Therapeutics: (Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Spasticity pipeline constitutes 20 key companies continuously working towards developing 20 Spasticity treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight. The … Continue reading → #Business #HealthMedicine #MarketingSales #PharmaceuticalsBiotech
Spasticity Pipeline and Clinical Trials Assessment 2023: FDA Approvals, Therapies and Key Companies involved by DelveInsight | Lundbeck, Revance Therapeutics, Ipsen, Saol Therapeutics
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The recent PDURS guidance from FDA is starting to get more and more attention. Having previously covered the pharmaceutical and generic drug sectors for 20 years on Wall Street, I’ve seen a lot of events and trends that have helped transform the industry. Digital will ultimately be one of them and the FDA has now provided the framework for that to happen.
The digital therapeutics market has faced challenges gaining widespread acceptance due to the lack of reliable clinical evidence. Now, the industry may be at a turning point. The FDA has created a digital health advisory committee and released draft regulatory guidance for prescription drug use-related software, which could have a significant impact on digital therapeutics. In this interview, Fritz Heese sits down with David Benshoof Klein, Co-founder and CEO of Click Therapeutics, Inc., to discuss the current state of digital therapeutics and its future direction > https://owy.mn/3Gv0xos #DigitalHealth #FDA #OWHealth
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Unmet clinical needs in complement therapeutics call for innovative solutions. Don't miss out our on-demand roundtable featuring experts who will share their expertise and insights on the challenges and solutions in developing next-generation complement therapeutics. Register now to join the discussion. https://hubs.ly/Q01WRwLw0 #DrugDiscovery #Pharma #Therapeutics #complementsystem #answersinlifescience #expertpartner #partnerwithus #complementinglifescience #complementterapeuthics #drugdevelopment #research
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MARKET ACCESS SURVEY: 47% of payers, IDNs, and other stakeholders plan to execute a prescription digital therapeutics strategy by 2025, according to our Second Annual Market Access Survey. - 40% say they will execute #AI plans by 2025 for administrative and manual functions, including streamlining prior authorization. “Organizations desire additional clarity regarding the value of prescription therapeutics and reimbursement,” says our colleague Tony Gibson. “CMS and FDA activity in this area will also spur payer planning in this area.” #marketaccess #pharma #biotech
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Pomerantz recently scored a major victory, overcoming in part a motion to dismiss its case against Y-mAbs Therapeutics, Inc., an #antibody therapy developer. According to the complaint, Y-mAbs failed to disclose to investors that the FDA had repeatedly advised the company that the effectiveness of the company's omburtamab therapy could not be reliably measured by the two studies it submitted, and therefore could not justify #FDA approval. Further, when its FDA application was denied, Y-mAbs allegedly told investors that the FDA merely wanted additional information, assuring investors that there would be no problem obtaining FDA approval. In October 2022, the FDA publicly released the three key issues with the application submitted by Y-mAbs and informed investors that the FDA Advisory Committee had voted unanimously that it could not approve the omburtamab therapy based on the submitted application. This news resulted in significant investor losses when Y-mAbs' share price plummeted. #SecuritiesLaw #InstitutionalInvestors #SecuritiesLitigation
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Effective timelines are crucial when it comes to developing a companion diagnostic. Learn about the roadblocks you can avoid and tips from our regulatory experts on streamlining your development in our webinar, "Companion Diagnostics: Strategies for Effective Co-Development With Therapeutics", now on-demand: https://hubs.ly/Q023kj3c0 Kennon Daniels, Ph.D. Margaret Curnutte
Companion Diagnostics: Strategies for Effective Co-Development with Therapeutics | Precision For Medicine
https://www.precisionformedicine.com
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Akili plans to move to a non-prescription model (OTC, Over-the-counter)to take control of its business. With its planned shift to a completely nonprescription model, Akili said in the release that it will submit data to the FDA next year to convert the pediatric version of its software from prescription to OTC labeling. Since Pear Therapeutics's bankruptcy, there has been a shift in efforts to make businesses viable in the digital therapeutics industry. The change in the business model of Akili, a pioneer in this industry, to OTC drugs, is noteworthy. #DTx #digitaltherapeutics
Akili cuts workforce another 40%, pivots to selling digital therapeutics over the counter
fiercebiotech.com
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