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FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted more than 13 years. Bakul Patel. Patel – who is currently director for digital health at the FDA – said on social media that he is “looking forward to learning from the teams in health across Google and Alphabet and helping build a unified digital health and regulatory strategy.” He was also involved in the creation of the FDA’s Dig
An expert from the AI-focused technology company shares insights as to how it can be harnessed to better interpret, and even predict, patient behavior.
SwanBio Therapeutics has raised $56 million in a second-round financing that will be used to advance its lead gene therapy candidate for adrenomyeloneuropathy (AMN) into clinical testing later this year. The Series B takes the total raised by the Philadelphia-based biotech to $133 million and is earmarked for a phase 1/2 trial of the gene therapy – codenamed SBT101 – in the second half of this year.
A leader from the neurobiomarker platform provider tells how use of ML and other advanced analytical tools can help make better use of complex information.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Considerable scientific progress across neurological diseases and disorders was reported at the recent 74th American Academy of Neurology (AAN) Annual Meeting. What may be important for healthcare professionals certainly makes encouraging news for patients waiting for effective solutions. One research-driven company with a strong patient focus in neurology is UCB.
The pharmaceutical company is partnering with Yseop to install the software companyâs Augmented Analyst, designed to elevate and accelerate data analysis.
Companies trying to bring digital therapeutic (DTx) products through development and onto the market have been navigating in uncharted waters for years. Now, trade organisation the Digital Therapeutics Alliance has provided a guide to help them during the journey. The DTx Value Assessment & Integration Guide lays out the DTA’s thinking on how developers can clinically evaluate DTx products, meet regulatory requirements to get the approved, and ensure their quality and security.
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Companies trying to bring digital therapeutic (DTx) products through development and onto the market have been navigating in uncharted waters for years. Now, trade organisation the Digital Therapeutics Alliance has provided a guide to help them during the journey. The DTx Value Assessment & Integration Guide lays out the DTA’s thinking on how developers can clinically evaluate DTx products, meet regulatory requirements to get the approved, and ensure their quality and security.
The digital therapeutics specialist has announced the last patient has ended participation in a study investigating a precision solution for hypertension.
Health data research in the UK is rapidly evolving, with new capabilities emerging through the rise of hybrid engagement and the accelerated adoption of digital technologies. At the height of the COVID-19 pandemic, these capabilities were put to the test, being used to compare hospital caseloads to research activity in real-time and enabling COVID-19 clinical trials to rapidly recruit participants across the UK.
Merck & Co has quietly added another drug to its immuno-oncology pipeline via an agreement with China’s Sichuan Kelun Pharmaceutical, and is keeping the details close to its chest. The US pharma group is paying $47 million in upfront payments to license rights to the undisclosed drug outside China, Hong Kong, Macao, and Taiwan, with another $1.36 billion in potential milestone payments plus royalties on sales.
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
Women with breast cancer in England and Wales will soon be able to access a new diagnostic based on an injectable magnetic marker liquid called Magtrace that will identify if the disease has spread around the body. The diagnostic developed by UK firm Endomag can be used to detect ‘sentinel’ lymph nodes – the first lymph node to which cancer cells are most likely to spread from a primary tumour – showing if the cancer has progressed beyond the breast tissue.
Nicotine patches are a useful tool in the management of smoking cessation. The success and tolerability of this form of nicotine replacement does require some pharmacology knowledge. I lay out my most important nicotine patch clinical pearls below. Nicotine Patch Clinical Pearls – Dosing Let’s start with the dosing of nicotine patches. A clinician must […].
The benefits of conducting a regular KOL validation exercise to refresh your KOL list are well established. Such exercises implemented on a regular basis ensure you avoid the dangers that come from working continuously with the same people while keeping your KOL list refreshed and relevant. But the risk of becoming myopic in your view of the KOL landscape, and possibly even your KOL decision-making, extends beyond just the actual list of your KOLs.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Brand new UK startup RQ Biotechnology has been thrust into the spotlight after signing a $157 million licensing deal with AstraZeneca for monoclonal antibodies intended to protect vulnerable and immunosuppressed people from COVID-19. The deal covers a portfolio of early-stage antibodies targeting SARS-CoV-2, adding to the pipeline of COVID drugs following AZ’s already available Evusheld (tixagevimab/cilgavimab) therapy, which has been approved for pre-exposure prophylaxis of COVID-19.
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