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Over three days of meetings, a group of FDA advisers discussed the tough trade-offs of accelerated immunotherapy approvals. Their decisions could escalate an already intense debate.
WHAT”S UP WITH THAT: A quick analysis of two pharma websites shows that Facebook, and others, are tracking users. Does pharma even know or care? With the release of Apple’s latest updates, privacy has suddenly become a big issue, especially for Facebook. So why then are some pharma websites tracking visitors for Facebook? As the diagrams below indicate both Enbrel.com and Humira.com are allowing Facebook to track visitors so they can serve them ads.
Medicago has started a rolling submission with Health Canada for its plant-derived adjuvanted COVID-19 vaccine candidate: championing a unique and versatile platform that can also be scaled up easily.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Far along in testing for a hemophilia treatment, BioMarin is expanding its gene therapy research into diseases of the central nervous system and aims to use some of the institute's technology.
QUICK READ: Patients are returning to their doctor’s office, and it’s not uncommon for appointments, or routine visits, to be scheduled weeks or months in advance. I talked to some thought leaders, and they said that they don’t have time for either virtual patient visits or online pharma detailing. About this time, every year, I get my annual physical, which is more like a request for a blood workup.
Leaked documents from provincial and municipal governments in China reveal a slew of previously unreported severe adverse events related to COVID-19 vaccines made and administered in China.
Leaked documents from provincial and municipal governments in China reveal a slew of previously unreported severe adverse events related to COVID-19 vaccines made and administered in China.
Conducting a clinical study in a pediatric patient population requires careful planning, as providing a benefit to a child without causing harm is a weighty responsibility. The first tasks in striking this balance are dose selection and dosing interval determination, and this blog post offers an overview on how PK modeling and simulation can be applied to optimize the safety and efficacy of a product for pediatric populations in clinical trials.
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
Ahead of CPhI Discover (17th-28th May, 2021) – global pharma’s largest ever virtual gathering – the CPhI executive post-pandemic pharma survey[i] predicts that pandemic supply chain issues have further cemented a push for repatriated manufacturing globally. The findings suggest that over the next five years, governments and companies will gradually look to reduce complexity and increase regional self-reliance.
Technology firm Jolly Good and Teijin Pharma have begun a partnership to develop virtual reality digital therapeutics (VR DTx) for major depressive disorder. The goal of the partnership for approval for the Japanese market from the Pharmaceuticals and Medical Devices Agency (PMDA). Jolly Good has already won a “Home Healthcare Award” in a programme held by Teijin in December last year.
AavantiBio, a gene therapy company focused on transforming the lives of patients with rare genetic diseases, and Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced a partnership to support the development and manufacturing of AavantiBio’s gene therapies, including its lead program in Friedreich’s Ataxia (FA).
The agency threatened to fine Acceleron for not posting study results to clinicaltrials.gov. Whether the action is a sign of a larger crackdown is unclear.
Tokyo 27th April 2021: CPhI Japan, the first large pharma event to trade in 2021, played host to 7214 attendees at the exhibition and a further 7204 virtual users from across the globe. The event, a key marker for the strength of the regional industry, has rebounded quickly with some 216 exhibitors searching for pharma partners. In fact, such has been the demand, CPhI Japan Connect – the event’s digital platform for international audiences – will remain open until the end of May.
As COVID-19 response initiatives and vaccine rollouts begin to bring the pandemic under control, we consider what changes to clinical trials will be made permanent.
Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Scivita Medical Technology Co., Ltd. (“Scivita Medical”) announced that it has raised nearly RMB0.4 Billion in Series A funding round, which has become one of the highest financing projects in the field of endoscope in China in recent years. The investment was jointly led by GL Ventures and Lilly Asia Ventures, with contribution from Matrix Partners China, Medtronic, Chengwei Capital and Shanghai Innochip Investment.
The neuroQWERTY technology can analyse people’s typing for signs of motor conditions like Parkinson’s disease – and now the team behind it is looking to expand into the notoriously-difficult area of dementia. Teresa Arroyo-Gallego tells us about the science behind the technology and how the team hopes to reshape cognitive screening. . While many disease areas are increasingly embracing digital forms of diagnosis and treatment, neurology is still largely stuck in an “analogue era”, according to n
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.
After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. The results come from a Phase II trial of the vaccine, called R21/Matrix-M (MM), which have been published in a pre-print study in the journal The Lancet.
The deal is another sign of Pfizer's interest in infectious disease beyond COVID-19, following the pharma's participation in an industry investment fund.
Reports of COVID-19 vaccinations causing blood clots has caused alarm in the general population. However due to the rarity of incidences from vaccination, myGP explores the most common causes of blood clots and how we can prevent them. Over 11 million doses of COVID-19 vaccines have been given across the UK, with blood clotting observed in a small sample of patients.
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