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Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months.
What is a health coach? A health coach is someone with expertise in wellness who assists people achieve good health by being a mentor and educator on lifestyle and nutritional changes. It is important to understand that health coaching is not only about nutrition, but instead, health coaches offer people a holistic approach to creating and sustaining healthy habits.
SUMMARY: With patients staying away from their doctors because of COVID, DTC messages need to add incentives and better messaging to get people to take action rather than wait. No one message will do this, however. Messages need to evolve in these special times. My doctor’s office recently sent me an email that they had plenty of telehealth appointments available for patients who didn’t want to come to the office.
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!
?The FDA's IND approval sets the stage for the very first Phase I/II trial to evaluate EBT-101 as a functional cure for chronic HIV based on the endpoints of safety, tolerability, and efficacy.
SUMMARY: Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high. Even if humoral immunity appears to wane, reductions in neutralizing antibody titre do not necessarily predict reductions in vaccine efficacy over time, and reductions in vaccine efficacy against mild disease do not necessarily predict reductions in the (typically higher) efficacy against severe disease.
SUMMARY: Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high. Even if humoral immunity appears to wane, reductions in neutralizing antibody titre do not necessarily predict reductions in vaccine efficacy over time, and reductions in vaccine efficacy against mild disease do not necessarily predict reductions in the (typically higher) efficacy against severe disease.
The European health tech industry has made a “quantum leap” into using digital health technology due to the pandemic with the help of a growing number of trailblazing entrepreneurs, according to AlbionVC. The London-based venture capital firm provides a useful overview of how healthcare has changed over the last decade, and where digital health is expected to make the most impact in the future, in their first Health Tech primer for Europe report.
In a back-and-forth meeting Friday, the committee opposed clearing a third shot widely for use in people older than 16, but agreed the benefits outweighed the risks for adults over 65 or those at risk of severe COVID-19.
The use of opioids for pain relief in patients awaiting hip and knee replacement surgery increased dramatically during the pandemic according to new research from the University of Aberdeen. Published in the BMJ Quality & Safety, the study found that the numbers of patients using opioids while waiting for surgery increased by 40% compared to pre-pandemic levels.
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
Deployment of digital health technologies during the pandemic improved patient satisfaction, expanded the delivery of care and augmented training of staff at a leading neurosurgery provider in the US, according to a new study. Faced with the disruption caused by the COVID-19 crisis, Cleveland Clinic centres implemented a number telehealth and audio-visual technologies to compensate for the difficulties in having face-to-face interactions with patients.
The move, which will affect an estimated 270 positions, follows a review by the company's board, and comes just weeks after one of its most advanced drugs failed a key test.
HONG KONG, Legend Capital led a new round of investment of PT Etana Biotechnologies Indonesia (Etana), along with Innovent Biologics, Inc. (Innovent) (HKEX: 01801), and a consortium led by UOB Venture Management (UOBVM). This round of funds will be used to further strengthen the company’s production, registration, clinical and commercialization capabilities, promote the company’s extensive and in-depth cooperation with biopharmaceutical companies, and lead the development of the Indo
The much-anticipated data arrive two days before an important FDA advisory meeting to discuss authorization of a booster dose for Pfizer's coronavirus vaccine.
Not enough is being done to ensure that patient voices are included in policymaking around digital health, says a new patient organisation in the UK, which aims to set that situation right. The Patient Coalition for AI, Data and Digital Tech in Health has brought together members of patient organisations, medical colleges and health charities to tackle issues such as ensuring equitable access to digital health services.
The pharma tech firm has forged a four-year partnership with the foundation to develop antivirals for COVID-19 and other viruses with pandemic potential.
Marion Gruber and Philip Krause, two top FDA vaccine reviewers who are unexpectedly departing this fall, joined senior WHO officials in saying booster vaccine doses are not yet widely needed.
Given the rising cost of medicines as a share of the NHS budget in England, the establishment of ICSs provides a timely opportunity to take stock on delivering medicines optimisation at local level, says NHS Gloucestershire CCG’s Ellen Rule. Medicines optimisation aims to improve health outcomes, service quality, and sustainability by ensuring patients are taking their prescribed medicines as recommended to derive the intended benefits and avoid incurring harms.
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.
This newfound ability to take tumor cells directly from a patient and incorporate them into a more clinically accurate glioblastoma model could lead to greater patient personalization in cancer therapeutics.
In a briefing document released Wednesday, agency reviewers did not make a strong case either for or against the broad authorization of boosters for the general public.
Researchers in the UK are working on an artificial intelligence (AI) algorithm to help diagnose deep vein thrombosis (DVT) from ultrasound images – and potentially prevent patients from receiving drugs unnecessarily. The team from Oxford University, Imperial College London and the University of Sheffield are working with German tech company ThinkSono on the smartphone-based app, called AutoDVT, and estimate it could cut the cost to health services of each examination by up to $150.
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.
The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies.
There has been a fourth patient fatality in Astellas’ clinical trial of its AT132 gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), which has been halted twice due to safety concerns. The latest suspension came after abnormal liver function tests (LFTs) were seen in a boy receiving the gene therapy, who has since passed away, according to a statement issued today by the Japanese drugmaker.
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