Bio Pharma Dive
AUGUST 11, 2023
Filed in Maryland district court, the lawsuit claims the biotech unjustly profited from using HeLa cells to develop AAV vectors for its gene therapy products.
Worldwide Clinical Trials
AUGUST 10, 2023
As one of the more recent fields to emerge in the clinical space, psychedelics have gained significant traction as a potential treatment for various neuropsychiatric diseases. With so many exciting developments in the last few years, it’s critical for the psychedelic community to come together to reflect on our progress, share the latest discoveries, and discuss the future of psychedelic research.
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Pharmaceutical Technology
AUGUST 11, 2023
Following the business expansion in 2022, Clinigen announced the divestment of four of its cancer therapies.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 10, 2023
The global COVID-19 pandemic has shown us just how devastating these outbreaks can be – and it could have been much worse. Now, scientists have developed an AI application that promises to warn us about dangerous variants in future pandemics.
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
Bio Pharma Dive
AUGUST 10, 2023
The acquisition follows a similar-sized, obesity-focused buyout by Eli Lilly last month and hands Novo a weight-loss medicine already in mid-stage testing.
Rethinking Clinical Trials
AUGUST 9, 2023
Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials Description Joseph Ali, Tanya Matthews, and Leslie J. Crofford discuss responding (or not) to signals of potential clinical significance in pragmatic clinical trials. Biography Joseph Ali, JD Assistant Professor, Dept. of International Health Johns Hopkins Bloomberg School of Public Health Core Faculty & Associate Director for Global Programs Johns Hopkins Berman Institute of Bioethics Tanya Matthe
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 9, 2023
Long COVID can live up to its name. A new study shows that certain symptoms of the condition, such as brain fogginess, can still be experienced in people with long COVID two years after the original infection.
Bio Pharma Dive
AUGUST 8, 2023
Treatment with Wegovy led to a 20% reduction in the relative risk of cardiovascular complications or death, a finding that could further shift how doctors treat obesity.
Rethinking Clinical Trials
AUGUST 9, 2023
Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape Description Kayte Spector-Bagdady and Stephanie Morain discuss the impact of a changing policy landscape on data sharing and pragmatic clinical trials. Biography Stephanie Morain, PhD, MPH Assistant Professor, Bloomberg School of Public Health, Johns Hopkins University Ethics and Regulatory Core Co-chair Kayte Spector-Bagdady, JD, MBioethics Associate Director, Center for Bioethics & Social Scien
Pharmaceutical Technology
AUGUST 10, 2023
AI is essential in drug discovery and development and a growing number of start-ups now operate in this area
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 7, 2023
Fitness trackers help you stay healthy by keeping count of your steps and monitoring your heart rate, driving you on to hit those cardio goals. New research from ETH Zürich in Switzerland could see future wearable devices (with perhaps a few implants and a touch of genetic engineering) boost our health directly.
Bio Pharma Dive
AUGUST 8, 2023
The Indianapolis drugmaker is now worth more than $500 billion, higher than any other pharmaceutical company, as analysts project lucrative markets for its obesity and Alzheimer's drugs.
Rethinking Clinical Trials
AUGUST 9, 2023
The Stepped Wedge Cluster Randomized Trial: Friend or Foe? Description Dr. Monica Taljaard and Dr. David Magnus discuss the pros and cons of the stepped wedge cluster randomized trial. Biography Monica Taljaard, PhD Senior Scientist, Clinical Epidemiology Program, Ottawa Hospital Research Institute Full Professor, Epidemiology and Community Medicine, University of Ottawa David Magnus, PhD Professor of Medicine and Biomedical Ethics and Professor of Pediatrics, Medicine, and by courtesy of Bioeng
Pharmaceutical Technology
AUGUST 8, 2023
Jacobio Pharma received breakthrough therapy designation (BTD) for glecirasib to treat pancreatic cancer patients with the KRAS G12C mutation.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 6, 2023
Of all the senses we love to indulge, scent is often neglected – but the right smells could be just what your brain needs to keep it whirring in old age.
Bio Pharma Dive
AUGUST 10, 2023
The planned facility in the biotech hotspot of Cambridge will include incubator space for startups and adds to Astellas’ R&D footprint in the Boston area.
Rethinking Clinical Trials
AUGUST 9, 2023
Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials Description Dr. Emily Largent discusses ethical considerations when vulnerable populations are subjects in pragmatic trials. Biography Emily A. Largent, JD, PhD, RN Emanuel & Robert Hart Assistant Professor of Medical Ethics and Health Policy Department of Medical Ethics and Health Policy University of Pennsylvania Perelman School of Medicine The post Ethical Considerations When Vulnerable Populations are Sub
Pharmaceutical Technology
AUGUST 9, 2023
The agreement for selling Scilex Holding Company stocks would raise funds to pay off Sorrento’s outstanding debts.
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 9, 2023
The pharmaceutical industry in the country is waiting for the positive government response on the suggestions on the draft notification about the list of over-the-counter (OTC) drugs under Schedule K of Drug Rules 1945 and laid down specific provisions for its regulation in the country.
Bio Pharma Dive
AUGUST 5, 2023
The agency turned back the companies' attempt to also win clearance for major depressive disorder, limiting its market potential.
Rethinking Clinical Trials
AUGUST 9, 2023
Informing and Consenting: What are the Goals? Description Drs. Pearl O’Rourke, David S. Wendler, Miguel Vazquez, and Michael Ho discuss the goals of informing and consenting. Biography Pearl O’Rourke, MD (retired) Harvard Medical School Ethics and Regulatory Core Co-chair David S. Wendler, PhD, MA Senior Researcher, Department of Bioethics, NIH Clinical Center Miguel Vasquez, MD Professor of Internal Medicine, UT Southwestern Medical Center ICD-Pieces Demonstration Project PI Michael Ho, MD, PhD
Pharmaceutical Technology
AUGUST 9, 2023
Ageing populations, rising obesity levels, and low staff retention have created a global healthcare crisis.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 8, 2023
To help the pharmaceutical companies located in Baddi and in Solan district of Himachal Pradesh (HP) to better their performances further, the Baddi Barotiwala Nalagarh Development Authority (BBNDA), under the Government of HP, will organize a National Pharma Summit in September in which all stakeholders of the Indian pharmaceutical sector and government officials of the […]
Bio Pharma Dive
AUGUST 8, 2023
The job cuts will affect “all areas of the company” and, combined with other cost-reduction efforts, lead to annualized savings of over $100 million, Emergent said.
Rethinking Clinical Trials
AUGUST 9, 2023
Joe Ali, a longtime member of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core, will present “Advancing Justice and Equity in Pragmatic Clinical Trials.” The presentation is part of the Spotlight on Pain Management series of the VA HSR&D Cyberseminars. Advance registration is required. VA HSR&D Cyberseminars: Spotlight on Pain Management “Advancing Justice and Equity in Pragmatic Clinical Trials” Joe Ali, PhD Johns Hopkins University Advan
Pharmaceutical Technology
AUGUST 7, 2023
Iveric Bio, an Astellas company, has received clearance from the US Food and Drug Administration (FDA) for IZERVAY.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 10, 2023
Ten collective stakeholders of Indian healthcare industry, including the industry associations of medical devices manufacturers, patient interest group, and healthcare providers, have jointly demanded to the Union health minister Dr Mansukh Mandaviya to recall the New Drugs, Medical Devices & Cosmetics Bill, 2023 that is listed to be tabled in Parliament during the ongoing session.
Bio Pharma Dive
AUGUST 9, 2023
Third Rock-founded Decibel, which has shed much of its value since a 2021 IPO, expected to run out of money within a year.
Rethinking Clinical Trials
AUGUST 8, 2023
From left: Dr. Steven George, Dr. Vincent Mor, and Dr. Angelo Volandes In an interview at this year’s NIH Pragmatic Trials Collaboratory Steering Committee annual meeting, Drs. Steven George, Vincent Mor, and Angelo Volandes discussed the complexity of intervention delivery in pragmatic clinical trials and the impact it can have on researchers’ ability to discern trial results. “Without delving deeply into the way in which an intervention can be integrated into an operating sys
Pharmaceutical Technology
AUGUST 7, 2023
Health Canada has granted approval for GSK’s Arexvy vaccine to prevent RSV-caused lower respiratory tract disease in older adults.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
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