Pharmaceutical Technology
AUGUST 9, 2023
The global pharmaceutical industry experienced a 52% decline in the number of artificial intelligence related patent applications in Q2 2023 compared with the previous quarter, according to GlobalData's Patent Analytics.
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.
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Pharmaceutical Technology
AUGUST 9, 2023
The global pharmaceutical industry experienced a 52% decline in the number of artificial intelligence related patent applications in Q2 2023 compared with the previous quarter, according to GlobalData's Patent Analytics.
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.
Pharmaceutical Technology
AUGUST 9, 2023
Eli Lilly and Company has posted reported net income of $1.76bn in the second quarter (Q2) of 2023 as against $952.5m in Q2 2022.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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
Pharmaceutical Technology
AUGUST 9, 2023
AGC has extended its Milan manufacturing facility to address the growing clinical trial and commercial demands.
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 9, 2023
Ageing populations, rising obesity levels, and low staff retention have created a global healthcare crisis.
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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
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 9, 2023
The global pharmaceutical industry experienced a 18.5% increased in patent fillings in Q2 2023 compared with the previous quarter, according to GlobalData's Patent Analytics.
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
Bio Pharma Dive
AUGUST 9, 2023
The Flagship-backed company claims its technology can create genetic drugs that work broadly to treat diseases caused by “stop” mutations.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
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
Bio Pharma Dive
AUGUST 9, 2023
The studies are another example of drugmakers exploring how so-called BTK inhibitors can be used to treat diseases outside of blood cancer.
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 9, 2023
GenScript Biotech has expanded the peptide production capabilities at its new life-sciences manufacturing facility located in Zhenjiang.
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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.
Rethinking Clinical Trials
AUGUST 9, 2023
Dr. Patrick Lawler In this Friday’s PCT Grand Rounds, Patrick Lawler of the McGill University Health Centre will present “The REMAP-CAP Adaptive Platform Trial: Recent Insights and Future Directions.” The Grand Rounds session will be held on Friday, August 11, 2023, at 1:00 pm eastern. The REMAP-CAP trial (Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia) has a novel adaptive trial design to evaluate several treatment options simult
Pharmaceutical Technology
AUGUST 9, 2023
Teknova has opened a new modular manufacturing facility in Hollister, California, US for custom, high-quality life sciences re-agents.
ACRP blog
AUGUST 9, 2023
Principal investigators (PIs) interviewed for a recent academic dissertation recognized the need for greater diversity among participants in the clinical trials they run but are frustrated that the inclusion/exclusion criteria handed to them by sponsors often don’t match the real-life situations of the average patient in their practice with the condition of interest.
Pharmaceutical Technology
AUGUST 9, 2023
Following the Phase III trials for remibrutinib meeting their primary endpoints, Novartis plans for regulatory submissions in 2024.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Fierce Pharma
AUGUST 9, 2023
AstraZeneca is often at the forefront when it comes to sustainability efforts among pharma companies. Now, the British drugmaker is doubling down on its clean energy commitments in Sweden.
Pharmaceutical Technology
AUGUST 9, 2023
Astex Pharmaceuticals and Merck (MSD) have expanded their collaboration to identify small molecule candidates for cancer treatment.
XTalks
AUGUST 9, 2023
California-based Tarsus Pharmaceuticals Inc., a leader in developing therapeutic solutions for common diseases with limited treatment alternatives, has secured approval from the US Food and Drug Administration (FDA) for its drug, Xdemvy (lotilaner ophthalmic solution) 0.25%. Xdemvy is now authorized to treat Demodex blepharitis, offering a new option for affected patients. “ Demodex blepharitis, easily diagnosed by the presence of eyelash collarettes, can result in ocular damage in multiple ways
Pharmaceutical Technology
AUGUST 9, 2023
Act4Biosimilars, an international advocacy organisation is pushing for country-specific initiatives to increase biosimilar usage.
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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.
Outsourcing Pharma
AUGUST 9, 2023
Nathan Johnson has 20 yearsâ experience in clinical research as an innovator and programmer with expertise in statistical analysis and reporting, SAS programming, standards development, and data management.
Pharmaceutical Technology
AUGUST 9, 2023
SK bioscience has announced plans to purchase Novavax shares by making an equity investment of $85m through a private placement.
BioPharma Reporter
AUGUST 9, 2023
Sigma Mostafa is the chief scientific officer of KBI Biopharma, a development and contract manufacturing organization serving the biopharmaceutical industry.
Pharmaceutical Technology
AUGUST 9, 2023
Celmatix and Aché Laboratórios have teamed up to develop melatonin receptor agonists for polycystic ovary syndrome (PCOS).
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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