Outsourcing Pharma
JANUARY 9, 2024
Medable Inc. has announced a new intelligent automation technology applied across its clinical trials platform it hopes will cut standard trial build timelines by at least half.
Bio Pharma Dive
JANUARY 9, 2024
Albert Bourla acknowledged Pfizer’s difficult 2023, while a biotech CEO spoke with BioPharma Dive about building neuroscience startups.
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AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 9, 2024
It seems the time that wounds take to heal is partly down to mentality: researchers have found that healing happens faster when the person involved thinks that time is progressing more quickly than it actually is.
Rethinking Clinical Trials
JANUARY 9, 2024
Speaker Speaker: Rui Wang, PhD Associate Professor of Population Medicine and Associate Professor in the Department of Biostatistics, Harvard Pilgrim Health Care Institute and Harvard Medical School Moderator: Fan Li, PhD Assistant Professor of Biostatistics, Yale School of Public Health Slides Keywords Cluster-randomized; Intervention; Missingness; Outcomes Key Points Cluster randomized trials are trials in which clusters of individuals rather than independent individuals ar
Bio Pharma Dive
JANUARY 9, 2024
Aiolos, which raised a Series A round three months ago, is developing an antibody that shares a target with Amgen and AstraZeneca’s Tezspire.
Rethinking Clinical Trials
JANUARY 9, 2024
Ethics and regulatory onboarding documentation is now available for iPATH, one of the NIH Pragmatic Trials Collaboratory's newest pragmatic clinical trials. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the study. The consultation took place by video conference and included representation from the study's principal investigator and study team, members of the NIH Collaboratory's Ethics and Regulator
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
JANUARY 9, 2024
Experts in the life-sciences industry are of the view that doing away with human studies for new drugs in India is unscientific and risky as patients here have different anthropometry.
Pharmaceutical Technology
JANUARY 9, 2024
The EC has granted approval for Pfizer’s Talzenna (talazoparib) to treat adults with metastatic castration-resistant prostate cancer (mCRPC).
Fierce Pharma
JANUARY 9, 2024
Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. | Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. Morgan Healthcare Conference on Monday, the company’s CEO, Albert Bourla, spoke bluntly about the hits the company took, and he acknowledged the underperformance of certain key launches.
Pharmaceutical Technology
JANUARY 9, 2024
Johnson & Johnson (J&J) has signed a definitive agreement for the acquisition of Ambrx Biopharma in a cash deal valued at $2bn.
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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
CTTI (Clinical Trials Transformation Initiative)
JANUARY 9, 2024
Today, the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced eight newly selected representatives for the Patient Engagement Collaborative (PEC). The group of 16 patients, caregivers, and patient group representatives meets with the FDA several times a year and discusses a variety of topics such as improving communication, education, and patient engagement related to medical product regulation.
Pharmaceutical Technology
JANUARY 9, 2024
dispenSense, part of Navi Group, is a Category Award Winner in three areas in the 2023 Pharmaceutical Technology Excellence Awards
BioPharma Reporter
JANUARY 9, 2024
We caught up with Kevin Knopp, CEO and co-founder of 908 Devices, to discuss the main obstacles in cell and gene therapy manufacturing and how the company's recent partnership with Terumo Blood and Cell Technologies is tackling these challenges.
Pharmaceutical Technology
JANUARY 9, 2024
The proceeds from the private placement will fund the development of Zealand’s obesity pipeline, including two Phase II candidates.
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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
Drug Patent Watch
JANUARY 9, 2024
A recent story by NPR echoes the findings of a collaboration between DrugPatentWatch and Bloomberg, which examined increasing competition between generic drug makers. The NPR article discusses the challenges in… The post NPR on how low Drug Prices can Shortages appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
JANUARY 9, 2024
Biocytogen Pharmaceuticals and Radiance Biopharma have signed an exclusive option and licence agreement for a BsADC.
pharmaphorum
JANUARY 9, 2024
Discover how the UK Biobank is leveraging technology and the power of genomics in data-driven disease research. Join the digital revolution in understanding and combating diseases using cutting-edge techniques and large-scale genomic data analysis.
Pharmaceutical Technology
JANUARY 9, 2024
Approval for zolbetuximab was quashed after the FDA found deficiencies in the company’s third-party manufacturing.
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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.
Outsourcing Pharma
JANUARY 9, 2024
Pharma company Mercaptor has announced its new âbreakthroughâ technology at J.P. Morgan HealthCare Conference which it says could transform Alzheimer's, TBI, and epilepsy treatment.
Pharmaceutical Technology
JANUARY 9, 2024
Set to lose Keytuda patent protection in 2028, MSD is shoring up its oncology portfolio with immunotherapies.
XTalks
JANUARY 9, 2024
Thyroid Awareness Month is marked every January to emphasize the importance of thyroid health. The theme of Thyroid Awareness Month 2024 is “Nurturing Thyroid Health: Knowledge, Detection and Wellness.” The month focuses on understanding the thyroid’s vital role in many bodily functions, encouraging testing and early treatment for thyroid dysfunctions and advocating for awareness about the different types of thyroid diseases.
pharmaphorum
JANUARY 9, 2024
In a new episode of the pharmaphorum podcast, host Nicole Raleigh speaks with Aman Wasan, CEO of ArisGlobal, about the digitisation of drug research and development, including using automation to analyse large datasets to identify new drug development opportunities, with patient safety ever at the forefront of such innovations.
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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.
XTalks
JANUARY 9, 2024
Swoop , a leader in healthcare marketing, recently introduced a groundbreaking portfolio of predictive AI targeting for pharmaceutical and life sciences advertisers. This innovation is set to transform the approach to direct-to-consumer (DTC) and healthcare provider (HCP) audience engagement, allowing for proactive involvement at pivotal points in the diagnosis and treatment journey.
Intouch Solutions
JANUARY 9, 2024
Artificial intelligence is reshaping how the world lives and works. But what does this mean, specifically, for marketers in the life sciences industry? How is it changing our jobs? How do we want it to? And what are the roadblocks we’re meeting as we try to implement AI solutions? At EVERSANA INTOUCH, we’re pharmatizing AI – and to do that optimally, we needed to know exactly what the biggest desires and barriers are.
BioPharma Reporter
JANUARY 9, 2024
Large-scale global serologic surveillance with real-time monitoring of the immune status of human populations and detection of viral outbreaks could be enabled by new technology from Picodya.
Intouch Solutions
JANUARY 9, 2024
At EVERSANA and EVERSANA INTOUCH, we have the pleasure of working alongside passionate and empathetic individuals who not only devote their career to helping others, but also spend time serving others outside of their work life. Supporting Those Affected by Lymphoma Amber Robinson, Manager, Sales Marketing Operations at EVERSANA INTOUCH, devotes her free time supporting those affected by the blood cancer Lymphoma.
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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.
pharmaphorum
JANUARY 9, 2024
Manufacturing problems have scuppered Astellas’ chances of approval in the US this month for zolbetuximab, currently leading the field among Claudin 18.2-targeted drug candidates for cancer.
Fierce Pharma
JANUARY 9, 2024
Two successful phase 3 trials put Astellas’ monoclonal antibody zolbetuximab on track to become the first approved therapy to treat one of the hottest targets in oncology—tumors that are claudin (C | Two successful phase 3 trials put Astellas’ monoclonal antibody zolbetuximab on track to become the first approved therapy to treat one of the hottest targets in oncology—tumors that are claudin (CLDN) positive.
pharmaphorum
JANUARY 9, 2024
Day 1 of JPM24 ended with no news on a rumoured takeover of Cytokinetics by Novartis, but Boston Scientific confirmed a $3.7bn bid for medtech specialist Axonics.
Drug Channels
JANUARY 9, 2024
For 2024, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again each excluded 600 or more drugs from their standard formularies. You can find our updated counting below. This year, Humira and its 13 biosimilars will provide the most intriguing formulary drama. Unfortunately, the gross-to-net bubble will remain a fixture for this category, despite a price war led by almost half of the biosimilars.
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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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