Clinical Research Trends & Insights for 2024 V4
WCG Clinical
DECEMBER 28, 2023
This content is password protected. To view it please enter your password below: Password: The post Clinical Research Trends & Insights for 2024 V4 appeared first on WCG.
Sat.Dec 23, 2023 - Fri.Dec 29, 2023
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Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management
ProRelix Research
DECEMBER 28, 2023
Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.
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Virtual Clinical Trial Companies: Bringing Revolution in Medical Research
Roots Analysis
DECEMBER 29, 2023
Clinical trials are prospective biomedical research studies designed to evaluate medical, surgical or behavioral interventions in people and investigate novel approaches for the diagnosis and prevention / treatment of diseases. In order to gain marketing approval from regulatory authorities for a novel therapeutic intervention, highly accurate and elaborate clinical trial data is required to validate the drug’s safety and effectiveness towards a specific target indication.
Ask Me Anything: An interview with Dr. Aaron Kowalski of JDRF [Video]
Antidote
DECEMBER 27, 2023
This interview features Dr. Aaron Kowalski from JDRF, who discusses diabetes clinical trials, upcoming research, and more.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
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
Diversity, Equity, and Inclusion in Rare Disease Clinical Trials:Â Current Opportunities and OutcomesÂ
WCG Clinical
DECEMBER 27, 2023
This content is password protected. To view it please enter your password below: Password: The post Diversity, Equity, and Inclusion in Rare Disease Clinical Trials: Current Opportunities and Outcomes appeared first on WCG.
The rapidly evolving role of patient organisations
pharmaphorum
DECEMBER 27, 2023
Patient organisations play a crucial role in the rapidly evolving landscape of healthcare, life sciences, and research. Learn about their role in advocacy, research, and navigating regulatory processes in this informative article.
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Hospital Price Transparency Gets a Boost by PatientRightsAdvocate.org
XTalks
DECEMBER 27, 2023
PatientRightsAdvocate.org (PRA), a leading non-profit organization championing the cause of healthcare price transparency in America, launched Hospital Price Files Finder , a freely available dashboard tool containing pricing files for 6,000 hospitals nationwide. It is a searchable tool containing all available hospital pricing files in spreadsheets that are human and machine-readable, converted from the original format as necessary.
FDA warns of rare hypersensitivity reaction due to antiseizure drugs
Pharmaceutical Technology
DECEMBER 29, 2023
FDA warns that levetiracetam and clobazam can cause DRESS, a rare hypersensitivity reaction which can be life threatening.
Amgen's request for full approval of Lumakras in lung cancer denied by FDA
Fierce Pharma
DECEMBER 27, 2023
Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. | Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California biopharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod.
BMS strikes again, with $4.1bn RayzeBio takeover bid
pharmaphorum
DECEMBER 27, 2023
Bristol-Myers Squibb makes a foray into the radiopharmaceutical category with a $4.
Amgen’s Tarlatamab Gets FDA Priority Review for Small Cell Lung Cancer
XTalks
DECEMBER 29, 2023
Amgen recently reported that the US Food and Drug Administration (FDA) has given priority review status to its drug candidate, tarlatamab, intended for the treatment of small-cell lung cancer (SCLC). If approved, tarlatamab could bring about significant improvements compared to existing options or potentially offer a treatment alternative in cases where no adequate therapy currently exists. “The FDA’s Priority Review designation for this application underscores the urgency to provide
BMS bags UK advanced melanoma win for Opdualag
Pharmaceutical Technology
DECEMBER 28, 2023
The MHRA gave Bristol Myers Squibb’s Opdualag marketing authorisation for advanced melanoma as part of Project Orbis.
Pfizer's Hospira recall spree bleeds into 2024 with product pulls for multiple hospital drugs in shortage
Fierce Pharma
DECEMBER 27, 2023
After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. | After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. Shortly before the holiday, Hospira announced two separate recalls over the potential presence of glass particulates in vials and syringes of certain hospital meds.
Navigating transplant networks: Ensuring equitable access and improving outcomes for highly sensitised kidney transplant patients
pharmaphorum
DECEMBER 29, 2023
Navigating transplant networks: Ensuring equitable access and improving outcomes for highly sensitised kidney transplant patients Mike.
The New Age of Decentralized Clinical Trials
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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
KarXT: A New Hope for Schizophrenia Patients, Phase III Trial Data Reveals
XTalks
DECEMBER 26, 2023
Karuna Therapeutics, a biopharmaceutical company dedicated to uncovering, advancing and providing groundbreaking medicines for individuals facing psychiatric and neurological conditions, has recently disclosed encouraging outcomes from the Phase III EMERGENT-2 trial of KarXT (xanomeline-trospium) in adults diagnosed with schizophrenia. “New treatments and novel mechanisms are urgently needed for people with schizophrenia because many don’t respond to their therapy and others only have a partial
AstraZeneca buys Chinese CAR-T biotech Gracell in a $1.2bn deal
Pharmaceutical Technology
DECEMBER 27, 2023
The deal is worth approximately $1.2bn in combined upfront and potential contingent value payments and is expected to close in Q1 2024.
Regeneron fends off Viatris' Eylea biosimilar with patent win
Fierce Pharma
DECEMBER 29, 2023
Armed with a new victory over Viatris in a patent dispute, Regeneron can knock off one contender in the Eylea biosimilar race. | A West Virginia judge found that Viatris' proposed biosimilar stepped on one of the three patents that Regeneron sued over. Shortly after, the company expanded its suit against another biosimilar contender, setting the stage for Regeneron's defense in Eylea's last few months of exclusivity.
Eisai working on wristband sensor for brain amyloid
pharmaphorum
DECEMBER 29, 2023
Eisai and Oita University have developed a machine learning-powered wearable that can predict whether someone is at risk of developing Alzheimer’s disease
How Machine Learning Drives Clinical Trial Efficiency
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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.
Effect of an Intensive Food-as-Medicine Program on Health and Health Care Use
JAMA Internal Medicine
DECEMBER 25, 2023
This randomized clinical trial examines whether an intensive food-as-medicine program can improve glycemic control and ,1rengagement with preventive health care compared with usual care among adults with diabetes and food insecurity.
J&J jumps on ADC train, signs $1.7bn licensing deal with LegoChem
Pharmaceutical Technology
DECEMBER 28, 2023
J&J has acquired a global license for South Korean LegoChem’s ADC for $100m upfront along with milestone-based payments and tiered royalties.
Innovative Nipocalimab Trial for HDFN Treatment Powered by BillionToOne
XTalks
DECEMBER 28, 2023
BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. The trial, a randomized, placebo-controlled, double-blind, multicenter study, aims to evaluate nipocalimab as a treatment for severe hemolytic disease of the fetus and newborn (HDFN) in pregnancies at risk.
AZ makes another cell therapy play with $1.2bn Gracell buy
pharmaphorum
DECEMBER 26, 2023
AstraZeneca agrees a $1.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
Which pharmaceutical companies have the most gel dosed drugs?
Drug Patent Watch
DECEMBER 29, 2023
This chart shows the pharmaceutical companies with the most gel dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most gel dosed drugs… The post Which pharmaceutical companies have the most gel dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.
Enveric’s EB-003 selected as lead candidate for mental health disorders
Pharmaceutical Technology
DECEMBER 29, 2023
Enveric Biosciences has selected EB-003 as its lead drug candidate from its EVM301 series for difficult-to-treat mental health disorders.
6 Top Picks: Clinical Trial Blogs Not to Miss
Imperical Blog
DECEMBER 27, 2023
The Imperial blog team took a look at our 2023 clinical trial blogs, and we’re shining the spotlight on our top six picks. So here they are, in no particular order: six clinical trial blogs worth reading (and re-reading). 1. Supply Chain: Master these key… The post 6 Top Picks: Clinical Trial Blogs Not to Miss appeared first on Imperial Clinical Research Services Blog.
BMS wagers $14bn on Karuna’s schizophrenia drug
pharmaphorum
DECEMBER 23, 2023
BMS has reached a $14bn agreement to buy Karuna and its KarXT schizophrenia candidate, due for an FDA verdict next September
New patent expiration for NOVO drug SAXENDA
Drug Patent Watch
DECEMBER 29, 2023
Annual Drug Patent Expirations for SAXENDA Saxenda is a drug marketed by Novo and is included in one NDA. It is available from one supplier. There are twenty-one patents protecting… The post New patent expiration for NOVO drug SAXENDA appeared first on DrugPatentWatch - Make Better Decisions.
BMS agrees to acquire Karuna Therapeutics for $14bn
Pharmaceutical Technology
DECEMBER 26, 2023
Bristol Myers Squibb (BMS) has signed a definitive agreement for the acquisition of Karuna Therapeutics for $14bn in cash.
Top 3 Manufacturing and Packaging Articles of 2023
Pharmaceutical Commerce
DECEMBER 29, 2023
Popular works in the category explore 340B guidelines, ‘smart pharma’ capabilities, and commercialization trends.
Cytokinetics rockets on positive heart drug trial
pharmaphorum
DECEMBER 28, 2023
Cytokinetics rises on report that its aficamten drug improved symptoms in people with rare disease obstructive hypertrophic cardiomyopathy
The New Age of Decentralized Clinical Trials
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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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