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.

Clinical Research 40

Clinical Research Research 40

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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FDA Compliance Compliance Clinical Trials Clinical Trials 52

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.

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Clinical Trials Clinical Trials Trials Research 40

Antidote

DECEMBER 27, 2023

This interview features Dr. Aaron Kowalski from JDRF, who discusses diabetes clinical trials, upcoming research, and more.

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Clinical Trials Clinical Trials Trials Research 113

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Clinical Supply

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.

Clinical Trials 40

Clinical Trials Clinical Trials Trials 40

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.

Life Science 62

Life Science Research 62

WCG Clinical

DECEMBER 27, 2023

This content is password protected. To view it please enter your password below: Password: The post Patient Recruitment Barriers in Oncology appeared first on WCG.

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Drug Discovery World

DECEMBER 28, 2023

Paediatric oncologist Gauri Sunkersett shares her unique background and research approach at AbbVie to help find answers for the youngest blood cancer patients. When I was a second-year resident training as a paediatric oncologist at Nicklaus Children’s Hospital, I met a teenage boy diagnosed with Hodgkin’s Lymphoma. He was admitted to the hospital for weekly chemotherapy.

Research 52

Research Clinical Trials Clinical Trials Development 52

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.

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Containment Compliance Production Development 69

Pharmaceutical Technology

DECEMBER 29, 2023

FDA warns that levetiracetam and clobazam can cause DRESS, a rare hypersensitivity reaction which can be life threatening.

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Drugs 278

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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

Clinical Trials

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.

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Trials 125

Drug Discovery World

DECEMBER 28, 2023

Oxford Target Therapeutics, a company developing a promising therapy for triple negative breast cancer, is one of three UK life science companies awarded research prizes by the Rosalind Franklin Institute, based in Oxfordshire, UK. The prizes, awarded in collaboration with the Science and Technology Facilities Council (STFC), a part of UKRI, enable the winners to benefit from the Franklin’s top-level technologies and support to move their work forward.

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Research Life Science Drugs Production 106

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

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Clinical Trials Clinical Trials FDA Approval Trials 119

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.

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Licensing Licensing 245

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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.

Clinical Trials

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.

Medicine 106

Medicine Clinical Trials Clinical Trials Trials 106

Drug Discovery World

DECEMBER 27, 2023

Kadans Science Partner has acquired space within the Knowledge Quarter, London to deliver laboratory accommodation to the UK life sciences market. The Knowledge Quarter Kings Cross boasts a range of academic, research, and scientific organisations from The Francis Crick Institute and University College London (UCL) to the Wellcome Trust, Google, GSK, Merck (MSD) and AstraZeneca.

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Life Science Marketing Drugs Research 98

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

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Trials FDA Approval Drugs Development 105

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.

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Drugs 244

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.

Clinical Research

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.

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Contamination Production Drugs 95

pharmaphorum

DECEMBER 29, 2023

Navigating transplant networks: Ensuring equitable access and improving outcomes for highly sensitised kidney transplant patients Mike.

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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.

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Trials Clinical Trials Clinical Trials Antibody 97

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.

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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

Clinical Research

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.

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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

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Development 96

Drug Discovery World

DECEMBER 27, 2023

As 2023 draws to a close, DDW’s Multimedia Editor and podcast host Megan Thomas rounds up all the free episodes of the DDW podcast that were released. You can also find The Drug Discovery World Podcast on Spotify , Google Play and Apple Podcasts. DDW Highlights Innovative. Evolving. Developing. Busy. These are just some of the words that come to mind when talking about not just the drug discovery sector, but the lives of those working in and around it.

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Clinical Trials Clinical Trials Drugs Development 69

Pharmaceutical Technology

DECEMBER 26, 2023

Bristol Myers Squibb (BMS) has signed a definitive agreement for the acquisition of Karuna Therapeutics for $14bn in cash.

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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.

Clinical Trials

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.

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Drugs Marketing 59

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

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Drugs 92

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.

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Clinical Trials Clinical Trials Trials Clinical Research 59

Pharmaceutical Technology

DECEMBER 28, 2023

The MHRA gave Bristol Myers Squibb’s Opdualag marketing authorisation for advanced melanoma as part of Project Orbis.

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Marketing 246

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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

Clinical Trials