Rethinking Clinical Trials

FEBRUARY 22, 2024

An updated template from the NIH Pragmatic Trials Collaboratory provides guidance for the transparent reporting of the primary results of pragmatic clinical trials. The template includes elements from the Consolidated Standards of Reporting Trials (CONSORT) and its extensions. It also addresses secondary use of electronic health record data, involvement of research partners and healthcare systems in the conduct of pragmatic trials, and special ethical and regulatory considerations.

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Trials Clinical Trials Clinical Trials Research 130

Bio Pharma Dive

FEBRUARY 22, 2024

The startup’s Series C round will support a clinical-stage drug the company thinks could address some of the weaknesses of other KRAS-targeting medicines.

Drugs 300

Drugs Medicine 300

Pharmaceutical Technology

FEBRUARY 22, 2024

US patients are travelling to avoid abortion bans, but a new study has found telehealth prescriptions to be safe and effective.

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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 22, 2024

Some form of brain injury could be behind the symptoms reported by those with long COVID, according to a new study, and adapting tests and treatments to match could aid progress in tackling the condition.

Scientist 199

Scientist Clinical Trials Clinical Trials Trials 199

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Clinical Supply

Pharmaceutical Technology

FEBRUARY 22, 2024

The company will evaluate an IMC-F106C/Opdivo combination treatment in a Phase III registrational study called PRISM-MEL-301.

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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 22, 2024

In its efforts to streamline and rationalise the sampling procedure and maintain a centralised monthly database the Central Drugs Standard Control Organisation (CDSCO) has released the final version of the regulatory guidelines for sampling of drugs, cosmetics and medical devices by drugs inspectors of the Central and State drug authorities.

Cosmetics 195

Cosmetics Drugs Clinical Trials Clinical Trials 195

Bio Pharma Dive

FEBRUARY 22, 2024

The commitment is part of a new initiative led by First Lady Jill Biden to change how research into diseases that predominantly affect women gets funded in the U.S.

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Research 171

Pharmaceutical Technology

FEBRUARY 22, 2024

The company’s monoclonal antibody therapy, IO-202, has received its second orphan drug designation as a treatment for a blood cancer, CMML.

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Antibody Drugs 130

Bio Pharma Dive

FEBRUARY 22, 2024

Richard Gonzalez led AbbVie to become one of the largest pharmaceutical firms, but the company's pricing and patent tactics brought criticism and scrutiny, too.

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Pharmaceutical Technology

FEBRUARY 22, 2024

The UK MHRA has revoked a conditional marketing authorisation for Novartis' Adakveo 10mg/ml to treat sickle cell disease patients.

Marketing 130

Marketing 130

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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

Bio Pharma Dive

FEBRUARY 22, 2024

The $260 million fund will be used to back startups working on new drugmaking approaches like protein degraders and RNA therapies.

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RNA Protein 171

Pharmaceutical Technology

FEBRUARY 22, 2024

Charles River has entered into a partnership with Wheeler Bio to expedite the progression from therapeutic discovery to manufacturing.

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Manufacturing 130

Bio Pharma Dive

FEBRUARY 22, 2024

Moderna is counting on an experimental RSV vaccine, currently under review by the FDA, to drive sales this year.

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Vaccination Vaccine Sales 164

Pharmaceutical Technology

FEBRUARY 22, 2024

AbbVie has signed an agreement with Tentarix Biotherapeutics to discover and develop biologic candidates in oncology and immunology.

Development 130

Development 130

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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

Outsourcing Pharma

FEBRUARY 22, 2024

The National Institute for Health and Care Excellence (NICE) has issued guidance recommending GSK's Omjjara (momelotinib) as a treatment option for disease-related splenomegaly.

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Clinical Development Development 111

Pharmaceutical Technology

FEBRUARY 22, 2024

United has commenced litigation with the FDA to combat Liquidia’s Yutrepia encroaching on the market for its leading drug Tyvaso.

Marketing 130

Marketing Drugs 130

Bio Pharma Dive

FEBRUARY 22, 2024

Novavax will pay the vaccine alliance up to $475 million over five years under the terms of the deal.

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Vaccination Vaccine 120

Pharmaceutical Technology

FEBRUARY 22, 2024

Ono Pharmaceutical has partnered with EME to advance the drug discovery of VHH antibodies to develop new therapeutic agents.

Antibody 130

Antibody Drugs Development 130

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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

Fierce Pharma

FEBRUARY 22, 2024

As Roche officially abandoned cancer drug Gavreto, its former partner Blueprint Medicines has found the RET inhibitor a new owner in the U.S. | As Roche officially abandoned cancer drug Gavreto, its former partner Blueprint Medicines has found the RET inhibitor a new U.S. owner in Rigel Pharmaceuticals.

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Medicine Drugs 106

Pharmaceutical Technology

FEBRUARY 22, 2024

One common factor can help make supply chains more comprehensible, resilient and valuable: data

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pharmaphorum

FEBRUARY 22, 2024

Discover how AI, automation, and blockchain technologies are revolutionising pharmaceutical case processing in compliance with FDA regulations. Explore the benefits of these advancements in this insightful article.

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Compliance Regulation 107

Pharmaceutical Technology

FEBRUARY 22, 2024

Harmony is advancing pitolisant into a Phase III clinical trial that is expected to start in Q1 2024.

Clinical Trials 130

Clinical Trials Clinical Trials Drugs Trials 130

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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.

Clinical Supply

Pharmaceutical Commerce

FEBRUARY 22, 2024

A cohort study investigates how a change in clinical guidelines, an expanded label, and reduction in drug prices can impact the use of PCSK9 inhibitors as a treatment for atherosclerotic cardiovascular disease.

Drugs 104

Drugs 104

XTalks

FEBRUARY 22, 2024

This episode of the Xtalks Food Podcast features an interview with with Chad Pawlak, CEO of Genvor, a developer of sustainable plant health solutions. Recently appointed CEO, Pawlak discussed his vision for Genvor under his leadership, specifically in the context of sustainability. He highlighted Genvor’s recent partnership with the US Department of Agriculture (USDA) that led to a significant publication on antimicrobial peptides (AMPs).

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Development Research 98

Pharma Times

FEBRUARY 22, 2024

The trial is recruiting patients in Leeds, Manchester, Oxford, London, Cambridge and Kent

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Clinical Trials Clinical Trials Trials Research 131

Outsourcing Pharma

FEBRUARY 22, 2024

An international initiative that recognizes, rewards, and benchmarks the reputations of pharma companies in patient engagement and centricity has opened.

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Pharma Companies 105

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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

BioPharma Reporter

FEBRUARY 22, 2024

MIP Discovery, a developer of non-biological affinity reagents designed to accelerate the production of cell and gene therapies, has closed a Â7 million Series A financing round, led by Mercia Ventures.

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Gene Reagent Gene Therapy Production 97

pharmaphorum

FEBRUARY 22, 2024

NICE has backed NHS use of Pfizer’s Litfulo for patients with alopecia areata, the first drug therapy for a condition that affects around 14,000 people

Drugs 104

Drugs 104

Fierce Pharma

FEBRUARY 22, 2024

Regeneron and Sanofi have reached another milestone as they look to add to their megablockbuster immunology drug Dupixent a new U.S. | Regeneron and Sanofi have reached another milestone is their advancement of Dupixent (dupilumab) as a potential treatment for uncontrolled chronic obstructive pulmonary disease (COPD) with type 2 inflammation as the FDA has accepted the companies’ application and designated it for priority review with a target action date of June 27.

Drugs 90

Drugs 90

pharmaphorum

FEBRUARY 22, 2024

In a dynamic healthcare market, securing top talent is essential for the success of any organisation. Advanced Clinical looks at innovative recruitment strategies and solutions to help you attract and retain the best healthcare professionals.

Marketing 94

Marketing 94

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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.

Clinical Supply