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 317

Drugs Medicine 317

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

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.

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Scientist Clinical Trials Clinical Trials Trials 243

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

Medicine

Pharmaceutical Technology

FEBRUARY 22, 2024

The FDA has accepted Regeneron’s biologics licence application (BLA) for linvoseltamab to treat multiple myeloma for priority review.

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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.

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Cosmetics Drugs Clinical Trials Clinical Trials 241

Pharmaceutical Technology

FEBRUARY 22, 2024

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

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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 189

Pharma Times

FEBRUARY 22, 2024

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

Clinical Trials 137

Clinical Trials Clinical Trials Trials Research 137

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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Vaccine Vaccination Sales 182

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Clinical Supply

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

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 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

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

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Vaccine Vaccination 133

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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

Pharmaceutical Technology

FEBRUARY 22, 2024

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

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Clinical Trials Clinical Trials Trials Drugs 130

pharmaphorum

FEBRUARY 22, 2024

On today’s episode of the pharmaphorum podcast, Jason Park, CEO of Empress Therapeutics, discusses his company's novel approach to small molecule drug discovery.

Genetics 119

Genetics Drugs 119

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.

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Marketing Drugs 130

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.

Medicine 116

Medicine Drugs 116

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Clinical Supply

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

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 116

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

pharmaphorum

FEBRUARY 22, 2024

Stay updated on the latest clinical trials happening from 29th January to 2nd February 2024. Explore trials by Vidac, Orion, Revolo Biotherapeutics, and Uvax Bio.

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Clinical Trials Clinical Trials Trials 114

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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

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

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 114

Marketing 114

Pharma Times

FEBRUARY 22, 2024

Pharmacy First will enable patients to receive treatment for seven common conditions

Pharmacy 114

Pharmacy 114

pharmaphorum

FEBRUARY 22, 2024

More digital health consolidation as Aptar buys Healint, a specialist in patient support apps and software to run virtual clinical trials and patient registries

Clinical Trials 111

Clinical Trials Clinical Trials Trials 111

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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

FEBRUARY 22, 2024

To get a pulse on Moderna following its “year of transition” in 2023, look no further than the company’s manufacturing operations. | To get a pulse on Moderna following its “year of transition” in 2023, look no further than the company’s manufacturing operations. The Cambridge, Massachusetts-based biotech has incurred a COVID-related wind-down charge on one hand, while it spends millions of dollars to bolster cancer vaccines at the same time.

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Contract Manufacturing Manufacturing Production Vaccine 110

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 105

Drugs 105

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

pharmaphorum

FEBRUARY 22, 2024

Regeneron should hear from the FDA in August on its application for multiple myeloma bispecific linvoseltamab after a priority review.

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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