The Pharma Data

JUNE 15, 2025

The data, which encompass up to 3 years of follow-up after a single infusion of the treatment, were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held from June 13–16 in Glasgow, United Kingdom.

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The Pharma Data

JUNE 12, 2025

The data, presented at the annual European Alliance of Associations for Rheumatology (EULAR 2025) congress in Barcelona, Spain, show that dapirolizumab pegol resulted in significant and clinically meaningful improvements in disease activity while addressing a major symptom that profoundly impacts patients’ daily lives — fatigue.

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Fierce BioTech

JULY 17, 2025

smarcus Thu, 07/17/2025 - 17:29 Ready to transform your obesity trial outcomes? Avacare Clinical Research Network Resource Type Whitepaper avacare_clinical_research_network_logo-250x190.png png Thu, 07/17/2025 - 17:29 Fierce Biotech Homepage Landing Page Url Download Today Byline Sponsored By: Avacare Clinical Research Network

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).

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Fierce BioTech

FEBRUARY 26, 2025

jpiatt Wed, 02/26/2025 - 09:26 Discover how to revolutionize your vaccine trials with Avacare's latest white paper. Discover innovative, data-driven recruitment strategies to ensure diverse, efficient, and high-quality vaccine trials.

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BioPharma Drive: Drug Pricing

JUNE 27, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules Biocryst is offloading part of its business to an Italian drugmaker for $250 million upfront.

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Advarra

MARCH 6, 2025

Launched in January 2025 , the Association of Multisite Research Corporations (AMRC) was set up by its founding members to advance the adoption of multisite clinical research corporations (MCRCs) to streamline, speed up, and improve the quality of clinical research. Jim Kremidas: Okay.

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PPD

FEBRUARY 19, 2024

The updated regulation is now the mandatory regulatory framework for which new applications for interventional and low interventional clinical trials in the EU must be assessed and authorized. The EU CTR brings major changes in the way organizations need to be structured and how clinical research will be planned, conducted and documented.

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PPD

NOVEMBER 30, 2023

To get a pulse on the changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 biotech and biopharma leaders for the second year in a row to illuminate industry trends, challenges and sentiments.

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Alta Sciences

JANUARY 27, 2025

[VIDEO SERIES] Discover the Teams Behind Our Clinical Success blussier Mon, 01/27/2025 - 17:31 HTML Think Altasciences Watch our video series spotlighting our superb clinical facilities and the talented, dedicated teams in Montral, Kansas, and Los Angeles. We hope you enjoy learning more about us!

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Fierce BioTech

DECEMBER 23, 2024

As Phase 1 clinical trials include several different design types with multiple objectives (e.g. On Demand Start Date Wed, 02/12/2025 - 15:00 First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), Listing Image DrVince_ListingLogo_250x190.png

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Alta Sciences

JANUARY 31, 2025

Guest Blog: Reflecting on the 2024 Society of Toxicology of Canada Symposium, by Ria Falvo, Director, Reporting pmjackson Fri, 01/31/2025 - 15:47 Ria Falvo, Director of Reporting, and Rina Massarelli, Associate Director of Safety Reporting, in Toronto, Ontario, for the 2024 STC Symposium. Tags Preclinical Research Weight 15

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PPD

JULY 20, 2023

In clinical research, the role of drug packaging systems cannot be overlooked. 1, 2025, all plastic packaging and manufacturing materials for pharmaceutical use must meet the updated USP <661.2> Confirmation that no negative interactions take place is crucial to patient safety. > and USP <661.1>

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Vial

APRIL 18, 2024

The urgency for novel therapeutic approaches makes ophthalmology a rapidly growing domain of clinical research. Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding. from 2023 to 2030.

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The Pharma Data

AUGUST 12, 2020

“Clinical trial diversity needs acceleration. We see tremendous opportunity for longer-term, sustainable impact by supporting ethnically diverse physician scientists to engage in clinical research while also establishing clinical research sites in diverse communities,” said Samit Hirawat, M.D.

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PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance.

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Conversations in Drug Development Trends

MAY 23, 2024

The Critical EU-CTR Transition Deadline The three-year transition period for clinical trials authorized under the CTD that are expected to continue beyond the critical deadline of 30 January 2025 are required to transition to the new EU-CTR via a transition application through the CTIS.

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The Pharma Data

NOVEMBER 10, 2020

Billion by 2025. Phase1b/2 clinical study to be conducted in the United States and several European countries. This potentially ground-breaking approach for immunotherapies originated in my laboratory and was subsequently reported by other researchers in the field.”. Grand View Research August 2018 ( [link] ).

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PPD

APRIL 30, 2024

Our PPD FSP regulatory affairs solutions teams, part of the PPD clinical research business of Thermo Fisher Scientific, regularly gather, assess and determine the impact of CTR intelligence. Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.

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Clinical Trials Regulations Trials Pharmaceutical Companies 52

Agency IQ

AUGUST 16, 2024

The road to research on psychedelic products is paved with obstacles. This means that research programs are subject to additional oversight from U.S. FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances.

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Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Read AgencyIQ’s extensive analysis of the draft guidance here.] When would the guidance go into effect? Are there any exemptions?

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FDA Law Blog: Drug Discovery

JUNE 9, 2025

Javitt — Thirty two years ago today, on June 10, 1993, Congress passed the landmark National Institutes of Health (NIH) Revitalization Act to remedy historical exclusion of women and minorities from research participation. Advancing the frontier of scientific knowledge has been an important rationale for diversifying trials.

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Alta Sciences

APRIL 4, 2025

Getting to the Heart of Science: How Clinical Research Saved My Life and Continues to Inspire Me pmjackson Fri, 04/04/2025 - 18:01 By Josiah Liang, Research Laboratory Technician, Clinical Diagnostic and Central Laboratory Services. How Clinical Research Saved My Life I was born in 2000.

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Vial

DECEMBER 8, 2023

With technological innovation and scientific research propelling the development of new therapies, anticipation for the future is high. The intention is to recruit 18 participants for the trial, with results expected to be announced in 2024 or 2025.

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Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Tags Clinical Trials Weight 15

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FDA Law Blog: Drug Discovery

JULY 9, 2024

Examples of these strategies include: Sustained community engagement; Providing cultural competency and proficiency training for investigators and research staff; Improving study participant awareness and knowledge of the clinical study (e.g., providing language assistance); Reducing participant burden (e.g.,

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Agency IQ

AUGUST 9, 2024

However, the road to research for these products is paved with obstacles. Research indicates that the effects from these substances for the treatment of mental health disorders may be both rapid in onset and long-lasting. For example, there are pathways for continued research under existing E.U. Although the E.U.

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Agency IQ

JUNE 28, 2024

BY LAURA DIANGELO, MPH | JUN 26, 2024 8:17 PM CDT Quick background: FDA’s work to advance clinical trial diversity through prospective planning The FDA has longstanding policy interests focused on research study diversity. See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ].

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Agency IQ

FEBRUARY 2, 2024

But there are some potential hints, such as an upcoming Friends of Cancer Research event at which several of FDA’s top officials will be speaking on the “implementation of diversity plans.” Califf Robert Califf February 15 Friends of Cancer Research Enhancing Diversity in Clinical Trials: Implementation of Diversity Plans Namandjé N.

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BioPharma Drive: Drug Pricing

JUNE 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Sponsored The golden era of GLP-1 drugs: How will it impact medicine and society? By Ned Pagliarulo • June 4, 2025 Keep up with the story.

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BioPharma Drive: Drug Pricing

JUNE 9, 2025

By Ned Pagliarulo • June 4, 2025 George Frey/Reuters Deep Dive A decade of cancer immunotherapy: Keytruda, Opdivo and the drugs that changed oncology Over the past 10 years, PD1-blocking medicines have transformed cancer care. © 2025 TechTarget, Inc. Hiroyuki Okuzawa is working to keep it that way. or its subsidiaries.

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BioPharma Drive: Drug Pricing

JUNE 30, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Sage to lay off most staff amid Supernus buyout The biotech expects to cut 338 employees, or nearly all of its payroll, according to a regulatory filing in Massachusetts.

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PPD

JANUARY 21, 2025

As 2025 kicks off, the biopharma and biotech industries find themselves at a pivotal juncture, navigating an era of rapid transformation marked by new technological advancements, evolving regulations and shifting industry priorities. The data revealed five key trends poised to shape biopharma and biotech in 2025. In 2024, the U.S.

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Clinical Trials Trials Clinical Research Drug Development 52

PPD

MAY 9, 2025

The PPD clinical research business of Thermo Fisher Scientific conducted its third annual Pulse Report a survey of 150 leaders from biotech and pharmaceutical organizations worldwide. As your organization evolves, tap into our expertise.

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Clinical Trials Drug Development Clinical Research Clinical Development 52

PPD

MARCH 19, 2025

Bespoke solutions are critical for successful drug development because each clinical research project has unique goals and challenges. Download the 2025 FSP Trends report The post Successfully Implementing an FSP Partnership in Todays Clinical Development Landscape appeared first on PPD.

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Broad Institute

APRIL 9, 2025

Upcoming talk Past talks 2025 Women's Health Research and Funding: Gaps and Opportunities March 4, 2025 Despite comprising half the global population, womens health remains critically underfunded in research and development.

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