PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). In addition, the constant evolution of EMA and Clinical Trials Coordination Group (CTCG) guidelines requires constant attention.

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BioPharma Drive: Drug Pricing

OCTOBER 4, 2023

The company is planning to start a Phase 3 trial of the vaccine this year, and is targeting a regulatory approval in 2025.

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BioPharma Drive: Drug Pricing

SEPTEMBER 28, 2023

The test developer will use the Series B funding to complete a 10,000-person clinical trial ahead of a planned launch in 2025.

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Fierce BioTech

SEPTEMBER 6, 2024

RWE Impact: When Empowered Patients Drive Pharma Outcomes pesurya Fri, 09/06/2024 - 11:33 Thu, 10/03/2024 - 11:00 Resource Type Webinar Leigh Ann Bruhn Arturo LoAIza-Bonilla MD Nico O'Kuinghttons Cathy Zaremba Promotion Start Mon, 09/09/2024 - 11:45 Promotion End Sun, 03/09/2025 - 11:45 Duration 60 Minutes Discover the transformative power of RWE.

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Fierce BioTech

AUGUST 7, 2024

: A Focus on ADC and Radioisotope Therapy pesurya Wed, 08/07/2024 - 11:14 Wed, 10/16/2024 - 14:00 Resource Type Webinar Promotion Start Fri, 08/16/2024 - 11:17 Promotion End Sun, 02/16/2025 - 11:00 Duration 60 Minutes Medical imaging is critical in clinical trials, serving as a key component in assessing treatment efficacy and safety.

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The Pharma Data

JUNE 11, 2023

Boehringer Ingelheim and Zealand Pharma announce phase II trial showed 14.9% The phase II clinical trial evaluating the effect of different doses of the novel glucagon/GLP-1 receptor dual agonist BI 456906 in people living with obesity or overweight without type 2 diabetes (NCT04667377) met its primary endpoint.

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KIF1A

AUGUST 28, 2024

2025 Conference Interest Survey : Help shape the future of our community by sharing your interest in the upcoming 2025 conference. We also extend our deepest gratitude to n-Lorem for creating and providing the ASO drug that made this trial possible. 2025 KAND Conference Interest Survey Call all KAND Community Stakeholders!

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The Pharma Data

JULY 15, 2021

Trial will include participants at risk for cognitive and functional decline related to Alzheimer’s disease. TRAILBLAZER-ALZ 3 will evaluate whether treatment with donanemab can slow the clinical progression of Alzheimer’s disease in trial participants. vice president of pain and neurodegeneration, Lilly.

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PPD

NOVEMBER 30, 2023

These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Overall, new technological approaches applied in these settings show remarkable potential to make trials more robust, promote more reliable data acquisition and keep trials on-time and on-budget. This year, the U.S.

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The Pharma Data

MARCH 23, 2023

In this landmark Phase 3 trial, patients with uncontrolled COPD achieved clinical outcomes with Dupixent at a magnitude never before seen with a biologic. Detailed efficacy and safety results from this trial will be presented in a future scientific forum. AEs leading to deaths were balanced between the two arms (1.7% placebo, 1.5%

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The Pharma Data

DECEMBER 14, 2020

15, 2020 /PRNewswire/ — Gmax Biopharm today holds ground-breaking ceremony for its Zhengzhou, China manufacturing site which is the production base for its GMA102 (T2D), GMA105 (obesity), and GMA301A/B (PAH for adult and children) drugs to be launched between 2023-2025, upon approval of respective clinical trials.

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LifeSciVC

AUGUST 21, 2024

At this point of the year, the JPMorgan conference seems like ancient history and you are looking into flights for JPM 2025. Clinical Trials Are your clinical trials on track? What has the impact of summer been on recruiting efforts and the ability to manage clinical trial participants? Was that only six months ago?

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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. Click to enlarge At several steps during CGT development and testing, sensitive, accurate and precise quantitation of CGT drug vectors is required.

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Vial

DECEMBER 8, 2023

In this article by Vial CRO (Contract Research Organization), we will explore five anticipated ophthalmology therapies in 2024, offering valuable insights for biotech startups, CROs, pharma companies, clinical sites, and scientists planning to conduct clinical trials.

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Drug Target Review

JANUARY 8, 2024

We hope to initiate the first human clinical trials with our lead indications in 2025, which would represent a monumental step forward for the field of cellular rejuvenation. With significant validation of our platform in hand, we are now rapidly advancing towards the clinic with our lead therapeutic, OSK.

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The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. Prescription Drug User Fee Rates for Fiscal Year 2025.

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Agency IQ

AUGUST 2, 2024

While the work on the pharma package will likely take quite some time, another deadline is coming up fast: the full transition of all clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation.

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LifeSciVC

JANUARY 16, 2024

Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Additional trials (e.g., The incretins as a class also look interesting across a number of follow-on indications, as evidenced by clinical trials in these areas (below).

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The Pharma Data

FEBRUARY 4, 2021

Financial Update: Sanofi confirms its target to expand its business operating income (BOI) margin to 30% by 2022, with the ambition for its BOI margin to exceed 32% by 2025. Sanofi’s 2025 People Ambitions are based on four key pillars and put patient lives at the center of the company’s business purpose.

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The Pharma Data

NOVEMBER 10, 2020

Billion by 2025. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. billion by 2025, according to Grand View Research 1. . P otential to be a safer and effective alternative to the intravenous immunotherapies currently used for Crohn’s Disease. NEW YORK and LONDON, Nov.

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Agency IQ

JULY 7, 2023

building off the EMA’s Strategy through 2025. Just as a quick reminder: Real-world Data (RWD) is data generated by the health care system outside clinical trials. Regulators at EMA have outlined their intent to “enable” RWE and “establish its value for regulatory decision-making” by 2025.

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The Pharma Data

FEBRUARY 8, 2021

Financial Update: Sanofi confirms its target to expand its business operating income (BOI) margin to 30% by 2022, with the ambition for its BOI margin to exceed 32% by 2025. Sanofi’s 2025 People Ambitions are based on four key pillars and put patient lives at the center of the company’s business purpose.

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Marketing Clinical Trials Disease Vaccine 52

Drug Target Review

NOVEMBER 29, 2023

By doing this, we get a superior understanding of which therapies will and will not work in human biology before a clinical trial. This validation helps us more clearly understand which therapies are likely to succeed in a human, and increase the likelihood of successful clinical trial success – even at the pre-clinical stage.

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The Pharma Data

NOVEMBER 26, 2020

The EGM resolved to approve the Board of Directors’ previous resolution on October 27, 2020 on a directed issue of 29,395,311 new shares and 14,697,655 new warrants of series 2020/2025, both to CASI Pharmaceuticals, Inc. per share during the period from and including 27 November 2020 up to and including 27 November 2025.

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The Pharma Data

JANUARY 19, 2021

TC-210 is currently in a Phase I/II trial for mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. TC-110 is in a Phase I/II trial for CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL).

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The Pharma Data

AUGUST 12, 2020

The BMS Foundation’s commitment to clinical trial diversity focuses on building clinical trial infrastructure in diverse communities and high disease burden areas in the U.S. Clinical trial diversity needs acceleration. and increasing the diversity of investigators through a fellowship program over five years. geographies.

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Clinical Trials Trials Disease Clinical Research 52

FDA Law Blog: Biosimilars

JUNE 21, 2023

Background – Strategic Priority to Advance Health Equity In CDRH’s 2022-2025 Strategic Priorities , “Advance Health Equity” is listed as one of the three strategic priorities along with “Promote a Modern and Diverse Workforce” and “Enhance Organizational Agility and Resilience.” We previously blogged on the draft guidance here.

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The Pharma Data

FEBRUARY 22, 2022

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “ We are making great progress on our ambition to be zero carbon across our global operations by the end of 2025 and carbon negative across our entire value chain by 2030.

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Agency IQ

AUGUST 16, 2024

SPA allows sponsors to gain regulatory perspective on whether a proposed trial design is adequate to support a marketing application, though the ultimate approval decision is based on the data submitted for review. FDA accepted the Lykos NDA in February 2024, and the submission received priority review.

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Agency IQ

AUGUST 23, 2024

EMA issues more updates to prepare for clinical trials transition Offices throughout the EU—including those of the EMA—have slowed operations for the summer holiday, but that didn’t keep the EMA from publishing a stack of updated documents. Per the CTR, all clinical trials are to be moved over to the CTIS by January 30, 2025.

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The Pharma Data

JANUARY 6, 2021

The radiopharmaceutical market is expected to grow to $15 billion by 2025 1 and there is a substantial opportunity to grow much faster if safety and tolerability of these effective treatments can be improved. (“POINT”), to provide access to Avacta’s pre|CISION technology for the development of tumour-activated radiopharmaceuticals.

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Agency IQ

MAY 10, 2024

In the several years that followed, a network of French pilot farms successfully trialed reduced pesticide use, though popular uptake was disappointingly modest, according to a 2015 roadmap for the next iteration of Ecophyto. Again, it emphasized a goal of reducing pesticide use by half, this time by 2025.

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The Pharma Data

JANUARY 12, 2021

The company has the ambition to deliver double-digit topline growth through 2025, targeting $9 to $10 billion in global revenue. Continued progress in advancing Phase 3 ULTOMIRIS trials in NMOSD and amyotrophic lateral sclerosis (ALS), which are now over 80 percent and 50 percent enrolled, respectively. Continued Pipeline Progress.

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Conversations in Drug Development Trends

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. Increased Transparency : Ensures that information on clinical trials is more accessible.

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Agency IQ

FEBRUARY 2, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires.

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The Premier Consulting Blog

MAY 14, 2023

All clinical trial or marketing applications submitted to the FDA must include a form that summarizes the content of the submission and any relevant information on the sponsor and drug for the reviewers. It will be valid until March 31, 2025. Consequently, the subsequent labeled field numbers have shifted by one.

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The Pharma Data

AUGUST 3, 2021

This pipeline has the potential to deliver up to 15 medicines for approval by 2025. A recent trial showed a significantly lower risk with empagliflozin of hospitalization for heart failure or cardiovascular death in adult patients with HFpEF. More than 60 million patients worldwide suffer from this disease, approx.

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