Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. Vial adopts a fixed-fee pricing model devoid of change orders to streamline cost-effectiveness in drug development.

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The Pharma Data

APRIL 6, 2022

” Integrating Pharmaceuticals and Oncology business units. Novartis will integrate the Pharmaceuticals and Oncology business units and create two separate commercial organizations with a stronger geographic focus – Innovative Medicines US and Innovative Medicines International. New Strategy & Growth Function.

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The Premier Consulting Blog

JULY 9, 2023

These evaluations include the active pharmaceutical ingredient (API), also known as the drug substance, and the drug product (formulated product). These ICH guidance documents apply at different stages of development and address specific concerns regarding certain types of impurities or degradants.

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Vial

MARCH 25, 2024

Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. With an international presence in nearly 60 countries, Worldwide is supported by over 3,400 team members. According to Hardman et al.,

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Metabolite Tales Blog

NOVEMBER 17, 2022

Due to internal hydrogen bonding, DELAQ is a linear, nonionized metabolite with a LogP of roughly 7. Figure 2: Internal hydrogen bonding of DELAQ In contrast to laquinimod, DELAQ is a very potent activator of the aryl hydrocarbon receptor (AhR). Studies in non-clinical species raised no obvious red flags of this clinical outcome.

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PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

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Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? IRL1117 is expected to be ready to move into clinical development at the end of 2024/first half 2025.

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Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. However, stakeholders should be aware that the leaked review contains no such analysis. The lack of dynamic analysis is not due to a lack of source material.”

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Vial

MARCH 27, 2024

The Costs of Working with a CRO Running clinical trials is an integral part of the pharmaceutical industry, crucial to the development and approval of new drugs and treatments. These services range from clinical study design and data management to statistical analysis and regulatory support.

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The Pharma Data

DECEMBER 15, 2020

The Data Contribution Agreement between Diamyd Medical and C-Path will allow for this unique set of fully anonymized clinical trial data to be integrated into an ever-growing list of committed trial data sets within the TOMI-T1D project. C-Path US is headquartered in Tucson, Arizona and C-Path, Ltd.

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The Pharma Data

OCTOBER 18, 2020

DUBLIN–( BUSINESS WIRE )– Inflection Biosciences Ltd , a company developing innovative therapeutics for the treatment of cancer, today announced the appointment of industry veteran Gregory I. Greg possesses a wealth of experience in developing new cancer therapeutics across multiple U.S. Berk, MD, to its Board of Directors.

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The Pharma Data

DECEMBER 28, 2020

She most recently comes from a position as Senior Medical Director at Ferring Pharmaceuticals in Copenhagen. Dr Reimer will replace Dr Charlotte Russel and be overall medically responsible for Alligator’s drug development candidates, with an emphasis on bringing mitazalimab and ATOR-1017 into Phase II efficacy studies.

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The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. By joining Innovent, Dr. Liu will be responsible for global R & D, pipeline strategy, business development and international operations.

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The Pharma Data

JANUARY 20, 2021

” “Dynacure is a leader in rare disease drug development, as evidenced by its lead product candidate DYN101, which is in clinical development for the treatment of Myotubular and Centronuclear Myopathies for which there are no FDA or EMA approved therapeutics,” said Ms. and international companies.

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The Pharma Data

DECEMBER 13, 2020

CEO of EdiGene, “Translating cutting-edge gene editing technologies into innovative solutions for patients requires deep internal R&D expertise as well as strong external partnerships. Dr. Zhang has around 20 years of experience in research and drug development in both industry and academia in the US. He received his B.S.

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Drug Discovery World

OCTOBER 10, 2022

Will an expansion in the use of effective digital biomarkers help improve the productivity of drug development in neuroscience? Increasingly, digital biomarkers are becoming more effectively used in the discovery and development of drugs that act in the central nervous system.

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The Pharma Data

DECEMBER 8, 2020

AbCellera’s AI-powered antibody discovery platform speeds the otherwise lengthy and grueling process by analyzing the database of natural immune systems to find antibodies that can be developed into drugs. Tackle the toughest problems in drug development.” SciNeuro Pharmaceuticals . Reduce cost.

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The Pharma Data

JULY 29, 2021

Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab Following 18 Months of Treatment in the Open-Label Extension of the Phase 2 Proof of Concept Study at 2021 Alzheimer’s Association International Conference (AAIC) . BioArctic has no development costs for lecanemab in AD. About Eisai Co.,

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Clinical Trials Treatment Clinical Development Disease 52

Agency IQ

JULY 21, 2023

An earlier report highlighted three key areas for international regulatory consideration when employing AI in drug development. The wide use of AI raises commensurately broad regulatory questions, according to a 2021 horizon scanning report from the International Coalition of Medicines Regulators (ICMRA).

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Science Clinical Trials Regulations Trials 40

Agency IQ

APRIL 12, 2024

In drug development, biochemical assays might be used to determine a product’s binding affinity to a target receptor of interest, along with the strength, stability and duration of the target-ligand complex after the product binds to the receptor. The new draft guidance can be broken into three main parts.

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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Science Vaccine Clinical Trials Pharmaceutical Companies 52

Conversations in Drug Development Trends

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. What Are Radiopharmaceuticals?

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Clinical Trials Regulations Therapies Clinical Development 52

Drug Discovery World

JANUARY 12, 2023

Here, Thomas reflects specifically on Anita Cooper’s prediction relating to the importance of clinical trials. . Following the launch of Protas, DDW spoke with Protas Chief Executive, Professor Sir Martin Landray, who echoed Cooper’s emphasis on the importance of clinical trial design.

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

The Pharma Data

OCTOBER 26, 2020

V590 — a SARS-CoV-2 vaccine candidate in development in collaboration with the International AIDS Vaccine Initiative (IAVI) that uses a recombinant vesicular stomatitis virus (rVSV) platform, the same platform used for Merck’s approved Ebola Zaire virus vaccine, will enter Phase 1 development shortly.

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PPD

DECEMBER 14, 2023

In an increasingly competitive clinical trial and post-marketing surveillance sphere, many companies have turned to outsourcing models to rapidly expand their capabilities, more efficiently leverage internal resources and reach a broader population of trial participants and research personnel.

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Clinical Development Clinical Trials International Trials 52

Conversations in Drug Development Trends

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. For example, there are accelerated pathways for oncology drug approval in the U.S., Japan, and China. and the U.S.

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The Pharma Data

NOVEMBER 5, 2020

Regeneron Pharmaceuticals, Inc. Key Pipeline Progress Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: Dupixent ® (dupilumab). About Regeneron Pharmaceuticals, Inc.

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Drug Target Review

SEPTEMBER 26, 2023

CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.

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Precision for Medicine

JANUARY 23, 2023

QuartzBio’s suite of end-to-end SaaS solutions provides pharmaceutical and biotech clients with a fully connected data ecosystem linking sample, biomarker, and clinical data to improve collaboration, planning and R&D productivity. About QuartzBio QuartzBio helps overcome the data chaos inherent in modern drug development.

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The Pharma Data

NOVEMBER 15, 2020

Her healthcare experience spans diagnostics, medical devices, pharmaceuticals, and digital health. She began her career as an investment banker at Nomura International Limited, from 1984-88, in Tokyo and London. and international experience. drug development initiative from 2012 to February 2019.

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Molecule Blog

MARCH 17, 2023

The Primitives of Biomedical Discovery and Development It’s noteworthy that the majority of approved medicines, around 60%, have their roots in academia, with the remaining 40% stemming from pharmaceutical research and discovery. These studies involve more in vivo testing in increasingly larger animals to evaluate safety and efficacy.

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Engineering Research Government Clinical Trials 52

Drug Discovery World

JULY 3, 2024

Protocol AI, which was created by Risklick, a spin-off from the University of Bern, uses artificial intelligence to enable faster drafting of clinical trial protocols with the aim of accelerating drug development, reducing costs and improving safety standards. CEO Dr Antonella Santuccione Chadha leads the project.

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