The Pharma Data

JANUARY 25, 2021

The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. ” “I am excited about the potential of NVG-291,” stated Dr. .” ” “I am excited about the potential of NVG-291,” stated Dr. Perry.

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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. For more information, please visit jdrf.org or follow us on Twitter: @JDRF.

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The Pharma Data

NOVEMBER 10, 2020

We believe switching to oral, nasal and inhalational administration of mAbs from the traditional intravenous administration could potentially be transformational for the future development of immunotherapies.”. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. Harrison, MD, Director, Summit Clinical Research. About PXL770.

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Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

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PPD

DECEMBER 12, 2023

A follow-the-sun model offers several advantages, but it takes specialized expertise to implement and operationalize for clinical development and post-marketing surveillance. Clinical research and post-marketing surveillance involves ongoing data analysis and interpretation. Rigorous data security measures are essential.

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Drug Target Review

SEPTEMBER 26, 2023

1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. 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. Ther Innov Regul Sci. Rockley KL.

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The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. Our core areas of research are: Immunology.

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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. Combination products are defined by the FDA as : “A product comprised of two or more regulated components (i.e.,

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The Pharma Data

NOVEMBER 22, 2020

Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent.

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