Agency IQ

OCTOBER 20, 2023

Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process.

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Agency IQ

SEPTEMBER 15, 2023

FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. First, Cathy Gelotte, a clinical pharmacology consultant, made the case that low bioavailability does not necessarily indicate a lack of efficacy.

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Drug Discovery World

NOVEMBER 9, 2023

These include: Samantha Bailey-Bucktrout, PhD, Senior Vice President, Akamis Bio, on: ‘Tumour specific immunogene therapy to deliver protein therapeutics to solid tumour microenvironments’. Jonathan Fisher, PhD, Group Leader, University College London, on: ‘Local secretion of immune active proteins for direct and bystander tumour killing’.

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Engineering Protein Production Therapies Science 130

Alta Sciences

AUGUST 28, 2023

There were no serious adverse events, and all treatment-emergent adverse events were mild and self-limiting. Importantly, the Principal Investigator determined that few adverse events were drug-related.” We are proud to support Ischemix in advancing this vital new therapy.” Stern, MD, Chief Medical Officer for Ischemix.

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Eye on FDA

AUGUST 4, 2021

Below is a chart that looks at 3 numbers – the number of AdComms; the number of new molecular entities approved each year, and the number of drugs that had breakthrough therapy designation. The most active of these committees with vacancies this year has been the Oncologic Drugs Advisory Committee.

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Drug Discovery World

AUGUST 15, 2023

We propose the evaluation of new electrophysiological recording and analysis techniques, using intact beating hearts and based on the fractionation analysis of paced electrocardiograms, to see if they have a higher degree of predictive validity in determining the risk of pharmacologically induced arrythmias in humans. 12(3): 197-202.

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The Premier Consulting Blog

JUNE 18, 2023

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. As a direct consequence, in silico methods in human clinical trials are emerging as an important new paradigm in the development of medical therapies – particularly useful for rare diseases.

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The Pharma Data

FEBRUARY 8, 2021

Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 1 Quality of life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate (FACT-P Total). Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent of patients in the combination arm versus 56.2

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Of note: A government shutdown would likely delay or cancel some of the events listed below.

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Agency IQ

FEBRUARY 23, 2024

Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies. LILLIAN SIU, an oncologist and clinical trialist at Toronto’s Princess Margaret Cancer Centre, was a panelist on the day’s second session.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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