The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

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The Pharma Data

MARCH 5, 2021

Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. Secondary endpoints include duration of response (DOR), overall survival (OS), safety, and pharmacokinetics (PK). Overall Response Rate (ORR) and Duration of Response, as determined by appropriate histology-specific response criteria).

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The Pharma Data

MARCH 8, 2021

We are delighted to share our early data at CROI 2021 supporting the potential for a once-yearly dosing regimen for islatravir using a subdermal implant,” said Dr. Joan Butterton, vice president, global clinical development, infectious diseases, Merck Research Laboratories. “We

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Agency IQ

AUGUST 16, 2024

Another addition to FDA’s general advice is a recommendation for sponsors to engage early with the FDA “early in clinical development” (as opposed to “at relevant milestone meetings”).

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The Pharma Data

MARCH 17, 2021

In adjuvant breast cancer trials, this includes the length of time before any cancer comes back, a new cancer develops or death. Secondary objectives include distant relapse-free survival, overall survival, safety, pharmacokinetics and health outcomes.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety. providing language assistance); Reducing participant burden (e.g.,

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Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. Good Laboratory Practice (GLP)-adherent toxicology studies (carcinogenicity, developmental and reproductive toxicology, etc.)

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Agency IQ

JUNE 28, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. representative population.

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