The Pharma Data

AUGUST 19, 2021

Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “We entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. **In 2018, Janssen Biotech, Inc. The most common Grade 3 or 4 laboratory abnormalities (?2%)

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The Pharma Data

JANUARY 3, 2021

Preclinical data from our laboratory have shown that the nasal administration of anti-CD3 stimulates Tregs that can suppress inflammation and ameliorate inflammatory diseases. The pharmacokinetics of nasally administered Foralumab will also be evaluated.

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The Pharma Data

APRIL 11, 2021

Laboratory abnormalities (all grades; Grade 3-4) ?20% Use of Retevmo for these indications is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 12 years and older. Monitor open growth plates in adolescent patients. About Lilly Oncology.

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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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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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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

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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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 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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