The Pharma Data

OCTOBER 18, 2020

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML.

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The Pharma Data

SEPTEMBER 15, 2020

The company announced the initiation of its Phase 1b clinical trial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814. In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. Internal Medicine.

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Agency IQ

JULY 26, 2024

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling.

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Agency IQ

AUGUST 9, 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.

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Agency IQ

DECEMBER 11, 2023

So far in 2023, the Office has co-authored fifteen guidance documents—the majority of which were drafts—offering insight into the agency’s thinking on several key policy issues, such as clinical trial diversity and the accelerated approval pathway. AgencyIQ has identified several major themes in the FDA’s oncology work.

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The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Late Breaking Oral Presentation OALC01LB03. Abstract 2361. Abstract 1914.

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The Pharma Data

JULY 21, 2021

These data were shared as a late-breaking oral presentation during the virtual 11 th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021). “The

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The Pharma Data

DECEMBER 13, 2020

The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. The primary endpoint of the trial will be NASH resolution with no worsening of fibrosis assessed on histology.

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The Pharma Data

NOVEMBER 4, 2020

and Canada) or (484) 365-2865 (International) five minutes prior to the start time. Concert Pharmaceuticals is a clinical stage biopharmaceutical company that is developing small molecule drugs that it discovered through the application of its DCE Platform® (deuterated chemical entity platform).

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The Pharma Data

SEPTEMBER 1, 2020

Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod. Author: Minton. Presentation Number: P1133. Presentation Topic: Reproductive Aspects and Pregnancy.

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The Premier Consulting Blog

FEBRUARY 11, 2025

Given the low patient numbers in rare diseases, sponsors may find themselves forced to consider specifically when, and for what purpose, patients can best be utilized in the clinical development program. Innovative approaches and FDA initiatives In addition to the special designations available (e.g.,

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The Pharma Data

SEPTEMBER 27, 2020

The data were presented at the virtual 25th International Annual Congress of the World Muscle Society. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. months later. None of these were attributed by the investigator as related to Evrysdi.

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