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Current Clinical Research Trends in GLP-1 (Glucagon-Like Peptide 1) Treatment

Conversations in Drug Development Trends

Due to this meaningful change, the first-ever GLP-1-Based Therapeutics Summit took place in Philadelphia on May 15-16th, 2024, serving as a platform for industry decision-makers to provide invaluable insights for therapeutic strategies.

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GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program

FDA Law Blog: Biosimilars

According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards. Complete numbers for 2023 and 2024 are not available, but it appears that FDA was only able to complete 537 BIMO inspections in 2022.

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Article EMA Thank You What we expect European regulators to do in March 2024

Agency IQ

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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What is the largest CRO in the US?

Vial

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). from 2024 to reach US$129.8 ’s services include supporting life sciences research, analytical solutions, and diagnostics or developing and manufacturing therapeutic interventions. billion by 2029.

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Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Agency IQ

In November, Congress passed a short-term CR that extended some federal funding (at current levels) through March 1, 2024. Notably, this explanation of what “excepted staff” does is different in both version of the 2024 contingency plan than what appeared in the 2023 contingency plan. What is happening now?

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Does the Drug Shortage White Paper Fall Short?

FDA Law Blog: Biosimilars

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

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First Participant Dosed in Pfizer’s Pivotal Phase 3 TALAPRO-3 Combination Study of Talazoparib and Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

The Pharma Data

The anticipated primary completion date is late-2024. Professor of Oncology at the University of Utah School of Medicine, Senior Director for Clinical Research Innovation at Huntsman Cancer Institute and member of the TALAPRO-3 steering committee. Source link:[link].

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