FDA Law Blog

NOVEMBER 10, 2024

Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

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The Pharma Data

MARCH 13, 2022

Arena has previously indicated that it expected the results of the Phase 3 ELEVATE-UC trial of etrasimod in ulcerative colitis during the first quarter of 2022. In particular, we’re hopeful that we can accelerate clinical development of etrasimod successfully to have a positive impact on those living with these debilitating diseases.”.

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pharmaphorum

JANUARY 5, 2021

If they had also predicted that the second person to receive the vaccine out of trial would be a gentleman named William Shakespeare, they would certainly have been dismissed as a fantasist. “The real impact on submissions and approvals will be in 2021 and beyond, when the pandemic’s true impact on clinical trials becomes apparent”.

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The Pharma Data

SEPTEMBER 15, 2020

Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. A Phase 3 trial is ongoing. Protease Inhibitor Program. Rare Disease.

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The Pharma Data

APRIL 26, 2021

COVID-19 negatively impacted demand, particularly: dermatology, ophthalmology, the breast cancer portfolio, Sandoz Retail and Anti-Infectives. Gained an EU label update to include data for axial manifestations of psoriatic arthritis (PsA), from the Ph3b MAXIMISE trial. Adakveo sales reached USD 37 million. Cosentyx. .

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XTalks

AUGUST 2, 2023

This is largely due to failed trials as a prophylaxis resulting in the European Committee for Medical Products (CHMP) recommending against the approval of Lagevrio. There was a record 34 approvals in major markets, and late-stage trials are commencing for medications including camizestrant, datopotamab deruxtecan and volrustomig.

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Pharma Marketing Network

MARCH 19, 2025

To maximize audience engagement, pharma brands should create peer-reviewed research summaries highlighting key findings from clinical trials, webinars and virtual conferences featuring leading medical experts discussing treatment advancements, and interactive case studies that allow HCPs to apply knowledge in real-world scenarios.

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