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Recent Alerts

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Pfizer granted priority review for new multiple myeloma therapy

High Priority

The FDA has granted priority review for Pfizer's novel BCMA-targeted therapy for relapsed/refractory multiple myeloma. The PDUFA date is set for October 15, 2025.

Implications:

This priority review could accelerate Pfizer's entry into the multiple myeloma market with a potential approval 4 months ahead of schedule. If approved, this would be the third BCMA-targeted therapy on the market, increasing competition in this space.

Recommendations:

Consider accelerating development timelines for competing multiple myeloma assets. Prepare market access strategy to differentiate from Pfizer's offering.

Multiple Myeloma Regulatory Curated
May 28, 2025 - 10:30 AM

AstraZeneca reports positive Phase 3 results for IL-13 inhibitor in severe asthma

Medium Priority

AstraZeneca announced positive topline results from their Phase 3 trial of their IL-13 inhibitor in severe asthma. The study met its primary endpoint of reduction in exacerbation rate.

Severe Asthma Clinical Trial
May 27, 2025 - 2:15 PM

BMS submits sNDA for psoriasis indication expansion

Low Priority

Bristol Myers Squibb has submitted a supplemental New Drug Application (sNDA) to expand the indication of their IL-17 inhibitor to include moderate-to-severe plaque psoriasis in adolescents.

Psoriasis Regulatory
May 24, 2025 - 3:40 PM

Data Snacks

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Multiple Myeloma Market Share Analysis

Analysis of Q1 2025 market share data for multiple myeloma therapies shows shifting dynamics with new entrants.

Multiple Myeloma May 26, 2025

Psoriasis Patient Journey Insights

New research reveals key decision points in the psoriasis patient journey and opportunities for intervention.

Psoriasis May 25, 2025

Severe Asthma Prescriber Trends

Analysis of prescribing patterns for biologics in severe asthma shows increasing adoption among pulmonologists.

Severe Asthma May 24, 2025

Pipeline Updates

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Company Asset Indication Phase Status Last Update
Pfizer PF-06863135 Multiple Myeloma Phase 3 Active May 28, 2025
AstraZeneca AZD-1402 Severe Asthma Phase 3 Active May 27, 2025
BMS BMS-986165 Psoriasis (Adolescent) Regulatory Submitted May 24, 2025
Roche RG-6234 Multiple Myeloma Phase 1 New May 26, 2025

Clinical Trials Updates

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NCT05123456

New Trial

Pfizer initiated a new Phase 3 trial for PF-06863135 in multiple myeloma patients who have received at least one prior line of therapy.

Multiple Myeloma Phase 3
Start Date: May 28, 2025 Primary Completion: June 2027

NCT05789012

Status Change

AstraZeneca's Phase 3 trial for AZD-1402 in severe asthma has completed enrollment ahead of schedule.

Severe Asthma Phase 3
Start Date: January 15, 2024 Primary Completion: December 2025

Weekly Snapshot

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Week of May 22-28, 2025

Key Highlights:

  • Pfizer's BCMA-targeted therapy received priority review
  • AstraZeneca reported positive Phase 3 results in severe asthma
  • BMS submitted sNDA for adolescent psoriasis indication

Clinical Trial Updates:

  • 2 new trials initiated (Multiple Myeloma, Psoriatic Arthritis)
  • 1 trial completed enrollment (Severe Asthma)
  • 1 trial reported topline results (Severe Asthma)
Published: May 29, 2025

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