Sept. 4 - Sanofi’s stumble, Biohaven 2.0’s launch prep and a new FDA rare disease pathway

Biohaven’s rare disease drug is ‘ready to ship on Day 1’ following FDA approval; FDA outlines new review pathway for drugs treating ultra-rare diseases; A drug discovery startup banks $150M for immune and obesity drugs

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Daily Dive

Sept. 4, 2025 | Today’s news and insights for biopharma leaders

TRENDLINE

Big Pharma Moves in Oncology

Cancer research dominates pharma R&D despite obesity’s rise. Explore AstraZeneca’s long-term strategy in lung cancer and discover where Daiichi Sankyo will go next with ADCs in this Trendline.

Sanofi’s touted eczema drug hits study goal, but data fall short of expectations

Data from the late-stage trial of amlitelimab weren’t as strong as the results seen in Phase 2, adding to doubts about a drug class once viewed as particularly promising.

UPDATED

Biohaven’s rare disease drug is ‘ready to ship on Day 1’ following FDA approval

CEO Vlad Coric said the company has a patient hub, payer managers and a small sales force set up to ensure a successful launch of Vyglxia, a brain medicine that could be approved this year.

FDA outlines new review pathway for drugs treating ultra-rare diseases

The agency's two main review offices will work together to flexibly evaluate medicines for serious conditions that affect fewer than 1,000 people in the U.S.

Design the optimal mix of buffer strategies for your facility

Biomanufacturers face complex buffer prep choices. This framework supports evaluating hybrid strategies using criteria to guide smarter, flexible decision-making. Download the white paper.

A drug discovery startup banks $150M for immune and obesity drugs

Enveda Biosciences has raised $300 million over the last year to make drugs to treat atopic dermatitis, asthma and more.

How to Accelerate Clinical Trial Enrollment

Clinical trial enrollment delays affect 80% of studies, costing sponsors time and money. Learn how centralized recruitment can accelerate enrollment while preserving site autonomy in this playbook.

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