Citeline, a Norstella company

Acting CBER Director Katherine Szarama said narrow development strategies and reduced advisory committee meetings are contributing to a perception of more surprise regulatory decisions.

Public Company Edition: Odyssey launched the 11th biopharma IPO in the US for 2026 and will report Phase II results for its lead program in 2027. Also, follow-on offerings raised $805m for Cytokinetics, $375m for Avalo, $350m for Viridian, $300m for Artiva and $299m for Aura.

Including coverage of deals involving Esperion/Archimed, Cue/Ascendant Health, OSR Holdings/BCM Europe, Teikoku Seiyaku/Curedisc, Dogwood/PRIDCor and more.

The company reported first quarter sales for the ATTR-CM drug that came in slightly above expectations while highlighting launch preparations for additional products.

“We have no plans to try to price through” a $25m to $30m headwind from costs and inflation, says CEO Richard Dierker. But it grows to $50 million to $150 million, “who knows where it stops, then you have to solve a different problem with different solutions.”

Confidence in the prospects for Germany’s in vitro diagnostics businesses has dipped to its lowest level since the VDGH industry association began surveying market sentiment. The IVDR and lower reimbursement are part of the problem. The industry says it’s time for action.

McKinsey & Co partner Bart Van de Vyver adds insight to dealmaking and growth trends as the firm releases its latest assessment of what’s driving strategic decision-making at the top end of the healthcare products industries.

Forty thousand laptops wiped. Manufacturing shut down. EPS down 8.5%. Yet Stryker walked out of its Q1 earnings call with full-year guidance intact, no identifiable customer losses and a CEO who said the company's brand emerged from the crisis stronger than it went in.