BioSpace News Archive

Close-up view of a vivid blue railway signal light illuminating a track at golden hour sunset, providing crucial safety guidance for efficient train operations and future transportation

CAR-T

Lilly, AbbVie climb aboard in vivo CAR T train—but safety remains a hurdle

Safety will be the key determinant of in vivo CAR T therapies, according to H.C. Wainwright’s Mitchel Kapoor, who noted that convenience and efficacy won’t be enough to impress investors in this space. Eli Lilly, AbbVie, AstraZeneca and more are up for the challenge.

July 27, 2026

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8 min read

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Tristan Manalac

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FDA

FDA has recommitted to adcomms—but to what end?

The FDA will hold advisory committee meetings this week for previously rejected investigational therapies from Replimune and Capricor Therapeutics. Some industry leaders were surprised the meetings were called at all, while many have questioned the rationale behind them and other adcomms on deck.

July 27, 2026

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5 min read

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Michael Gibney

China

Summit, Merck must navigate new regulatory terrain in China-first cancer landscape

Summit Therapeutics revealed positive Western data last week from a Phase 3 trial of lung cancer candidate ivonescimab. In a flipped geographical clinical trials landscape, what more will be required for Summit and China-based partner Akeso—and other transnational tandems—to secure FDA approval?

July 27, 2026

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10 min read

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Heather McKenzie

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Insights

Denmark’s foundation‑fueled biotech boom redraws the Nordic map

Investment and a maturing talent base have propelled Denmark ahead of its Nordic peers, drawing Swedish companies and exposing regional gaps in capital and scale.

July 27, 2026

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4 min read

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Jennifer C. Smith-Parker

Press Releases

NovaBridge Biosciences to Hold Annual General Meeting on September 8, 2026

July 27, 2026

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6 min read

Press Releases

Ultragenyx Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) - July 24, 2026