BioSpace News Archive

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MASH

Boehringer Ingelheim Axes MASH Pact With OSE After Disappointing Mid-Stage Data

OSE Immunotherapeutics has kicked off a strategic realignment initiative that involves deprioritizing the AbbVie-partnered OSE-230 and focusing its resources on the late-stage development of its ulcerative colitis candidate lusvertikimab.

March 3, 2026

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2 min read

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Tristan Manalac

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Opinion

Navigating the FDA After the Storm To Advance Drug Candidates

Here’s how drug developers can best approach interactions with the agency following last year’s seismic changes to its leadership, workforce and policies.

March 3, 2026

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4 min read

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John Kirk

Downtown Holly Springs , North Carolina,

Manufacturing

How North Carolina Attracted Amgen and Roche To Become a Next-Gen Obesity Drug Production Hotspot

Infrastructure and location have helped make Holly Springs a future hub for obesity drug production, with Amgen and Roche planning to manufacture GLP-1 therapies there to compete in the growing market.

March 3, 2026

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4 min read

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Nick Paul Taylor

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Gene therapy

Intellia’s CRISPR Gene Therapy Free To Move Forward After FDA Fully Lifts Hold

The FDA last October paused Intellia Therapeutics’ late-stage CRISPR studies after detecting life-threatening enzyme elevations in one patient, who died a few days later.

March 3, 2026

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2 min read

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Tristan Manalac

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FDA

FDA’s Circle of Trust Is Shrinking, Making Many Decisions Feel Like ‘Fiat’

FDA decisions lack majority consensus, experts agree, possibly leading to less nuanced verdicts on new drug applications. This type of “fiat” decision-making, as multiple regulatory experts have called it, is also bleeding into the agency’s policymaking.

March 3, 2026

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4 min read

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Heather McKenzie

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Venture capital

After Exiting 2seventy, Chip Baird Took a 180 to Food Allergy With Newly Launched Poplar

Poplar Therapeutics is seeking a “step change” in the treatment of food allergy and other atopic conditions, with $95 million raised to date, including a $45 million series A extension that closed Tuesday.

March 3, 2026

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3 min read

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Annalee Armstrong

IN PARTNERSHIP WITH MEDSIR

Webinar: The Future is Collaborative: Transforming Clinical Trials

This webinar explores how collaborative-initiated trials and Investigator-Initiated Trials (IITs) are complementing traditional drug development to accelerate innovation, advance precision medicine, and address clinically meaningful questions.

March 3, 2026

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1 min read

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BioSpace Insights

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Complete response letters

REGENXBIO’s Hunter Rejection Hinged on Inadequate Controls, Surrogate Endpoint

In a complete response letter published by the FDA on Monday, the agency said a resubmission for REGENXBIO’s Hunter syndrome gene therapy should provide evidence of normalized or improved biomarker levels or neurodevelopmental outcomes.

March 3, 2026

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2 min read

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Tristan Manalac

Press Releases

Advancing Influenza Vaccine Development: Sino Biological Launches Antigens for the 2026-2027 Northern Hemisphere Influenza Vaccine Strains

March 3, 2026

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3 min read

Press Releases

Cell-free DNA offers early warning for bloodstream infections in kids with leukemia

March 3, 2026

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4 min read