BioSpace News Archive

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Viral Vector Manufacturing: Case Studies and Considerations from a CDMO Perspective

Optimization Through Culture, Quality Control and Regulatory Standards

November 3, 2025

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14 min read

Pictured: uniQure headquarters in Amsterdam

Huntington’s disease

FDA Does ‘About-Face’ on UniQure’s Huntington’s Gene Therapy

A month after sparking optimism for patients with Huntington’s disease with highly positive data for AMT-130, uniQure revealed Monday that the FDA may be changing its tune on the evidence required for an approval application, a change of direction Stifel called “very challenging” for uniQure.

November 3, 2025

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3 min read

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Heather McKenzie

IN PARTNERSHIP WITH ELEMENT

Pharma Faces Investor Woes and Tariff Threats, Turns to AI and Collaboration for Survival

Industry leaders say uncertainty in funding, clinical development and manufacturing is driving companies to embrace digital transformation, streamlined operations and strategic partnerships to navigate a turbulent market and global tariff pressures.

November 3, 2025

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5 min read

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BioSpace Insights

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Neuroscience

Roche Piles $55M Into Blood-Brain Barrier Tech With Manifold

Manifold will use its tissue-targeting shuttle technology to help Roche develop new therapeutics for diseases of the central nervous system.

November 3, 2025

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1 min read

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Annalee Armstrong

Illustration of cardboard box filled with office supplies, a computer keyboard, lamp, and a potted plant

Layoff Tracker

Sensei Plans to Cut Workforce While Considering Strategic Alternatives

Follow along as BioSpace tracks job cuts and restructuring initiatives.

November 3, 2025

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77 min read

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BioSpace Editorial Staff

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Immunology and inflammation

Neurocrine Goes to China To Grow Pipeline in up to $881M TransThera Deal

At the center of the licensing deal is an NLRP3 inhibitor that has shown “encouraging efficacy in acute inflammation models,” according to TransThera, indicating its potential in various metabolic and inflammatory diseases.

November 3, 2025

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1 min read

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Dan Samorodnitsky

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Mergers & acquisitions

UPDATE: Pfizer Files Lawsuits Against Novo Nordisk, Metsera To Stop Rival Bid

Pfizer has filed two separate lawsuits in an effort to stop Novo Nordisk’s unsolicited bid to acquire obesity biotech Metsera.

November 3, 2025

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4 min read

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Tristan Manalac

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS).

Gene editing

FDA Eyes Accelerated Reviews for Gene Editing Therapies

Vinay Prasad, chief of the FDA’s Center for Biologics Evaluation and Research, is planning to publish a paper this month to outline his office’s thinking on accelerating gene editing reviews.

November 3, 2025

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2 min read

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Tristan Manalac

FDA CDER director George Tidmarsh speaking in an FDA video

FDA

UPDATE: Tidmarsh Waffles on Resignation, Will Fight To Clear Name

Less than 24 hours after resigning his post as the FDA’s head drug regulator, George Tidmarsh is reportedly reconsidering his decision and vowing to fight for his name and credibility amid a probe into his “personal conduct” at the agency.

November 3, 2025

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3 min read

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Tristan Manalac

Press Releases

New Post-Hoc Analysis Shows Patients Whose Clinicians Had Access to GeneSight Results for Depression Treatment Are More Likely to Feel Better Sooner

November 3, 2025

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4 min read